BusinessWire reports that Angioscore, Inc., has just submitted a Citizen Petition to the Food and Drug Administration (FDA) for the Agency deny a patent term extension to Abbott Cardiovascular Systems, Inc. (ACS). Abbott has requested a patent term extension for its rapid exchange angioplasty catheters. AngioScore, based in Freemont, CA, also develops angioplasty catheters, for use in treatment of cardiovascular disease.

Under federal law, anyone may request or petition the FDA to change or create an Agency policy or regulation. The FDA then considers every petition and must respond within 180 days by either approving or denying such petition (in whole or in part), or providing a tentative response as to why it has been unable to reach a decision.

Abbott's 233 patent is entitled, "Angioplasty Apparatus Facilitating Rapid Exchanges," and is exclusively licensed to Abbott. The patent was filed in 1994 and expires at the end of October of 2008. The Drug Price Competition and Patent Term Restoration Act (popularly known as the "Hatch-Waxman" Act) allows for patent restoration when owners of patents of certain drugs, medical devices and food additives have lost time awaiting pre-market government regulatory approval.
AngioScore's petition makes several arguments against ACS's approval, including that ACS's patent would "frustrate the policies" behind the patent terms in the Hatch-Waxman Act regarding patent term extensions. AngioScore particularly emphasizes that the patent would be extended when ACS has already "enjoyed full benefit" through its entire term, including asserting the patent against Medtronic, Inc. in 2001 litigation.

Thomas R. Trotter, president and CEO of AngioScore, stated: "The Hatch-Waxman Act was created by Congress to provide a mechanism for compensating patent holders and their licensees for the time period a product claimed in the patent was under review by the FDA and not commercially available in the United States. In this particular case, far from being deprived of the commercial value of this patent due to FDA review, Abbott and their licensees have enjoyed unprecedented commercial success for over a decade, since this patent was granted, generating billions of dollars in sales from the protection this patent provided. We are confident that once the FDA has had an opportunity to fully review the facts in this case it will recommend to the U.S. Patent Office (PTO) that this PTE request be denied."

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