271(e) : CAFC Alert

Federal Circuit Judges Spar over Post-FDA-Approval Application of Hatch-Waxman Safe Harbor

Nicolas Seckel | September 4, 2012

Momenta Pharma v. Amphastar Pharma

August 3, 2012

Panel:  Rader, Dyk and Moore.  Opinion by Moore.

Summary:

Momenta sued Amphastar for infringement of Momenta’s drug testing method.  Amphastar argued that its use of Momenta’s patented method for testing Amphastar’s commercial batches is covered by the exception to infringement for activities related to FDA regulatory review under the “safe harbor” provision of section 271(e)(1). The District Court issued a preliminary injunction against Amphastar, holding that the “safe harbor” is limited to pre-FDA approval activities.  The Federal Circuit vacates the injunction.  Amphastar’s activities took place after FDA marketing approval of Amphastar’s product, but the plain language of the statutory “safe harbor” covers all uses of a patented invention that are “reasonably related” to submission of information under FDA regulatory review.  Since Amphastar’s manufacturing batch testing was mandated by FDA for commercialization, and not “routine” information gathered “voluntarily,” Amphastar’s use of Momenta’s patented method is exempted by the “safe harbor.”


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