A Medical Device Daily

A UK appeals court has upheld a decision by the UK High Court of Justice to revoke the UK portion of European Patent (EP) 0 706 376 B1 to Angiotech Pharmaceuticals (Vancouver). The patent, related to the use of coronary stents, is exclusively licensed to Boston Scientific (Natick, Massachusetts).

In February 2005, Conor Medsystems initiated proceedings against Angiotech and the University of British Columbia in the High Court of Justice in the UK, requesting that the court invalidate the patent on the grounds that all claims of the patent either lack novelty or are obvious in light of the state of scientific knowledge at the priority date of the patent.

In February 2006, the High Court of Justice rendered its decision, agreeing with those arguments, and on May 31, 2006, Angiotech appealed the decision. On Jan. 16 the appeals court dismissed the appeal.

In response, Angiotech in a statement said that the patent at issue “represents only one of several patents in several patent families which provide international protection for Angiotech’s paclitaxel-eluting stent technology. In Europe, after extensive opposition proceedings, the European Patent Office upheld the validity of Angiotech’s European counterpart of this UK patent. As a result, in all other designated member European countries of the EPO, this patent continues to be enforceable.”

Bill Hunter, president/CEO of Angiotech, said, “As expected, given that the UK seldom upholds the rights of a patent holder, Angiotech’s appeal to reverse a previous decision was denied.” He said the decision “does not impact other patents relating to our paclitaxel stent technology in the UK, and we continue to feel very confident in the strength of our patent portfolio protecting paclitaxel-eluting stents.”

Paul Donovan, spokesman for Boston Scientific, said, “While we are disappointed with the Court’s decision, we are confident in the strength and validity of Angiotech’s patent portfolio elsewhere around the world.”

In other legalities:

• PainCare Holdings (Orlando, Florida) reported that it received notification from the U.S. Securities and Exchange Commission indicating that it has completed its review of the company’s Form 10Ks for FY05 and FY04 and that it “has no further comment at this time.”

Randy Lubinsky, company CEO, said, “Following the SEC’s original inquiries into PainCare’s financial accounting and reporting practices in late 2005, we endured well over a year of ensuing costly challenges that called into question the integrity, character and commitment of our management team. . . . Although there remain a few lingering issues that resulted from our financial restatements, the completion of the SEC’s review of our filings largely puts to rest a very difficult chapter in the history of our company.”

Through its proprietary network and in partnerships throughout the U.S. and Canada, PainCare treats pain stemming from neurological and musculoskeletal conditions and disorders.

In other legalities:

• Four medical, healthcare and public health groups will continue their legal challenge of three clean air mercury rules from the U.S. Environmental Protection Agency (EPA) by filing a brief no later than Jan. 26 in a lawsuit asking the Washington D.C. Circuit Court to overturn what it calls “weak EPA rules, which threaten public health.”

The organizations — the American Academy of Pediatrics (AAP), American Nurses Association (ANA), American Public Health Association (APHA) and Physicians for Social Responsibility (PSR) — say that Americans are exposed to unsafe levels of methyl mercury from environmental sources. Methyl mercury emissions from coal-fired power plants make up more than 40% of all such emissions in the U.S., making power plants the single largest source of uncontrolled mercury pollution in the U.S.

The groups say that the EPA’s final mercury rule delays significant mercury reductions for 10 to 15 years longer than the federal Clean Air Act Requires and substitutes an inappropriate “cap-and-trade” scheme for strong technology.

Georges Benjamin, MD, executive director of the APHA, said, “Methyl mercury poses serious health risks to both young and old alike. But the risks are disproportionately greater for minorities and people living in under-served communities who are more likely to live in potential toxic hot spots and are at greater risk of exposure.”