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

United States District Court, D. Massachusetts

February 7, 2018



          Nathaniel M. Gorton, United States District Judge.

         In July, 2017, after a nine-day trial, the jury returned a verdict in favor of defendants Amphastar Pharmaceuticals, Inc. and International Medication Systems, Ltd. (collectively, “Amphastar” or “defendants”). Although that jury found that Amphastar had infringed the patent held by plaintiffs Momenta Pharmaceuticals, Inc. and Sandoz Inc. (collectively, “Momenta” or “plaintiffs”) during the course of defendants' manufacture and sale of generic enoxaparin, it also found that the infringed patent claims were invalid because they were not enabled and had inadequate written descriptions.

         In the same case, this Court sought an advisory verdict from the jury with respect to the equitable defenses of waiver and estoppel and the jury found in favor of defendants as to both defenses. Amphastar's motion for the Court to adopt the jury's advisory verdict with respect to the equitable defenses is currently pending before the Court. For the reasons that follow, that motion will be allowed, in part, and denied, in part.

         I. Background

         A. The Patent and Infringing Procedures

         Enoxaparin is an anticoagulant used to prevent blood clots. Momenta is the assignee of U.S. Patent No. 7, 575, 886 (“the '886 patent”), issued in August, 2009, which is directed at a set of manufacturing quality control processes that ensure that each batch of generic enoxaparin includes the individual sugar chains characteristic of Lovenox. The individual sugar chains are referred to in the patent as “a structural signature associated with the non naturally occurring sugar associated with peak 9” and have since been identified as 1, 6-anhydro rings.

         Amphastar received FDA approval to market its generic enoxaparin product in September, 2011. Two days later, Momenta filed a complaint alleging that Amphastar infringed its ‘886 patent by manufacturing generic enoxaparin for commercial sale using its patented method. Momenta alleged that three of Amphastar's manufacturing control procedures infringe the ‘886 patent: 1) the Disaccharide Building Block (“DBB”) procedure, 2) the 15-25% procedure which Amphastar performed at the time of FDA approval of its generic version of enoxaparin (“the 15-25% procedure”) and 3) the revised 15-25% procedure which it adopted after FDA approval (“the revised 15-25% procedure”).

         B. Momenta's Non-Disclosure of the ‘886 Patent to the United States Pharmacopeia

         The United States Pharmacopeia (“USP”) is a scientific, standard-setting organization (“SSO”). Pursuant to the Federal Food, Drug, and Cosmetics Act, 21 U.S.C. § 301 et seq., drugs sold in the United States must conform to USP National Formulary (“USP-NF”) standards. In 2006, the USP began looking for a method to test compounds with 1, 6-anhydro rings to incorporate into the enoxaparin monograph. Although Momenta had already applied for its ‘886 patent, in April, 2008, it began participating on the advisory panel that chose the 1, 6-anhydro test method as Chapter <207> of the USP-NF (“USP <207>”). Specifically, Zachary Shriver, the inventor of the ‘886 patent, participated in the panel. Momenta did not disclose to the USP the ‘886 patent application.

         Momenta and Dr. Shriver opposed the adoption of USP <207> and stated that, at least, alternative methods should be allowed. The USP ultimately approved USP <207> as the official test to determine whether enoxaparin conforms to the structure in the USP monograph but also announced that manufacturers would be able to use alternative tests. In Amphastar's view, Momenta had a duty to disclose that its ‘886 patent would cover USP <207> and, because it did not, the equitable defenses of waiver and estoppel apply.

         C. Procedural History

         In October, 2011, this Court enjoined Amphastar from advertising or selling the allegedly infringing enoxaparin. That decision included a preliminary finding that the safe harbor provision in 35 U.S.C. § 271(e)(1) did not protect Amphastar's infringing activities. In August, 2012, the Federal Circuit Court of Appeals (“the Federal Circuit”) vacated the preliminary injunction and found that this Court applied “an unduly narrow interpretation” of the safe harbor provision. Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 686 F.3d 1348, 1349 (Fed. Cir. 2012). It explained that Amphastar's post-approval use of the patented process to run quality control tests fell within the scope of the safe harbor provision because it generated information for records that Amphastar needed for continued FDA approval. Id. at 1357-61.

         In July, 2013, this Court entered summary judgment in Amphastar's favor finding, at the direction of the Federal Circuit, that Amphastar's activities were protected by the safe harbor provision and therefore did not infringe. Because, apparently, no act of obeisance goes unpunished, a different panel of the Federal Circuit then vacated this Court's grant of summary judgment to Amphastar and held, in November, 2015, that the safe harbor provision did not apply to its infringing activities. Momenta Pharm., Inc. v. Teva Pharm. USA Inc., 809 F.3d 610, 613 (Fed. Cir. 2015).

         In April, 2017, defendants moved for summary judgment of invalidity and non-infringement and plaintiffs cross-moved for summary judgment of dismissal of the equitable defenses of waiver and estoppel or, alternatively, for a separate hearing on those defenses. In June, 2017, this Court denied all three motions. The nine-day jury trial in July, 2017 resulted in a verdict as previously described.

         II. Motion for the Court to Adopt the Jury's Advisory Verdicts

         A. Advisory Jury Verdict

         Where a trial is held before a district court with an advisory jury, the court must support its determination with sufficiently comprehensive factual findings. Transmatic, Inc. v. Gulton Indus., Inc., 53 F.3d 1270, 1275 (Fed. Cir. 1995). Under Fed.R.Civ.P. 52(a),

[i]n all actions tried upon the facts without a jury or with an advisory jury, the court shall find the facts specially and state separately its conclusions of law thereon.

Fed. R. Civ. P. 52(a). A court can permissibly give to a jury a legal issue for an “advisory” resolution whose “ultimate determination is reserved for the court”. Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1358 (Fed. Cir. 2012) (reviewing the district court's order granting judgment as a matter of law after an advisory verdict on nonobviousness) (citing Spectralytics, Inc. v. Cordis Corp., 649 F.3d 1336, 1341-42 (Fed. Cir. 2011)). While the Court must make its own findings of fact and conclusions of law, the findings of the jury made in an advisory capacity are entitled to some deference. See e.g., Felker v. Pepsi-Cola Co., 899 F.Supp. 882, at 888-89 (D. Conn. 1995) (noting that “it would be purposeless to have an advisory jury unless some degree of deference was shown to its opinions”).

         Accordingly, as required by Fed.R.Civ.P. 52(a), this Court will make findings of fact and conclusions of law with reference to the jury's advisory verdict.

         B. Waiver

         i. Legal Standard

         To succeed on a waiver defense, a defendant must prove either express or implied waiver by clear and convincing evidence. Qualcomm Inc. v. Broadcom Corp., 548 F.3d 1004, 1020 (Fed. Cir. 2008). Express waiver requires a showing that a plaintiff intentionally waived its right to enforce a patent. Id. Implied waiver occurs if the behavior of the patent owner

was so inconsistent with an intent to enforce its rights as to induce a reasonable belief that such right has been relinquished.

Hynix Semiconductor Inc. v. Rambus Inc., 645 F.3d 1336, 1348 (Fed. Cir. 2011) (quoting Qualcomm, 548 F.3d at 1020).

         The Federal Circuit has determined that a finding of implied waiver is warranted if a patent owner 1) had a duty to disclose information to an SSO and 2) breached that duty. Id. In evaluating whether such a duty existed, the Federal Circuit has adopted a two-step approach, first examining whether the policies of the SSO unambiguously impose a duty to disclose on participants and second, if the policies are ambiguous, evaluating whether participants in the SSO understood them to impose a duty to disclose. Qualcomm, 548 F.3d at 1012. Courts apply an objective standard when evaluating whether a duty to disclose existed, asking whether the patent at issue “reasonably might be necessary” to comply with the standard. Id. 1018 (quoting Rambus Inc. v. Infineon Techs. Ag, 318 F.3d 1081, 1100 (Fed. Cir. 2003)).

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