A Diagnostics & Imaging Week

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 US. 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. 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.

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.

In other patent news:

• Revolutions Medical (RMC; Mount Pleasant, South Carolina) has filed for patent protection in Australia, which finalizes all the countries the company has identified to be the most important for its Rev Vac safety syringe.

China, Japan, Mexico, Canada and Europe international patent applications have already been filed. "As we get closer to the marketing of our proprietary Rev Vac safety syringe, it was clear to us to have our patents protected internationally. With the completion of the Australian filing we feel very comfortable that we have fully protected our syringe from patent infringement and now we look to protect our four U.S. pending patents, internationally, for our proprietary Rev Color MRI and Rev 3D MRI technology," said CEO Ron Wheet, CEO.

In June 2007, RMC filed for four U.S. patents for its technology for MRI, including color, 3-D and auto segmentation of images.

"The indications are that our technology claims in our pending four U.S. patents are strong and Rev Med will be filing additional international patent protection in a number of other countries, as well as Europe," says Richard Theriault, president of Strategic Product Development and a consultant to Revolutions Medical.

RMC develops safety-engineered medical devices and provides software solutions and proprietary tools that are compatible with standard MRIs and standard PACS.

• Prometheus Laboratories (San Diego) reported the issuance of U.S. patent No. 7,361,733, "Compositions and Methods for the Therapy and Diagnosis of Inflammatory Bowel Disease," which protects a flagellin peptide useful in the detection of antibodies to the flagellin CBir1, or anti-CBir1, for determining the presence of inflammatory bowel disease (IBD).

This proprietary technology is used in the company's Prometheus IBD Serology 7 test and its recently launched Prometheus IBS Diagnostic test. Prometheus has exclusive rights to this technology under an agreement with Corixa.

The patent provides a means of detecting the presence and levels of CBir1 antibodies in a patient sample. About 50% of patients with Crohn's disease have a positive response to anti-CBir1. The presence of anti-CBir1 identifies a subset of patients with Crohn's disease who were not previously detected by other serologic markers.

Before the introduction of anti-CBir1, patients who were pANCA positive may have been diagnosed as having ulcerative colitis. However, anti-CBir1 helps physicians to further characterize pANCA-positive patients and distinguish between ulcerative colitis and ulcerative colitis-like Crohn's disease.

In addition, anti-CBir1 may be associated with more complicated Crohn's disease and with phenotypes involving small bowel disease, such as fibrostenosis and internal perforating disease.

Prometheus Laboratories is a specialty pharmaceutical company.