Sanofi-Aventis U.S. LLC et al v. Merck Sharp & Dohme Corp.

ANSWERING BRIEF in Opposition re MOTION to Extend Technical Expert Report Deadlines

D. Del.January 10, 2018

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE SANOFI-AVENTIS U.S. LLC, SANOFI- AVENTIS DEUTSCHLAND GMBH, and SANOFI WINTHROP INDUSTRIE, Plaintiffs, v. MERCK SHARP & DOHME CORP., Defendant. C.A. No. 16-812-RGA DEFENDANT MERCK SHARP & DOHME CORP.’S ANSWERING BRIEF IN RESPONSE TO PLAINTIFFS’ MOTION TO EXTEND EXPERT REPORT DEADLINES Defendant Merck Sharp & Dohme Corp. (“Merck”) hereby submits its answering brief in response to the motion filed by Plaintiffs Sanofi-Aventis U.S. LLC et al. (“Sanofi”) to extend expert report deadlines. I. INTRODUCTION Sanofi seeks to delay most of the dates on the schedule in this case by 60 days—and vacate the trial date—because it does not want to submit opening expert reports in support of Sanofi’s infringement contentions before the Court issues its ruling on claim construction. However, the Court’s Scheduling Order, in typical Delaware fashion, did not link the date for opening expert reports to the issuance of the claim construction ruling. The parties have proceeded on the basis that expert reports would be due as scheduled regardless of whether a claim construction ruling had issued. For example, Merck disclosed its invalidity and non- infringement contentions based on the parties’ alternative claim constructions. Similarly, Sanofi Case 1:16-cv-00812-RGA-MPT Document 189 Filed 01/10/18 Page 1 of 6 PageID #: 4667 2 had no trouble providing its infringement contentions in a similar manner. And the experts have been drafting their reports in that manner as well. Now, just days before the expert report deadline, Sanofi seeks at the last minute to overhaul the schedule, losing the trial date in the process, because it does not want its expert to provide opinions on the alternative constructions. We do not know Sanofi’s reason. Perhaps Sanofi’s expert has balked at providing an opinion consistent with Sanofi’s position that Merck’s product infringes because miniscule amounts of polysorbate are allegedly present in Merck’s products due to the use of a cleaning solvent – which certainly would have no impact on stability whatsoever. Perhaps Sanofi is concerned about how its expert’s infringement opinions under Merck’s proposed construction might affect Sanofi’s positions on validity. Perhaps Sanofi seeks to conduct more testing or retain a new expert. Whatever Sanofi’s last minutes concerns, that is no reason to delay expert reports, much less trial. Indeed, Sanofi’s changes to the schedule would badly prejudice Merck. If Sanofi can delay a ruling in this case, it could keep Merck’s product off the market for several additional months even if Merck ultimately prevails at trial. II. BACKGROUND The Scheduling Order (D.I. 17, D.I. 138) entered in this matter scheduled a four-day trial to start on May 29, 2018. The Scheduling Order sets dates for other events leading up to trial, including the deadlines for the pretrial order, close of expert discovery, and three rounds of expert reports. Merck has already agreed to a 30-day extension on expert reports, so that opening expert reports are now due January 16, 2017. Sanofi proposes to push all of those dates back at least 60 days, and to delay trial by as much as four months. Case 1:16-cv-00812-RGA-MPT Document 189 Filed 01/10/18 Page 2 of 6 PageID #: 4668 3 III. ARGUMENT Under Fed. R. Civ. P. 16, the Court’s schedule “may be modified only for good cause and with the judge’s consent.” To establish good cause, Sanofi must show that “the schedule cannot be met despite [its] diligence.” Intellectual Ventures I LLC v. Check Point Software Techs. Ltd., 215 F. Supp. 3d 314, 340 (D. Del. 2014) (under Rule 16, “[g]ood cause is present when the schedule cannot be met despite the moving party’s diligence.”). Here, Sanofi does not even allege that it will be unable to prepare its opening expert reports in time, even after Merck agreed to Sanofi’s earlier request for a one month extension. Sanofi argues that the deadlines for expert reports—and the subsequent dates including trial—should be extended “because the claim construction ruling is very likely to have an effect on Plaintiffs’ theories of infringement concerning the patents-in-suit, the number of asserted claims, Defendant’s selection of prior art invalidity references, and Defendant’s affirmative defenses.” However, the fact that a court has not issued a claim construction ruling is not good cause for delaying expert reports. In Delaware, expert reports are routinely due before the claim construction ruling issues, and therefore parties in Delaware “regularly” address alternative constructions in their reports. Xerox Corp. v. Google, Inc., Claim Constr. Hr’g. Tr. (C.A. No. 10–136 D.I. 197 at 111) (observing that within District of Delaware, parties “regularly” have to write expert reports addressing alternative constructions when Court does not issue its final claim construction ruling until after expert reports are due). Indeed, courts have found that “[w]hen claim construction remains an open issue at the time the parties serve expert reports and infringement contentions, the parties have an obligation ‘to prepare for the fact that the court may adopt [the other party’s claim] construction.’” St. Clair Intellectual Prop. Consultants, Inc. v. Matsushita Ele. Indus. Case 1:16-cv-00812-RGA-MPT Document 189 Filed 01/10/18 Page 3 of 6 PageID #: 4669 4 Co., Ltd., 2012 WL 1015993, at *5 (D. Del. March 26, 2012), aff’d (Fed. Cir. 2013), quoting Union Carbide Chems. & Plastics Tech. Corp. v. Shell Oil Co., 270 F. Supp. 2d 519, 524 (D. Del. 2003). Here, the Court’s schedule is consistent with this general approach in Delaware – the dates for expert reports and other events are not conditioned on the Court first construing the claims. The parties have been litigating on that basis so far, and there is no reason to change now. It is routine and straightforward to write the expert reports to disclose opinions addressing infringement and invalidity under both parties’ proposed constructions. Sanofi asserts that it “will be able to further limit the number of patents-in-suit and asserted claims” if the Court grants an extension and therefore “maximize efficiencies” in expert discovery. But Sanofi does not need an extension on expert reports to drop asserted patents and claims; it can do that whenever the Court issues its claim construction ruling. The only “efficiency” Sanofi might have gained from an extension is the possibility of drafting shorter opening expert reports. But that does not meet the standard for good cause, and in any case, Sanofi lost that modest benefit by waiting until the week before opening reports to file this motion. Merck’s experts, and undoubtedly Sanofi’s experts, have already been preparing their reports on the basis on alternative claim constructions. Sanofi’s true agenda may be to avoid having its experts take positions in their opening reports that might conflict with positions Sanofi would like to take with respect to validity. However, that is not a basis for an extension, particularly given the “obligation” in Delaware to address alternative claim constructions in expert reports if the claim construction ruling has not issued. Case 1:16-cv-00812-RGA-MPT Document 189 Filed 01/10/18 Page 4 of 6 PageID #: 4670 5 Moreover, Sanofi’s request should be denied in light of the prejudice to Merck of postponing trial. Merck has tentative approval for its NDA. If Merck’s product does not infringe a valid claim of Sanofi’s patents—as Merck expects to show at trial—then Merck should be allowed to launch its product as soon as this litigation is resolved. Sanofi argues that if the court can hold trial by the end of September, “there would be more than adequate time to accommodate post-trial briefing and a final decision prior to the expiration of the 30-month stay.” Sanofi, however, ignores the fact that an earlier ruling from this Court in Merck’s favor would lift the stay, regardless of whether the 30 months has elapsed. Thus, the 2-4 month postponement of trial that Sanofi seeks could keep Merck off the market for months longer than would be the case under the current schedule, costing Merck significant revenues due to lost sales. The question of when Merck should be permitted to bring its product to the market should be decided on the merits, not through an extension to the expert report deadline. According to Sanofi, the “efficiencies” from not having to address alternative claim constructions in its opening expert reports would “outweigh any prejudice to Defendant in moving the trial date.” Sanofi has no basis for that claim; it simply dismisses the prejudice to Merck out of hand. Any alleged “efficiencies” from submitting somewhat shorter opening expert reports would be outweighed by the inefficiency of extending the litigation by at least two more months, if not much longer. Indeed, Sanofi may be seeking an extension at this late date to give it time to submit additional expert reports or conduct additional testing. Merck notes that after Sanofi filed its motion for an extension on January 8th, it disclosed another expert witness to Merck the same day. Thus, if anything, providing Sanofi two extra months to re-consider and revise its opinions and testing will likely lead to more work, not less. Case 1:16-cv-00812-RGA-MPT Document 189 Filed 01/10/18 Page 5 of 6 PageID #: 4671 6 Given that the experts on both sides have almost completed expert reports based on alternative claim constructions, the best course for achieving “efficiencies” is for the parties to serve those reports as prepared. When the court provides its claim constructions, the case will proceed based on the opinions provided under the constructions selected by the court. For the reasons set forth above, Merck respectfully requests that the Court deny Sanofi’s motion. Dated: January 10, 2018 OF COUNSEL: Raymond N. Nimrod Gregory D. Bonifield John P. Galanek Amanda Antons Quinn Emanuel Urquhart & Sullivan, LLP 51 Madison Avenue, 22nd Floor New York, NY 10010 (212) 849-7000 CONNOLLY GALLAGHER LLP /s/ Arthur G. Connolly, III Arthur G. Connolly, III (#2667) Ryan P. Newell (#4744) Mary I. Akhimien (#5448) The Brandywine Building 1000 West Street Wilmington, DE 19801 (302) 757-7300 aconnolly@connollygallagher.com rnewell@connollygallagher.com makhimien@connollygallagher.com Attorneys for Defendant Merck Sharp & Dohme Corp. Case 1:16-cv-00812-RGA-MPT Document 189 Filed 01/10/18 Page 6 of 6 PageID #: 4672