A Medical Device Daily

A UK patents court has upheld the validity of Edwards Lifesciences' (Irvine, California) Andersen patent for transcatheter valve technology, but found that CoreValve's (also Irvine) ReValving system for transcathether aortic valve replacement does not infringe.

"While we did not prevail on infringement, we are pleased the court upheld the validity of our UK patent, which strengthens this key patent in the Andersen patent family," said Larry Wood, Edwards' corporate VP, transcatheter valve replacement. "This is an important component of Edwards' intellectual property in transcatheter heart valve technology, and represents one element of our broader leadership strategy."

The case was initiated by CoreValve in the UK in September 2007, Edwards said. In response, Edwards counter-sued, claiming infringement of the patent. While the court upheld Edwards' patent, it found that CoreValve's specific product design does not infringe, the company reported. Edwards said it succeeded in having CoreValve's invalidity claims dismissed on all grounds.

Edwards said it remains convinced that the CoreValve product infringes and will consider an appeal of this aspect of the case. The ruling has no effect on sales of the Edwards Sapien transcatheter heart valve in the UK or anywhere else, the company said.

"We are gratified by the decision in the UK court. While an appeal of this ruling is possible, we will continue to vigorously defend our own intellectual property and our legal right to continue to clinically evaluate and market our ReValving system for the treatment of patients worldwide," said Daniel Lemaitre, CoreValve's president/CEO. He added that last year more than 2,000 patients outside the U.S. received a ReValving system, and CoreValve hopes that twice as many patients will be treated with the technology in 2009.

Separately, Edwards has a lawsuit against CoreValve in the U.S. for infringement of the U.S. Andersen patents, and the Federal Patent Court in Munich, Germany is expected to rule on the validity of the company's German Andersen patent early this year, Edwards said. In October 2008, the District Court of D sseldorf found no infringement of that patent by CoreValve, a decision that Edwards has appealed.

According to CoreValve, because Edwards has only filed European lawsuits in the UK and Germany, these rulings protect patient access to CoreValve's system for percutaneous aortic valve replacement in high-risk patients with advanced aortic valve disease throughout Europe.

CoreValve says its ReValving system allows percutaneous aortic valve replacement and is intended to provide an alternative to open-heart surgery. The ReValving system procedures are performed on the beating heart without cardiac assistance or rapid pacing, the company notes, and may result in less trauma to the patient.