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Amgen Inc. v. Sanofi

United States District Court, D. Delaware

August 28, 2019

AMGEN INC., AMGEN MANUFACTURING, LIMITED, and AMGEN USA INC., Plaintiffs;
v.
SANOFI, SANOFI-AVENTIS U.S. LLC, AVENTISUB LLC, f/d/b/a AVENTIS PHARMACEUTICALS INC., and REGENERON PHARMACEUTICALS, INC., Defendants.

          Melanie K. Sharp, James L. Higgins, and Michelle M. Ovanesian, YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE; William G. Gaede, III (argued), MCDERMOTT WILL & EMERY LLP, Menlo Park, CA; Sarah Chapin Columbia and K. Nicole Clouse, MCDERMOTT WILL & EMERY LLP, Boston, MA; Rebecca Harker Durtry, MCDERMOTT WILL & EMERY LLP, Washington, DC; Christopher B. Mead, LONDON & MEAD, Washington, DC; Keith R. Hummel, David N. Greenwald, Lauren A. Moskowitz, Geoffrey G Hu, and Sharonmoyee Goswami, CRAVATH, SWAINE & MOORE LLP, New York, NY; Lauren Martin and Megan Y. Yung, 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, DC; David K. Barr and Daniel L. Reisner, ARNOLD & PORTER KAYE SCHOLER LLP, New York, NY; Deborah E. Fishman, ARNOLD & PORTER KAYE SCHOLER LLP, Palo Alto, CA; John Josef Molenda and Vishal Chandra Gupta, STEPTOE & JOHNSON LLP, New York, NY, attorneys for Defendants.

          MEMORANDUM OPINION

          ANDREWS U.S. DISTRICT JUDGE

         Currently pending before the Court are Defendants' Renewed Motion for Judgment as a Matter of Law ("JMOL") that the Asserted Patent Claims are Invalid and, in the alternative, Motion For a New Trial.[1] (D.I. 883, 886). I have reviewed the briefing for these motions. (D.I. 885, 888, 922, 923, 982, 983). I heard helpful oral argument on August 8, 2019. (Hr'g Tr.). The Parties submitted supplemental letters after argument. (D.I. 1045, 1046).

         I. BACKGROUND

         Plaintiffs Amgen, Inc., Amgen Manufacturing, Ltd., and Amgen USA Inc. filed suit against Defendants Sanofi, Sanofi-Aventis U.S. LLC, Aventisub LLC, and Regeneron Pharmaceuticals, Inc. on October 17, 2014 alleging infringement of U.S. Patent Nos. 8, 583, 698 ("the '698 patent"), 8, 829, 165 ("the '165 patent"), and 8, 859, 741 ("the '741 patent"). (D.I. 1, 10, 184). Plaintiffs later amended the Complaint to add claims of infringement of U.S. Patent Nos. 8, 871, 913 ("the '913 patent"), 8, 871, 914 ("the '914 patent"), 8, 883, 983 ("the '983 patent"), and 8, 889, 834 ("the '834 patent"). (D.I. 184). The parties stipulated to infringement of selected claims for trial, [2] (D.I. 235), and tried issues of validity to the jury in March 2016. During trial, the Court granted JMOL of non-obviousness and no willful infringement. (D.I. 345 at 1076:6-1077:6; D.I. 302). The issue of damages was not tried to the jury. (D.I. 346 at 1285:16-20). The jury determined the patents were valid. (D.I. 303). Plaintiffs moved for a permanent injunction (D.I. 306), which was granted (D.I. 392), and then stayed. (D.I. 401). Defendants appealed. (D.I. 402).

         On appeal, the Federal Circuit affirmed the grant of Plaintiffs' JMOL of non-obviousness and the denial of Defendants' JMOL of no written description and enablement but reversed for errors made in evidentiary rulings and jury instructions and remanded the case for a new trial on written description and enablement. Amgen Inc. v. Sanofi, 872 F.3d 1367, 1381-82 (Fed. Cir. 2017). The Federal Circuit also vacated the permanent injunction. Id.

         On remand, the Parties tried the issues of written description and enablement to the jury.[3]The jury verdict found claim 7 of the '741 patent and claims 19 and 29 of the '165 patent valid, but invalidated claims 7 and 15 of the '165 patent for lack of written description. (D.I. 817). Defendants now ask that the Court overturn the jury verdict under Federal Rule of Civil Procedure 50(b) or grant a new trial under Rule 59. (D.I. 883, 886).

         The claims of the '165 patent still in dispute read as follows:

1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: SI53, 1154, P155, R194, D238, A239, 1369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.
19. The isolated monoclonal antibody of claim 1 wherein the isolated monoclonal antibody binds to at least two of the following residues S153, 1154, P155, R194, D238, A239, 1369, S372, D374, C375, T377, C378, F379, V380, or S381 of PCSK9 listed in SEQ ID NO:3.
29. A pharmaceutical composition comprising an isolated monoclonal antibody, wherein the isolated monoclonal antibody binds to at least two of the following residues S153, 1154, P155, R194, D238, A239, 1369, S372, D374, C375, T377, C378, F379, V380, or S381 of PCSK9 listed in SEQ ID NO:3 and blocks the binding of PCSK9 to LDLR by at least 80%.

         ('165 patent, els. 1, 19, 29 (disputed claims bolded)). The claim of the '741 patent still in dispute reads as follows:

1. An isolated monoclonal antibody that binds to PCSK9, wherein the isolated monoclonal antibody binds an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO: 3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.
2. The isolated monoclonal antibody of claim 1, wherein the isolated monoclonal antibody is a neutralizing antibody.
7. The isolated monoclonal antibody of claim 2, wherein the epitope is a functional epitope.

         ('741 patent, els. 1-2, 7 (disputed claim bolded)).

         II. LEGAL STANDARD

         A. JUDGMENT AS A MATTER OF LAW

         Judgment as a matter of law is appropriate if "the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for [a] party" on an issue. Fed.R.Civ.P. 50(a)(1). "Entry of judgment as a matter of law is a 'sparingly' invoked remedy, granted only if, viewing the evidence in the light most favorable to the nonmovant and giving it the advantage of every fair and reasonable inference, there is insufficient evidence from which a jury reasonably could find liability." Marra v. Phila. Hous. Auth., 497 F.3d 286, 300 (3d Cir. 2007) (cleaned up).

         "To prevail on a renewed motion for JMOL following a jury trial, a party must show that the jury's findings, presumed or express, are not supported by substantial evidence or, if they were, that the legal conclusion(s) implied [by] the jury's verdict cannot in law be supported by those findings." Pannu v. Iolab Corp., 155 F.3d 1344, 1348 (Fed. Cir. 1998) (alterations in original). "'Substantial' evidence is such relevant evidence from the record taken as a whole as might be accepted by a reasonable mind as adequate to support the finding under review." Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed. Cir. 1984).

         In assessing the sufficiency of the evidence, the Court must give the non-moving party, "as [the] verdict winner, the benefit of all logical inferences that could be drawn from the evidence presented, resolve all conflicts in the evidence in his favor and, in general, view the record in the light most favorable to him." Williamson v. Consol Rail Corp., 926 F.2d 1344, 1348 (3d Cir. 1991). The Court may "not determine the credibility of the witnesses [nor] substitute its choice for that of the jury between conflicting elements in the evidence." Per kin-Elmer, 732 F.2d at 893. Rather, the Court must determine whether the evidence supports the jury's verdict. See Dawn Equip. Co. v. Ky Farms Inc., 140 F.3d 1009, 1014 (Fed. Cir. 1998); Gomez v. Allegheny Health Servs. Inc., 71 F.3d 1079, 1083 (3d Cir. 1995) (describing standard as "whether there is evidence upon which a reasonable jury could properly have found its verdict"); 9B Charles Alan Wright & Arthur R. Miller, Federal Practice and Procedure § 2524 (3d ed. 2008) ("The question is not whether there is literally no evidence supporting the party against whom the motion is directed but whether there is evidence upon which the jury might reasonably find a verdict for that party.").

         Where the moving party bears the burden of proof, the Third Circuit applies a different standard. This standard '"requires the judge to test the body of evidence not for its insufficiency to support a finding, but rather for its overwhelming effect.'" Fireman's Fund Ins. Co. v. Videfreeze Corp., 540 F.2d 1171, 1177 (3d Cir. 1976) (quoting Mihalchak v. Am. Dredging Co., 266 F.2d 875, 877 (3d Cir. 1959)). The Court '"must be able to say not only that there is sufficient evidence to support the finding, even though other evidence could support as well a contrary finding, but additionally that there is insufficient evidence for permitting any different finding.'" Id. at 1177 (quoting Mihalchak, 266 F.2d at 877).

         B. NEW TRIAL

         Federal Rule of Civil Procedure 59(a)(1)(A) provides, in pertinent part: "The court may, on motion, grant a new trial on all or some of the issues-and to any party- .. . after a jury trial, for any reason for which a new trial has heretofore been granted in an action at law in federal court . . . ." Among the most common reasons for granting a new trial are: (1) the jury's verdict is against the clear weight of the evidence, and a new trial must be granted to prevent a miscarriage of justice; (2) newly discovered evidence exists that would likely alter the outcome of the trial; (3) improper conduct by an attorney or the court unfairly influenced the verdict; or (4) the jury's verdict was facially inconsistent. See Zarow-Smith v. N.J. Transit Rail Operations, Inc., 953 F.Supp. 581, 584-85 (D.N.J. 1997).

         The decision to grant or deny a new trial is committed to the sound discretion of the district court. See Allied Chem. Corp. v. Daiflon, Inc., 449 U.S. 33, 36 (1980); Olefins Trading, Inc. v. Han Yang Chem. Corp., 9 F.3d 282, 289 (3d Cir. 1993) (reviewing district court's grant or denial of new trial motion under the "abuse of discretion" standard). Although the standard for granting a new trial is less rigorous than the standard for granting judgment as a matter of law-in that the Court need not view the evidence in the light most favorable to the verdict winner-a new trial should only be granted where "a miscarriage of justice would result if the verdict were to stand," the verdict "cries out to be overturned," or where the verdict "shocks [the] conscience." Williamson, 926 F.2d at 1352-53.

         III. DISCUSSION

         A. Judgment as a Matter of Law of No. Written Description

         Defendants argue that no reasonable jury could conclude that the claims are supported by written description under either the representative species test or the structural features test. (D.I. 888 at 4-5).

         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. "This inquiry, as we have long held, is a question of fact. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context." Ariad, 598 F.3d at 1351 (internal citations omitted). For patents that claim a broad genus (a major class or kind of thing) while disclosing only species of that genus (subclasses), the written description requirement is more specific. There are two tests. They are the representative species test and the structural features test. The Federal Circuit has summarized their requirements as follows:

Demonstrating possession "requires a precise definition" of the invention. To provide this "precise definition" for a claim to a genus, a patentee must disclose "a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can visualize or recognize the members of the genus."

Amgen, 872 F.3d at 1373 (quoting Ariad, 598 F.3d at 1350).

         The representative species test does not require disclosure of every species in the genus and there is no bright-line rule "governing [] the number of species that must be disclosed to describe a genus claim, as this number necessarily changes with each invention, and it changes with progress in a field." Ariad, 598 F.3d at 1351. However, "merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species." Id. at 1350. "One needs to show that . . . one has conceived and described sufficient representative species encompassing the breadth of the genus." AbbVie, 759 F.3d at 1300.

         Under the structural features test, "[f]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function," such that disclosure of the function implicitly discloses the common structural features of the genus. Ariad, 598 F.3d at 1350.

         "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). Because lack of written description, "like any other ground of invalidity, must be established by clear and convincing evidence," Defendants' burden on a JMOL motion is "doubly high: it must show that no reasonable jury could have failed to conclude that [Defendants'] case had been established by clear and convincing evidence." Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1353 (Fed. Cir. 2003) (internal citation omitted).

         I start with the representative species test. Defendants argue that to satisfy the representative species test in the antibody context, the patentee "must adequately describe representative antibodies to reflect the structural diversity of the claimed genus" and "describe some species representative of antibodies that are structurally similar to" infringing antibodies. AbbVie, 759 F.3d at 1301. Defendants argue that Plaintiffs have not satisfied the representative species test because the undisputed evidence at trial indicated that the amino acid sequences of the disclosed antibodies and the infringing Competitor Antibodies[4] were completely different from one another. (D.I. 888 at 6-7). Plaintiffs argue that there was substantial evidence submitted at trial supporting a jury finding that the disclosed antibodies were representative of the structural diversity of the genus, including the Competitor Antibodies. (D.I. 923 at 5-6).

         I agree with Plaintiffs that substantial evidence supports the jury verdict under the representative species test. The record contains contradictory evidence on (1) what the appropriate comparison metric was, (2) whether there was sufficient similarity between the amino acid sequences of the Competitor Antibodies and the disclosed examples in the patents, and (3) whether there was functional similarity between the Competitor Antibodies and the disclosed examples in the patents.

         First, Plaintiffs' experts repeatedly disputed the use of amino acid sequence as an appropriate comparison to determine whether the disclosed species were representative of the genus. (D.I. 865 at 638:8-11, 768:18-20, 765:10-766:12, 769:14-770:24). Plaintiffs' experts testified that three-dimensional structure was the appropriate metric for comparison and presented substantial evidence of similarity in the three-dimensional structure of the antibodies disclosed in the patent and the Competitor Antibodies.[5] (Id. at 621:5-629:1, 633:12-637:17, 764:6-767:15, 724:9-10, 725:21-727:4, 772:154-775:17; D.I. 864 at 449:5-9).

         Second, even if amino acid sequence was the appropriate metric for comparison, substantial evidence supported a finding of structural similarity between the Amgen Antibodies and the Competitor Antibodies. The amino acid sequence differences between the Competitor Antibodies are not as extreme as in AbbVie. In AbbVie, the Court determined that "[a]ll of the antibodies described in AbbVie's patents were derived from Joe-9 and have VH3 type heavy chains and Lambda type light chains" and "the patents [did] not describe any example [] of fully human IL-12 antibodies having heavy and light chains other than the VH3 and Lambda types." AbbVie, 759 F.3d at 1300. Unlike there, here there was testimony of 80% similarity between the disclosed antibodies and the Competitor Antibodies' amino acid sequences, (D.I. 864 at 371:2-10, 374:19-24), and the disclosed antibodies cover more classes of antibodies than the patent disclosed in AbbVie. (D.I. 865 at 771:3-11). Dr. Rees testified that there are eight different families of binding and blocking antibodies disclosed by the patents. (D.I. 865 at 771:3-11).

         Third, Plaintiffs presented substantial evidence of functional similarity. There was significant testimony that the antibodies disclosed in the 2008 patent application, while binding to different residues[6] across the "sweet spot," blocked PCSK9 binding to LDL-R through a variety of binding interactions. (D.I. 864 at 471:24-372:6; D.I. 865 at 630:14-25, 649:10-650:1, 651:1-652:11).

         The jury was entitled to credit the testimony of Plaintiffs' experts. Thus, substantial evidence in the record supports the jury verdict of validity under the representative species test.

         Because satisfaction of the representative species test is sufficient to support a finding of validity under written description, I need not address the Common Structural Features Test. Defendants have failed to show "that no reasonable jury could have failed to conclude that [Defendants'] case [for lack of written description] had been established by clear and convincing evidence." Boehringer, 320 F.3d at 1353 (internal citation omitted). I will therefore deny Defendants' motion for JMOL on the issue of written description.

         B. Judgment as a Matter of Law of No. Enablement

         Defendants argue that no reasonable jury could conclude that the asserted claims were enabled. (D.I. 888 at 13-14). Defendants advance two arguments: (1) the claims are not enabled because the vast majority of antibodies within the full scope of the claims are impossible to make, and (2) undue experimentation is required to make antibodies within the claimed genus. (Id. at 14). The Parties agreed at oral argument ...


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