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

United States District Court, D. Massachusetts

July 13, 2018



          Nathaniel M. Gorton United States District Judge

         In July, 2017, after a nine-day jury trial, a jury found that defendants Amphastar Pharmaceuticals, Inc. and International Medication Systems, Ltd. (collectively, “Amphastar” or “defendants”) 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. The jury also found, however, that the infringed patent claims were invalid because they were not enabled and had inadequate written descriptions.

         The instant dispute involves the surety bond posted by Momenta to cover Amphastar's damages arising from an October 7, 2011 Temporary Restraining Order and an October 28, 2011 preliminary injunction (“the injunctions”). Pending before the Court are (1) Amphastar's motion to enforce liability on the bonds (Docket No. 1151) and (2) Momenta's motion to defer consideration of defendants' motion to enforce liability on the bonds pending exhaustion of its appeal to the United States Court of Appeals for the Federal Circuit (“the Federal Circuit”) (Docket No. 1162).

         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 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. The Court's order enjoined Amphastar from advertising, offering for sale or selling in the United States any generic enoxaparin product alleged to infringe the ‘886 patent. As a condition for the injunctive relief, the Court required Momenta to post two surety bonds in the amounts of $50, 000 and $100, 000, 000 for the temporary restraining order and the preliminary injunction, respectively. The Court subsequently denied two motions to stay or dissolve the preliminary injunction filed by Amphastar.

         Amphastar filed an interlocutory appeal of the Court's order entering the preliminary injunction and in August, 2012, 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 that its activities were protected by the safe harbor provision and therefore did not infringe. During the pendency of that appeal, this Court considered a motion to enforce liability on the surety bonds and a motion to defer consideration of that motion pending exhaustion of appeals. The Court determined that it was appropriate to defer consideration of the motion to enforce liability on the bonds. The Federal Circuit then vacated this Court's grant of summary judgment to Amphastar and held, in November, ...

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