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Amgen Inc. v. Sanofi

United States District Court, D. Delaware

February 8, 2019


          Melanie K. Sharp (argued), James L. Higgins, and Michelle M. Ovanesian, YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE; William G. Gaede III, MCDERMOTT WILL & EMERY LLP, Menlo Park, CA; Sarah C. Columbia and K. Nicole Clouse, MCDERMOTT WILL & EMERY LLP, Boston, MA; Rebecca Harker Duttry, MCDERMOTT WILL & EMERY LLP, Washington, D.C.; Christopher B. Mead, LONDON & MEAD, Washington, D.C.; Keith R. Hummel, David N. Greenwald, Lauren A. Moskowitz, Geoffrey G. Hu, and Sharonmoyee Goswami, CRAVATH, SWAINE & MOORE LLP, New York, NY; Lauren Martin, QUINN EMANUEL URQUHART & SULLIVAN, LLP, Boston, MA, attorneys for Plaintiffs.

          David E. Wilks and Scott B. Czerwonka, WILKS, LUKOFF & BRACEGIRDLE, LLC, Wilmington, DE; Matthew M. Wolf (argued), ARNOLD & PORTER KAYE SCHOLER LLP, Washington, D.C.; David K. Barr and Daniel L. Reisner, ARNOLD & PORTER KAYE SCHOLER LLP, New York, NY; John Josef Molenda and Vishal Chandra Gupta, STEPOE & JOHNSON LLP, New York, NY; Paul D. Clement and George W. Hicks, Jr., KIRKLAND & ELLIS LLP, Washington, D.C., attorneys for Defendants.



         Currently pending before the Court is Defendants' Motion for Judgment on the Pleadings under Rule 12(c). (D.I. 448). The Parties have fully briefed the issues. (D.I. 449, 452, 453). The Court heard oral argument on January 3, 2019. (D.I. 703). For the following reasons, Plaintiffs' Motion is granted-in-part and denied-in-part.

         I. BACKGROUND

         Plaintiffs Amgen, Inc., Amgen Manufacturing Limited, and Amgen USA Inc. (collectively "Plaintiffs") filed suit against Defendants Sanofi, Sanofi-Aventis U.S. LLC, Aventisub LLC, and Regeneron Pharmaceuticals, Inc. (collectively "Defendants") on October 17, 2014. (D.I. 1). Plaintiffs assert that Defendants' manufacture and sale of Praluent, a drug that treats patients with high levels of low density lipoprotein cholesterol, infringes claims of U.S. Patent Nos. 8, 829, 165 ("the '165 patent") and 8, 859, 741 ("the '741 patent") (collectively, "the asserted patents"). (D.I. 1). The parties stipulated to infringement of certain claims on February 22, 2016. (D.I. 235). During trial, the Court issued two Rule 50(a) orders. The Court determined that as a matter of law, the patent claims were non-obvious and Plaintiffs had failed to meet the burden of showing that Defendants' infringement was willful. (D.I. 345 at 5:2-3; D.I. 302). The case was submitted to the jury on the remaining invalidity issues: lack of written description and enablement. The trial resulted in a judgment for Plaintiffs that the patents are not invalid. (D.I. 304). After trial, Defendants moved for renewed judgment as a matter of law on patent validity and for a new trial. (D.I. 331, 332). Plaintiffs moved for a permanent injunction. (D.I. 336). The Court denied Defendants' post-trial motions and entered final judgment in favor of Plaintiffs under Rule 54(b) on January 3, 2017. (D.I. 390, 391). The Court granted Plaintiffs' motion for a permanent injunction on January 5, 2017. (D.I. 392).

         Defendants appealed from the Rule 54(b) judgment. (D.I. 402). The Federal Circuit determined that the Court had erred in precluding post-priority date evidence relevant to written description and enablement, and by giving faulty jury instructions on written description. Amgen Inc. v. Sanofi, 872 F.3d 1367, 1371 (Fed. Cir. 2017). The Federal Circuit remanded for a new trial on written description and enablement. Id. Defendants now move for judgment on the pleadings regarding Plaintiffs' willful infringement claim. (D.I. 448).


         A Rule 12(c) motion for judgment on the pleadings is reviewed under the same standard as a Rule 12(b)(6) motion to dismiss when the Rule 12(c) motion alleges that the plaintiff failed to state a claim upon which relief can be granted. See Turbe v. Gov 't of the Virgin Islands, 938 F.2d 427, 428 (3d Cir. 1991); Revell v. Port Auth, 598 F.3d 128, 134 (3d Cir. 2010). The court must accept the factual allegations in the complaint and take them in the light most favorable to the non-moving party. See Erickson v. Pardus, 551 U.S. 89, 94 (2007); Christopher v. Harbury, 536 U.S. 403, 406 (2002). "When there are well-ple[d] factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief." Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009). The court must "draw on its judicial experience and common sense" to make the determination. See Id. In ruling on a motion for judgment on the pleadings, the court is generally limited to the pleadings. Mele v. Fed. Reserve Bank of N.Y., 359 F.3d 251, 257 (3d Cir. 2004). The court may, however, consider documents incorporated into the pleadings and those that are in the public record. Pension Ben. Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir. 1993).


         Defendants argue Plaintiffs have waived their willful infringement claim by failing to cross-appeal the Court's adverse ruling of no willfulness as a matter of law ("the willfulness ruling"), and that Plaintiffs' preservation arguments are unavailing. (D.I. 449 at 4, 7). Plaintiffs argue that no waiver has occurred because 1) the willfulness ruling was not a final judgment that could be appealed, 2) even if final, an appeal of the willfulness ruling would have been dismissed, and 3) the amended 54(b) judgment recognized that the willfulness ruling was superseded by Halo. (D.I. 452 at 9-10, 14).

         Courts routinely hold that a party that fails to cross-appeal an adverse ruling has waived that claim on remand. See ART Midwest Inc. v. Atlantic Limited P 'ship XII, 742 F.3d 206, 211 (5th Cir. 2014); Lazare Kaplan Int'l Inc. v. Photoscribe Techs., Inc., 714 F.3d 1289, 1294 (Fed. Cir. 2013). Waiver is only proper where the party who failed to cross-appeal was required to do so. "[A] party must file a cross-appeal if, although successful in the overall outcome in the district court, the party seeks, on appeal, to lessen the rights of its adversary or to enlarge its own rights." Lazare, 714 F.3d at 1293; see also Aventis Pharma S.A. v. Hospira, Inc., 637 F.3d 1341, 1343 (Fed. Cir. 2011) ("A cross-appeal may only be filed when a party seeks to enlarge its own rights under the judgment or to lessen the rights of its adversary under the judgment.") (cleaned up).

         A. The Willfulness Ruling was an Appealable Judgment under 28 U.S.C. § 1292

         The parties dispute whether the Court's Rule 50(a) JMOL ruling of no willful infringement was subject to appeal. (D.I. 449 at 7-8; see D.I. 453 at 9). Specifically, Plaintiffs assert that the willfulness ruling was not "certified" as a final judgment because it was not included in the Rule 54(b) judgment from which Defendants appealed. (D.I. 452 at 9). I disagree with Plaintiffs and ...

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