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

United States District Court, D. Massachusetts

June 21, 2016



          Nathaniel M. Gorton Judge

         This is a patent infringement case in which plaintiffs Momenta Pharmaceuticals, Inc. and Sandoz Inc. (collectively, "Momenta" or "plaintiffs") claim that defendants Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Actavis, Inc. and Watson Pharma, Inc. (collectively, "Amphastar" or "defendants") infringed their patent during the course of defendants' manufacture and sale of generic enoxaparin products.

         Pending before the Court is Momenta's renewed motion for leave to amend its infringement contentions with respect to the Disaccharide Building Block Procedure ("DBB test"). For the following reasons, that motion will be allowed.

         I. Background

         In July, 2010, after receiving approval from the United States Food and Drug Administration ("the FDA"), Momenta began to market the first generic version of Lovenox (otherwise known as enoxaparin) in the United States. 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 control processes that ensure that each batch of generic enoxaparin includes the individual sugar chains characteristic of Lovenox.

         Amphastar received FDA approval to market its generic enoxaparin product in September, 2011. Momenta initiated this lawsuit two days later by filing a complaint alleging that Amphastar infringed its ‘886 patent by manufacturing generic enoxaparin for commercial sale using the patented methods.

         In October, 2011, this Court allowed Momenta's motion for injunctive relief by enjoining Amphastar from advertising, offering for sale or selling allegedly infringing enoxaparin products. 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 because it used the patented process to test products after it had already obtained FDA approval, such that the use was not "reasonably related to the development and submission of information" to the FDA.

         Momenta served Amphastar in February, 2012 with its initial infringement contentions which accused two Amphastar procedures: the "Approved 15-25% Procedure" which Amphastar performed at the time of FDA approval and the "Revised 15-25% Procedure" which it adopted after FDA approval.

         In August, 2012, the Federal Circuit Court of Appeals ("the Federal Circuit") vacated this Court's 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)("Momenta I"). It explained that Amphastar's post-approval use of the patented process to run quality control tests on its products fell within the scope of the safe harbor provision because its use generated information for records that Amphastar needed for continued FDA approval. Id. at 1357-61.

         In mid-August, 2012, this Court stayed the case pending the completion of appellate proceedings and denied all outstanding motions without prejudice. The Federal Circuit denied Momenta's petition for a rehearing en banc in November, 2012.

         This Court removed the stay in mid-January, 2013. Amphastar moved for summary judgment. Momenta served Amphastar with amended infringement contentions in February, 2013 which additionally accused the DBB test and a "Batch-to-Batch Procedure". In May, 2013, Momenta served Amphastar with its second amended infringement contentions adding "further documentary support" for its DBB and Batch-to-Batch contentions based upon Amphastar's delayed production of the testing records and Abbreviated New Drug Application ("ANDA") materials. Momenta did not seek leave to amend its infringement contentions on either occasion but did so in June, 2013.

         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. The Court also denied Momenta leave to amend the infringement contentions with respect to the DBB test as "futile" because Amphastar's use of that test fell within the safe harbor provision pursuant to 35 U.S.C. § 271(e)(1).

         The Federal Circuit vacated this Court's grant of summary judgment to Amphastar in November, 2015 and held this time 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).[1] The Federal Circuit also suggested that:

Given our vacation of summary judgment on the reach of ยง 271(e)(1), the district court may choose to reconsider on remand its denial of leave [to amend the ...

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