Bayer Healthcare Pharmaceuticals Inc. v. Biogen Idec Inc.REPLY BRIEF to Opposition to MotionD.N.J.April 17, 2017David E. De Lorenzi Charles H. Chevalier GIBBONS P.C. One Gateway Center Newark, NJ 07102 (973) 596-4743 Of Counsel Wayne M. Barsky Robert A. Vincent Timothy P. Best Katherine Q. Dominguez Jaysen S. Chung Christine L. Ranney GIBSON, DUNN & CRUTCHER LLP 2029 Century Park East Los Angeles, CA 90067 (310) 557-8183 Attorneys for Defendants and Counterclaimants EMD Serono, Inc. and Pfizer Inc. UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY IN RE BIOGEN ’755 PATENT LITIGATION : : : : : : : : : : : : : Civil Action No.: 10-cv-02734(CCC)(JBC) Honorable Claire C. Cecchi SERONO’S REPLY IN SUPPORT OF MOTION FOR SUMMARY JUDGMENT OF INVALIDITY UNDER 35 U.S.C. § 103 Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 1 of 17 PageID: 31517 TABLE OF CONTENTS Page i I. INTRODUCTION ....................................................................................................................... 1 II. DISCUSSION ............................................................................................................................ 2 A. Biogen Admitted That The Claims Of The ’755 Patent Are Invalid ...................... 2 B. Biogen’s Sworn Admissions Are Binding As A Matter Of Law............................ 6 C. As A Matter Of Law, Biogen Cannot Create A Genuine Issue of Material Fact By Contradicting Its Own Sworn Admissions ................................................ 9 III. CONCLUSION ....................................................................................................................... 12 Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 2 of 17 PageID: 31518 TABLE OF AUTHORITIES Page(s) ii Cases Abbott GmbH & Co., KG v. Centocor Ortho Biotech, Inc., 971 F. Supp. 2d 171 (D. Mass. 2013) ........................................................................................6 Aerel, S.R.L. v. PCC Airfoils, L.L.C., 448 F.3d 899 (6th Cir. 2006) ...................................................................................................11 Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310 (Fed. Cir. 2008)................................................................................................11 Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293 (Fed. Cir. 2007)..................................................................................................6 CIT Group/Equipment Financing, Inc. v. Rosenblum, No. 90-1117, 1990 WL 191911 (D.N.J. Nov. 19, 1990) .........................................................10 Cleveland v. Policy Mgmt. Sys. Corp., 526 U.S. 795 (1999) .............................................................................................................9, 10 Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560 (Fed. Cir. 1988)..................................................................................................9 Cromling v. Pittsburgh & Lake Erie R.R. Co., 327 F.2d 142 (3d Cir. 1963).......................................................................................................2 In re Cygnus Telecomms. Tech., LLC, Patent Litig., 536 F.3d 1343 (Fed. Cir. 2008)............................................................................................8, 10 Flintkote Co. v. Lysfjord, 246 F.2d 368 (9th Cir.) ..............................................................................................................2 Gallant v. Telebrands Corp., 35 F. Supp. 2d 378 (D.N.J. 1998) ..............................................................................................7 Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367 (Fed. Cir. 2005)..................................................................................................7 Kalis v. Colgate-PalmOlive Co., 231 F.3d 1049 (7th Cir. 2000) .................................................................................................11 Martin v. Merrell Dow Pharm., Inc., 851 F.2d 703 (3d Cir. 1988).......................................................................................................9 Merck & Co., Inc. v. Teva Pharm. USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005)..................................................................................................9 Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 3 of 17 PageID: 31519 TABLE OF AUTHORITIES (continued) Page(s) iii Messerschmidt v. U.S., 29 Fed. Cl. 1 (Ct. Fed. Cl. 1993)................................................................................................7 Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059 (Fed. Cir. 1998)..................................................................................................9 Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324 (Fed. Cir. 2009)................................................................................................11 Pfizer Inc. v. Teva Pharm. USA, Inc., No. 04-754, 2006 WL 3041102 (D.N.J. Oct. 26, 2006) ............................................................7 Sinskey v. Pharmacia Ophthalmics, Inc., 982 F.2d 494 (Fed. Cir. 1992)..................................................................................................10 Tanabe Seiyaku Co. v. U.S. Int’l Trade Comm’n, 109 F.3d 726 (Fed. Cir. 1997)....................................................................................................7 Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 4 of 17 PageID: 31520 1 I. INTRODUCTION Facts are stubborn things. Biogen admits that the DNA sequence for IFN-β was publicly known before June 6, 1980, the earliest priority date asserted by Biogen for the ’755 patent. And Biogen admitted in sworn testimony that, once the DNA sequence for IFN-β was known it would have been “routine,” “straightforward,” and “obvious” for a person of ordinary skill in the art to make recombinant IFN-β and use it to treat human tumors and viruses—the precise subject matter claimed in the ’755 patent. In an effort to avoid the natural consequence of those admissions, Biogen makes three principal arguments. First, Biogen argues that the Fiers Affidavit does not concede that it would have been obvious to treat tumors and viruses with biologically active IFN-β in therapeutically effective amounts. Biogen’s Opposition (ECF No. 558) (“Opp’n.”) 3–4, 23–25. In fact, Biogen expressly admitted that “with the DNA sequence for beta interferon in hand, a person of ordinary skill on March 25, 1980 would have expected to express biologically active beta interferon in E. coli using nothing but routine skill and experimentation.” Mot. (ECF No. 505-1), Ex. A (“Fiers Aff.”) ¶ 55. In addition, Biogen admitted that, once that DNA sequence was known, “there was no invention required to produce either a polypeptide having only the recited sequence . . . or to produce a composition characterized by it for use in the treatment of tumors or viruses” (Fiers Aff. ¶ 93(a) at p. 77), and that these “uses of the [recombinant] beta interferon” polypeptide were “routine and not an invention” (Fiers Aff. ¶ 55) (emphases added). Section II.A, infra. Second, without citing a single supporting authority, Biogen argues that it is not bound by its sworn admissions in the Fiers Affidavit. Opp’n. 6–7, 33–36. Courts in this District and the Federal Circuit have rejected this contention and bound patent owners to inventor’s admissions as a matter of law. Section II.B, infra. Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 5 of 17 PageID: 31521 2 Third, Biogen argues that, even if it is bound by the Fiers Affidavit, there is contradictory evidence that creates issues of fact precluding summary judgment. Opp’n. 4–6, 29–33. Courts in this District, the Third Circuit, the Federal Circuit, and even the Supreme Court have all expressly rejected this stratagem. As a matter of law, a party cannot avoid summary judgment by the simple expedient of introducing evidence contradicting its own prior admissions. Thus, neither Biogen’s experts’ declarations contradicting Biogen’s admissions, nor Biogen’s purported evidence of secondary considerations, can create a “genuine” issue of fact. Section II.C, infra. II. DISCUSSION A. Biogen Admitted That The Claims Of The ’755 Patent Are Invalid It is undisputed that the DNA sequence for IFN-β was publicly known by mid-April 1980 (almost two full months before Biogen’s claimed priority date of June 6, 1980). Fiers Aff. ¶¶ 68–79; Opp’n. 25. Eight years before the ’755 patent issued, Biogen expressly admitted in sworn testimony1 that, once this DNA sequence was known, it would have been routine and straightforward for a person of ordinary skill to use “standard techniques” to make recombinant IFN-β polypeptide and prepare compositions of it for treating human tumors and viruses. Fiers Aff. ¶¶ 56, 64. Biogen’s sworn admissions are directed to precisely what is claimed in the ’755 patent: administering a recombinant IFN-β polypeptide for the treatment of human tumors and viruses. Biogen’s admissions are statements of scientific fact—not Canadian law, as Biogen 1 Biogen does not contest that the admissions in the Fiers Affidavit, which it procured, submitted and relied on, are its own admissions—nor could it. The Third Circuit has made clear that “[s]tatements of another person are admissible as if they were the admissions of a party to a legal proceeding if, among other bases . . . the court finds that the declarant was authorized by the party to make the statement, or that ‘the party, with knowledge of the content of the statement by words or conduct manifested his adoption or approval of the statement or his belief in its truth.’” Cromling v. Pittsburgh & Lake Erie R.R. Co., 327 F.2d 142, 147 (3d Cir. 1963) (citing Flintkote Co. v. Lysfjord, 246 F.2d 368, 383 (9th Cir.)). Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 6 of 17 PageID: 31522 3 suggests2—and mandate a finding that the claims of the ’755 patent are invalid as obvious. Fiers Aff. ¶¶ 78–79. For example, Biogen admitted that, once the “remaining piece of the puzzle” (i.e., the DNA sequence) was known, “no invention” was required to make the recombinant polypeptide or a composition for treating tumors and viruses because “all of these steps were obvious at the time”: On March 25, 1980, I had the complete sequence of beta interferon and there was no invention required to produce either a polypeptide having only the recited sequence or having at a minimum that sequence or to produce a composition characterized by it for use in the treatment of tumors or viruses. Fiers Aff. ¶ 93(a) at p. 77 (emphasis added). . . . [A]s of mid-April 1980, the DNA and amino acid sequences of human interferon beta were widely available to the skilled workers in interferon art. Accordingly, anyone whose date of “invention” is after mid-April 1980 cannot claim any invention in the use of that nucleotide sequence to produce a polypeptide characterized by that amino acid sequence. With the nucleotide sequence in hand, such expression was routine and not an invention. The same is true for expression vectors, hosts and processes used in that expression and compositions and uses of the beta interferon produced by them. All of these steps were obvious at the time. Once the DNA sequence was available, to the skilled worker they could be carried out using standard molecular biology technology. Fiers Aff. p. 55–56 (internal citations omitted) (emphasis added). Biogen now tries to minimize the impact of its sworn admissions. Biogen argues that the Fiers Affidavit does not address producing 1) biologically active protein, or 2) using it in therapeutically effective amounts as part of 3) a method of treatment. Opp’n. 23–26. These are the only asserted distinctions between what Biogen explicitly admitted in 2001 would have been 2 Biogen contends that unspecified “large portions” of the affidavit are “legal argument” about “Canadian law,” Opp’n. 2, but Biogen fails to identify any specific statement falling into that category. Nor could it do so, as the Fiers Affidavit is a sworn statement from a Belgian scientist, made on personal knowledge, about the state of recombinant DNA technology in 1980 and what would have been within the ken of the skilled worker at the time. Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 7 of 17 PageID: 31523 4 obvious, and what Biogen claims in the ’755 patent. Once again, the undisputed facts get in Biogen’s way. 1. Biogen Expressly Admitted That Making Biologically Active Recombinant IFN-β Would Have Been Obvious. Biogen expressly admitted that, once the DNA (i.e., nucleotide) sequence was known, it would have been straightforward and routine for a person of ordinary skill to “express biologically active” recombinant IFN-β. Fiers Aff. ¶ 55 (“with the DNA sequence for beta interferon in hand, a person of ordinary skill on March 25, 1980 would have expected to express biologically active beta interferon in E. coli using nothing but routine skill and experimentation”); Fiers Aff. ¶ 66 (the DNA sequence for IFN-β “was the last piece of the puzzle needed to produce recombinant beta interferon. It enabled us, and would have enabled any skilled worker, to produce biologically active beta interferon in E. coli”) (emphasis added). 2. Biogen Expressly Admitted That Using Recombinant IFN-β to Treat Viruses and Tumors Would Have Been Obvious. Biogen unequivocally admitted that “produc[ing] a composition” with recombinant IFN-β “for the treatment of human tumors and viruses” would have been “obvious” and “routine” to a person of ordinary skill once the DNA sequence for IFN- β was known. Section II.A, supra; Fiers Aff. ¶ 93(a) at pp. 75–77 (there can be “no invention” in claims directed to a “composition for treating human tumors and viruses” because, inter alia, the compositions “had long been used [by 1979] to treat human tumors and viruses”) (emphasis added); Fiers Aff. ¶ 93(c) at p. 78 (“The produced polypeptide would then be used to prepare compositions for use in treating human tumors and viruses just as native beta interferon had been used to prepare those compositions for many years”) (emphasis added). Biogen further admitted that these “uses of the beta interferon” polypeptides were “routine and not an invention.” Fiers Aff. ¶ 55. Thus, Biogen explicitly admitted both that it was obvious to Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 8 of 17 PageID: 31524 5 produce recombinant IFN-β for the treatment of human tumors and viruses, and obvious to use that recombinant IFN-β to treat human tumors and viruses. Biogen’s protest that it never admitted the obviousness of making compositions that treat tumors and viruses using “therapeutically effective amounts,” Opp’n. 23–25, is also belied by the undisputed facts. Either a) the recombinant protein “treats” and is “therapeutically effective,” or b) it does not “treat” and is not “therapeutically effective.” There is no middle ground where a recombinant protein treats but is not therapeutically effective, and Biogen does not argue otherwise. Indeed, although Biogen submits expert declarations from three scientists (Garcia, Green, and Murray) in connection with this motion, not one of those individuals supports Biogen’s bizarre suggestion that it would have been obvious to a person of ordinary skill to use recombinant IFN-β to treat tumors and viruses, but somehow not obvious to do so with “therapeutically effective” amounts of the very same compound. 3. Biogen Expressly Admitted That a Method of Treating Viruses and Tumors Would Have Been Obvious. Biogen next asserts that it is the format of its ’755 patent claims (i.e., a method for treating) that distinguishes the ’755 patent claims from Biogen’s sworn admissions. Opp’n. 22–26. It is undisputed that all claims of the ’755 patent recite “a method for . . . treating a viral condition[], viral disease, cancers or tumors . . . .” Here, Biogen expressly admitted that, once the DNA sequence was known, no invention would have been required for a person of ordinary skill to make recombinant IFN-β “for use in the treatment of tumors or viruses.” Fiers Aff. ¶ 93(a) at pp. 75–77 (asserting that there can be “no invention” in claims directed to a “composition for treating human tumors and viruses” because, inter alia, the compositions “had long been used [by 1979] to treat human tumors and viruses”) (emphasis added). Using recombinant IFN-β “in the treatment of tumors or viruses” (which Biogen Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 9 of 17 PageID: 31525 6 unequivocally admitted would have been routine and obvious in 1980) is indisputably a method that is within the scope of each claim of the ’755 patent. Abbott GmbH & Co., KG v. Centocor Ortho Biotech, Inc., 971 F. Supp. 2d 171, 186 (D. Mass. 2013), aff’d, 759 F.3d 1285 (Fed. Cir. 2014) (citing Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1300 (Fed. Cir. 2007)) (“[A]n invention is obvious if a single embodiment falling within the scope of the claims is obvious,” and thus, “the obviousness of any single method” that falls within the scope of a method claim “renders the claim obvious.”). 4. Whether the PTO Considered The Fiers Affidavit Is Irrelevant. Opp’n. 30–31. The Court may freely assume for purposes of this motion that the PTO Examiner considered the Fiers Affidavit. All that means is that the PTO erred in permitting the ’755 patent to issue, but this would be the case whether the Examiner considered the Fiers Affidavit or not. And, while not material to this motion, it remains undisputed (as Biogen concedes) that Biogen first submitted the Fiers Affidavit to the PTO in an untimely and improper filing only after the PTO notified Biogen that it had already allowed the ’755 patent claims. 5. Whether the Canadian Patent Office Adopted Biogen’s Admissions Is Irrelevant. Biogen argues that the “most important fact” is that the Canadian Patent Office (“CPO”) “rejected” the Fiers Affidavit assertions. Opp’n. 3, 31. Whether that is true or not (in fact, it is false) is not relevant to this motion, which is based solely on Biogen’s sworn, repeated, and unequivocal admissions—not on any action of the CPO in response to those admissions.3 B. Biogen’s Sworn Admissions Are Binding As A Matter Of Law Biogen argues that it is not bound by its sworn admissions, but fails to cite a single 3 Similarly immaterial is the fact that Biogen elected to pay royalties to Serono on Sugano’s protein patent and thus maintain a covenant not to sue from Sugano, no doubt because Biogen concluded that Sugano’s DNA claims cannot be used as prior art to invalidate Sugano’s protein claims. See Opp’n. 5, 10. Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 10 of 17 PageID: 31526 7 authority supporting that assertion—choosing instead to quibble with the decisions of courts in this District and the Federal Circuit that Serono cited in its moving papers. Opp’n. 33–36. For example, Biogen attempts to distinguish Gallant v. Telebrands Corp., 35 F. Supp. 2d 378 (D.N.J. 1998), as merely “involving vacating a prior summary judgment ruling,” and Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367 (Fed. Cir. 2005), as “not even about summary judgment, but rather claim construction.” Opp’n. 34. Biogen misses the point. In Gallant, this Court followed Federal Circuit authority in holding that a party could not “assume a contrary position” to “admissions [made] to the European Patent Office.” 35 F. Supp. 2d at 400 (citing, e.g., Tanabe Seiyaku Co. v. U.S. Int’l Trade Comm’n, 109 F.3d 726, 733 (Fed. Cir. 1997)); accord Pfizer Inc. v. Teva Pharm. USA, Inc., No. 04-754, 2006 WL 3041102, at *4–5 (D.N.J. Oct. 26, 2006) (holding that expert affidavits on which the plaintiff had relied in “briefs it submitted to the European Patent Office” were party admissions, and thus the patent owner could not “use the expert affidavits to support its European patent application and then deny that it accepts the truth of the information contained therein.”). Similarly, the Federal Circuit in Gillette bound the defendant to its admissions in the European Patent Office. 405 F.3d at 1374. Thus, Gillette, Gallant, and Teva make clear that a party is bound by, and cannot later contradict, admissions previously made (as they were here) in a foreign patent tribunal.4 Biogen further argues that, for the doctrine of judicial estoppel to apply, the Court must consider “whether the party has succeeded in persuading a court to accept that party’s earlier position.” Opp’n. at 34. That may well be true, but Serono’s motion is not based on the doctrine of judicial estoppel. Here, Biogen is bound by its sworn admissions regardless of 4 Likewise, in Messerschmidt v. U.S., the court explicitly relied on the plaintiff’s sworn admissions regarding the obviousness of its patent claims in reaching the “inescapable” conclusion that all of the claims were obvious. 29 Fed. Cl. 1, 33, 3 (Ct. Fed. Cl. 1993). Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 11 of 17 PageID: 31527 8 whether it “succeeded” before the CPO. Indeed, the Federal Circuit has explicitly rejected Biogen’s argument that it would be bound only if it had “succeeded” in the CPO. In re Cygnus Telecomms. Tech., LLC, Patent Litig., 536 F.3d 1343, 1347, 1354 (Fed. Cir. 2008) (“Cygnus”). In Cygnus, the Federal Circuit affirmed the district court’s grant of summary judgment that the asserted claims were invalid under the on-sale bar of 35 U.S.C. § 102(b), which invalidates a patent where the invention was ready for patenting and sold more than one year before the applicable filing date. Id. In granting summary judgment, the district court relied on the named inventor’s declaration attesting to his reduction to practice (i.e., completion) of the invention—thus making it ready for patenting— more than one year before the date on which the relevant application was filed. Id. at 1350. As Biogen attempts to do here, Cygnus argued on appeal that it “should not be bound by [the inventor’s] sworn statements” because, among other reasons, “the PTO did not ultimately rely on that declaration to issue the patents.” Id. at 1354. The Federal Circuit rejected that argument, holding that “Cygnus is bound by the statements [the inventor] made in his declaration to the PTO, regardless of whether the declaration was necessary for the issuance of the patent.” Id. (emphasis added). Thus, regardless of whether the applicant “succeeded” in persuading the PTO that its invention was ready for patenting, and wholly independent of the judicial estoppel doctrine, Cygnus was nonetheless “bound” to its inventor’s admission as a matter of law. Together with the decisions in Gillette, Gallant, and Messerschmidt, the Federal Circuit’s decision in Cygnus stands for the dispositive proposition that a patent owner is bound by an inventor’s sworn testimony. That is true regardless of whether the testimony is submitted to a federal court (Messerschmidt), the PTO (Cygnus), or (as here) a foreign patent office (Gallant, Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 12 of 17 PageID: 31528 9 Teva, and Gillette).5 C. As A Matter Of Law, Biogen Cannot Create A Genuine Issue of Material Fact By Contradicting Its Own Sworn Admissions Biogen contends there is “a vast amount” of evidence contradicting its sworn admissions in the Fiers Affidavit, but does not make any effort to explain the contradiction between those sworn admissions and the position it now attempts to advance in opposing this motion. Opp’n. 29–33. Biogen does submit a declaration from its retained expert, Dr. Michael Green, who asserts that the Fiers Affidavit procured by Biogen “suffers from hindsight bias.” Opp’n 26. Putting aside the sheer irony of that claim, coming as it does 15 years after the date of the Fiers Affidavit, it is not an explanation for Biogen’s self-contradictory statements; on the contrary, it is an acknowledgment of that contradiction, one that neither reconciles nor explains why Biogen should fairly be permitted to take a position here that flatly conflicts with its previous sworn admissions. As the Supreme Court has observed, “a party cannot create a genuine issue of fact sufficient to survive summary judgment simply by contradicting his or her own previous sworn statement . . . without explaining the contradiction or attempting to resolve the disparity.” Cleveland v. Policy Mgmt. Sys. Corp., 526 U.S. 795, 806 (1999). The Third Circuit has also expressly rejected Biogen’s argument that it can defeat summary judgment by the simple expedient of 5 See generally, Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1569 (Fed. Cir. 1988) (holding that the patentee’s “admission during prosecution” that the claimed substitutions could “be made without undue experimentation” was “strong evidence” that the claims were obvious, and were “binding upon him”) (internal quotations omitted); Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1064 (Fed. Cir. 1998) (holding that the claimed invention was invalid under 35 U.S.C. § 112, ¶ 1 based on named inventor’s sworn admissions in a prior, unrelated case); Merck & Co., Inc. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1375 (Fed. Cir. 2005) (relying on the named inventors’ admissions that “the difference in dosing amount [of the claimed drug was] obvious” to hold that the asserted claims were obvious). Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 13 of 17 PageID: 31529 10 flatly contradicting its sworn admissions—as Serono previously noted and Biogen wholly ignores. Martin v. Merrell Dow Pharm., Inc., 851 F.2d 703, 706 (3d Cir. 1988) (affirming summary judgment in favor of defendant based on plaintiff’s deposition admissions notwithstanding contradictory affidavit evidence, where the plaintiff “provided no satisfactory explanation for the later contradiction”). Likewise, the District of New Jersey explicitly rejected Biogen’s tactics in CIT Group/Equipment Financing, Inc. v. Rosenblum, granting summary judgment in favor of the plaintiff based on the defendants’ admissions and noting that the defendants’ earlier statements could not “now be contradicted for the purpose of opposing a summary judgment motion.” No. 90-1117, 1990 WL 191911, at *5 (D.N.J. Nov. 19, 1990). The Federal Circuit’s precedent directly aligns with the Third Circuit on this issue. Sinskey v. Pharmacia Ophthalmics, Inc., 982 F.2d 494, 498 (Fed. Cir. 1992) (“To allow [a party] to preclude summary judgment simply by contradicting [its] own prior statements would seriously impair the utility of Federal Rule of Civil Procedure 56”). For example, in Cygnus, the Federal Circuit affirmed summary judgment based on the plaintiff’s admissions despite contradictory evidence submitted by the plaintiff in opposition to that motion. The Federal Circuit ruled that the plaintiff had “simply failed to offer sufficient evidence” or any explanation that would “undermine the force of [the] sworn admission,” explicitly noting that a “party cannot create a genuine issue of fact sufficient to survive summary judgment simply by contradicting his or her own previous sworn statement . . . without explaining the contradiction or attempting to resolve the disparity.” 536 F.3d at 1354 (quoting Cleveland, 526 U.S. at 807) (internal quotations omitted). Moreover, the Federal Circuit held that “[a]ny alleged internal inconsistencies” in the inventor’s statements to the PTO “were the responsibility of [the plaintiff], as the applicant, and d[id] not provide an excuse for [the Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 14 of 17 PageID: 31530 11 plaintiff] to disavow the clear statements by the inventor regarding the date of reduction to practice.” Id. Biogen offers no explanation from Dr. Fiers, Dr. Haley, or others directly involved in the Canadian prosecution or the U.S. prosecution to explain its contradictory statements. See also Kalis v. Colgate-PalmOlive Co., 231 F.3d 1049, 1056 (7th Cir. 2000) (later affidavit insufficient to create genuine dispute of fact where “affidavit does not function to clarify prior statements, but . . . appears to be an effort to undo (contradict) the effects of the [prior] testimony”); Aerel, S.R.L. v. PCC Airfoils, L.L.C., 448 F.3d 899, 908 (6th Cir. 2006) (“A directly contradictory affidavit should be stricken unless the party opposing summary judgment provides a persuasive justification for the contradiction.”). Nor does Biogen’s purported evidence of secondary considerations, such as long-felt need, raise any genuine issue of material fact, since that evidence is likewise offered by Biogen for the purpose of contradicting its own sworn admissions. Opp’n. 6, 8, 19, 32–33. Indeed, even in the absence of such sworn admissions by the patent owner, evidence of secondary considerations is routinely held by the Federal Circuit not to overcome an otherwise strong showing of obviousness on summary judgment. E.g., Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1332–33 (Fed. Cir. 2009) (affirming summary judgment of invalidity based on obviousness despite evidence of secondary considerations, including long-felt need); Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008) (affirming the district court’s grant of summary judgment and holding that “[t]he secondary consideration evidence in this case does not overcome the strong case of obviousness”). Accordingly, the well-established precedent of the Supreme Court, the Third Circuit, and the Federal Circuit makes clear that Biogen cannot avoid the case-dispositive consequences of its prior sworn admissions simply by offering evidence that contradicts such admissions. Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 15 of 17 PageID: 31531 12 III. CONCLUSION An oath is a solemn and central feature of our jurisprudence, regardless of whether it is taken in court or, as here, in writing and signed under penalty of perjury. Biogen procured, submitted, and relied on the sworn testimony of the sole inventor that the subject matter of the ’755 patent claims would have been routine, straightforward, and obvious to a person of ordinary skill once the DNA sequence for IFN-β was known. And here, it is undisputed that the DNA sequence was in fact known almost two months before Biogen’s June 6, 1980 filing. This Court should accordingly rule that the ’755 patent claims are invalid under Section 103 as a matter of law, and put a halt to Biogen’s continued, improper pursuit of this litigation. Dated: April 17, 2017 By: s/ David E. De Lorenzi David E. De Lorenzi Charles H. Chevalier GIBBONS P.C. One Gateway Center Newark, NJ 07102-5310 Telephone No.: (973) 596-4500 Of Counsel Wayne M. Barsky Robert A. Vincent Timothy P. Best Katherine Q. Dominguez Jaysen S. Chung Christine L. Ranney GIBSON, DUNN & CRUTCHER LLP 2029 Century Park East, Suite 4000 Los Angeles, CA 90067-3026 (310) 557-8183 Attorneys for Defendants and Counterclaimants EMD Serono, Inc. and Pfizer Inc. Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 16 of 17 PageID: 31532 13 Case 2:10-cv-02734-CCC-JBC Document 595 Filed 04/17/17 Page 17 of 17 PageID: 31533 David E. De Lorenzi Charles H. Chevalier GIBBONS P.C. One Gateway Center Newark, NJ 07102 (973) 596-4743 Of Counsel Wayne M. Barsky Robert A. Vincent Timothy P. Best Katherine Q. Dominguez Jaysen S. Chung Christine L. Ranney GIBSON, DUNN & CRUTCHER LLP 2029 Century Park East Los Angeles, CA 90067 (310) 557-8183 Attorneys for Defendants and Counterclaimants EMD Serono, Inc. and Pfizer Inc. UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY IN RE BIOGEN ’755 PATENT LITIGATION : : : : : : : : : : : : : : : Civil Action No.: 10-cv-02734(CCC)(JBC) Honorable Claire C. Cecchi OBJECTIONS AND RESPONSES TO BIOGEN’S RESPONSE TO SERONO’S STATEMENT OF UNDISPUTED MATERIAL FACTS IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT OF INVALIDITY UNDER 35 U.S.C. § 103 Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 1 of 32 PageID: 31534 Pursuant to Federal Rule of Civil Procedure 56 and Local Rule 56.1, Defendants EMD Serono, Inc. and Pfizer Inc. (collectively, “Serono”) submit the following responses and objections to Biogen’s Response to Serono’s Statement of Undisputed Material Facts in Support of Its Motion for Summary Judgment of Invalidity Under 35 U.S.C. § 103 (ECF No. 579). 1. As of June 6, 1980, the DNA sequence for human interferon beta (“IFN-β”) polypeptide was publicly known and in the prior art. Chung Declaration Ex. A, U.S. Patent No. 7,588,755 (the “Fiers ’755 patent”) at 5:56–64; see infra, Statement of Undisputed Material Fact #22. Biogen states in the Fiers ’755 Patent that, by June 6, 1980, Dr. Tadatsugu Taniguchi had “reported” in an article published in the journal, Gene, “the full nucleotide sequence for his hybridizing clone” and an amino acid sequence that “is identical to the amino acid sequence described” in the Fiers ’755 Patent specification. Ex. A at 5:56–64. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey v. Globus Med., Inc., No. 11-2240, 2014 WL 1876957, at *2 n.3 (D.N.J. Mar. 11, 2014) (holding that objections to statement of undisputed material facts as “not relevant” were “not permissible responses under the local rules”); Bell v. Lockheed Martin Corp., No. 08-6292, 2014 WL 2920503, at *1 n.3 (D.N.J. June 27, 2014); Durkin v. Wabash Nat’l, No. 10-2013, 2013 WL 1314744, at *6 (D.N.J. Mar. 28, 2016). In addition, Serono objects to Biogen’s arguments that the “asserted claims . . . are directed to methods of treatment using recombinant IFN-β” and “are not directed to methods of making recombinant IFN-β, to recombinant IFN-β itself, or to DNA encoding IFN-β,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 1. For the same reasons, Serono objects to Biogen’s arguments regarding whether “the mere knowledge of the DNA sequence for IFN-β renders obvious the Fiers ’755 Patent claims,” including whether “Dr. Fiers was the first to recombinantly express IFN-β polypeptides and demonstrate that those polypeptides are, in fact, biologically active,” and that “the fact that the Patent Office nevertheless granted the Fiers ’755 Patent claims provides proof that the Fiers ’755 Patent claims are novel and non-obvious over the Taniguchi DNA sequence.” Id. at 2–3. Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 2 of 32 PageID: 31535 2 2. As of June 6, 1980, it was known in the art, and expected, that unglycosylated IFN-β “still retains most or all of its IFN activity,” as compared to natural human IFN-β. Chung Declaration Ex. A at 2:17–31. RESPONSE: Serono objects to Biogen’s arguments that “[a] person of ordinary skill in the art would not have had a reasonable expectation that recombinant IFN-β would be biologically active and thus could be used therapeutically like native, human IFN-β,” including its interpretation of the ’755 patent specification, as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 4–6. 3. On April 1, 1981, Biogen filed Canadian Patent Application No. 374,378 (the “’378 application”), seeking claims to IFN-β polypeptide and preparations thereof for human therapeutic use. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. In addition, Serono objects to Biogen’s arguments that “[t]he claims of Biogen’s Canadian patent application were not at issue in the conflict proceeding and thus not a subject of discussion in the Fiers Affidavit,” and that Biogen’s “Canadian patent application claimed more than just IFN-β polypeptide and preparations thereof for human therapeutic use,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 6–7. 4. At the time that Biogen filed the ’378 application, other applicants were also seeking in Canada patents relating to IFN-β. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. 5. On March 3, 1998, a Canadian conflict proceeding was declared between Biogen’s ’378 application and two other applications. Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 3 of 32 PageID: 31536 3 RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that “[t]he claims of Biogen’s Canadian patent application were not at issue in the conflict proceeding and thus not a subject of discussion in the Fiers Affidavit,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 8. For the same reasons, Serono objects to Biogen’s arguments regarding the “standards of obviousness in Canadian versus United States patent law,” as well as “the standard for inventiveness in Canada.” Id. 6. When the conflict proceeding was declared, Canadian law—unlike United States law—permitted conflicting applicants to rely on work performed overseas to establish a date of invention. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. In addition, Serono objects to Biogen’s arguments that “[t]he claims of Biogen’s Canadian patent application were not at issue in the conflict proceeding, and thus not a subject of discussion in the Fiers Affidavit,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 9. For the same reasons, Serono further objects to Biogen’s arguments regarding the “standards of obviousness in Canadian versus United States patent law,” as well as “the standard for inventiveness in Canada.” Id. at 10. 7. On November 22, 2001, with the intention of obtaining priority for its claims to IFN-β polypeptide and therapeutically useful compositions of it, Biogen submitted the affidavit of named inventor Dr. Walter Fiers (the “Fiers Affidavit”), which Dr. Fiers signed on November 19, 2001. Chung Declaration Ex. B, Fiers Affidavit. Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 4 of 32 PageID: 31537 4 RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments regarding the “standards of obviousness in Canadian versus United States patent law,” as well as “the standard for inventiveness in Canada,” because they are “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 10–11. For the same reasons, Serono further objects to Biogen’s arguments regarding the claims involved in the Canadian conflict proceeding and whether they “cover[ed] subject matter other than IFN-β polypeptide and therapeutically useful compositions of it.” Id. at 11. 8. In the Fiers Affidavit, Biogen stated, “By late 1978, a large number of clinical applications for beta interferon had been discussed in the literature and small scale, but successful, clinical applications and compositions of native beta interferon isolated from cells, including fibroblast cells, in the treatment of viruses and tumors had been published. See ¶ 23(i) and the references cited therein, infra.” Id. ¶ 9. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. In addition, Serono objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 8. For the same reasons, Serono objects to Biogen’s arguments that “the discussion of therapeutic uses of native IFN-β in” the Fiers Affidavit does not render the claims of the ’755 patent obvious. Id. 9. In the Fiers Affidavit, Biogen stated that the draft ’378 application “also reported the well-known therapeutic and clinical applications that had been described for native beta interferon, even though it was only available from culture cells in small amounts (less than 30 U/ml).” Id. ¶ 23(i). Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 5 of 32 PageID: 31538 5 RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 13. For the same reasons, Serono objects to Biogen’s arguments that “the discussion of therapeutic uses of native IFN-β in” the Fiers Affidavit does not render the ’755 patent claims obvious. Id. 10. In the Fiers Affidavit, Biogen stated, “Finally, the draft application specifically disclosed that it was known that unglycosylated interferon (e.g., that produced using glycosylation inhibitors in native cells) retained most of its biological activity (Fiers Exhibit 10, p.3).” Id. ¶ 23(j). RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. In addition, Serono objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 14. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments that “[t]he prior art cited in the Fiers Affidavit from 1977 and 1978 . . . only suggests that partially unglycosylated interferon species Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 6 of 32 PageID: 31539 6 or mixtures of glycosylated and unglycosylated interferon species can retain its biological activity.” Id. at 14–15. 11. In the Fiers Affidavit, Biogen stated, “Once we had identified the complete sequence for beta interferon, I do not believe that there were any other inventive steps required to develop and perfect the subject matter of the conflict claims.” Id. ¶ 55. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. In addition, Serono objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 15. Serono also objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s argument that “Dr. Fiers’s statement that he did not believe that ‘there were any other inventive steps required to develop and perfect the subject matter of the conflict claims’ was provided under or meets the standard for obviousness under United States patent law.” Id. at 15–16. Serono further objects to Biogen’s arguments regarding “the standards of obviousness in Canadian versus United States patent law,” as well as “the standard for inventiveness in Canada,” because they also constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. at 16. Finally, for the same reasons, Serono objects to Biogen’s arguments about whether “Dr. Fiers believed that his own invention was obvious,” including what the “United States Patent Office . . . believed,” whether the “Canadian Patent Office . . . disagreed with Dr. Fiers and rejected the arguments made in the Fiers Affidavit,” “the state of art as of June 6, 1980,” and secondary considerations of non-obviousness. Id. at 16–19. Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 7 of 32 PageID: 31540 7 12. In the Fiers Affidavit, Biogen stated, “I believe that with the DNA sequence for beta interferon in hand, a person of ordinary skill in the art on March 25, 1980 would have expected to express biologically active beta interferon in E. coli using nothing but routine skill and experimentation.” Id. ¶ 55. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. In addition, Serono objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 20. Serono also objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including whether “Dr. Fier[s]’s statement that he believed that a person of ordinary skill would have been able to express biologically active IFN-β in E. coli ‘using nothing but routine skill and experimentation’ was provided under or meets the standard for obviousness under United States patent law.” Id. For the same reasons, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law” and “the standard for inventiveness in Canada.” Id. 13. In the Fiers Affidavit, Biogen stated, “I have attached . . . a copy of a May 23, 1996 Declaration of Dr. Michael Houghton. It was filed by Opponent Schering AG during opposition proceedings against Biogen’s European patent 41313 that corresponds to my Canadian patent application in this conflict . . . Dr. Houghton’s opinion is consistent with mine. The expression of a DNA sequence encoding beta interferon in 1980 did not require invention.” Id. ¶ 56. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. In addition, Serono Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 8 of 32 PageID: 31541 8 objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 21. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including whether “Dr. Fiers’s statement that Dr. Houghton’s opinions submitted under European law agreed that expression ‘did not require invention’ was provided under or meets the standard for obviousness under United States patent law.” Id. Finally, Serono objects to Biogen’s arguments regarding the “state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. at 22. 14. In the Fiers Affidavit, Biogen stated, “I have also attached a Declaration of Dr. Derynck, my former student (Fiers Exhibit 31). It was also filed by Opponent Schering AG in, the European opposition. Dr. Derynck is now a Professor at the University of California (San Francisco) and has no interest or involvement in this conflict proceeding, in the prior European opposition or with Biogen. Dr. Derynck had the same opinion as Dr. Houghton and I did. The expression of a DNA sequence encoding beta interferon in 1980 did not require invention.” Id. ¶ 57. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. In addition, Serono objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 22–23. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 9 of 32 PageID: 31542 9 biologically active,” including whether “Dr. Fiers’s statement that Dr. Derynck’s opinions submitted under European law agreed that expression ‘did not require invention’ was provided under or meets the standard for obviousness under United States patent law.” Id. at 23. Finally, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law” and “the standard for inventiveness in Canada,” as well as the “state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. 15. In the Fiers Affidavit, Biogen stated, “On March 25, 1980, I believe that the skilled worker would have expected unglycosylated beta interferon to be biologically active. Scientific reports from 1977 and 1978 had already demonstrated that native beta interferon, which is glycosylated, could be produced in unglycosylated form (e.g., using glycosylation inhibitors, like tunicamycin) and still have biological activity.” Id. ¶ 62. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. In addition, Serono objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 24. Serono also objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments that “[t]he prior art cited in the Fiers Affidavit from 1977 and 1978, which is the same as what was cited in the Fiers ’755 Patent, only suggests that partially unglycosylated interferon species or mixtures of glycosylated and unglycosylated interferon species can retain its biological activity.” Id. at 24–25. Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 10 of 32 PageID: 31543 10 16. In the Fiers Affidavit, Biogen stated, “I believe that Genentech’s argument is inconsistent with what was thought at the time and later confirmed to be true—unglycosylated beta interferon is biologically active. In my beta interferon project, I always expected that the unglycosylated beta interferon that I intended to produce in E. coli would be biologically active. Had I had any other expectation, it would have made no sense for me, or anyone else of skill in the art, to embark on a beta interferon cloning project in 1979-1980. The only hosts that were available at that time for the expression of cloned DNA sequences were bacterial hosts. They did not glycosylate proteins. Therefore, if anyone believed that unglycosylated beta interferon would not be biologically active, they would not have put in the significant and time consuming effort to clone its DNA sequence.” Id. ¶ 63. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. In addition, Serono objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 26. For the same reasons, Serono also objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments regarding “the state of art as of June 6, 1980” and Biogen’s legal argument and conclusion that “a person of ordinary skill in the art would not have had a reasonable expectation that recombinant IFN-β would be biologically active and thus could be therapeutically like native, human IFN-β.” Id. 17. In the Fiers Affidavit, Biogen stated, “On March 25, 1980, I also verily believe that producing mature beta interferon in E. coli from a DNA sequence encoding beta interferon would have required nothing but the routine application of the standard techniques of molecular biology.” Id. ¶ 64. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 11 of 32 PageID: 31544 11 Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 27. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments regarding whether “Dr. Fiers’s statement that expression ‘would have required nothing but routine application of the standard techniques of molecular biology’ was provided under or meets the standard for obviousness under United States patent law.” Id. In addition, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” and “the state of art as of June 6, 1980.” Id. at 27–28. 18. In the Fiers Affidavit, Biogen stated, “I believe, therefore, that the technique of the Goeddel paper could also have easily and routinely been used to construct a DNA sequence that would produce mature beta interferon directly.” Id. ¶ 64. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 28. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 12 of 32 PageID: 31545 12 including Biogen’s arguments regarding whether “Dr. Fiers’s statement that ‘the technique of the Goeddel paper could also have easily and routinely been used’ was provided under or meets the standard for obviousness under United States patent law.” Id. In addition, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” and “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. at 28–29. Finally, on the same basis, Serono objects to Biogen’s arguments regarding “whether one of ordinary skill in the art would have been able to use Goeddel’s 1979 expression system to successfully express biologically active recombinant IFN-β in therapeutically effective amounts” and “whether the expression technique discussed above would lead to biological activity by any expressed recombinant IFN-β.” Id. at 29–30. 19. In the Fiers Affidavit, Biogen stated, “The Goeddel paper, in fact, teaches that its semi-synthetic technique is directly applicable to proteins made as inactive precursors, like beta interferon.” Id. ¶ 64. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 30. For the same reasons, Serono further objects to Biogen’s arguments regarding “the state of art as of June 6, 1980,” whether “one of ordinary skill in the art would have been able to use Goeddel’s 1979 expression system to successfully express biologically active recombinant IFN-β in therapeutically effective amounts,” and “whether the Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 13 of 32 PageID: 31546 13 expression techniques above would lead to biological activity by any expressed recombinant IFN-β.” Id. at 30–31. 20. In the Fiers Affidavit, Biogen stated, “[A]ll that was needed to produce mature beta interferon directly was to cleave the DNA encoding pre-beta interferon . . . at a convenient restriction site upstream of the signal sequence or within the signal sequence and digest the cleaved DNA to an area close to the ATG of mature interferon . . . A modification of this technique was also used in the Harvard University laboratory of Dr. Ptashne by Dr. Taniguchi when they expressed beta interferon from Taniguchi’s pre-beta interferon DNA sequence.” Id. ¶ 65. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 32. For the same reasons, Serono further objects to Biogen’s arguments regarding “the state of art as of June 6, 1980,” whether “one of ordinary skill in the art would have been able to use Goeddel’s 1979 expression system to successfully express biologically active recombinant IFN-β in therapeutically effective amounts,” “whether one of ordinary skill in the art would have been able to use the Ptashne expression system . . . to successfully express biologically active recombinant IFN-β in therapeutically effective amounts,” and “whether the expression techniques discussed above would lead to biological activity by any expressed recombinant IFN-β.” Id. at 32–33. 21. In the Fiers Affidavit, Biogen stated, “[T]he complete DNA sequence encoding human beta interferon and [the identification of] which of the amino acids in the sequence encoded mature beta interferon . . . was the last piece of the puzzle needed to produce recombinant beta interferon. It enabled us, and would have enabled any skilled worker, to produce biologically active beta interferon in E. coli.” Id. ¶ 66. Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 14 of 32 PageID: 31547 14 RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 33–34. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments regarding whether “Dr. Fiers’s statement that the DNA sequence [of IFN-β] ‘was the last piece of the puzzle needed’ and ‘enabled [him], and would have enabled any skilled worker’ was provided under or meets the standard for obviousness under United States patent law.” Id. at 34. In addition, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” and “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. 22. In the Fiers Affidavit, Biogen stated, “As the result of Dr. Weissmann’s dissemination of his preprints, I believe that by mid-April 1980, the DNA and amino acid sequences that characterize beta interferon were widely available to those interested in interferon and doing research on it . . . As I have already explained, once the skilled worker had the DNA sequence of beta interferon in hand, such expression was routine and not an invention.” Id. ¶ 76. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 15 of 32 PageID: 31548 15 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 35. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments regarding whether “Dr. Fiers’s statement that having the DNA sequence in hand meant that expression was ‘routine and not an invention’ was provided under or meets the standard for obviousness under United States patent law.” Id. Finally, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” and “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. at 35–36. 23. In the Fiers Affidavit, Biogen stated, “I believe that conception of each of these claims requires possession of a specific DNA sequence and confirmation that the sequence either corresponds to that known for native beta interferon (Fiers Exhibit 8) or expression of beta interferon activity.” Id. at Section VI.A (page 45). RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 36. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments regarding whether “Dr. Fiers’s statement that ‘conception requires Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 16 of 32 PageID: 31549 16 possession . . . or expression’ was provided under or meets the standard for obviousness under United States patent law.” Id. at 36–37. Finally, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” and “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. at 37. 24. In the Fiers Affidavit, Biogen stated, “I note that these claims say nothing about how the recited E. coli host is constructed or the process carried out, except that the host is transformed with a vector that contains the beta interferon DNA sequence. This is because all of the steps were well known and routine.” Id. ¶ 84(a). RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 37–38. For the same reasons, Serono further objects to Biogen’s arguments that “the asserted claims of the Fiers ’755 Patent are directed to methods of treatment using recombinant IFN-β” and “not directed to methods of host cell transformation, to methods of making recombinant IFN-β, to recombinant IFN-β itself, or to DNA encoding IFN-β,” as well as Biogen’s arguments that “[w]hether the steps of constructing an E. coli host were well known and routine has no bearing on whether the method-of-treatment claims of the Fiers ’755 Patent are obvious.” Id. at 38. On the same basis, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 17 of 32 PageID: 31550 17 including Biogen’s arguments regarding whether “Dr. Fiers’s statement that the steps for constructing a host ‘were well known and routine’ was provided under or meets the standard for obviousness under United States patent law.” Id. Finally, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” and “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. at 38–39. 25. In the Fiers Affidavit, Biogen stated, “I understand the term ‘characterized by’ to mean in this and the other conflict claims that the polypeptide must have as a principal characteristic the recited amino acid sequence, but the polypeptide is not necessarily limited to that sequence alone. However, even if the term requires that the polypeptide have only the recited sequence, my conception date would be the same. On March 25, 1980, I had the complete DNA and amino acid sequences of beta interferon and there was no invention required to produce an E. coli host transformed with a vector comprising a nucleotide sequence encoding either a polypeptide having only the recited sequence or having at a minimum that sequence.” Id. ¶ 84(a). RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 39. For the same reasons, Serono further objects to Biogen’s arguments that “the asserted claims of the Fiers ’755 Patent are directed to methods of treatment using recombinant IFN-β” and “not directed to methods of host cell transformation, to methods of making recombinant IFN-β, to recombinant IFN-β itself, or to DNA encoding IFN-β,” as well as Biogen’s arguments that “[w]hether the transformation of a host cell ‘could be carried out using standard molecular biology technology’ has no bearing on whether the method-of- Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 18 of 32 PageID: 31551 18 treatment claims of the Fiers ’755 Patent are obvious.” Id. at 39–40. On the same basis, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments regarding whether “Dr. Fiers’s statement that ‘no invention’ was required to produce an E. coli host was provided under or meets the standard for obviousness under United States patent law.” Id. at 40. Finally, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” and “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. at 40–41. 26. In the Fiers Affidavit, Biogen stated, “Once the DNA sequence was available, to the skilled worker they could be carried out using standard molecular biology technology.” Id. ¶ 84(b). RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 41. For the same reasons, Serono further objects to Biogen’s arguments that “the asserted claims of the Fiers ’755 Patent are directed to methods of treatment using recombinant IFN-β” and “not directed to methods of host cell transformation, to methods of making recombinant IFN-β, to recombinant IFN-β itself, or to DNA encoding IFN-β,” as well as Biogen’s arguments that “[w]hether the steps of constructing an E. coli host were well known and routine has no bearing on whether the method-of-treatment claims of the Fiers ’755 Patent Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 19 of 32 PageID: 31552 19 are obvious.” Id. at 41–42. On the same basis, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments regarding whether “Dr. Fiers’s statement that expression could be carried out ‘using standard molecular technology’ was provided under or meets the standard for obviousness under United States patent law.” Id. at 42. Finally, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” and “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. 27. In the Fiers Affidavit, Biogen stated, “Unglycosylated beta interferon was known in the art in 1979.” Id. ¶ 85(a). RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 43. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments that “[a]lthough unglycosylated beta interferon was known in the art in 1979, a person of ordinary skill in the art would not have had a reasonable expectation that recombinant IFN-β would be biologically active and thus could be used therapeutically like Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 20 of 32 PageID: 31553 20 native, human IFN-β.” Id. at 43. Finally, Serono objects to Biogen’s arguments regarding “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. at 43–44. 28. In the Fiers Affidavit, Biogen stated, “A process for producing a polypeptide which contains the amino acid sequence of human fibroblast interferon, which process comprises (a) obtaining mRNA from human fibroblasts, (b) preparing double-stranded cDNA from said mRNA, (c) inserting said cDNA into a plasmid, (d) transforming E. coli with said plasmid, (e) detecting and isolating a transformant which expresses said interferon, and (f) culturing the isolated transformant of step (e) to produce said interferon. … Each of the steps recited in this claim were part of my early 1978 protocol for cloning and expressing beta interferon. They are merely standard technology. The only novel part of the claim is the DNA sequence of beta interferon.” Id. ¶ 91. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 44–45. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments regarding whether “Dr. Fiers’s statement that the steps for Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 21 of 32 PageID: 31554 21 expression in the listed conflict claim were ‘merely standard technology’ was provided under or meets the standard for obviousness under United States patent law.” Id. at 45. Finally, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” and “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. 29. In the Fiers Affidavit, Biogen stated, “[T]he methods to produce proteins in E. coli were well known before March 25, 1980.” Id. ¶ 91(a). RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 46. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments regarding whether “Dr. Fiers’s statement that ‘the methods to produce proteins in E. coli were well known’ was provided under or meets the standard for obviousness under United States patent law.” Id. Finally, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” “whether . . . expression techniques were well known means that one of ordinary skill in the art would have had a Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 22 of 32 PageID: 31555 22 reasonable expectation of success,” and “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. at 46–47. 30. In the Fiers Affidavit, Biogen stated, “With that sequence [for IFN-β] it was straight forward and simple to produce beta interferon in E. coli.” Id. ¶ 91(c). RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 47–48. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments regarding whether “Dr. Fiers’s statement that it was ‘straight forward and simple’ to produce IFN-β in E. coli was provided under or meets the standard for obviousness under United States patent law.” Id. at 48. Finally, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” and “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. 31. In the Fiers Affidavit, Biogen stated, “These compositions [of natural human IFN- β] were well known before 1979 and had long been used by that date to treat human tumors and viruses.” Id. ¶ 93(a). RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 23 of 32 PageID: 31556 23 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 49. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “the discussion of therapeutic uses of native IFN-β . . . renders obvious Dr. Fiers’s inventive work in establishing biological activity and obtaining therapeutically effective amounts of recombinant IFN-β obtained from non-human host cells for use in methods of treatment,” as well as Biogen’s arguments that “[a]lthough it was known that natural IFN-βs could have far-reaching therapeutic potential, as of June 1980, researchers could not reliably purify the interferons to homogeneity in therapeutically effective amounts, even after a great deal of effort by many,” and that “there was no reasonable expectation that recombinant IFN-β would possess biological activity necessary for therapeutic use because of its unpredictability.” Id. 32. In the Fiers Affidavit, Biogen stated, “The produced [IFN-β] polypeptide would then be used to prepare compositions for use in treating human tumors and viruses just as native beta interferon had been used to prepare those compositions for many years. The only remaining piece to the puzzle to produce beta interferon was the March 25, 1980 DNA sequence. With that sequence it was straight forward to produce recombinant beta interferon and prepare compositions using it.” Id. ¶ 93(c). RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments that the Fiers Affidavit “was also submitted in a Canadian patent proceeding involving Canadian patent claims that have different subject matter from that of the Fiers ’755 Patent claims,” as they constitute “legal arguments or conclusions of law” prohibited by Local Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 24 of 32 PageID: 31557 24 Rule 56.1(a). ECF No. 579 at 50. For the same reasons, Serono further objects to Biogen’s arguments regarding whether “Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active,” including Biogen’s arguments regarding whether “Dr. Fiers’s statement that the DNA sequence [for IFN-β] ‘was the remaining piece to the puzzle’ to produce beta interferon and that it was ‘straight forward’ to produce recombinant beta interferon and prepare compositions using it was provided under or meets the standard for obviousness under United States patent law.” Id. at 50– 51. Finally, Serono objects to Biogen’s arguments regarding “[t]he differences between the standards of obviousness in Canadian versus United States patent law,” “the standard for inventiveness in Canada,” and “the state of art as of June 6, 1980,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). Id. at 51. 33. Biogen’s expert witness, John Doll, who is a former U.S. Patent & Trademark Office (“PTO”) Commissioner for Patents, testified that Biogen’s submission of the Fiers Affidavit to the PTO “did not comply” with the then controlling PTO rules. Chung Declaration Ex. C, 12/7/16 Deposition Transcript of John Doll at 128:13–129:5. RESPONSE: Biogen’s objections on the basis of relevancy are improper under this District’s Local Rules, including Local Rule 56.1. See, e.g., Seavey, 2014 WL 1876957, at *2 n.3; Bell, 2014 WL 2920503, at *1 n.3; Durkin, 2013 WL 1314744, at *6. Serono also objects to Biogen’s arguments regarding whether “the Examiner reviewed the Fiers Affidavit” or “consider[ed] the Fiers Affidavit in deciding whether to issue the Fiers ’755 Patent,” as they constitute “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a). ECF No. 579 at 51–52. Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 25 of 32 PageID: 31558 25 RESPONSES TO BIOGEN’S “SUPPLEMENTAL STATEMENT OF ADDITIONAL MATERIAL FACTS” 34. The Fiers Affidavit set forth a March 25, 1980 invention date for all conflict claims, including the DNA sequence for IFN-β, the expression of IFN-β from the DNA sequence, and the preparation of compositions of that IFN-β. See, e.g., Ex. 44 (Fiers Affidavit) ¶¶ 28-31; Mitchell Ex. A ¶ 63. RESPONSE: Undisputed that, in the Fiers Affidavit, Biogen stated, “I have, therefore, on the advice of my Canadian patent agent, Ogilvy Renault, decided to rely on March 25, 1980 as the first date on which my full length sequence was disclosed to others.” Ex. 44 (Fiers Affidavit) ¶¶ 28–31. To the extent Biogen characterizes or otherwise argues about the meaning of this statement, Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. 35. The Fiers Affidavit separately confirmed that Dr. Fiers had actually expressed biologically active unglycosylated polypeptide characterized by the amino acid sequence of human beta interferon no later than April 26, 1980. See Ex. 44 (Fiers Affidavit) at 22 (Sec. III); Mitchell Ex. A ¶ 66. RESPONSE: Undisputed that, in the Fiers Affidavit, Biogen stated, “I EXPRESSED A BIOLOGICALLY ACTIVE UNGLYCOSYLATED POLYPEPTIDE CHARACTERIZED BY THE AMINO ACID OF HUMAN BETA INTERFERON NO LATER THAN APRIL 26, 1980.” Ex. 44 (Fiers Affidavit) at 22 (section III). To the extent Biogen characterizes or otherwise argues about the meaning of this statement, Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. 36. With respect to conflict claims relating to the IFN-β polypeptide and compositions, the Fiers Affidavit states: “Were the conflict examiner to consider it to be an invention to express beta interferon with the DNA sequence in hand, which I believe is not the case, my conception date can be no later than April 26, 1980.” See, e.g., Ex. 44 (Fiers Aff.), at 57, 77; Mitchell Decl. ¶ 35. Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 26 of 32 PageID: 31559 26 RESPONSE: Undisputed that, in the Fiers Affidavit, Biogen stated, “Were the Conflict Examiner to consider it to be an invention to express beta interferon with the DNA sequence in hand, which I believe is not the case, my conception date is no later than April 26, 1980.” Ex. 44 (Fiers Affidavit) at 77. To the extent Biogen characterizes or otherwise argues about the meaning of this statement, Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. 37. Canadian conflict proceeding procedures do not allow participants to file briefs, and thus the only opportunity for participants to present argument regarding an inventor’s asserted priority date will be through affidavits. See, e.g., Mitchell Decl. ¶ 38; Ex. 72 (Fisk Dep.), 106:5–17. RESPONSE: Undisputed that, in a Canadian conflict proceeding, there is “no provision for filing” briefs. Ex. 72 (Fisk Dep.), 106:5–17. To the extent Biogen characterizes or otherwise argues about the meaning of this fact, Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. 38. On July 21, 2005, the Canadian Patent Office issued two separate decisions for the DNA conflict claims and the polypeptide conflict claims. See, e.g., Mitchell Ex. A ¶ 67. RESPONSE: Undisputed that, on July 21, 2005, the Canadian Patent Office issued: (1) a decision in the conflict proceeding between Biogen and Genentech, Inc. (the “Biogen- Genentech Decision”), which involved conflict claims C1, C7 to C11, and C17 to C19 (Ex. 46 (Biogen-Genentech Decision) at BIMA00290440–42); and (2) a decision in the conflict proceeding between the Juridical Foundation, Japanese Foundation for Cancer Research (“JFCR”), Biogen, and Genentech (the “JFCR-Biogen-Genentech Decision”), which involved conflict claims C2 to C6. Ex. 45 (JFCR-Biogen-Genentech Decision) at BIMA00290448–49. To the extent Biogen characterizes or otherwise argues about the meaning of the conflict claims, Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 27 of 32 PageID: 31560 27 Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. 39. In one decision, the Canadian Patent Office granted Dr. Fiers an invention date of April 3, 1980 for the DNA sequence of IFN-β. See Ex. 45 (’378 Application, 7/21/05, Commissioner’s Decision on C2-C6) at 4. RESPONSE: Undisputed that, in the JFCR-Biogen-Genentech conflict proceeding, the Canadian Patent Office “decided to award the date of April 3, 1980 as the verified date of invention for conflict claims C2 to C6 on the grounds that this is the date on which the invention was complete and had been disclosed to others.” Ex. 45 (JFCR-Biogen-Genentech Decision) at BIMA00290446. To the extent Biogen characterizes or otherwise argues about the meaning of this decision, Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. 40. In the other decision, the Canadian Patent Office granted Dr. Fiers a later invention date of April 26, 1980 for the IFN-β polypeptide and preparation of compositions thereof. See Ex. 46 (’378 Application, 7/21/05 Commissioner’s Decision for Polypeptide Claims) at 4. RESPONSE: Undisputed that, in the Biogen-Genentech conflict proceeding, the Canadian Patent Office “determine[d] that the inventor named by Biogen in application number 374,378 is the first inventor of the subject matter defined by conflict claims C1, C7 to C11 and C17 to C19 on the basis of a date of invention of April 26, 1980,” where at least Conflict Claims 18 and 19 each recited a “composition for treating human tumors and viruses.” Ex. 46 (Biogen- Genentech Decision) at BIMA00290439, BIMA00290442 (emphasis added). To the extent Biogen characterizes or otherwise argues about the meaning of this decision, Serono objects to Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 28 of 32 PageID: 31561 28 this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. 41. The Canadian Patent Office’s determination was based on the date that Dr. Fiers stated he had used a vector to actually express the polypeptide of the conflict claims. See Ex. 46 (’378 Application, 7/21/05 Commissioner’s Decision for Polypeptide Claims) at 3; Mitchell Ex. A ¶ 93. RESPONSE: Undisputed that the Canadian Patent Office relied on Biogen’s sworn statements in the Fiers Affidavit regarding the expression of the IFN-β polypeptide to “determine that the inventor named by Biogen in application number 374,378 is the first inventor of the subject matter defined by conflict claims C1, C7 to C11 and C17 to C19 on the basis of a date of invention of April 26, 1980,” where at least Conflict Claims 18 and 19 each recited a “composition for treating human tumors and viruses.” Ex. 46 (Biogen-Genentech Decision) at BIMA00290438–39, BIMA00290442 (emphasis added). To the extent Biogen characterizes or otherwise argues about the meaning of this decision, Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. 42. The Canadian Patent Office did not award priority of invention of the DNA sequence to Dr. Fiers because it found that Dr. Sugano had an earlier invention date of February 2, 1980. See Mitchell Decl. ¶¶ 22–24; Ex. 45 (7/21/05 Conflict Decision on DNA Claims), at 5. RESPONSE: Undisputed that the Canadian Patent Office “determine[d] that the inventors named by [JFCR] in application number 363,628 are the first inventors of the subject matter defined by conflict claims C2 to C6 on the basis of a date of invention of February 5, 1980 as against a date of invention of April 3, 1980 for Biogen in application number 374,378 or against a date of invention of May 25, 1980 for Genentech in application number 386,573,” where conflict claims C2 to C6 recited the DNA sequence, “a recombinant vector comprising” the sequence, an “E. coli transformed with a recombinant vector comprising” the sequence, or Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 29 of 32 PageID: 31562 29 processes for “preparing a recombinant vector” and/or “E. coli containing a recombinant vector comprising” the nucleotide sequence. Ex. 45 (JFCR-Biogen-Genentech Decision) at BIMA00290447–49. To the extent Biogen characterizes or otherwise argues about the meaning of this decision, Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. 43. The Canadian Patent Office did not award priority of invention to Dr. Sugano for the polypeptides or compositions because his patent application on the DNA sequence did not present any claims for polypeptides or compositions. See, e.g., Mitchell Decl. ¶¶ 26, 34; Mitchell Ex. A ¶ 71; Ex. 46 (7/21/05 Conflict Decision on Protein Claims). RESPONSE: Undisputed that the conflict proceeding between Biogen’s application no. 374,378 and Genentech’s application no. 386,573, which involved conflict claims C1, C7 to C11, and C17 to C19, did not include JFCR. Ex. 46 (Biogen-Genentech Decision). To the extent Biogen characterizes or otherwise argues about the meaning of this decision, Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. 44. The Canadian Patent Office did not adopt Dr. Fiers’s argument that the same invention date should be awarded for the DNA sequence and its expression. See, e.g., Mitchell Ex. A ¶¶ 92-98; compare Ex. 45 (7/21/05 Conflict Decision on DNA Claims) with Ex. 46 (7/21/05 Conflict Decision on Protein Claims). RESPONSE: Undisputed that the Canadian Patent Office awarded an invention date of April 3, 1980 for conflict claims C2 to C6 (Ex. 45, BIMA00290446), and an invention date of April 26, 1980 for conflict claims C1, C7 to C11, and C17 to C19 (Ex. 46, BIMA00290439). To the extent Biogen characterizes or otherwise argues about the meaning of this decision, Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 30 of 32 PageID: 31563 30 45. There are vast differences between the obviousness laws in Canada versus the United States, which have changed over time and can depend on context. Ex. 72 (Fisk Dep.), 161:23–162:6 (describing differences as “the subject of a master’s degree”); see Ex. 72 (Fisk Dep.), 38:13–21, 161:2–162:15. RESPONSE: Serono objects to these statements as “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and as such require no response. Moreover, the imprecision of the statements (as to timeframe, context, and the like) render them not amenable to assent or dispute. 46. Canadian patent law did not permit claims for methods of treatment at the time of the conflict proceedings in which the Fiers Affidavit was submitted. See Ex. 72 (Fisk Dep.), 32:18–22, 33:11–17. RESPONSE: Undisputed that, at the time of the Biogen-Genentech conflict proceeding and the JFCR-Biogen-Genentech conflict proceeding in which Biogen submitted the Fiers Affidavit, Canadian patent law did not permit claims reciting methods of treatment. To the extent Biogen characterizes or otherwise argues about the content of the law, Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. 47. None of the conflict claims requires therapeutically effective amounts of recombinant IFN-β. See Mitchell Decl. ¶ 41 (Mitchell Rep. at ¶ 109, Exhibit L). RESPONSE: Undisputed that the conflict claims in the Canadian conflict proceedings do not recite the words “therapeutically effective amounts.” To the extent Biogen characterizes or otherwise argues about the meaning of the conflict claims, Serono objects to this purported statement of fact as improper because it constitutes “legal arguments or conclusions of law” prohibited by Local Rule 56.1(a), and therefore requires no response. Dated: April 17, 2017 By: /s/ David E. De Lorenzi David E. De Lorenzi Charles H. Chevalier Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 31 of 32 PageID: 31564 31 GIBBONS P.C. One Gateway Center Newark, New Jersey 07102-5310 Telephone No.: (973) 596-4500 Facsimile No.: (973) 596-0545 Of Counsel Wayne M. Barsky Robert A. Vincent Timothy P. Best Katherine Q. Dominguez Jaysen S. Chung Christine L. Ranney GIBSON, DUNN & CRUTCHER LLP 2029 Century Park East, Suite 4000 Los Angeles, CA 90067-3026 (310) 557-8183 Attorneys for Defendants and Counterclaimants EMD Serono, Inc. and Pfizer Inc. Case 2:10-cv-02734-CCC-JBC Document 595-1 Filed 04/17/17 Page 32 of 32 PageID: 31565 David E. De Lorenzi Charles H. Chevalier GIBBONS P.C. One Gateway Center Newark, NJ 07102 (973) 596-4743 Of Counsel Wayne M. Barsky Robert A. Vincent Timothy P. Best Katherine Q. Dominguez Jaysen S. Chung Christine L. Ranney GIBSON, DUNN & CRUTCHER LLP 2029 Century Park East Los Angeles, CA 90067 (310) 557-8183 Attorneys for Defendants and Counterclaimants EMD Serono, Inc. and Pfizer Inc. UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY IN RE BIOGEN ’755 patent LITIGATION : : : : : : : : : : : : : : : Civil Action No.: 10-cv-02734(CCC)(JBC) Honorable Claire C. Cecchi EVIDENTIARY OBJECTIONS TO BIOGEN’S DECLARATIONS AND OTHER EVIDENCE SUBMITTED IN OPPOSITION TO SERONO’S MOTION FOR SUMMARY JUDGMENT OF INVALIDITY UNDER 35 U.S.C. § 103 Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 1 of 42 PageID: 31566 1 Serono hereby submits the following evidentiary objections to the declarations and other evidence that Biogen submitted in its Opposition to EMD Serono, Inc. and Pfizer Inc.’s Motion for Summary Judgment of Invalidity Under 35 U.S.C. § 103. I. OBJECTIONS TO BIOGEN’S DECLARATIONS Serono objects to the following declarations on which Biogen relies in its Opposition: 1. Serono generally objects to the declaration of Michael R. Green (ECF No. 564) to the extent that it contains unsupported, conclusory assertions, which are insufficient to preclude summary judgment. Lujan v. Nat’l Wildlife Federation, 497 U.S. 871, 888–90 (1990); Fireman’s Ins. Co. of Newark, New Jersey v. DuFresne, 676 F.2d 965, 969 (3d Cir. 1982) (“Rule 56(e) does not allow a party resisting [a motion for summary judgment] to rely merely upon bare assertions, conclusory allegations or suspicions.”); In re Human Tissue Prods. Liability Litig., 582 F. Supp. 3d 644, 682–83 (D.N.J. 2008) (“The nonmoving party [facing a summary judgment motion] may not rely upon bare assertions or conclusory allegations, but must adduce evidence establishing that there is a genuine factual dispute for trial.”) (citing DuFresne, 676 F.2d at 969). In addition, Serono objects to Dr. Green’s declaration to the extent that he relies on his or another witness’s expert reports, which are hearsay under Federal Rule of Evidence 802 as to Biogen to which no exception applies, and are therefore inadmissible. Finally, Serono objects to Dr. Green’s declaration to the extent that it offers testimony that is irrelevant and/or immaterial to the instant Motion. 2. Serono generally objects to the declaration of John Doll (ECF No. 567) to the extent that it contains unsupported, conclusory assertions, which are insufficient to preclude summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods., 582 F. Supp. 3d at 682–83. In addition, Serono objects to Mr. Doll’s declaration to the extent that he relies on his or another witness’s expert reports, which are hearsay under Federal Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 2 of 42 PageID: 31567 2 Rule of Evidence 802 as to Biogen to which no exception applies, and are therefore inadmissible. Finally, Serono objects to Mr. Doll’s declaration to the extent that it offers testimony that is irrelevant and/or immaterial to the instant Motion. 3. Serono generally objects to the declaration of Robert Mitchell (ECF No. 569) to the extent that it contains unsupported, conclusory assertions, which are insufficient to preclude summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods., 582 F. Supp. 3d at 682–83. In addition, Serono objects to Mr. Mitchell’s declaration to the extent that he relies on his or another witness’s expert reports, which are hearsay under Federal Rule of Evidence 802 as to Biogen to which no exception applies, and are therefore inadmissible. Finally, Serono objects to Mr. Mitchell’s declaration to the extent that it offers testimony that is irrelevant and/or immaterial to the instant Motion. 4. Serono generally objects to the declaration of Thomas John (Jock) Murray (ECF No. 570) to the extent that it contains unsupported, conclusory assertions, which are insufficient to preclude summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods., 582 F. Supp. 3d at 682–83. In addition, Serono objects to Dr. Murray’s declaration to the extent that he relies on his or another witness’s expert reports, which are hearsay under Federal Rule of Evidence 802 as to Biogen to which no exception applies, and are therefore inadmissible. Finally, Serono objects to Dr. Murray’s declaration to the extent that it offers testimony that is irrelevant and/or immaterial to the instant Motion. 5. Serono generally objects to the declaration of K. Christopher Garcia (ECF No. 573) to the extent that it contains unsupported, conclusory assertions, which are insufficient to preclude summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods., 582 F. Supp. 3d at 682–83. In addition, Serono objects to Dr. Garcia’s declaration Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 3 of 42 PageID: 31568 3 to the extent that he relies on his or another witness’s expert reports, which are hearsay under Federal Rule of Evidence 802 as to Biogen to which no exception applies, and are therefore inadmissible. Finally, Serono objects to Dr. Garcia’s declaration to the extent that it offers testimony that is irrelevant and/or immaterial to the instant Motion. II. OBJECTIONS TO BIOGEN’S EXHIBITS Serono objects to the following exhibits on which Biogen relies in its Opposition: Ex. # Description Objection 44 Fiers Affidavit (BIMA00290246- BIMA00290327) FRE 802 Insofar as Biogen refers to passages of the Fiers Affidavit merely to respond to Serono’s discussion of it, Serono does not object to such use. Where Biogen attempts to use the Fiers Affidavit to prove the truth of the matter asserted with respect to, e.g., Dr. Fiers’s efforts, the Fiers Affidavit is an out-of-court statement that is hearsay as to Biogen to which no exception applies. 65 Excerpts of 7/29/16 Expert Report of Jeffrey V. Ravetch FRE 802 The excerpts of Dr. Ravetch’s expert report are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, the state of the art regarding IFN-β and uses thereof, and a publication by Dr. Fiers. These excerpts are thus hearsay as to Biogen to which no exception applies. 75 Excerpts of Transcript of 1/12/17 Deposition of Michael R. Green FRE 802 The excerpts from the deposition testimony of Dr. Green are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, statements made in the Fiers Affidavit and the obviousness of the ’755 patent claims. Dr. Green’s testimony is thus hearsay as to Biogen Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 4 of 42 PageID: 31569 4 Ex. # Description Objection to which no exception applies. FRE 702 In addition, Dr. Green lacks the relevant expertise to offer an expert opinion with respect to the issue of Dr. Fiers’s state of mind at the time of drafting and executing the Fiers Affidavit, including whether the Fiers Affidavit “suffers from hindsight bias.” Therefore, his testimony is not admissible expert opinion. See Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 591 (1993); Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147-48 (1999). 76 Excerpts of Transcript of 8/22/12 Deposition of James Haley FRE 802 The excerpts from the deposition testimony of Mr. Haley are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, prosecution of the application giving rise to the ’755 patent. Mr. Haley’s testimony is thus hearsay as to Biogen to which no exception applies. 84 Excerpts of Transcript of 7/22/16 Deposition of Bart Newland FRE 802, 805 The excerpts from the deposition testimony of Mr. Newland are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, Biogen’s business relationship with Serono or the content of out-of-court conversations with Serono representatives. Mr. Newland’s testimony is thus hearsay as to Biogen and/or hearsay within hearsay to which no exception applies. 98 R. Derynck, et al., Isolation and structure of a human fibroblast interferon gene, Nature 285:542–547 (1980) FRE 802 Biogen attempts to use the publication of this article to prove the truth of the matter asserted with respect to, for example, the obviousness of the ’755 patent claims. The article, and the publication thereof, are thus hearsay as to Biogen to which no exception applies. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 5 of 42 PageID: 31570 5 Ex. # Description Objection 99 R. Derynck, et al., Expression of human fibroblast interferon gene in Escherichia coli, Nature 287:193– 197 (1980) FRE 802 Biogen attempts to use the publication of this article to prove the truth of the matter asserted with respect to, for example, the obviousness of the ’755 patent claims. The article, and the publication thereof, are thus hearsay as to Biogen to which no exception applies. 100 W. Fiers, Cloning and Expression of Human Interferon-β: From BC to AC, Verh. K. Acad. Geneeskd. Belg. 71(1–2):45 (2009) FRE 802 The statements in this article are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, the obviousness of the ’755 patent claims. The statements in the article are thus hearsay as to Biogen to which no exception applies. 109 Excerpts of 7/29/16 Expert Report of Lawrence Pfeffer FRE 802 The excerpts of Dr. Pfeffer’s expert report are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, the state of the art regarding IFN-β and uses thereof, and one of Dr. Fiers’s publications. These excerpts are thus hearsay as to Biogen to which no exception applies. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 6 of 42 PageID: 31571 6 III. OBJECTIONS TO BIOGEN’S EVIDENCE IN ITS SPECIFIC RESPONSES TO SERONO’S ALLEGATIONS Serono objects to the following evidence on which Biogen relies in its Specific Responses to Serono’s Allegations: Biogen’s Specific Response to Serono’s Allegations Objection SUF 1 (at p. 2) The Fiers ’755 patent teaches that those different DNA sequences create the same amino-acid sequences; the DNA sequences are degenerate. See Ex. 1 at col 5:58–61. Serono objects to Biogen’s mischaracterization of the ’755 patent. SUF 1 (at p. 2) Dr. Fiers was the first to recombinantly express IFN-β polypeptides and demonstrate that those polypeptides are, in fact, biologically active. See, e.g., Green Decl. ¶ 54; Ex. 1 (Fiers ’755 patent) col. 37:18–46:37. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. Finally, Serono objects to Biogen’s mischaracterization of the ’755 patent. SUF 1 (at p. 2) Fiers went on to disclose that biologically active recombinant IFN- β could be made in therapeutically effective amounts. See, e.g., Green Decl. ¶ 54; Ex. 1 (Fiers ’755 patent) col. 37:18– 46:37. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. Finally, Serono objects to Biogen’s mischaracterization of the ’755 patent. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 7 of 42 PageID: 31572 7 Biogen’s Specific Response to Serono’s Allegations Objection SUF 2 (at p. 3) As of June 6, 1980, it was still unknown whether unglycosylated IFN-β would be biologically active like native, human IFN-β. See, e.g., Green Decl. ¶¶ 54-83; Garcia Decl. ¶ 40-44. FRE 702 Dr. Green’s and Dr. Garcia’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682– 83. SUF 2 (at p. 3) A person of ordinary skill in the art would not have had a reasonable expectation that recombinant IFN-β would be biologically active and thus could be used therapeutically like native, human IFN-β. Green Decl. ¶¶ 54- 92; Garcia Decl. ¶¶ 49, 30-50. FRE 702 Dr. Green’s and Dr. Garcia’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682– 83. SUF 2 (at p. 4) For the first scenario, the Fiers ’755 patent teaches that when certain interferon species, such as lymphoblastoid interferon—which is primarily interferon-alpha, not IFN-β— have some of their sugars, or carbohydrates removed, a smaller glycosylated form of interferon is formed, which may still exhibit interferon-like activity. Id. at col. 2:17– 31. Serono objects to Biogen’s mischaracterization of the ’755 patent. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 8 of 42 PageID: 31573 8 Biogen’s Specific Response to Serono’s Allegations Objection SUF 2 (at p. 4) Rather, the cited references merely teach that interferon species with some, but not all of the sugars removed, may retain biological activity. Garcia Decl. ¶ 45. FRE 401, 402, and 403 Paragraph 45 of Dr. Garcia’s declaration fails to support this statement, and therefore is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Dr. Garcia’s declaration. SUF 2 (at pp. 4–5) For the second scenario, the Fiers ’755 patent teaches that when “purported” inhibitors of glycosylation are used during the synthesis of certain interferon species, including leukocyte interferon—which is primarily interferon-alpha, not IFN-β— and mouse L cell interferon, a mixture of interferon and a smaller form of interferon is formed. Ex. 1 (Fiers ’755 patent), col. 2:17–31. Serono objects to Biogen’s mischaracterization of the ’755 patent. SUF 2 (at p. 5) That mixture may still exhibit interferon-like activity. Ex. 1 (Fiers ’755 patent), col. 2:17–31. Serono objects to Biogen’s mischaracterization of the ’755 patent. SUF 2 (at p. 5) Again, the Fiers ’755 patent does not teach that the “smaller form of IFN-β which still retains most or all of its IFN activity” is unglycosylated IFN-β. Rather, a person of ordinary skill in the art, reading the Fiers ’755 patent and referenced citations would have expected that “the activity that remained was due to residual glycosylated material.” Garcia Decl. ¶¶ 41, 42 FRE 702 Dr. Garcia’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 9 of 42 PageID: 31574 9 Biogen’s Specific Response to Serono’s Allegations Objection SUF 2 (at pp. 5–6) Indeed, the only referenced citation to IFN-β in that passage in the Fiers ’755 patent, Havell, teaches that IFN-β activity is reduced when produced in human fibroblast cultures in the presence of inhibitors of glycosylation. See, e.g., Green Decl. Ex. A ¶ 85; Green Decl. Ex. B ¶ 84 (citing Havell); Garcia Decl. ¶ 47 (same). FRE 401, 402, and 403 Paragraphs 84 and 85 of Dr. Green’s declaration and paragraph 47 of Dr. Garcia’s declaration fail to support this statement, and therefore are inadmissible as irrelevant because they have no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Dr. Green’s and Dr. Garcia’s declarations. FRE 802 The excerpts of Exhibits A and B to Dr. Green’s declaration (Dr. Green’s expert reports), as well as Havell, are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims. These excerpts are thus hearsay as to Biogen to which no exception applies. SUF 2 (at p. 6) As such, one of skill in the art would have expected that “inhibitors of glycosylation ‘suppress the production of biologically active interferon by virtue of their interfering with the proper glycosylation of the molecule.’” See generally Green Decl. ¶ 78; Garcia Decl. ¶ 46 . FRE 401, 402, and 403 Paragraph 78 of Dr. Green’s declaration and paragraph 46 of Dr. Garcia’s declaration fail to support this statement, and therefore are inadmissible as irrelevant because they have no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Dr. Green’s and Dr. Garcia’s declarations. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 10 of 42 PageID: 31575 10 Biogen’s Specific Response to Serono’s Allegations Objection SUF 4 (at p. 8) The Goeddel Canadian ’573 application was not filed until September 24, 1981. See Ex. 106 and Ex. 107. FRE 401, 402, and 403 Exhibits 106 and 107 fail to support this statement, and therefore are inadmissible as irrelevant because they have no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Exhibits 106 and 107. SUF 5 (at p. 8) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23-162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 5 (at pp. 8–9) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 11 of 42 PageID: 31576 11 Biogen’s Specific Response to Serono’s Allegations Objection SUF 6 (at p. 10) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23-162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 6 (at p. 10) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2–162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 7 (at p. 11) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23-162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 12 of 42 PageID: 31577 12 Biogen’s Specific Response to Serono’s Allegations Objection SUF 7 (at p. 11) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2–162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 7 (at p. 11) Further, the Canadian conflict proceeding involved claims that were not limited to the use of biologically active and therapeutically effective amounts of recombinant IFN-β produced from a nonhuman host cell, as required by the Fiers ’755 patent claims. Mitchell Decl. ¶¶ 15, 41; Ex. 43 (’378 App., 3/3/99 Institution of Conflict Proceeding) at 1. FRE 702 Mr. Mitchell’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. FRE 401, 402, and 403 Exhibit 43 fails to support this statement, and therefore is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Exhibit 43. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 13 of 42 PageID: 31578 13 Biogen’s Specific Response to Serono’s Allegations Objection SUF 8 (at p. 12) It is undisputed that the Fiers Affidavit includes the language set forth above, but to the extent Serono implies that such language is relevant to the (non)obviousness of the Fiers ’755 patent claims, it is disputed that the discussion of therapeutic uses of native IFN-β in that statement renders obvious Dr. Fiers’s inventive work in establishing biological activity and obtaining therapeutically effective amounts of recombinant IFN-β obtained from non- human host cells for use in methods of treatment, as recited by the Fiers ’755 patent claims. Green Decl. ¶¶ 52-53; Garcia Decl. ¶¶ 51-54. FRE 401, 402, and 403 Paragraphs 52–53 of Dr. Green’s declaration and paragraphs 51–54 of Dr. Garcia’s declaration fail to support this statement, and therefore are inadmissible as irrelevant because they have no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Dr. Green’s and Dr. Garcia’s declarations. SUF 9 (at p. 13) It is undisputed that the Fiers Affidavit includes the language set forth above, but to the extent Serono implies that such language is relevant to the (non)obviousness of the Fiers ’755 patent claims, it is disputed that the discussion of therapeutic uses of native IFN-β in that statement renders obvious Dr. Fiers’s inventive work in establishing biological activity and obtaining therapeutically effective amounts of recombinant IFN-β obtained from non- human host cells for use in methods of treatment, as recited by the Fiers ’755 patent claims. Green Decl. ¶¶ 52-53; Garcia Decl. ¶¶ 51-54. FRE 401, 402, and 403 Paragraphs 52–53 of Dr. Green’s declaration and paragraphs 51–54 of Dr. Garcia’s declaration fail to support this statement, and therefore are inadmissible as irrelevant because they have no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Dr. Green’s and Dr. Garcia’s declarations. SUF 10 (at p. 14) Paragraph 23(j), from which Serono quotes, refers in full to prior art from 1977 and 1978 that was discussed, among others, to the draft application for Dr. Fiers’s April 1980 British application. Ex. 44 (Fiers Aff.), ¶ 23(j). Serono objects to Biogen’s mischaracterization of Exhibit 44. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 14 of 42 PageID: 31579 14 Biogen’s Specific Response to Serono’s Allegations Objection SUF 10 (at p. 14) That same discussion was also present in Dr. Fiers’s subsequent June 1980 British application and the specification of the ’755 patent. Green Decl. Ex. C ¶¶ 28-49. FRE 802 The excerpts of Exhibit C to Dr. Green’s declaration (Dr. Green’s expert report) are out-of- court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, the sworn statements in the Fiers Affidavit. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. SUF 11 (at p. 16) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 15 of 42 PageID: 31580 15 Biogen’s Specific Response to Serono’s Allegations Objection SUF 11 (at p. 16) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 11 (at p. 16) Dr. Fiers’s statement, made in 2001 about knowledge in 1980, suffers from hindsight bias. Green Decl. ¶¶ 89-92 (Green Rebuttal Rep. ¶¶ 21, 296); Ex. 75 (Green Dep., 1/12/17), 449:18–450:8. FRE 802 The excerpts of Dr. Green’s rebuttal expert report and of Dr. Green’s deposition testimony are out-of- court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 16 of 42 PageID: 31581 16 Biogen’s Specific Response to Serono’s Allegations Objection SUF 11 (at p. 16) Dr. Fiers, as a person of extraordinary skill in the art, cannot speak to the knowledge of a person of ordinary skill in the art in June 6, 1980, the relevant standard for obviousness. Green Decl. ¶ 90 (Green Rebuttal Rep. ¶ 296). FRE 802 The excerpts of Dr. Green’s rebuttal expert report are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. SUF 11 (at p. 17) The Fiers ’755 patent itself attributes the DNA sequence to Dr. Taniguchi, and thus provides contemporaneous evidence that, when Dr. Fiers wrote his initial application in 1980, he himself considered his method of treatment to be patentable over that DNA sequence. Ex. 1 col. 5: 49–53. Serono objects to Biogen’s mischaracterization of the ’755 patent. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 17 of 42 PageID: 31582 17 Biogen’s Specific Response to Serono’s Allegations Objection SUF 11 (at p. 17) The United States Patent Office issued a restriction requirement, indicating that it believed method-of-treatment claims to be patentably distinct from DNA sequence claims. It also allowed the method-of- treatment claims to issue, over both Dr. Taniguchi’s DNA sequence, and the Fiers Affidavit itself. See Doll Decl. ¶ 45 (Doll Rep. ¶ 203). FRE 802 The excerpts of Mr. Doll’s expert report are out-of- court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 401, 402, and 403 Paragraph 45 of Mr. Doll’s declaration fails to support this statement, and therefore is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Mr. Doll’s declaration. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 18 of 42 PageID: 31583 18 Biogen’s Specific Response to Serono’s Allegations Objection SUF 11 (at p. 17) The Canadian Patent Office, too, disagreed with Dr. Fiers and rejected the arguments made in the Fiers Affidavit. See, e.g., Mitchell Decl. ¶¶ 34– 35 (Mitchell Rep. ¶¶ 94–95); Ex. 45 (7/21/05 Conflict Decision on DNA Claims), at 4; Ex. 46 (7/21/05 Conflict Decision on Protein Claims) at 4; see also Biogen’s Response to Serono’s Fact No. 7. FRE 702 Mr. Mitchell’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. FRE 401, 402, and 403 Exhibits 45 and 46 fail to support this statement, and therefore are inadmissible as irrelevant because they have no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Exhibits 45 and 46. FRE 802 The excerpts of Mr. Mitchell’s expert report are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims and the sworn statements in the Fiers Affidavit. These excerpts are thus hearsay as to Biogen to which no exception applies. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 19 of 42 PageID: 31584 19 Biogen’s Specific Response to Serono’s Allegations Objection SUF 11 (at pp. 17–18) Dr. Fiers’s work in producing recombinant IFN-β, including what he himself called an “exceptionally sensitive IFN-β assay system,” contradicts any characterization of expression as routine and standard. Green Decl. ¶ 78 (Green Rebif Rep. ¶ 95) (citing Dr. Fiers’s 2009 article); Green Decl. ¶ 98–101; Ex. 75 (Green Dep., 1/12/17), 678:8–679:21. FRE 802 The excerpts of Dr. Green’s expert report, the 2009 article, and of Dr. Green’s deposition testimony— which Biogen has failed to provide to the Court— are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims and the sworn statements in the Fiers Affidavit. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 401, 402, and 403 Paragraphs 78 and 98–101 of Dr. Green’s declaration, and the excerpts of Dr. Green’s deposition testimony—which Biogen has failed to provide to the Court—fail to support this statement, and therefore are inadmissible as irrelevant because they have no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Dr. Green’s declaration. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 20 of 42 PageID: 31585 20 Biogen’s Specific Response to Serono’s Allegations Objection SUF 11 (at p. 18) The scientific journal Nature published Dr. Fiers’s work in obtaining his DNA sequence and, shortly thereafter, his expression of biologically active recombinant protein. The short interval between Dr. Fiers’s publications is an objective indicator of non- obviousness, and demonstrates the excitement in the field for Dr. Fiers’s achievement. See Green Decl. ¶¶ 81–82 (Green Rebuttal Rep. ¶ 158). FRE 802 The excerpts of Dr. Green’s rebuttal expert report and the article in Nature are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. SUF 11 (at p. 18) Two of Bayer’s technical experts, including one who was researching the biological activity of interferons in the late 1970s and early 1980s, Dr. Lawrence Pfeffer, conceded that Dr. Fiers’s second paper underwent “an unusually rapid review period.” Ex. 109 (Pfeffer Report), ¶ 218; Ex. 65 (Ravetch Report), ¶¶ 392–93. FRE 802 The excerpts of Dr. Pfeffer’s and Dr. Ravetch’s expert reports are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims. These excerpts are thus hearsay as to Biogen to which no exception applies. Finally, Serono objects to Biogen’s mischaracterization of Dr. Pfeffer’s and Dr. Ravetch’s expert reports. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 21 of 42 PageID: 31586 21 Biogen’s Specific Response to Serono’s Allegations Objection SUF 11 (at p. 18–19) While Serono’s expert, Dr. Lodish, may dispute this, Dr. Green will explain how one of ordinary skill would not have reasonably expected recombinant IFN-β expressed by an E. coli host cell to have biological activity. See, e.g., Green Decl. ¶¶ 55–59, 69 (Green Rebuttal Rep. ¶¶ 62–116). Dr. Garcia will confirm the same. Garcia Decl. ¶ 34–40 (Garcia Rep. ¶¶ 37–43). FRE 802 The excerpts of Dr. Green’s and Dr. Garcia’s expert reports are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 702 Dr. Green’s and Dr. Garcia’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682– 83. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 22 of 42 PageID: 31587 22 Biogen’s Specific Response to Serono’s Allegations Objection SUF 11 (at p. 19) There was a long-felt need for recombinant, biologically active IFN-β, which shows that obtaining it was not obvious. Both Drs. Murray and Green will testify that Dr. Fiers’s achievement of recombinant expression of biologically active IFN-β met a long-felt need to obtain amounts of that product needed for IFN-β therapy. Murray Decl. ¶ 16–17 (Murray Rep. ¶¶ 50–112); Green Decl. ¶ 85 (Green Rebif Rep. ¶ 161). FRE 802 The excerpts of Dr. Green’s and Dr. Murray’s expert reports are out-of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 702 Dr. Green’s and Dr. Murray’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682– 83. SUF 11 (at p. 19) Many other groups, with Dr. Taniguchi’s DNA sequence in hand, tried and failed to express recombinant, biologically active IFN-β. See, e.g., Green Decl. ¶ 45, 55–59, 93–95 (Green Rebuttal Rep. ¶¶ 62–85). FRE 802 The excerpts of Dr. Green’s expert report are out- of-court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 23 of 42 PageID: 31588 23 Biogen’s Specific Response to Serono’s Allegations Objection SUF 12 (at p. 20) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 12 (at p. 20) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 13 (at p. 21) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 24 of 42 PageID: 31589 24 Biogen’s Specific Response to Serono’s Allegations Objection SUF 13 (at pp. 21–22) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 14 (at p. 23) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 14 (at p. 23) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 25 of 42 PageID: 31590 25 Biogen’s Specific Response to Serono’s Allegations Objection SUF 15 (at p. 24) It is undisputed that the Fiers Affidavit contains the statement set forth above, but Biogen disputes this alleged fact to the extent Serono alleges that Dr. Fiers admitted that it was obvious, under United States law, that recombinantly expressed IFN-β from a non-human host cell would be biologically active. The factual basis for this dispute is set forth in Biogen’s response to Serono’s Alleged Fact Nos. 2, 10. (Note that Paragraph 62, from which Serono quotes, in full refers to prior art from 1977 and 1978 that was discussed, among others, in Dr. Fiers’s April 1980 British application. Ex. 44 (Fiers Aff.), ¶ 62. Serono objects to Biogen’s mischaracterization of Exhibit 44. SUF 15 (at pp. 24–25) That same discussion was also present in Dr. Fiers’s subsequent June 1980 British application and the specification of the ’755 patent. Green Decl. Ex. C ¶¶ 28-49. FRE 802 The excerpts of Exhibit C to Dr. Green’s declaration (Dr. Green’s expert report) are out-of- court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, the sworn statements in the Fiers Affidavit. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 26 of 42 PageID: 31591 26 Biogen’s Specific Response to Serono’s Allegations Objection SUF 17 (at p. 27) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 17 (at p. 27) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 18 (at p. 28–29) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 27 of 42 PageID: 31592 27 Biogen’s Specific Response to Serono’s Allegations Objection SUF 18 (at p. 29) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 18 (at pp. 29–30) One of ordinary skill in the art would not have expected in 1980 to be able to apply Dr. Goeddel’s technique successfully to IFN-β. See Green Decl. ¶¶ 59-81. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. SUF 18 (at p. 30) Expression of biologically active IFN-β is significantly different from the recombinant expression of the other previously- expressed proteins, particularly due to the cotranslational and/or post-translational modifications necessary to obtain properly folded biologically active IFN- β. See Green Decl. ¶¶ 72-80. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 28 of 42 PageID: 31593 28 Biogen’s Specific Response to Serono’s Allegations Objection SUF 19 (at p. 31) Expression of biologically active IFN-β is significantly different from the recombinant expression of the other previously- expressed proteins, particularly due to the cotranslational and/or post-translational modifications necessary to obtain properly folded biologically active IFN- β. See Green Decl. ¶¶ 72-80. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. SUF 20 (at pp. 32–33) Biogen further disputes whether one of ordinary skill in the art would have been able to use the Ptashne expression system, discussed in the latter half of Paragraph 65, to successfully express biologically active recombinant IFN-β in therapeutically effective amounts. Green Decl. ¶¶ 60-61. FRE 401, 402, and 403 Paragraphs 60–61 of Dr. Green’s declaration fail to support this statement, and therefore are inadmissible as irrelevant because they have no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Dr. Green’s declaration. SUF 20 (at p. 31) One of ordinary skill in the art would not have expected in 1980 to be able to apply the Ptashne expression system successfully to IFN-β. Green Decl. ¶¶ 60-61. FRE 401, 402, and 403 Paragraphs 60–61 of Dr. Green’s declaration fail to support this statement, and therefore are inadmissible as irrelevant because they have no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Dr. Green’s declaration. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 29 of 42 PageID: 31594 29 Biogen’s Specific Response to Serono’s Allegations Objection SUF 20 (at p. 34) Expression of biologically active IFN-β is significantly different from the recombinant expression of the other previously- expressed proteins, particularly due to the cotranslational and/or post-translational modifications necessary to obtain properly folded biologically active IFN- β. See Green Decl. ¶¶ 72-80. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. SUF 21 (at p. 34) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 21 (at p. 34) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 30 of 42 PageID: 31595 30 Biogen’s Specific Response to Serono’s Allegations Objection SUF 22 (at p. 35) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 22 (at p. 35–36) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 23 (at p. 37) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 31 of 42 PageID: 31596 31 Biogen’s Specific Response to Serono’s Allegations Objection SUF 23 (at p. 37) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 24 (at p. 38) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 24 (at p. 38–39) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 32 of 42 PageID: 31597 32 Biogen’s Specific Response to Serono’s Allegations Objection SUF 25 (at p. 40) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 25 (at p. 40) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 26 (at p. 42) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 33 of 42 PageID: 31598 33 Biogen’s Specific Response to Serono’s Allegations Objection SUF 26 (at p. 42) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 28 (at p. 45) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 28 (at p. 45) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 34 of 42 PageID: 31599 34 Biogen’s Specific Response to Serono’s Allegations Objection SUF 29 (at p. 46) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 29 (at p. 46) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 30 (at p. 48) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 35 of 42 PageID: 31600 35 Biogen’s Specific Response to Serono’s Allegations Objection SUF 30 (at p. 48) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 31 (at p. 49) Although it was known that natural IFN-βs could have far-reaching therapeutic potential, as of June 1980, researchers could not reliably purify the interferons to homogeneity in therapeutically effective amounts, even after a great deal of effort by many. See Green Decl. ¶¶ 44–48, 93–95. FRE 702 Dr. Green’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. SUF 31 (at pp. 49–50) Further, as of June 1980, there was no reasonable expectation that recombinant IFN-β would possess biological activity necessary for therapeutic use because of its unpredictability. See Green Decl. ¶¶ 52-53, 87. FRE 401, 402, and 403 Paragraphs 52–53 and 87 of Dr. Green’s declaration fail to support this statement, and therefore are inadmissible as irrelevant because they have no tendency to make Biogen’s purported fact more or less probable. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Additionally, Serono objects to Biogen’s mischaracterization of Dr. Green’s declaration. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 36 of 42 PageID: 31601 36 Biogen’s Specific Response to Serono’s Allegations Objection SUF 32 (at p. 51) The differences between the standards of obviousness in Canadian versus United States patent law “could be the subject of a master’s degree.” See Ex. 72 (Fisk Dep.), 161:23- 162:6. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. SUF 32 (at p. 51) Indeed, the standard for inventiveness in Canada has fluctuated over time and can carry different meaning depending on context. See Ex. 72 (Fisk Dep.), 38:13–21, 161:2– 162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 37 of 42 PageID: 31602 37 Biogen’s Specific Response to Serono’s Allegations Objection SUF 33 (at pp. 51–52) Regardless of whether the submission of the Fiers Affidavit was complaint with then- controlling PTO rules, the Examiner reviewed the Fiers Affidavit and did not withdraw the Fiers ’755 patent claims from allowability or allowance. See Doll Decl. ¶ 45 (Doll Rep. ¶ 203). FRE 802 The excerpts of Mr. Doll’s expert report are out-of- court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 702 Mr. Doll’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. SUF 33 (at p. 53) It is undisputed that Mr. Doll testified that the June 2009 Information Disclosure Statement (IDS) by which the Fiers Affidavit was submitted to the United States Patent Office “did not comply” with the then- controlling PTO rules, but to the extent Serono implies that the Patent Office therefore did not review or consider the Fiers Affidavit in deciding whether to issue the Fiers ’755 patent, Biogen disputes this proposed fact because the prosecution records show that the Examiner reviewed and signed the IDS, writing “ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH” without lining through any references. See Ex. 23 (’930 Appl., 6/12/09 Office Action) at *4 (capitalization in original); Doll Decl. ¶ 43. FRE 702 Mr. Doll’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. Additionally, Serono objects to Biogen’s mischaracterization of Exhibit 23. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 38 of 42 PageID: 31603 38 Biogen’s Specific Response to Serono’s Allegations Objection SUF 33 (at p. 53) Mr. Doll will explain that, under Patent Office practice and procedures, this means that the Examiner reviewed each of the materials submitted with that IDS. See Doll Decl. ¶¶ 42–45. FRE 702 Mr. Doll’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. SUF 33 (at p. 53) Mr. Doll will also explain that, under Patent Office practice and procedures, the Examiner had the ability to withdraw the patent claims from allowance or issue but the Examiner, nonetheless, did not do so. See Doll Decl. ¶ 45 (Doll Rep. ¶ 203). FRE 802 The excerpts of Mr. Doll’s expert report are out-of- court statements that Biogen attempts to use to prove the truth of the matter asserted with respect to, for example, obviousness of the ’755 patent claims. These excerpts are thus hearsay as to Biogen to which no exception applies. FRE 702 Mr. Doll’s conclusory assertions upon which Biogen relies to make this statement lack any factual support. As such, they are not based on sufficient facts or data and are not the product of reliable principles and methods. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. In addition, such conclusory assertions are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 39 of 42 PageID: 31604 39 IV. OBJECTIONS TO BIOGEN’S EVIDENCE IN ITS SUPPLEMENTAL STATEMENT OF FACT Serono objects to the following evidence on which Biogen relies in its Supplemental Statement of Fact: Biogen’s Supplemental Statement of Fact Objection 35. The Fiers Affidavit separately confirmed that Dr. Fiers had actually expressed biologically active unglycosylated polypeptide characterized by the amino acid sequence of human beta interferon no later than April 26, 1980. See Ex. 44 (Fiers Affidavit) at 22 (Sec. III); Mitchell Ex. A ¶ 66. FRE 802 On this issue, the Fiers Affidavit is an out-of-court statement Biogen attempts to use to prove the truth of the matter asserted with respect to production of beta interferon polypeptides. The Fiers Affidavit is therefore hearsay as to Biogen to which no exception applies. FRE 602, 701, 702 Mr. Mitchell lacks the relevant expertise to offer an expert opinion with respect to the scientific issue whether Dr. Fiers produced recombinant polypeptides on any given date. Therefore, his testimony is not admissible expert opinion. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. Nor has Biogen propounded evidence demonstrating that he has personal knowledge of Dr. Fiers’s research. Therefore, his testimony on this matter is not competent percipient testimony. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 40 of 42 PageID: 31605 40 Biogen’s Supplemental Statement of Fact Objection 36. With respect to conflict claims relating to the IFN-β polypeptide and compositions, the Fiers Affidavit states: “Were the conflict examiner to consider it to be an invention to express beta interferon with the DNA sequence in hand, which I believe is not the case, my conception date can be no later than April 26, 1980.” See, e.g., Ex. 44 (Fiers Aff.), at 57, 77; Mitchell Decl. ¶ 35. FRE 602, 701, 702 Mr. Mitchell lacks the relevant expertise to offer an expert opinion with respect to scientific issues regarding the lack of inventiveness of producing recombinant IFN-β in E. coli bacteria, nor can he or anyone offer an expert opinion as to the internal thoughts of the “conflict examiner.” Therefore, his testimony is not admissible expert opinion. See Daubert, 509 U.S. at 591; Kumho Tire, 526 U.S. at 147–48. Nor has Biogen propounded evidence demonstrating that he has personal knowledge these matters. Therefore, his testimony on this matter is not competent percipient testimony. 37. Canadian conflict proceeding procedures do not allow participants to file briefs, and thus the only opportunity for participants to present argument regarding an inventor’s asserted priority date will be through affidavits. See, e.g., Mitchell Decl. ¶ 38; Ex. 72 (Fisk Dep.), 106:5–17. FRE 401, 402, and 403 Paragraph 38 of Mr. Mitchell’s declaration provides no support for this statement, and therefore is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the declaration. Likewise, the cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s assertion, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. 43. The Canadian Patent Office did not award priority of invention to Dr. Sugano for the polypeptides or compositions because his patent application on the DNA sequence did not present any claims for polypeptides or compositions. See, e.g., Mitchell Decl. ¶¶ 26, 34; Mitchell Ex. A ¶ 71 ; Ex. 46 (7/21/05 Conflict Decision on Protein Claims). FRE 702 Mr. Mitchell’s conclusory assertions on which Biogen relies to make this statement lack any factual support. In addition, such conclusory assertions in an affidavit are insufficient to overcome summary judgment. Lujan, 497 U.S. at 888–90; DuFresne, 676 F.2d at 969; Human Tissue Prods, 582 F. Supp. 3d at 682–83. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 41 of 42 PageID: 31606 41 Biogen’s Supplemental Statement of Fact Objection 45. There are vast differences between the obviousness laws in Canada versus the United States, which have changed over time and can depend on context. Ex. 72 (Fisk Dep.), 161:23–162:6 (describing differences as “the subject of a master’s degree”); see Ex. 72 (Fisk Dep.), 38:13– 21, 161:2–162:15. FRE 401, 402, and 403 The cited portions of Mr. Fisk’s deposition transcript do not support Biogen’s statement, and Biogen mischaracterizes Mr. Fisk’s testimony. Thus, the deposition testimony is inadmissible as irrelevant because it has no tendency to make Biogen’s purported fact more or less probable than it would be without the deposition testimony. Any potential probative value is substantially outweighed by danger of confusion and unfair prejudice. Dated: April 17, 2017 By: /s/ David E. De Lorenzi David E. De Lorenzi Charles H. Chevalier GIBBONS P.C. One Gateway Center Newark, New Jersey 07102-5310 Telephone No.: (973) 596-4500 Facsimile No.: (973) 596-0545 Of Counsel Wayne M. Barsky Robert A. Vincent Timothy P. Best Katherine Q. Dominguez Jaysen S. Chung Christine L. Ranney GIBSON, DUNN & CRUTCHER LLP 2029 Century Park East, Suite 4000 Los Angeles, CA 90067-3026 (310) 557-8183 Attorneys for Defendants and Counterclaimants EMD Serono, Inc. and Pfizer Inc. Case 2:10-cv-02734-CCC-JBC Document 595-2 Filed 04/17/17 Page 42 of 42 PageID: 31607
