Momenta Pharma., Inc. v. Amphastar Pharma., Inc.

Because all of defendant’s activity fell under the safe harbor provision, it could not constitute patent infringement.

Fall 2013

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Momenta Pharma., Inc. v. Amphastar Pharma., Inc., C. A. No. 11-11681-NMG, 2013 U.S. Dist. LEXIS 101292 (D. Mass. July 19, 2013) (Gorton, J.)

Drug Product and Patent(s)-in-Suit: Lovenox® (enoxaparin); U.S. Pat. Nos. 7,575,866 (“the ’866 patent”)

Nature of the Case and Issue(s) Presented: In July, 2010, after receiving FDA approval, plaintiffs began marketing generic Lovenox in the US. Amphastar received FDA approval to market its generic Lovenox on September 19, 2011. Momenta, the assignee of the ’866 patent, filed suit two days later alleging that Amphastar infringes the ’866 patent by manufacturing generic Lovenox for commercial sale using the claimed methods.

Plaintiffs moved for a temporary restraining order and preliminary injunction, which the court granted. On appeal, the Federal Circuit vacated the preliminary injunction.

Amphastar moved for summary judgment and judgment on the pleadings, and Momenta requested leave to amend its infringement contentions. The Court granted Amphastar’s motion for summary judgment and denied Momenta’s motion as futile.

Why Amphastar Prevailed: The court found that all of Amphastar’s allegedly infringing activity is subject to the § 271(e)(1) safe harbor and cannot constitute patent infringement. In doing so, the court rejected the three arguments Momenta proffered.

First, Momenta argued that the application of the safe harbor provision was inappropriate because the FDA has not mandated the use of the particular infringing test. Put another way, “Amphastar’s use of Momenta’s patented process was entirely voluntary” because the FDA has not specifically required Amphastar to use the test covered by the ’866 patent. Because the Federal Circuit (i) gave the safe harbor provision a “wide berth;” and (ii) held that the safe harbor does not mandate the use of a non-infringing alternative when one exists, the court found that the language of the safe harbor provision does not limit its application to tests that are explicitly contemplated by the FDA. The court further held that if the safe harbor covered only infringing tests that are required by the FDA, it would be in conflict with the Supreme Court’s holding in Merck v. Integra Lifesciences (pre-filing tests that were not ultimately submitted to the FDA were still covered by the safe harbor because such pre-filing tests could never have been required by the FDA).

Second, Momenta argued that Amphastar’s “routine, post-approval recordkeeping” is not “submission of information” to the FDA because Amphastar does not actually “submit” those results, therefore such maintenance is not covered by the safe harbor. The court dismissed the argument, too, because the Federal Circuit expressly held that the maintenance of records for FDA inspection “satisfies the requirement that the uses be reasonably related to the development and submission of information to the FDA.”

Third, Momenta argued that Amphastar’s alleged use of the patented method during manufacturing “so that it can sell [generic Lovenox] and earn profit” makes that use not “solely” for “uses reasonably related to the development and submission of information” to the FDA. But Federal Circuit precedent also dispatched with this argument. The Federal Circuit held previously that “alternate uses [of test data] are irrelevant to the qualification to invoke the § 271(e)(1) shield” because the safe harbor allows alleged infringers to use test data for “more than FDA approval.”

Finally, because it is “illogical to suggest that conducting further tests”—which was the subject of Momenta’s motion to amend its infringement contentions—“is not an act of infringement  due to the safe harbor but simply looking at the data produced by those tests is somehow an act of infringement,” the court found Momenta’s proposed motion to amend its infringement contentions futile.

Back to Top