Generic Drug Testing “Safe Harbor” Expanded by Recent Court Decision to Include Post-approval Activities Under Hatch-Waxman


[author: Michael Shuster]

The August 2012 decision in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, Inc. has expanded the “safe harbor” provisions of Hatch-Waxman, with serious implications for the pharma and biotech industries.

Hatch-Waxman contains a "safe harbor" provision for the use of patented inventions "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.” 35 U.S.C. § 271(e)(1)

Generally understood as a provision permitting companies to test or experiment with patented inventions prior to an FDA submission - such as a generic drug maker prior to submission of an ANDA - the provision's scope has expanded over the years.

The biochemical facts of the Momenta v. Amphastar case are involved, but it boils down to a conflict between two generic producers of the anti-coagulant drug enoxaparin (brand name: Lovenox). Momenta, which had received FDA approval for its ANDA on enoxaparin in July 2010 owns a patented method for ensuring enoxaparin's bioequivalence to Lovenox. Amphastar's ANDA was approved by FDA in September of 2011. Momenta alleged that Amphastar was in ongoing violation of the Momenta patents in determining the bioequivalence of its own version of enoxaparin. Without establishing bioequivalence, generics cannot be legally marketed.

Momenta was granted a preliminary injunction, but the Court of Appeals for the Federal Circuit vacated, reasoning that Amphastar's batch testing of its enoxaparin for purposes of establishing bioequivalence fell under the Hatch-Waxman safe harbor. The majority found that Amphastar's ongoing testing was part of a system of required record keeping for FDA, and thus brought the testing within Hatch-Waxman safe harbor.

A strong dissent from Chief Judge Rader suggests that we have not heard the end of this case. Perhaps further appeal and an en banc hearing may be in store.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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