The District Court of Düsseldorf, Germany, has rejected Edwards Lifesciences’ assertion that CoreValve is infringing Edwards’ German Anderson patent for a transcatheter heart valve technology.
The Irvine, Calif.-based CoreValve said the ruling protects its rights to continue expanded clinical evaluation of its system for percutaneous aortic valve replacement in high-risk patients with advanced aortic valve disease in Germany.
Edwards said it “remains convinced” that CoreValve’s product infringes its intellectual property and will promptly appeal this decision. The Irvine, Calif.-based company said the ruling has no effect on sales of the Edwards Sapien transcatheter heart valve in Germany or elsewhere.
“We will continue to vigorously defend our own intellectual property and our legal right to continue to develop and clinically evaluate our ReValving system for the treatment of patients worldwide," said Daniel Lemaitre, CoreValve's CEO and president.
“While we are disappointed by this initial court decision, defending our intellectual property is only one element of our broader leadership strategy,” said Larry L. Wood, Edwards’ corporate vice president of transcatheter valve replacement.
Separately, the Federal Patent Court in Munich, will rule on the validity of Edwards' Andersen patent in early 2009. Edwards said it also has lawsuits against CoreValve in the U.K. and the U.S. for infringement of the Andersen family of patents.
Currently, the CoreValve ReValving System will not be available in the U.S. for clinical trials or for sale.