Judicial developments in the US Hatch-Waxman infringement safe harbor

Abstract

Life science companies often seek guidance on whether certain current or proposed activities fall within the Hatch-Waxman safe harbor, which exempts from infringement the making, using, offering to sell or sale within the US, or the importation into the US, of “a patented invention … 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 …”. In 2005, the US Supreme Court provided some clarity as to the scope of this safe harbor. In Merck KGaA v. Integra Lifesciences I, Ltd, the Court held that the exemption from infringement can reach certain preclinical experiments, outlining one test by which such preclinical experiments can be shown to be sufficiently ‘reasonably related’ to FDA submission as to qualify for the safe harbor. On remand of the case from the Supreme Court, the Court of Appeals added further explanatory detail. In late 2008, however, much of that hard-won clarity was lost when the Court of Appeals, in Proveris Scientific Corp. v. Innovasystems, Inc., addressed the ‘patented invention’ language of the statutory exemption, and articulated a two part test that is, in the opinion of the authors, unnecessary, unwarranted and unworkable.

Keywords::

• FDA
• Hatch-Waxman Act
• infringement
• Merck KGaA v. Integra Lifesciences I, Ltd.
• patent term extension
• Proveris Scientific Corp. v. Innovasystems, Inc
• safe harbor
• 35 USC § 156
• 35 USC § 271(e)(1)