FDA : 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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CAFC holds all the claims of a patent have the same expiration date, whether the claims are drawn to the product subject to patent term extension or not

Lee Wright | April 11, 2012

Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc.

August 23, 2011

Panel: Lourie, Plager and Dyk.  Opinion by Judge Lourie.  Concurrence-in-part and dissent-in part by Dyk.

Summary:

Today, we bring you the second in a series of three articles regarding an important case from last year.   For part 1, click here.  This article discusses the following question:

Question: Where a patent has been granted an extension of term due to regulatory review, is there a different expiration date for the claims that were the subject to the regulatory review and the claims that do not claim the approved product?

Answer:  The expiration date is not determined on a claim by claim basis.

A patent, and therefore all of the claims in the patent, have the same expiration date, which is the expiration date as extended by patent term extension.


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