Amgen Inc. v. Hospira, Inc.

336 F.Supp.3d 333

AMGEN INC. and Amgen Manufacturing, Limited, Plaintiffs,

v.HOSPIRA, INC., Defendant.

Civil Action No. 15-cv-839-RGA

United States District Court, D. Delaware.

Signed August 27, 2018

Robert W. Whetzel and Jason J. Rawnsley, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; Kevin M. Flowers, Mark H. Izraelewicz, John R. Labbé, Julianne M. Hartzell, Benjamin T. Horton, Tiffany D. Gehrke, and Douglas G. Bolesch, MARSHALL, GERSTEIN & BORUN LLP, Chicago, IL; Nicholas Groombridge, Eric Alan Stone, Jennifer H. Wu, and Stephen A Maniscalco, PAUL, WEISS, RIFKIND, WHARTON & GARRISON LLP, New York, NY., Attorneys for Plaintiffs

Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP, Wilmington, DE; Thomas J. Meloro, Michael W. Johnson, Heather M. Schneider, Dan Constantinescu, M. Diana Danca, Tara L. Thieme, and Philip F. DiSanto, WILKIE FARR & GALLAGHER LLP, New York, NY., Attorneys for Defendant.

MEMORANDUM OPINION

ANDREWS, U.S. DISTRICT JUDGE

On September 18, 2015, Amgen, Inc. and Amgen Manufacturing, Limited (collectively, "Amgen") sued Hospira, Inc. for infringement of U.S. Patent No. 5,856,298 under 35 U.S.C. §§ 271(a) and 271(e)(2)(C) and for infringement of U.S. Pat. No. 5,756,349 under § 271(a). (D.I. 1). The '298 patent and the '349 patent cover erythropoietin ("epoetin" or "EPO") isoforms and aspects of their production. Hospira submitted Biologic License Application ("BLA") No. 125-545 to the FDA in December 2014, seeking FDA approval for Hospira's epoetin biosimilar product. (D.I. 290-1 at 1). Amgen asserts that Hospira's manufacture of drug substance for its epoetin biosimilar drug product infringes claims 24 and 27 of the '298 patent and claims 1-7 of the '349 patent. (D.I. 290 at 1).

I held a jury trial from September 18-22, 2017. (D.I. 328-332 ("Trial Tr.") ).¹ The jury found each of the asserted claims not proved invalid, decided that the asserted claims of the '349 patent were not infringed, and returned a verdict of infringement of all asserted claims of the '298 patent. (D.I. 325 at 2). Of Hospira's twenty-one accused drug substance batches, the jury found seven batches entitled to the safe harbor defense. (Id. at 3). The jury awarded Amgen $70 million in damages for Hospira's infringement. (Id. at 4).

Presently before the Court are Hospira's Rule 50(a) Motion for Judgment as a Matter of Law on the Issues of Safe Harbor, Noninfringement, Invalidity, and Damages and related briefing (D.I. 336, 337, 348, 351), Hospira's Motion for Judgment as a Matter of Law Under Rule 50(b) and, in the Alternative, For Remittitur or New Trial Under Rule 59 and related briefing (D.I. 355, 357, 374, 381), Hospira's Motion to Seal Confidential Exhibits Admitted at Trial and related briefing (D.I. 361, 369, 370), Amgen's Renewed Motion for Judgment as a Matter of Law of Infringement of the '349 Patent or, in the Alternative, for a New Trial and related briefing (D.I. 356, 358, 373, 380), and Amgen's Motion for Prejudgment and Post-judgment Interest and related briefing (D.I. 352, 376, 382).

I. LEGAL STANDARDS

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) (citation omitted).

In assessing the sufficiency of the evidence, the Court must give the nonmovant, "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." Perkin-Elmer Corp. v. Computervision Corp. , 732 F.2d 888, 893 (Fed. Cir. 1984). Rather, the Court must determine whether the evidence reasonably supports the jury's verdict. See Gomez v. Allegheny Health Servs. Inc. , 71 F.3d 1079, 1083 (3d Cir. 1995) ; 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 movant bears the burden of proof, the Third Circuit applies a stricter standard. Fireman's Fund Ins. Co. v. Videfreeze Corp. , 540 F.2d 1171, 1177 (3d Cir. 1976). To grant judgment as a matter of law in favor of a party that bears the burden of proof on an issue, the Court "must be able to say not only that there is sufficient evidence to support the [movant's proposed] 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.

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) when 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) when newly discovered evidence exists that would likely alter the outcome of the trial; (3) when improper conduct by an attorney or the court unfairly influenced the verdict; or (4) when 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) (citations omitted).

The decision to grant or deny a new trial is committed to the sound discretion of the district court. Allied Chem. Corp. v. Daiflon, Inc. , 449 U.S. 33, 36, 101 S.Ct. 188, 66 L.Ed.2d 193 (1980) ; Olefins Trading, Inc. v. Han Yang Chem Corp. , 9 F.3d 282, 289 (3d Cir. 1993). 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" or where the verdict "cries out to be overturned" or "shocks [the] conscience." Williamson , 926 F.2d at 1352-53.

II. HOSPIRA'S 50(a) AND 50(b) MOTIONS

Hospira's Rule 50(a) motion raises the same issues as its Rule 50(b) motion.² Having considered and decided the issues in ruling on Hospira's Rule 50(b) motion, I will dismiss Hospira's Rule 50(a) motion as moot.

Hospira seeks judgment as a matter of law on the issues of the applicability of its safe harbor defense, noninfringement and invalidity of the '298 patent, and damages. (D.I. 357, pp. 1-22). Alternatively, Hospira seeks a new trial based on what it characterizes as improper jury instructions on the safe harbor defense and third party liability, improper claim construction, and contradictory infringement and validity verdicts. (Id. pp. 22-30). Finally, Hospira argues that it is entitled to a remittitur of the damages award. (Id. p. 28).

A. JMOL

1. Safe Harbor

The parties dispute whether any reasonable jury could have found some, but not all, of Hospira's drug substance batches protected by the "safe harbor" defense. (Id. p. 1; D.I. 374, p. 2).

The Biologics Price Competition and Innovation Act of 2009 ("BPCIA") "create[s] an artificial ‘act of infringement,’ similar to that of 35 U.S.C. § 271(e)(2)(A), and [allows] infringement suits to begin based on the filing of a biosimilar application prior to FDA approval and prior to marketing of the biological product." Amgen Inc. v. Sandoz Inc. , 877 F.3d 1315, 1321 (Fed. Cir. 2017) (citing 35 U.S.C. § 271(e)(2)(C), (e)(4), (e)(6) ). Section 271(e)(1) carves out an exception to this rule, creating a "safe harbor" defense for defendants when their otherwise-infringing activities are "solely for uses reasonably related" to obtaining FDA approval. 35 U.S.C. § 271(e)(1) ("It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products."); Abtox, Inc. v. Exitron Corp. , 122 F.3d 1019, 1027 (Fed. Cir. 1997) ("By its terms, this shield from infringement permits use of ‘patented invention[s]’ to acquire information for regulatory approval of ‘drugs or veterinary biological products.’ ") (brackets in original). "As long as the activity is reasonably related to FDA approval, [a party's] intent or alternative uses are irrelevant to its qualification to invoke the section 271(e)(1) shield." Abtox , 122 F.3d at 1030.

Hospira asserts that no reasonable jury could find that the safe harbor defense did not protect each of its twenty-one drug substance batches. (D.I. 357, p. 1). Additionally, Hospira contends that Amgen's arguments improperly limited the applicability of the safe harbor defense to batches required for FDA approval. (Id. p. 5). Since each batch was used for one or more of biosimilarity³ testing, updating product specifications, process validation, stability testing, or continued process verification, Hospira insists that no reasonable jury could...