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Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc.

United States District Court, D. Massachusetts

June 29, 2017

MOMENTA PHARMACEUTICALS, INC. AND SANDOZ INC., Plaintiffs,
v.
AMPHASTAR PHARMACEUTICALS, INC. AND INTERNATIONAL MEDICATION SYSTEMS, LTD., Defendants.

          MEMORANDUM & ORDER

          Nathaniel M. Gorton United States District Judge

         In this case plaintiffs Momenta Pharmaceuticals, Inc. and Sandoz Inc. (collectively, “Momenta” or “plaintiffs”) allege that defendants Amphastar Pharmaceuticals, Inc. and International Medication Systems, Ltd. (collectively, “Amphastar” or “defendants”) infringed Momenta's U.S. Patent No. 7, 575, 886 (“the ‘886 patent”). This Court convened a status conference on June 21, 2017, and took under advisement the issue of the scope of the pending jury trial, i.e. the extent to which Amphastar's equitable defenses will be addressed at that trial.

         Momenta asserts that the equitable defenses should be addressed in a separate hearing after the trial because the issues that the jury must decide, infringement, validity and damages, are separate from the equitable defenses which examine whether there was a duty to disclose the ‘886 patent to the United States Pharmacopeia (“the USP”) and whether Momenta breached that duty. Amphastar contends that there is substantial commonality between the evidence of its defenses to Momenta's claims and the evidence of equitable defenses. Because the Court agrees that there is a substantial overlap rendering separation of the evidence problematic, the defendants will be permitted to offer evidence relative to their equitable defenses at the trial.

         I. Legal Standard

         Equitable defenses involve matters of law and thus “factual issues [underlying such defenses] ordinarily are not jury questions.” Baxter Healthcare Corp. v. Spectramed, Inc., 49 F.3d 1575, 1584 (Fed. Cir. 1995). Although the Federal Circuit Court of Appeals (“Federal Circuit”) has stated that it is “not the preferred course”, it upholds a district court's decision to “delegate aspects of the inequitable conduct inquiry to juries” as long as such delegation does not result in prejudice or an unfair trial. Rothman v. Target Corp., 556 F.3d 1310, 1322-23 (Fed. Cir. 2009).

         Bifurcation is warranted if the claims and equitable defenses "are distinct and without commonality either as claims or in a relation to the underlying fact issues." DeKalb Genetics Corp. v. Syngenta Seeds, Inc., 2008 WL 382385, at *2 (E.D. Mo. Feb. 12, 2008) (quoting Old Town Canoe Co. v. Confluence Holdings Corp., 448 F.3d 1309, 1322 (Fed.Cir. 2006)). Conversely, when there is “overlapping of evidence on all issues, ” courts have conducted one trial with respect to the claims and equitable defenses. Genentech, Inc. v. Wellcome Found. Ltd., No. 88-330, 1990 WL 69187, at *14 (D. Del. Mar. 8, 1990). When evidence of equitable defenses overlaps with matters that are clearly for the jury to decide, such as issues of infringement, validity and damages in this case, courts have availed themselves of advisory jury verdicts. See Qualcomm Inc. v. Broadcom Corp., 548 F.3d 1004, 1009 (Fed. Cir. 2008). Nevertheless, the equitable defenses ultimately remain a question of law for the Court to decide. See id.

         II. Application

         Amphastar contends that the evidence as to equitable defenses significantly overlaps with the jury questions. Its argument addresses five specific examples.

         A. Whether the Failure of Momenta and Dr. Shriver to Disclose the ‘886 Patent is an Admission of Non-Infringement

         In Amphastar's view, Momenta did not disclose the ‘886 patent to the USP for either of two reasons: 1) it did not believe the patent covered the <207> method or 2) it knew that the patent covered <207> but did not disclose it anyway. Thus, argues Amphastar, the non-disclosure is relevant to both its non-infringement and its waiver and equitable estoppel defenses.

         Momenta replies that 1) Amphastar's argument assumes that there was a duty to disclose, 2) Amphastar concedes that the so-called DDB procedure is not the equivalent of UPS <207> and thus the waiver defense does not apply to it and 3) Amphastar's contention that the allegedly infringing 15-25% procedures are essentially the same as USP <207> is part of its waiver defense, not an undisputed fact.

         Momenta further asserts that the only relevant comparison for infringement is 1) the language of the claims as construed by the Court and 2) Amphastar's conduct. In its view, Dr. Shriver's opinions are irrelevant to infringement. Amphastar responds that, in support of its invalidity defense, it plans to seek testimony from Dr. Shriver about whether the specification of the ‘886 patent would “allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” See Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (internal quotations and citations omitted).

         Amphastar's contention that its claim of non-infringement and its equitable defenses of estoppel and waiver are inextricable is well taken. While the existence of a duty to disclose is factually disputed, if there was such a duty, Dr. Shriver's non-disclosure bears on whether a person of ordinary skill in the art would understand what the patentee invented.

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