Hatch-Waxman Safe Harbor Inapplicable To Research Tools

In a decision that will have far reaching implications for drug and medical device development, the Court of Appeals for the Federal Circuit held yesterday that the Hatch-Waxman safe harbor of 35 U.S.C. § 271(e)(1) is inapplicable to patented research tools that are not themselves subject to the FDA review process.  While the decision is good news for the providers of research tools such as drug screening assays, it will make drug and medical device development in the United States costlier and more risky.

The case is Proveris Scientific Corp. v. Innovasystems, Inc. (.pdf) (No. 2007-1428), decided August 5, 2008.  In rejecting the § 271(e)(1) exemption, the court reasoned that Congress must have intended that the safe harbor protect only those entities adversely affected by the de facto extension of patent life at the end of the patent term while they await FDA approval for a product that is subject