DEXCEL PHARMA TECHNOLOGIES LTD. et al v. SUN PHARMA GLOBAL FZE et al

BRIEF in Support

D.N.J.June 18, 2018

David A. Crichlow (admitted pro hac vice) KATTEN MUCHIN ROSENMAN LLP 575 Madison Avenue New York, New York 10022-2858 (212) 940-8800 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY DEXCEL PHARMA TECHNOLOGIES LTD. and DEXCEL LTD., Plaintiffs, -against- SUN PHARMA GLOBAL FZE, SUN PHARMA GLOBAL INC., SUN PHARMACEUTICAL INDUSTRIES, INC., and SUN PHARMACEUTICAL INDUSTRIES, LTD., Defendants. Civil Action No.: 2:15-cv-08017 (SDW)(LDW) DEXCEL PHARMA TECHNOLOGIES LTD. and DEXCEL LTD., Plaintiffs, -against- DR. REDDY’S LABORATORIES, LTD. and DR. REDDY’S LABORATORIES, INC., Defendants. Civil Action No.: 2:15-cv-08042 (SDW)(LDW) SUN DEFENDANTS’ BRIEF IN SUPPORT OF MOTION IN LIMINE TO EXCLUDE DEXCEL’S PROPOSED DEPOSITION DESIGNATIONS OF SUN’S INVALIDITY EXPERT DR. UMESH BANAKAR Gregory D. Miller Gene Y. Kang RIVKIN RADLER LLP 21 Main Street, Court Plaza South West Wing, Suite 158 Hackensack, NJ 07601-7021 (201) 287-2460 Stephen P. Benson (admitted pro hac vice) Brian J. Sodikoff (admitted pro hac vice) Kimberly A. Beis (admitted pro hac vice) KATTEN MUCHIN ROSENMAN LLP 525 West Monroe Street Chicago, Illinois 60661-3693 (312) 902-5200 Attorneys for Sun Pharma Global FZE, Sun Pharma Global Inc., Sun Pharmaceutical Industries, Inc., and Sun Pharmaceutical Industries, Ltd. Case 2:15-cv-08017-SDW-LDW Document 209 Filed 06/18/18 Page 1 of 10 PageID: 2959 i TABLE OF CONTENTS I. DEXCEL HAS FAILED TO MEET THE REQUIREMENTS OF RULE 26 IN DESIGNATING DR. BANAKAR AS DEXCEL’S EXPERT WITNESS ................................................................... 1 II. THERE ARE NO EXCEPTIONAL CIRCUMSTANCES IN THIS CASE JUSTIFYING DEXCEL’S DESIGNATION OF DR. BANAKAR’S TESTIMONY .................................................. 4 III. BANAKAR WAS RETAINED AS AN INVALIDITY EXPERT ........................................................ 6 IV. CONCLUSION ........................................................................................................................ 7 Case 2:15-cv-08017-SDW-LDW Document 209 Filed 06/18/18 Page 2 of 10 PageID: 2960 ii TABLE OF AUTHORITIES Page(s) Cases Dudley Flying Serv., Inc. v. Ag Air Maint. Servs., Inc., No. 3:13-CV-00156-KGB, 2015 WL 1757886 (E.D. Ark. Apr. 17, 2015) ...............................5 FMC Corp. v. Vendo Co., 196 F. Supp. 2d 1023 (E.D. Cal. 2002)......................................................................................5 In re Homestore.com, Inc., No. CV 01-11115 RSWL CWX, 2011 WL 291176 (C.D. Cal. Jan. 25, 2011) .........................5 Inline Connection Corp. v. AOL Time Warner Inc., 472 F. Supp. 2d 604 (D. Del. 2007) ...........................................................................................3 Meyers v. Pennypack Woods Home Ownership Assn., 559 F.2d 894 (3d Cir. 1977).......................................................................................................3 Newman v. GHS Osteopathic, Inc., Parkview Hosp. Div., 60 F.3d 153 (3d Cir. 1995).........................................................................................................1 R.C. Olmstead, Inc. v. CU Interface, LLC, 657 F. Supp. 2d 899 (N.D. Ohio 2009), aff’d, 606 F.3d 262 (6th Cir. 2010) ............................4 Rubel v. Eli Lilly & Co., 160 F.R.D. 458 (S.D.N.Y. 1995) ...............................................................................................5 Weisbrot v. Schwimmer, No. CIV A 97-2711 FLW, 2007 WL 2683642 (D.N.J. Sept. 7, 2007) ..................................4, 5 Rules Fed. R. Civ. P. 26 .................................................................................................................1, 2, 3, 4 Fed. R. Civ. P. 37 .............................................................................................................................1 Fed. R. Evid. 403 .........................................................................................................................4, 5 Fed. R. Evid. 702 .............................................................................................................................6 Case 2:15-cv-08017-SDW-LDW Document 209 Filed 06/18/18 Page 3 of 10 PageID: 2961 1 Dr. Umesh Banakar (“Banakar”) has been retained by Sun as its invalidity expert. During the course of his engagement on this matter, Banakar has spent considerable time reviewing Dexcel’s patent, along with prior art and other scholarly sources, in order to arrive at an expert opinion on the question of whether Dexcel’s patent is valid. Based on his scientific knowledge and experience, combined with his examination of Dexcel’s patent, Banakar reached the conclusion that Dexcel’s patent is invalid, on the basis of obviousness. Banakar was not asked, and has not undertaken, to study either Sun or Dexcel’s products, to examine their composition, or to form an opinion as to whether Sun’s product infringes on Dexcel’s patent (assuming that said patent was valid). Despite the fact that Banakar a) was never identified as one of Dexcel’s experts during discovery, b) was engaged as Sun’s expert, and c) was engaged as an invalidity expert and thus has done no study of the infringement facts at issue in this litigation, Dexcel now seeks to designate portions of his testimony to support its infringement position. Such designations are entirely inappropriate and Dexcel should be barred from offering them into evidence. I. DEXCEL HAS FAILED TO MEET THE REQUIREMENTS OF RULE 26 IN DESIGNATING DR. BANAKAR AS DEXCEL’S EXPERT WITNESS Dexcel cannot rely on Banakar’s expert testimony because it failed to meet any of the various requirements set out in Fed. R. Civ. P. 26 that are intended to alert opposing parties to proposed experts, along with their qualifications, opinions and methods, in order to prevent trial by ambush. The consequences for failure to adhere to the disclosure requirements of Rule 26 are governed by Fed. R. Civ. P. 37, which dictates that “the party is not allowed to use that information or witness to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless.” Fed. R. Civ. P. 37(c)(1). See also, Newman v. GHS Osteopathic, Inc., Parkview Hosp. Div., 60 F.3d 153, 156 (3d Cir. 1995) (“Rule 37 is Case 2:15-cv-08017-SDW-LDW Document 209 Filed 06/18/18 Page 4 of 10 PageID: 2962 2 written in mandatory terms and is designed to provide a strong inducement for disclosure of Rule 26(a) material.”) First, Dexcel failed to fulfill its obligation under Fed. R. Civ. P. 26(a)(2)(D) governing the timing of disclosure of expert testimony, which must be made “at the times and in the sequence that the court orders.” Dexcel was required to disclose any expert it intended to rely on at trial no later than the date set for opening expert reports, which were scheduled for service last July. See, [Amended Scheduling Order, D.E. 95] and [Plaintiff’s Request for a Five Day Extension, D.E. 100]. Dexcel did not designate Banakar at that time. Nor did Dexcel identify Banakar as a witness it intended to rely upon at trial, in its infringement case or otherwise, as part of its April pretrial order. [Amended Scheduling Order, D.E. 170]. It was only after the parties agreed to bifurcate infringement and invalidity that Dexcel disclosed its intent to rely on Banakar.1 Pursuant to Rule 26 and this Court’s amended scheduling order, Dexcel’s attempted reliance is improper and too late. Second, even if Dexcel’s disclosure of Banakar had been timely, it still fails to satisfy the substantive disclosure requirements of Rule 26. Parties must submit a written and signed report for every expert they expect to offer, and that report must contain: (i) a complete statement of all opinions the witness will express and the basis and reasons for them; (ii) the facts or data considered by the witness in forming them; (iii) any exhibits that will be used to summarize or support them; (iv) the witness's qualifications, including a list of all publications authored in the previous 10 years; (v) a list of all other cases in which, during the previous 4 years, the witness testified as an expert at trial or by deposition; and 1 Dexcel has never explained nor sought to justify its delay in designating Banakar. Dexcel simply informed Sun on May 2, 2018, after the parties agreed to bifurcation, and apparently because of the agreement to bifurcate, that it intended to submit deposition designations for Banakar. Case 2:15-cv-08017-SDW-LDW Document 209 Filed 06/18/18 Page 5 of 10 PageID: 2963 3 (vi) a statement of the compensation to be paid for the study and testimony in the case. Fed. R. Civ. P. 26(a)(2)(B); see also, Inline Connection Corp. v. AOL Time Warner Inc., 472 F. Supp. 2d 604, 615 (D. Del. 2007) (excluding expert’s opinion on the doctrine of equivalence as it had not been disclosed in his expert report, nor subsequently disclosed in a supplemental report.) Dexcel has not even tried to meet this obligation. The only information Dexcel supplied is a statement of Banakar’s qualifications, which is largely copied and pasted from Sun’s (timely) disclosure of Banakar’s qualifications in his invalidity report first served last July. Notably, Dexcel has not disclosed the substance of Banakar’s opinions that it is planning to use at trial, let alone the materials he considered in reaching those opinions nor the infringement issues his opinions are intended to support. The reason Dexcel fails to supply this information is simple, it’s because they have never developed it - Banakar was never asked by any party to formulate an opinion regarding infringement, the only issue to be addressed at the upcoming trial, and thus it is clear that Dexcel’s intention to rely on Banakar owes more to a desire to prejudice Sun by calling its expert than to elucidate matters for the Court’s understanding. Dexcel’s failure to adhere to its disclosure obligations should result in the exclusion of Banakar from the infringement trial. The Third Circuit has identified four factors (now generally referred to as the “Pennypack Factors”) to consider in determining whether exclusion is warranted: (1) the prejudice or surprise of the party against whom the excluded evidence would have been admitted; (2) the ability of the party to cure the prejudice; (3) the extent to which allowing the evidence would disrupt the orderly and efficient trial of the case or other cases in the court; and (4) bad faith or willfulness in failing to comply with a court order or discovery obligation. See generally, Meyers v. Pennypack Woods Home Ownership Assn., 559 F.2d 894, Case 2:15-cv-08017-SDW-LDW Document 209 Filed 06/18/18 Page 6 of 10 PageID: 2964 4 904 (3d Cir. 1977). Each of these factors weigh in favor of exclusion. Sun was entirely surprised by Dexcel’s designation of Banakar in the most recent Pretrial Order. Expert discovery has closed, and thus Sun is not in a position to further its knowledge. Trial is mere weeks away, and reopening expert discovery at this stage will inevitably delay matters. Finally, Dexcel has willfully failed to honor its disclosure obligations, and the only conclusion to be drawn from its actions is that Dexcel is not acting in good faith. This game playing is inappropriate and should be barred. II. THERE ARE NO EXCEPTIONAL CIRCUMSTANCES IN THIS CASE JUSTIFYING DEXCEL’S DESIGNATION OF DR. BANAKAR’S TESTIMONY Dexcel simply has no right to call Sun’s expert. Neither the Federal Rules of Evidence nor the Federal Rules of Civil Procedure explicitly set out a rule for when a party may call its opposing party’s expert witness in its own case in chief. However, in considering this question federal courts have looked Fed. R. Civ. P. 26’s standard for permitting discovery of consulting experts, who may not be deposed except “on showing exceptional circumstances under which it is impracticable for the party to obtain facts or opinions on the same subject by other means.” Fed. R. Civ. P. 26(b)(4)(D)(ii). See R.C. Olmstead, Inc. v. CU Interface, LLC, 657 F. Supp. 2d 899 (N.D. Ohio 2009), aff’d, 606 F.3d 262 (6th Cir. 2010) (“The overwhelming majority of courts hold that a party may re-designate an expert as non-testifying, and that this insulates the expert from deposition by other parties absent a showing of ‘exceptional circumstances.’”) Judge Wolfson, of the District of New Jersey, has held that the “exceptional circumstances” test is the appropriate inquiry for a court to make when a party seeks to use an opposing party’s expert at trial. Weisbrot v. Schwimmer, No. CIV A 97-2711 FLW, 2007 WL 2683642, at *6 (D.N.J. Sept. 7, 2007) (disallowing defendant from using plaintiff’s expert where that expert had no “specialized skill set that Defendants cannot obtain from another expert” and “Defendants have Case 2:15-cv-08017-SDW-LDW Document 209 Filed 06/18/18 Page 7 of 10 PageID: 2965 5 had more than ample time to obtain any and all experts they require for trial.”). Those few federal courts that have not adopted this test use a balancing methodology under Fed. R. Ev. 403 instead. Under either standard, where a party has the ability to obtain expert testimony without subpoenaing its adversary’s expert, courts overwhelmingly refuse to allow that testimony. See, e.g., Dudley Flying Serv., Inc. v. Ag Air Maint. Servs., Inc., No. 3:13-CV-00156-KGB, 2015 WL 1757886 (E.D. Ark. Apr. 17, 2015) (denying permission to examine adversary’s expert at trial under “special circumstances” test); In re Homestore.com, Inc., No. CV 01-11115 RSWL CWX, 2011 WL 291176 (C.D. Cal. Jan. 25, 2011) (refusing to admit testimony under “exceptional circumstances” test upon finding that proposed testimony was not unique and the party proposing testimony could find another expert); FMC Corp. v. Vendo Co., 196 F. Supp. 2d 1023 (E.D. Cal. 2002) (considering both the “exceptional circumstances” test and the balancing standard and deciding that the testimony was not permitted under either); Rubel v. Eli Lilly & Co., 160 F.R.D. 458 (S.D.N.Y. 1995) (holding that under the balancing principals of FRE 403 “the prejudice to the defendant and the Court’s interest in avoiding cumulative evidence substantially outweigh any legitimate need” for this testimony). Courts are particularly disinclined to permit a party to call its adversary’s expert in an effort at game playing. See Weisbrot, 2007 WL 2683642 at *6 (“it appears that Defendants’ desire to use Dr. Gizzi as an expert arises from nothing more than the fact that Dr. Gizzi was originally retained by Plaintiff”); Rubel, 160 F.R.D. at 460. Since Dexcel has its own infringement experts, there are no “exceptional circumstances” justifying its use of Banakar’s testimony. Case 2:15-cv-08017-SDW-LDW Document 209 Filed 06/18/18 Page 8 of 10 PageID: 2966 6 III. BANAKAR WAS RETAINED AS AN INVALIDITY EXPERT The testimony that Dexcel has identified in its designations is inadmissible because it is opinion testimony that fails to fulfill the requirements of expert testimony. Fed. R. Ev. 702 requires that a party seeking to provide expert testimony must show: “(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.” Sun agrees that Banakar has sufficient scientific and technical knowledge in general to qualify as an expert, which is why Sun designated him as its invalidity expert. In his work to prepare an expert opinion on the validity of Dexcel’s patent, Banakar spent substantial time researching and studying facts and prior art relating to Dexcel’s patent in order to gather sufficient facts and data to render his opinion. However, Banakar has not studied Sun’s product, nor compared it to Dexcel’s, to determine if the ANDA production described in Sun’s ANDA infringes the patents- at-issue. Ultimately, Banakar’s work in this case has not exposed him to “sufficient facts or data” relevant to the infringement controversy to form a reliable opinion as required by the Federal Rules of Evidence. Because Banakar’s expertise is not accompanied by sufficient facts or data on the question of whether Sun’s omeprazole product infringes upon Dexcel’s patent, his testimony on that topic is inadmissible non-expert opinion testimony, notwithstanding the novel argument Dexcel advanced in support of its proposal to offer Banakar as a witness, on the basis that it would be the “testimony of an individual with relevant things to say.”2 2 Comment by Dexcel’s counsel, Eric Stops, during a meet-and-confer regarding the pretrial order, May 30, 2018. Case 2:15-cv-08017-SDW-LDW Document 209 Filed 06/18/18 Page 9 of 10 PageID: 2967 7 IV. CONCLUSION For the reasons detailed above, Sun respectfully requests that the Court bar Dexcel from designating testimony from Dr. Umesh Banakar during the infringement trial. Dated: June 18, 2018 By: s/ Gregory D. Miller Gregory D. Miller Gene Y. Kang RIVKIN RADLER LLP 21 Main Street, Court Plaza South West Wing, Suite 158 Hackensack, New Jersey 07601 (201) 287-2460 Stephen P. Benson (admitted pro hac vice) Kimberly A. Beis (admitted pro hac vice) KATTEN MUCHIN ROSENMAN LLP 525 West Monroe Street Chicago, Illinois 60661-3693 (312) 902-5200 David A. Crichlow (admitted pro hac vice) KATTEN MUCHIN ROSENMAN LLP 575 Madison Avenue New York, New York 10022-2858 (212) 940-8800 Case 2:15-cv-08017-SDW-LDW Document 209 Filed 06/18/18 Page 10 of 10 PageID: 2968