Two recent conflicting Federal Circuit cases (Classen and Momenta) interpreting the Hatch-Waxman safe harbor provision (35 USC 271(e)(1)) have stirred debate in the biosimilars community.  While the new biosimilars pathway (the Biologics Price Competition and Innovation Act) is different from Hatch-Waxman of course, and its interpretation by FDA is still evolving, the controversy

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

On April 17, 2012, the U.S. Supreme Court issued a unanimous decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, holding that a generic drug manufacturer may file a counterclaim to force correction of an overbroad use code that encompasses unclaimed methods of using the drug at issue. In interpreting the text of

The Hatch-Waxman Act, a federal law passed in 1984, was designed to streamline the process for bringing generic drugs to market. Under the law, generic drug manufacturers may file an abbreviated new drug application (ANDA) with the FDA toward approval for generic versions of already-approved drugs.
Such filings are founded on bioequivalence studies instead of clinical studies. In the filings, generic manufactures also must certify that the listed drug is not patented, that the patent has expired or that the patent is invalid or will not be infringed by the generic drug.

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