Genentech, Inc. et al v. Amgen Inc.

REPLY BRIEF re MOTION to Dismiss Based upon Defendant's Unenforceability Counterclaims and to Strike Defendant's Eleventh Affirmative Defense

D. Del.March 14, 2019

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE GENENTECH, INC and CITY OF HOPE, Plaintiffs, v. AMGEN INC., Defendant. ) ) ) ) ) ) ) ) ) ) ) C.A. No. 18-00924-CFC PLAINTIFFS’ REPLY BRIEF IN SUPPORT OF THEIR MOTION TO DISMISS DEFENDANT’S UNENFORCEABILITY COUNTERCLAI MS AND TO STRIKE DEFENDANT’S ELEVENTH AFFIRMATIVE DEFE NSE Of Counsel: William F. Lee Lisa J. Pirozzolo Emily R. Whelan Kevin S. Prussia Andrew J. Danford WILMER CUTLER PICKERING HALE AND DORR LLP 60 State Street Boston, MA 02109 (617) 526-6000 Robert J. Gunther, Jr. WILMER CUTLER PICKERING HALE AND DORR LLP 7 World Trade Center 250 Greenwich Street New York, NY (212) 230-8800 Daralyn J. Durie Adam R. Brausa DURIE TANGRI LLP 217 Leidesdorff Street San Francisco, CA 94111 (415) 362-6666 MCCARTER & ENGLISH, LLP Michael P. Kelly (#2295) Daniel M. Silver (#4785) Renaissance Centre 405 North King Street, 8th Floor Wilmington, DE 19801 (302) 984-6300 mkelly@mccarter.com dsilver@mccarter.com Counsel for Plaintiffs Genentech, Inc. and City of Hope Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 1 of 15 PageID #: 11444 i TABLE OF CONTENTS Page I. INTRODUCTION ............................................................................... 1 II. ARGUMENT ........................................................................................... 2 A. The Court Should Dismiss Amgen’s Unenforceability Counterclaim For The ’213 Patent (Count 3) And Strike Amgen’s Eleventh Affirmative Defense. ................................. 2 B. The Court Should Dismiss Amgen’s Unenforceability Counterclaims For The Remaining Seventeen Patents-In- Suit (Counts 1-2 and 4-18). ..................................................... 7 III. CONCLUSION ........................................ ......................................... 10 Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 2 of 15 PageID #: 11445 ii TABLE OF AUTHORITIES Page(s) Cases Akzo N.V. v. Int’l Trade Comm’n, 808 F.2d 1471 (Fed. Cir 1986) .................................................................................... 4 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ......................................................................................... 7, 8, 10 Bayer Schering Pharma AG v. Barr Labs., Inc., No. 05-cv-2308 (PGS), 2008 WL 628592 (D.N.J. Mar. 3, 2008) ........................................... 5 Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) ................................................................................................... 8 Butamax Advanced Biofuels LLC v. Gevo, Inc., No. 11-54-SLR, 2012 U.S. Dist. LEXIS 86215 (D. Del. June 21, 2012) ................................ 6 Cellectis S.A. v. Precision Biosciences, 883 F. Supp. 2d 526 (D. Del. 2012) .............................................................................. 3, 5 Fowler v. UPMC Shadyside, 578 F.3d 203 (3d Cir. 2009) ................................................................................. 7, 10 Genetic Techs. Ltd. v. Interleukin Genetics Inc., No. 10-CV-69-BBC, 2010 WL 3362344 (W.D. Wis. Aug. 24, 2010) ..................................... 8 Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d 1291 (Fed. Cir. 2011) ................................................................................... 9 Genzyme Corp. v. Transkaryotic Therapies, Inc., No. 00-677, 2004 U.S. Dist. LEXIS 19250 (D. Del. Sept. 27, 2004) .................................. 3, 4 IBM v. Priceline Grp., Inc., 2017 U.S. Dist. LEXIS 54285 (D. Del. Apr. 10, 2017) .................................................. 6, 7 Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363 (Fed. Cir. 2008) ............................................................................... 2, 3 Quest Integrity USA, LLC v. Clean Harbor Indus. Servs., Inc., No. 14-1483-SLR, 2015 U.S. Dist. LEXIS 95148 (D. Del. July 22, 2015) ............................. 6 Refac Int’l, Ltd. v. Lotus Dev. Corp., 81 F.3d 1576 (Fed. Cir. 1996)..................................................................................... 6 Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 3 of 15 PageID #: 11446 iii Ring Plus, Inc. v. Cingular Wireless Corp., 614 F.3d 1354 (Fed. Cir. 2010) ................................................................................... 6 Rothman v. Target Corp., 556 F.3d 1310 (Fed. Cir. 2009) ................................................................................... 2 Sepracor Inc. v. Teva Pharm. USA, Inc., No. 09-cv-01302 (DMC)(MF), 2010 WL 2326262 (D.N.J. June 7, 2010) .............................. 5 Southco, Inc. v. Penn Eng’g & Mfg. Corp., 768 F. Supp. 2d 715 (D. Del. 2011) .................................................................................. 5 SunPower Corp. v. PaneClaw, Inc., No. 12-1633-MPT, 2016 WL 5107029 (D. Del. Sept. 19, 2016) ............................................ 3 Wyeth Holdings Corp. v. Sandoz, Inc., No. 09-955-LPS-CJB, 2012 WL 600715 (D. Del. Feb. 3, 2012) ............................................ 5 Young v. Lumenis, Inc., 492 F.3d 1336 (Fed. Cir. 2007) ................................................................................... 3 Statutes 35 U.S.C. § 271(e)(2)(C)(i) ............................................................................................... 9 Rules Federal Rule of Civil Procedure 8(a) ........................................................................ 1, 7, 8 Federal Rule of Civil Procedure 9(b) ................................................................................ 8 Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 4 of 15 PageID #: 11447 1 I. INTRODUCTION Amgen has not identified any factual dispute that would prevent the Court from disposing of its unenforceability defenses at the pleadings stage. For the ’213 patent, Amgen argues that there is a factual dispute as to whether Genentech’s statements to the patent examiner constituted permissible attorney argument or improper material misrepresentations. But Amgen’s position cannot be reconciled with long-standing Federal Circuit precedent that an applicant’s statements concerning the teachings of the prior art cannot, as a matter of law, support a claim of inequitable conduct so long as the patent examiner was capable of assessing the applicant’s arguments on her own. Amgen has not pleaded any facts alleging that the patent examiner here was incapable of fully evaluating Genentech’s statements concerning the prior art for herself, and Amgen’s unenforceability counterclaim for the ’213 patent ad related Eleventh Affirmative Defense are therefore legally deficient. Indeed, Amgen does not even engage with the many cases dismissing a defendant’s unenforceability counterclaims in exactly these circumstances, and the cases that Amgen does discuss only underscore the need to plead facts alleging that the patent examiner was incapable of evaluating the applicant’s arguments (which Amgen has failed to do here). For the remaining seventeen patents-in-suit, pursuant to Federal Rule of Civil Procedure Rule 8(a), Amgen is obligated to plead at least some facts supporting its counterclaims-and Amgen has pleaded none. Instead, Amgen asserts that there are “a number of ways” in which the patents-in-suit might be unenforceable-for example, based upon the recent or anticipated expiration of certain patents, or decisions in other proceedings concerning the validity of those patents. But Amgen does not dispute that an expired patent remains enforceable against past infringement occurring during the patent’s term. And Amgen’s speculation about future possible outcomes in other proceedings is not a basis for pleading unenforceability. The Court therefore should also dismiss Amgen’s unenforceability counterclaims for the remaining patents-in-suit. Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 5 of 15 PageID #: 11448 2 II. ARGUMENT A. The Court Should Dismiss Amgen’s Unenforceability Counterclaim For The ’213 Patent (Count 3) And Strike Amgen’s Eleventh Affirmative Defense. Amgen’s unenforceability counterclaim for the ’213 patent and its related Eleventh Affirmative Defense rest entirely on statements concer ing the teachings of two prior art references (Queen 1989 and the ’101 patent) that Genent ch’s prosecution counsel made to the patent examiner during prosecution of the ’213 patent. (D.I. 94 at 5-6.) Amgen does not allege that prosecution counsel had any information uniquely in its possession concerning those publicly available references or that the examiner was otherwise incapable of evaluating the teachings of those references on her own. (See D.I. 80, Aff. Defs. ¶¶ 11-23.) Amgen’s inequitable conduct theory instead rests solely on the notion that prosecution counsel allegedly misrepresented what the prior art before the examiner disclosed. (Id.) That is legally insufficient to plead inequitable conduct. The Federal Circuit “has made clear that an applicant is free to advocate its interpretation of its claims and the teachings of prior art” without fear of committing inequitable conduct. Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1379 (Fed. Cir. 2008); see also Rothman v. Target Corp., 556 F.3d 1310, 1328-29 (Fed. Cir. 2009) (“While the law prohibits genuine misrepresentations of material fact, a prosecuting attorney is free to present argument in favor of patentability without fear of committing inequitable conduct.”). An applicant’s statements concerning the teachings of the prior art are thus, as a matter of law, not material misrepresentations that could support inequitable conduct where, as here, there is no alleg tion that the patent examiner lacked the ability to evaluate the applicant’s characterizations n her own. That is because “the Patent Act gives the examiner the discretion to reject or accept an applicant’s arguments based on the examiner’s own conclusions regarding the prosecution record.” Rothman, 556 F.3d at 1330. Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 6 of 15 PageID #: 11449 3 What is missing from Amgen’s unenforceability counterclaim for the ’213 patent and its related Eleventh Affirmative Defense is any allegation that the examiner was incapable of evaluating the applicant’s statements concerning the teachings of Queen 1989 and the ’101 patent on her own. Absent any such allegation, Amgen has not sufficiently pleaded an inequitable conduct defense. Innogenetics, 512 F.3d at 1379 (“[O]ur precedent has made clear that an applicant is free to advocate its interpretation of its claims and the teachings of prior art. … Given that the [prior art reference] had been submitted for the patent examiner to examine herself, she was free to accept or reject the patentee’s arguments distinguishing its invention from the prior art.”); Young v. Lumenis, Inc., 492 F.3d 1336, 1349 (Fed. Cir. 2007) (“[The applicant] argued against the rejection, and the examiner was free to reach his own conclusions and accept or reject [the applicant’s] arguments. We therefore fail to see how the [applicant’s statements], which consist of attorney argument and an interpretation of what the prior art discloses, constitute affirmative misrepresentations f material fact.”). Indeed, prior decisions in this District in precisely these circumstances have applied that precedent to hold that the defendant’s inequitable conduct defense was legally deficient and could not proceed beyond the pleadings stage. See, e.g., SunPower Corp. v. PaneClaw, Inc., No. 12-1633-MPT, 2016 WL 5107029, at *10 (D. Del. Sept. 19, 2016) (holding that defendant did “not adequately plead inequitable conduct” based upon alleged misrepresentations of the prior art because “[t]he examiner had the expertise to examine the prior art reference and consider [the applicant’s] argument against the rejection”); Cellectis S.A. v. Precision Biosciences, 883 F. Supp. 2d 526, 535 (D. Del. 2012) (dismissing inequitable conduct defense as inadequately pleaded where the “examiners were free to credit or discount [the applicants’] characterizations of [the prior art] in view of their own readings”); Genzyme Corp. v. Transkaryotic Therapies, Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 7 of 15 PageID #: 11450 4 Inc., No. 00-677, 2004 U.S. Dist. LEXIS 19250, at *6 (D. Del. Sept. 27, 2004) (“[A]ny mischaracterization of the [prior art] is not actionable because ‘the examiner was free to reach his own conclusion regarding … the art in front of him.’” (quoting Akzo N.V. v. Int’l Trade Comm’n, 808 F.2d 1471, 1482 (Fed. Cir 1986)) (emphasis added). Amgen does not engage with this long line of precednt. Instead, Amgen advocates a bright-line rule that an inequitable conduct defense based upon an alleged misrepresentation of the prior art during prosecution “raises a factual dispute that is not properly resolved on a motion to dismiss”-namely, whether the applicant’s statements were permissible “attorney argument” or improper “misleading statements.” (D.I. 94 at 11-12.) However, as the cases cited above illustrate, the dividing line between permissible attorney argument (which cannot, as a matter of law, support inequitable conduct) and material misrepresentations (which can) is whether the patent examiner was capable of evaluating the applicant’s statements concerning the prior art on her own. Where, as here, there is no allegation that the examiner was incapable of assessing the applicant’s statements concerning the prior art for herself, there is no factual dispute to resolve and the applicant’s statements fall on the side of permissible attorney argument. See, e.g., Genzyme, U.S. Dist. LEXIS 19250, at *6 (“[A]ny mischaracterization of the [prior art] is not actionable because ‘[t]he examiner was free to reach his own conclusion regarding … the art in front of him.’” (quoting Akzo, 808 F.2d at 1482)). Amgen’s contrary rule that whether an applicant’s statements are permissible attorney argument or impermissible material misrepresentations presents “a factual dispute that is not properly resolved on a motion to dismiss” (D.I. 94 at 11-12) would foreclose dismissal of inequitable conduct claims whenever the defendant alleges that the applicant mischaracterized the prior art. That is not the law, and Amgen’s poiti n cannot be reconciled with the numerous Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 8 of 15 PageID #: 11451 5 cases dismissing inequitable conduct claims in exactly these circumstances. See, e.g., Cellectis, 883 F. Supp. 2d at 535; Sepracor Inc. v. Teva Pharm. USA, Inc., No. 09-cv-01302 (DMC)(MF), 2010 WL 2326262, at *6-7 (D.N.J. June 7, 2010); Bayer Schering Pharma AG v. Barr Labs., Inc., No. 05-cv-2308 (PGS), 2008 WL 628592, at *49-50 (D.N.J. Mar. 3, 2008). Amgen’s cited cases do not hold otherwise and, if anything, only highlight the type of allegations necessary to plead a material misrepresntation and survive a motion to dismiss (which are entirely absent here). In Wyeth Holdings Corp. v. Sandoz, Inc., No. 09-955-LPS-CJB, 2012 WL 600715, at *12 (D. Del. Feb. 3, 2012), the defendant alleged that the applicant’s arguments had misrepresented “Wyeth’s internal testing procedures and protocols” that it was “uniquely qualified to characterize and explain,” and that certain data necessary to evaluate the applicant’s arguments “was never provided by Wyeth to the Examiner in any form.” Thus, according to the defendant, the examiner lacked sufficient information to evaluate the applicant’s arguments and “had no way of independently learning” that information. Id. at *11. Similarly, in Southco, Inc. v. Penn Eng’g & Mfg. Corp., 768 F. Supp. 2d 715, 722 (D. Del. 2011), the applicant submitted a drawing figure of a prior art device, but there was “no way to tell” from that figure whether certain relevant features were present. The applicant nevertheless presented arguments about the features of the device, while at the same time withholding a physical sample in its possession that “would have demonstrated the falsity of [the applicant’s] arguments” to the patent examiner. Id. Again, what allowed the defendant to sufficiently plead inequitable conduct in Southco was the allegation that the applicant had information not available to the examiner that was es ential to evaluating the applicant’s arguments. Amgen has alleged no such information disparity in this case, or any other reason that the patent examiner could not evaluate Genentech’s statements on her own. Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 9 of 15 PageID #: 11452 6 The only other case that Amgen cites where inequitable conduct was found based upon statements concerning the teachings of the prior art is Ring Plus, Inc. v. Cingular Wireless Corp., 614 F.3d 1354 (Fed. Cir. 2010). But the inequitable conduct finding in that case was based upon a factual misstatement in the specification of the patent itself, not any attorney argument describing the disclosure of the references. Id. at 1359. In fact, the Federal Circuit rejected the defendant’s argument that the applicant’s arguments to the patent examiner about the teachings of the prior art constituted a material misrepresentation. Id. at 1360. Amgen also cites Butamax Advanced Biofuels LLC v. Gevo, Inc., No. 11-54-SLR, 2012 U.S. Dist. LEXIS 86215, at *10 (D. Del. June 21, 201 ), Refac Int’l, Ltd. v. Lotus Dev. Corp., 81 F.3d 1576, 1584 (Fed. Cir. 1996), Quest Integrity USA, LLC v. Clean Harbor Indus. Servs., Inc., No. 14-1483-SLR, 2015 U.S. Dist. LEXIS 95148, at *15-16 (D. Del. July 22, 2015), and IBM v. Priceline Grp., Inc., 2017 U.S. Dist. LEXIS 54285, at *39-40 (D. Del. Apr. 10, 2017). (See D.I. 94 at 11-12.) But the inequitable conduct claims in those cases did not rest on allegations that the applicant had mischaracterized the teachings of pri r art references that the examiner had before her; instead, the inequitable conduct claims in those cases were based upon the applicant’s alleged withholding of information within its possession from the patent xaminer. See Butamax, 2012 U.S. Dist. LEXIS 86215, at *7 (alleging that the applicant “knew of prior art that contradicted its contention” that the claimed inventio achieved unexpected results, but failed to disclose that prior art to the examiner); Refac, 81 F.3d at 1581 (explaining inequitable conduct allegations based upon the applicant’s failure to disclose that an individual who submitted a declaration during prosecution had a prior employment r lationship with applicant); Quest Integrity, 2015 U.S. Dist. LEXIS 95148, at *11-12 (alleging that the applicant failed to disclose commercial sales that occurred more than one year befo e the filing of the patent application, as Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 10 of 15 PageID #: 11453 7 well as prior art references that formed the basis for the rejection of a parallel patent application in Europe); IBM, 2017 U.S. Dist. LEXIS 54285, at *3-10 (alleging tha the applicant failed to disclose certain publications, commercial activity, and developments in a parallel patent prosecution). Amgen thus has cited no case in which an inequitable conduct claim has been allowed to proceed in these circumstances. On the contrary, Amgen’s cited cases highlight the need to allege facts suggesting that the patent examiner lacked sufficient information to evaluate the applicant’s arguments-which Amgen has failed to allege here. Because Amgen has pleaded no factual allegation that the examiner was incapable of evaluating Genentech’s statements concerning the teachings of Queen 1989 and the ’101 patent, this case falls squarely within established precedent holding that an attorney’s arguments concerning the teachings of the prior art is legally insufficient to support an inequitable conduct defense. The Court therefore should dismiss Amgen’s u enforceability defense for the ’213 patents (Count 3) and strike Amgen’s related Eleventh Affirmative Defense. B. The Court Should Dismiss Amgen’s Unenforceability Counterclaims For The Remaining Seventeen Patents-In-Suit (Counts 1-2 and 4-18). Amgen’s unenforceability allegations for the remaining seventeen patents-in-suit also fall short of the applicable pleading standard. Under Federal Rule of Civil Procedure 8(a), “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In other words, “a complaint must do more than allege … entitlement to relief”; it must “‘show’ such an entitlement with its facts.” Fowler v. UPMC Shadyside, 578 F.3d 203, 211 (3d Cir. 2009) (emphasis added). Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 11 of 15 PageID #: 11454 8 What Amgen has pleaded for the remaining seventeen patents-in-suit falls well short of satisfying Rule 8(a).1 Indeed, Amgen has pleaded no facts whatsoever in support of its unenforceability counterclaims for those patents and instead simply asserted the bare legal conclusion that the asserted patents are “unenforceable.” (D.I. 80, Countercl. ¶¶ 63-64, 77-78, 84-85, 91-92, 98-99, 105-106, 112-113, 119-120, 126- 7, 133-134, 140-141, 147-148, 154-155, 161-162, 168-169, 175-176; see also D.I. 86 at 16-17 (showing Amgen’s boilerplate langua e repeated for each patent).) Such “‘naked assertion[s]’ devoid of ‘further factual enhancement’” are insufficient to state a claim. Iqbal, 556 U.S. at 678 (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 557 (2007)); see also Genetic Techs. Ltd. v. Interleukin Genetics In ., No. 10-CV-69- BBC, 2010 WL 3362344, at *2 (W.D. Wis. Aug. 24, 2010) (“Defendant relies on the bare assertion that the claims are unenforceable. Such assertions, unsupported by additional factual allegations, cannot satisfy Rule 8.”). Despite failing to plead any theory of unenforceability for these patents, Amgen now asserts that its counterclaims may be referring to a “number of ways” in which Genentech’s patents may be “unenforceable now or in the near term”-for example, due to patent expiration or rulings in other proceedings. (D.I. 94 at 13.) That too is insufficient to put Plaintiffs on notice of the factual basis for Amgen’s counterclaims. See, e.g., Genetic Techs, 2010 WL 3362344, at *1-2 (granting motion to dismiss unenforceability counterclaim where defendant “did not specify in its counterclaim what it means by ‘unenforceability’”). Indeed, Amgen’s vague description of 1 Amgen notes that Plaintiffs previously moved to dismiss Amgen’s unenforceability counterclaims for, among other things, failure to meet the heightened pleading standard under Federal Rule of Civil Procedure 9(b). (D.I. 94 at 2 n.2, 13 n.4.) But the fact that Genentech also previously moved to dismiss these counterclaims under Rule 9(b) only underscores that Amgen has provided no notice of what its theory of unenforceability actually is. There is no way to discern the basis for Amgen’s unenforceability counterclaims from what Amgen has pleaded, and that is exactly why Plaintiffs have moved to dismiss them. Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 12 of 15 PageID #: 11455 9 the “number of ways” that it could potentially assert unenforceability (D.I. 94 at 13) confirms that even Amgen does not know the basis for its counterclaims. In any case, the theories of unenforceability that Amgen attempts to advance in its opposition only highlight the absence of any legally cognizable basis to state an unenforceability defense for those patents. Amgen contends that the patents-in-suit may be unenforceable for three reasons: (1) “many of the asserted patents will expire shortly-or, in three cases, have already expired”; (2) “many of these patents are also being challenged in other district court and Federal Circuit proceedings”; and (3) “the U.S. Patent Office has found claims of three of Genentech’s asserted patents unpatentable.” (D.I. 94 at 13-14.) Even if Amgen had pleaded those theories (it did not), they would not be legaly sufficient to state a claim. First, Amgen’s arguments with respect to patent expiration are not sufficient to state a claim for unenforceability because the patents-in-suit remain enforceable as to any past infringement even after they expire. See, e.g., Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d 1291, 1299 (Fed. Cir. 2011) (patentees may sue for past infringement of an expired patent). Amgen’s filing for FDA approval of its biosimilar product is itself an act of patent infringement that occurred prior to the expiration of any of the patents-in-suit. See 35 U.S.C. § 271(e)(2)(C)(i). And although four of the patents-in-suit will expire in the next four months, there is still a possibility of prospective nfringement even for those patents because Amgen has refused to state that it will refrain from any further infringement of those patents prior to their expiration. Amgen thus has no basis to assert the expiration of the patents-in-suit is a basis for stating a claim of unenforceability. Second, Amgen’s vague assertion that the patents in Pla tiffs’ second amended complaint could be found invalid in separate proceedings at some point in the future does not Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 13 of 15 PageID #: 11456 10 satisfy Iqbal. It is not enough to allege facts to “permit the court to infer the mere possibility” of entitlement to relief. Iqbal, 556 U.S. at 679 (emphasis added). The complaint mus “‘show’ such an entitlement with its facts.” Fowler, 578 F.3d at 211 (emphasis added). Amgen’s speculation about possible future outcomes in other proceedings does not provide it with a basis to state a claim for unenforceability. Third, the fact that certain claims from three patents in Plaintiffs’ second amended complaint have been found unpatentable in inter partes reviews (“IPRs”) does not support an unenforceability counterclaim.2 Indeed, even Amgen admits that those IPR decisions d not render any of the patents-in-suit unenforceable today; Amgen merely speculates that those patents may become unenforceable if those decisions are upheld on appeal. (D.I. 94 at 14 (“Once Genentech has exhausted its right to appeal and the patent is held invalid, it will not be enforceable.”).) Amgen cannot assert a placeholder un nforceability counterclaim now on the hope that it might someday have facts to support it. III. CONCLUSION For the foregoing reasons, and for the reasons describ d in Plaintiffs’ Opening Brief (D.I. 86), Plaintiffs respectfully request that the Court dismiss each of Amgen’s counterclaims for unenforceability and strike Amgen’s Eleventh Affirmative Defense and Prayer for Relief E, which seeks a declaration that the claims of the pat nts-in-suit are unenforceable. 2 The Court previously ordered Plaintiffs to narrow this case to ten patents and two claims per patent to litigate. (D.I. 44 ¶ 8.) None of the narrowed set of patents and claims that Plaintiffs have chosen to assert in this case were invalidated in IPR. Indeed, the patentability of asserted claims 65 and 79 of the ’213 patent was upheld in four IPRs. Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 14 of 15 PageID #: 11457 11 Dated: March 14, 2019 Of Counsel: William F. Lee Lisa J. Pirozzolo Emily R. Whelan Kevin S. Prussia Andrew J. Danford WILMER CUTLER PICKERING HALE AND DORR LLP 60 State Street Boston, MA 02109 (627) 526-6000 william.lee@wilmerhale.com lisa.pirozzolo@wilmerhale.com emily.whelan@wilmerhale.com kevin.prussia@wilmerhale.com andrew.danford@wilmerhale.com Robert J. Gunther Jr. WILMER CUTLER PICKERING HALE AND DORR LLP 7 World Trade Center 250 Greenwich Street New York, NY 10007 (212) 230-8800 robert.gunther@wilmerhale.com Daralyn J. Durie Adam R. Brausa DURIE TANGRI LLP 217 Leidesdorff St. San Francisco, CA 94111 (415) 362-6666 ddurie@durietangri.com abrausa@durietangri.com MCCARTER & ENGLISH, LLP /s/ Daniel M. Silver Michael P. Kelly (#2295) Daniel M. Silver (#4758) Renaissance Centre 405 North King Street, 8th Floor Wilmington, DE 19801 (302) 984-6300 mkelly@mccarter.com dsilver@mccarter.com Counsel for Plaintiffs Genentech, Inc. and City of Hope. Case 1:18-cv-00924-CFC Document 97 Filed 03/14/19 Page 15 of 15 PageID #: 11458