Intellectual Property Law

FDA research safe harbor does not extend to devices not subject to FDA approval

By McKee, Voorhees & Sease, P.L.C.

In a decision Tuesday, the Federal Circuit affirmed a district court's holding of patent infringement on the basis that the "safe harbor" provision of the Hatch-Waxman Act, § 271(e)(1), did not insulate the accused activity from infringement and that the district court did not err in granting a judgment as a matter of law in favor the plaintiff on infringement and the defendant's invalidity defenses.

The Federal Circuit stated that the safe harbor provision of the Hatch-Waxman Act was enacted by Congress to eliminate two unintended distortions of the effective patent term resulting from the premarket approval required of certain products pursuant to the Food, Drug, and Cosmetic Act.  The first was to extend the patent term of patents covering products subject to regulatory delays caused by the FDA approval process.  The second was to insulate from infringement liability actions for purposes that are solely "reasonably related" to an FDA submission.  

Here, the infringing device was not itself subject to FDA approval, but was used to perform tests that facilitate FDA approval for other devices.  The court held that the "safe harbor" provision applied only to products which themselves are subject to FDA premarket approval, and thus faced the unintended distortions to of an effective patent term.  As a result, the court affirmed the district court's holding that the safe harbor of § 271(e)(1) did not apply.

More detail of Proveris Sci. Corp. v. Innovasystems, Inc. after the jump.

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Full post as published by FileWrapper on August 07, 2008 (boomark / email).