hatch-waxman : CAFC Alert

Beware of Relying on a Single Example, Since It May Limit Claim Scope

| October 17, 2013

Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals, et al.

September 26, 2013

Panel:  Lourie, Schall and Reyna.  Opinion by Lourie


In this case arising from an ANDA, the claims recited the vague term of “essentially free of”, which was undefined by the specification.  Although probably never intended to limit the scope of the claims, the CAFC held that the content of the sole substantive example in the specification and a declaration citing this—which was heavily relied upon during prosecution—defined the scope of this ambiguous term.  However, the patent owner managed to win the litigation nonetheless, due to the CAFC recognizing the ineffectiveness of an unconventional “certification” of non-infringement to the district court which contradicted the defendant’s FDA filing.

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

| September 4, 2012

Momenta Pharma v. Amphastar Pharma

August 3, 2012

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


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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