Momenta Pharma, Inc. v. Teva Pharma. USA, Inc., No. 14-1274 (Fed. Cir. 2015)
Annotate this CaseEnoxaparin, an anticoagulant that helps prevent blood clots, was approved for U.S. marketing in 1993 under the name Lovenox. In 2010, Momentaed market a generic version of enoxaparin. Momenta is also the assignee of the 886 patent, directed to a process used to ensure each batch of generic enoxaparin meets quality standards. Teva, another generic manufacturer, sought to enter the enoxaparin market. It does not manufacture enoxaparin, but sources it from an Italian company that manufactures, analyzes, tests, packages, and labels Teva’s generic version of enoxaparin. Momenta sued Teva for infringement, asserting that it intended to market in the U.S. an enoxaparin product that was manufactured using a process covered by the 886 patent. The court found Teva’s conduct did not infringe because it fell within the safe harbor in 35 U.S.C. 271(e)(1); it is not infringement for a party to use a patented invention “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.” The court also rejected Momenta’s contention that Teva’s U.S. sales constitute infringement under section 271(g), which prohibits selling within the U.S. a product which is made by a process patented in the U.S. The Federal Circuit affirmed as to noninfringement under 271(g), but vacated the “safe harbor” determination.
Some case metadata and case summaries were written with the help of AI, which can produce inaccuracies. You should read the full case before relying on it for legal research purposes.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.