June 10, 2015
The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between activities that fall outside the safe harbor provision of 35 U.S.C. § 271(e)(1) from those that fall within it and are consequently exempt from claim for patent infringement. Pharmaceutical researchers that avail themselves of the safe harbor’s protection may benefit from this additional guidance.

The Hatch-Waxman safe harbor is an important exemption that furthers Congress’ goal of bringing generic drug and medical device products to market as soon after patent expiration as possible. Nonetheless, courts’ interpretations of the statutory text continue to evolve, and particular conduct needs to be carefully evaluated on a case-by-case basis.

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