A Medical Device Daily

AngioScore (Fremont, California) a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, reported that it has submitted a Citizen Petition with the 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 (Abbott Park, Illinois).

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 Trotter, president/CEO of AngioScore, said, "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. 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."

Abbott has come under a great deal of legal scrutiny recently. In June, the U.S. Department of Justice (DoJ) subpoenaed Abbott Laboratories in connection with the marketing and sales of the company's biliary stents (Medical Device Daily, July 29, 2008). The government is investigating whether the company violated civil or criminal laws in connection with Medicare and Medicaid reimbursements paid to third parties.

In July, Bayer AG (Leverkusen, Germany) won a court ruling that an Abbott patent used in glucose-testing products is not enforceable because a company attorney used misrepresentations to get the patent approved, according to a Bloomberg report (MDD, July 2, 2008).

Abbott first sued Bayer in 2005, claiming patent infringement seeking unspecified damages, Bloomberg said. The cases were later combined with other lawsuits brought against BD (Becton, Dickinson; Franklin Lakes, New Jersey) and Nova Biomedical (Waltham, Massachusetts), with the trial starting earlier this summer.

And in March Church & Dwight (Princeton, New Jersey), a manufacturer of personal care, household and specialty products, reported that it has won a favorable ruling in an infringement action against Abbott in the U.S. District Court for the District of New Jersey involving pregnancy tests marketed by Abbott under its Fact Plus trademark.

Church & Dwight asserted that Abbott had infringed three of its patents through the sale of Fact Plus pregnancy tests from April 1999 through the end of September 2003.

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