Momenta Pharms., Inc. v. Amphastar Pharms., Inc., Civil Action No. 11-11681-NMG

• Decision Date: 16 June 2017
• Docket Number: Civil Action No. 11-11681-NMG
• Parties: MOMENTA PHARMACEUTICALS, INC. and SANDOZ INC., Plaintiffs, v. AMPHASTAR PHARMACEUTICALS, INC. and INTERNATIONAL MEDICATION SYSTEMS, LTD., Defendants.
• Court: U.S. District Court — District of Massachusetts

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

Civil Action No. 11-11681-NMG

United States District Court District of Massachusetts

June 16, 2017

MEMORANDUM & ORDER

GORTON, J.

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. and International Medication Systems, Ltd., (collectively, "Amphastar" or "defendants"), infringed their patent during the course of defendants' manufacture and sale of generic enoxaparin products.

Pending before the Court are Amphastar's motion for summary judgment of invalidity and non-infringement and Momenta's motions for summary judgment dismissing Amphastar's equitable defenses and for a hearing. For the reasons that follow, those motions will be denied.

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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 quality 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. 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 alleges 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").

In October, 2011, this Court allowed Momenta's motion for a preliminary injunction and enjoined Amphastar from advertising

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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 Amphastar 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.

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). 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. The Federal Circuit denied Momenta's petition for a rehearing en banc in November, 2012.

In July, 2013, this Court entered summary judgment in Amphastar's favor finding, at the direction of the Federal Circuit, that its activities were protected by the safe harbor provision and therefore did not infringe. Because, apparently, no act of obeisance goes unpunished, the Federal Circuit then vacated this Court's grant of summary judgment to Amphastar and

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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).¹ The Federal Circuit also suggested that:

the district court may choose to reconsider on remand its denial of leave [to amend the infringement contentions] in light of our holding.

Id. at 622.

In June, 2016, this Court allowed plaintiffs' renewed motion to amend its infringement contentions with respect to the DBB test. Further litigation maneuvering ensued and, in April, 2017, this Court allowed defendants' motion to amend their non-infringement contentions as to the DBB test.

That month, defendants moved for summary judgment of invalidity and non-infringement. Plaintiffs timely opposed that motion and cross-moved for summary judgment of dismissal of the equitable defenses of waiver and estoppel or, alternatively, for a separate hearing on those defenses. This memorandum and order addresses those motions all of which, for the following reasons, will be denied.

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II. Motions for Summary Judgment

The role of summary judgment is "to pierce the pleadings and to assess the proof in order to see whether there is a genuine need for trial." Mesnick v. Gen. Elec. Co., 950 F.2d 816, 822 (1st Cir. 1991). The burden is on the moving party to show, through the pleadings, discovery and affidavits, "that there is no genuine dispute as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). A fact is material if it "might affect the outcome of the suit under the governing law." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A genuine issue of material fact exists where the evidence with respect to the material fact in dispute "is such that a reasonable jury could return a verdict for the nonmoving party." Id.

If the moving party has satisfied its burden, the burden shifts to the non-moving party to set forth specific facts showing that there is a genuine, triable issue. Celotex Corp. v. Catrett, 477 U.S. 317, 324 (1986). The Court must view the entire record in the light most favorable to the non-moving party and indulge all reasonable inferences in that party's favor. O'Connor v. Steeves, 994 F.2d 905, 907 (1st Cir. 1993). Summary judgment is appropriate if, after viewing the record in the non-moving party's favor, the Court determines that no

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genuine issue of material fact exists and that the moving party is entitled to judgment as a matter of law.

A. Amphastar's Motion for Summary Judgment

Amphastar moves for summary judgment on the grounds of 1) a lack of patentable subject matter, 2) indefiniteness and 3) non-infringement.

1. Legal Standard for Patentable Subject Matter

The parties agree that the two-step framework for patentable subject matter described in Mayo Collaborative...