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Inc. v. Perrigo Co.

United States District Court, D. Massachusetts

November 17, 2017




         On June 21, 2017, the United States Court of Appeals for the Federal Circuit, by Judge Wallach, deactivated the appeals filed by defendants Perrigo Company and L. Perrigo Company (collectively, “Perrigo”). See Docket # 319. Accordingly, before me now are Perrigo's renewed motions for judgment as a matter of law and, in the alternative, motions for a new trial. See Docket ## 298, 300, 303, 306. Plaintiffs Brigham and Women's Hospital, Inc., and Investors Bio-Tech, L.P. (collectively, “Brigham”) oppose all these motions and separately move to amend the August 9, 2017, final judgment (Docket # 344).

         I. Procedural Background

         The court held an eight-day jury trial which concluded on December 14, 2016, with a jury verdict in favor of plaintiffs. See Docket # 222. Specifically, the jury found (1) direct, induced, contributory, and willful infringement by Perrigo of all asserted claims of U.S. Patent No. 5, 229, 137 (“the '137 patent”); (2) an effective priority date of March 1990; and (3) all asserted claims valid. It declined to award pre-judgment interest but awarded Brigham $10, 210, 071 in damages and rejected Perrigo's laches defense, finding that Brigham knew or should have known of their infringement claim against Perrigo as of August 11, 2008. Judgment was entered on December 19, 2016, without specifying the amount of damages owed to Brigham. On January 24, 2017, Perrigo filed several motions for judgment as a matter of law or a new trial under Federal Rules of Civil Procedure 50(d) and 59(d). Brigham opposed these motions on the ground that they had not been timely filed, and further argued that Perrigo failed to timely appeal from the December 2016 judgment. In a memorandum and order issued on April 24, 2017, I denied Perrigo's post-trial motions. The Federal Circuit, however, ruled that the December 2016 judgment was not final because “the issue of enhanced damages had not been resolved, ” Docket # 319, at 3, and therefore denied Brigham's motion to dismiss the appeals. Subsequently, this court entered a final judgment in accordance with the December 14, 2016, jury verdict and the court's April 24, 2017, memorandum and order. See Docket # 342. The Federal Circuit deactivated the appeals and instructed the court to consider the pending post-judgment motions.

         II. Factual Background

         A. '137 Patent

         The '137 patent discloses Dr. M. Michael Wolfe's invention of pharmaceutical medications and methods for providing humans with instant and sustained relief from the pain, discomfort, and other symptoms associated with episodic heartburn.[1] Claim 1, the only independent claim asserted, of the '137 patent claims:

A method of providing immediate and sustained relief from pain, discomfort and/or symptoms associated with episodic heartburn in a human, said method comprising:
orally administering to a human together or substantially together an antacid in an amount effective to substantially neutralize gastric acid and a histamine H2-receptor antagonist in an amount effective to substantially inhibit or block gastric acid secretion for providing the human with immediate and sustained relief from pain, discomfort and/or symptoms associated with episodic heartburn, the immediate and sustained relief provided lasting longer in duration than when the human is orally treated with only the antacid and the immediate and sustained relief provided being faster than and lasting at least about as long in duration as when the human is orally treated with only the histamine H2-receptor antagonist.

Docket # 299-2 (JTX-001), Col. 7:23-42. Brigham also asserts that Perrigo infringed dependent claims 4, 5, 6, 7 and 12.[2]

         B. The License Agreement

         In 1996, Brigham and Johnson & Johnson Merck Consumer Pharmaceuticals (“JJMCP”) entered into an exclusive license agreement (the “License Agreement”) that gave JJMCP the first right, but not obligation, “to prosecute . . . any infringement of the ['137 patent] that involves products or methods in which FAMOTIDINE is combined or used in combination simultaneously or substantially simultaneously with an ANTACID.” Docket # 304-2, at DTX-0005-0014. The parties agreed to notify each other “promptly of each such infringement of which [Brigham] or JJMCP is or becomes aware.” Id.

         Section 8.6 of the License Agreement further provides:

If, after the expiration of one hundred and twenty (120) days from a request to do so, JJMCP has not demonstrated that in fact no infringement has occurred, obtained a discontinuance of infringement, or brought suit against the third party infringer, then [Brigham] shall have the right after such one hundred twenty (120) day notice period, but not the obligation, to bring suit against such infringer and at its option to join JJMCP as a party plaintiff, provided that [Brigham] shall bear all the expenses of such suit.

Id. at DTX-0005-0016.

         Section 11.6, under “Termination, ” states:

The termination of this Agreement for any reason shall not relieve any party of any obligation relating to activities occurring prior to the effective date of such termination, nor shall any party be deemed to waive any right to seek damages, equitable relief or other remedies following any termination of the Agreement.

Id. at DTX-0005-0022.

         1. Perrigo's ANDA and Launch of Its Generic Product

         On December 23, 2004, Perrigo sent Brigham its Paragraph IV notice letter informing Brigham that it had submitted an Abbreviated New Drug Application (“ANDA”) to the FDA for permission to market famotidine/antacid chewable tablets prior to the expiration of the '137 patent, and its certification of invalidity and non-infringement. Docket # 333-3. On January 4, 2005, Brigham in turn notified JJMCP. Citing to paragraph 8.1 of the License Agreement, Brigham sought a response from JJMCP whether it would elect to pursue Perrigo. See Docket # 307-4, at DTX-0071-0002. On January 31, 2005, JJMCP informed Brigham that it would “refrain from exercising its rights under Article 8.1 of [the License Agreement] at this time, ” and that “[t]his election applies to Perrigo's activities and actions associated with the filing of an [ANDA] . . . for permission to market famotidine/antacid chewable tablets prior to expiration of [the '137 patent].” Docket # 333-5, at PTX-016.0001. JJMCP elected instead to sue Perrigo under its own separate patent, which triggered the thirty-month statutory stay on approval of Perrigo's ANDA. See Docket # 225, at 64:11-18 (Jury Trial Day 3 Tr.). Consequently, Brigham declined to file suit in 2005 because “[it] had no reason to file a lawsuit. There's not going to be a product launch [for another 30 months due to JJMCP's litigation], but, more importantly, if Johnson & Johnson succeeded, then Perrigo could never launch a product. So, in 2005, [Brigham] had absolutely no reason to do anything other than to see what happens.” Id. at 64:19-24.

         Perrigo launched Famotidine Complete (the “Generic Product”) in 2008.[3]Brigham declined to file suit at that time because it decided not “to engage in protracted and expensive litigation with a generic company that may never sell much of their product, ” id. at 68:3-7. In 2013, Brigham eventually brought suit against Perrigo for direct infringement because the '137 patent was soon expiring and Perrigo was “sell[ing] tens of million of dollars worth of product, ” id. at 69:21-22.

         III. Standard

         “The standard for granting a Rule 50 motion is stringent. ‘Courts may only grant a judgment contravening a jury's determination when the evidence points so strongly and overwhelmingly in favor of the moving party that no reasonable jury could have returned a verdict adverse to that party.'” Malone v. Lockheed Martin Corp., 610 F.3d 16, 20 (1st Cir. 2010) (quoting Rivera Castillo v. Autokirey, Inc., 379 F.3d 4, 9 (1st Cir. 2004)). In making its determination, the court may not weigh the evidence, determine the credibility of the witnesses presented, or attempt to resolve conflicting testimony. MacQuarrie v. Howard Johnson Co., 877 F.2d 126, 128 (1st Cir. 1989).

         Under Federal Rule of Civil Procedure 59(a), a court may order a new trial “only if the verdict is against the law, against the weight of the credible evidence, or tantamount to a miscarriage of justice.” Crowe v. Marchand, 506 F.3d 13, 19 (1st ...

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