On August 3, 2012, the Federal Circuit issued a decision holding that the safe harbor provision of the Hatch Waxman Act, 35 U.S.C. § 271(e)(1), covers post-approval testing as long as it is "reasonably related" to the submission of information the FDA. (Momenta Pharma v. Amphastar Pharma, Fed. Cir., No. 2012-1062, 8/3/12).

Amphastar received FDA approval to market a generic version of a drug that prevents blood clots. Momenta was the assignee of a patent covering a method for analyzing the drug for the presence of a particular compound. Such quality control testing was required by the FDA when manufacturing batches of the drug in order to confirm the presence of the compound. Momenta brought a claim for patent infringement against Amphastar, and the district court granted a preliminary injunction preventing Amphastar from selling its product.

On appeal, the Federal Circuit found that the district court incorrectly concluded that Momenta was likely to succeed on the merits of its patent infringement claim because the district court had interpreted the safe harbor provision too narrowly. The Hatch Waxman safe harbor permits otherwise infringing activities to occur if they are "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." 35 U.S.C. § 271(e)(1).

The Federal Circuit dismissed Momenta's argument that the safe harbor only applies to testing that is conducted in order to obtain regulatory approval of a product. The court found that the testing in this case was reasonably related to the development and submission of information to the FDA because the testing records had to be retained for at least one year after the expiration date of the batch and had to be available for FDA inspection at any time. See 21 C.F.R. § 211.180. The court distinguished prior cases by emphasizing the fact that these test results were not "routine submissions" to the FDA, but were required to maintain FDA approval of the drug. Based on its reading of the safe harbor provision the Federal Circuit vacated the district court's preliminary injunction and remanded the case.

In dissent, Judge Rader argued that the safe harbor provision should cover only pre-approval activities and not post-approval activities related to manufacturing. He argued that the narrower reading of the safe harbor provision is supported by the legislative history of the Hatch Waxman Act and Supreme Court precedents. He also expressed concern that this decision would reduce the value of manufacturing method patents.

What This Means for You

The Federal Circuit has held that the safe harbor provision should be read broadly to include post-approval testing. Generic drug companies will benefit from an expanded application of the safe harbor. However, this decision could have a significant impact on holders of patents for processes that are used to generate information submitted to the FDA. It remains to be seen whether the Federal Circuit will rehear the case en banc.

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