Reining In The Scope Of Safe Harbor

Law360, New York (August 8, 2008, 12:00 AM EDT) -- In a decision sure to be welcomed by many research tool patent holders, the Federal Circuit, in Proveris Scientific Corp. v. Innovasystems Inc. (Aug. 5, 2008), departs from a line of cases that have expansively interpreted the “safe harbor” provisions of the Hatch-Waxman Act.

The decision reins in the scope of the safe harbor, finding that it does not reach devices that are not themselves subject to an FDA pre-market approval process, even if they are used to obtain data for FDA submissions.

While not directly...
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