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Hatch-Waxman Watch: Safe Harbor Edition

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Hatch-Waxman Watch: Safe Harbor Edition


Hatch-Waxman Watch: Safe Harbor Edition

Last week, two district courts dispensed with lawsuits based on the protections afforded by the safe harbor provision of the Hatch-Waxman statute.  Both of the cases relied heavily on the Federal Circuit case Momenta Pharm. v. Amphastar Pharm., 686 F.3d 1348 (2012).  In fact, one of the cases was theMomenta case back at the Massachusetts District Court.  The other case was in the Southern District of New York, and in that case, the dismissal occurred at the pleadings stage.  Because both cases looked to 35 U.S.C. § 271(e)(1), it is useful to review this provision, which reads:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States 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.

The Federal Circuit Momenta case interpreted this language broadly, stating that the "language unambiguously applies to submissions under any federal law, providing that the law 'regulates the manufacture, use, or sale of drugs.'"  Therefore, according to current Federal Circuit jurisprudence, the safe harbor is not limited to pre-approval activities (see Momenta); it is not limited to information that is actually submitted to the FDA, provided the FDA requires that records be maintained for possible inspection (see Momenta); and it is OK if the information has alternative uses, such as for fund raising or other business purposes (see Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1030 (Fed. Cir. 1997)).  It is with this understanding that the lower courts proceeded.


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(These latest Intellectual Property (IP) news and events presented here, are prepared and compiled by us, the World Patent & Trademark Law Office (WPTO), for your reference and information)