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Amgen Inc. v. Sanofi

United States District Court, D. Delaware

January 18, 2019


          Melanie K. Sharp, 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, 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 are Plaintiffs' Motion for Partial Summary Judgment (D.I. 634), Defendants' Cross-Motion for Summary Judgment on Estoppel (D.I. 673), and Defendants' Motion for Summary Judgment on Invalidity. (D.I. 630). The Parties have fully briefed the issues. (D.I. 631, D.I. 635, D.I. 674, D.I. 678, D.I. 691, D.I. 693). For the following reasons, Plaintiffs' Motion for Partial Summary Judgment and Defendants' Motion for Summary Judgment on Invalidity are DENIED. Defendants' Cross-Motion is GRANTED.

         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 "Amgen 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) rulings. 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 issues: written description and enablement of the patent claims. 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. (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 had improperly instructed the jury 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.

         The parties now move for summary judgment. Defendants move for summary judgment that the asserted patents are "invalid on written description and enablement grounds." (D.I. 631 at 6; D.I. 630). Plaintiffs move for partial summary judgment to "estop Defendants from arguing that Amgen's selected claims lack written description and enablement." (D.I. 635 at 8; D.I. 634). Defendants cross-move for summary judgment on estoppel. (D.I. 673).


         "The court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). The moving party has the initial burden of proving the absence of a genuinely disputed material fact relative to the claims in question. Celotex Corp. v. Catrett, 477 U.S. 317, 330 (1986). Material facts are those "that could affect the outcome" of the proceeding, and "a dispute about a material fact is 'genuine' if the evidence is sufficient to permit a reasonable jury to return a verdict for the nonmoving party." Lamont v. New Jersey, 637 F.3d 177, 181 (3d Cir. 2011) (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)). The burden on the moving party may be discharged by pointing out to the district court that there is an absence of evidence supporting the non-moving party's case. Celotex, 477 U.S. at 323.

         The burden then shifts to the non-movant to demonstrate the existence of a genuine issue for trial. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87 (1986); Williams v. Borough of West Chester, Pa., 891 F.2d 458, 460-61 (3d Cir. 1989). A non-moving party asserting that a fact is genuinely disputed must support such an assertion by: "(A) citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations ..., admissions, interrogatory answers, or other materials; or (B) showing that the materials cited [by the opposing party] do not establish the absence ... of a genuine dispute ...." Fed.R.Civ.P. 56(c)(1).

         When determining whether a genuine issue of material fact exists, the court must view the evidence in the light most favorable to the non-moving party and draw all reasonable inferences in that party's favor. Scott v. Harris, 550 U.S. 372, 380 (2007); Wishkin v. Potter, 476 F.3d 180, 184 (3d Cir. 2007). A dispute is "genuine" only if the evidence is such that a reasonable jury could return a verdict for the non-moving party. Anderson, 477 U.S. at 247-49. If the non-moving party fails to make a sufficient showing on an essential element of its case with respect to which it has the burden of proof, the moving party is entitled to judgment as a matter of law. See Celotex Corp., 477 U.S. at 322.


         A. Defendants' Motion for Summary Judgment of Invalidity

         Defendants ask the Court for summary judgment of invalidity for lack of written description and no enablement. (D.I. 630). Plaintiffs assert that genuine disputes of material fact preclude summary judgment. (D.I. 678 at 5). I agree with Plaintiffs.

         1. Written Description

         The written description requirement contained in 35 U.S.C. § 112, ¶ 1 requires that the specification "clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed." Ariad Pharm., Inc., v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (cleaned up). "In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Id. The written description inquiry is a question of fact. See Id. Although it is a question of fact, "[c]ompliance with the written description requirement... is amenable to summary judgment in cases where no reasonable fact finder could return a verdict for the non-moving party." PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008). "A party must prove invalidity for lack of written description by clear and convincing evidence." Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682 (Fed. Cir. 2015).

         Defendants assert that no disputes of material fact exist and that the patent is invalid for lack of written description. (D.I. 631 at 14). Plaintiffs argue that there are genuine disputes of material facts under both the common structural features test and representative species test. (D.I. 678 at 6-7). I agree with Plaintiffs that genuine issues of material fact preclude summary judgment on the written description defense.

         First, the parties dispute whether the specification discloses a common structural feature of the claimed antibodies. (D.I. 631 at 15-17; D.I. 678 at 9-11). Defendants argue that the Federal Circuit's opinion in Amgen stands for the proposition that an antibody cannot be described by its function-binding to an antigen. (D.I. 631 at 16-17). However, in Amgen, the Federal Circuit recognized that it is "hotly disputed [whether] knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies." 872 F.3d at 1378. The parties' experts continue to dispute whether the function of binding correlates to the structure of the antibody. (D.I. 631 at 16-17; D.I. 678 at 10-11). ...

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