August 25, 2008 - Angioplasty catheter maker AngioScore Inc. said today it submitted a citizen petition with the FDA requesting the agency deny a patent term extension (PTE) request for a patent covering rapid exchange angioplasty catheters made by Abbott Laboratories.
AngioScore’s petition argues Abbott’s PTE request is fatally flawed in several key areas and granting the PTE would subvert the key principles for which Congress created the Hatch-Waxman Act, which is the basis for the PTE request.
“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 U.S.,” said Thomas R. Trotter, president and CEO of AngioScore. “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 that this PTE request be denied.”
A copy of the Citizen Petition docket may be found at www.regulations.gov/fdmspublic/component/main?main=DocketDetail &d=FDA-2008-P-0473
For more information: www.angioscore.com