Hatch-Waxman Safe Harbor Only Applies to Producsts that the FDA Regulates

Proveris Scientific Corporation v. Innovasystems, Inc., [2007-1428] (August 5, 2008) [SCHALL, Bryson, Gajarsa] The Federal Circuit JMOL in favor of Proveris on infringement of United States Patent No. 6,785,400 and on Innova’s affirmative defenses.
DISCUSSION: Proveris sued Innova alleging infringement of the ’400 patent. Innova attempted to invoke the safe harbor provision of the Hatch-Waxman Act, which provides that it is not an act of infringement to us 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 or veterinary biological products. Noting that the Hatch-Waxman Act was intended to eliminate the market distortions caused by FDA approval process, the Federal Circuit concluded that because the accused device is not subject to FDA premarket approval, and therefore faces no regulatory barriers to market entry upon patent expiration, Innova is not a party who could be said to be adversely affected by the second kind of distortion -- approval delays to entering the market upon patent expiration. The Federal Circuit also noted that Proveris was not a party who was affected by the first kind of distortion – approval delays in the initial entry into the mark. The Federal Circuit found this symmetry followed the Supreme Court’s instruction regarding a “perfect fit” between products subject to the extensions and safe harbors of the statute. The Federal Circuit said:

Because Proveris’s patented product is not subject to a required FDCA approval process, it is not eligible for the benefit of the patent term extension afforded by 35 U.S.C. §156(f). At the same time, because Innova’s OSA device also is not subject to a required FDCA approval process, it does not need the safe harbor protection afforded by 35 U.S.C. § 271(e)(1).

The Federal Circuit affirmed the other decisions of the district court regarding the admission of evidence and expert testimony.