August 25, 2008
AngioScore Submits Citizen Petition Requesting FDA Action to Deny Patent Term Extension Based on Abbott Angioplasty Catheter
AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, today announced that it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA) requesting the Agency's action to deny a Patent Term Extension (PTE) request for a patent covering rapid exchange angioplasty catheters made by Abbott Laboratories (NYSE:ABT).
AngioScore's petition argues that Abbott's PTE request is fatally flawed in several key areas and that granting the PTE would subvert the key principles for which Congress created the Hatch-Waxman Act, which is the basis for the PTE request.
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."
A copy of the Citizen Petition docket may be found at the following link: http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail &d=FDA-2008-P-0473 (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)
AngioScore, Inc (www.angioscore.com) is a privately funded endovascular company located in Fremont, California. AngioScore can be contacted at (510) 933-7900 or [email protected]
Note: This press release contains forward-looking statements that are based upon management's current expectations and are inherently uncertain. Actual results and timing of events could differ materially from current expectations and forward-looking statements.