PDL BioPharma, Roche cancer, ophthalmic, inflammation news
PDL said it received a letter on Aug. 11 from Genentech Inc. asserting that four of the Roche unit's products do not infringe supplementary protection certificates (SPCs) covering PDL's royalty rights in Europe. PDL said the SPCs covering the products - cancer drugs Avastin bevacizumab and Herceptin trastuzumab; ophthalmic drug Lucentis ranibizumab; and asthma drug Xolair omalizumab - extend the company's European patent protection until 2014. PDL said royalties on sales of the products that are made or sold outside the U.S. accounted for about 30% of its total 1H10 revenue of $182.4 million.
PDL said it believes that its SPCs are enforceable against Genentech's products and intends to vigorously assert its SPC-based patent rights. PDL also believes that Genentech's ability to challenge infringement is limited due to a 2003 settlement of an IP dispute between the companies that requires Genentech to establish non-infringement "by a considerably higher standard than that typically applied by the courts." PDL also said that "Genentech waived its right to challenge the validity of PDL's patent rights, including its SPCs" under the settlement. ...