Transkaryotic announces victory in Genzyme patent litigation.

Transkaryotic Therapies, Inc. (Cambridge, MA; 617-349-0271) announced that the Honorable Gregory M. Sleet of the United States District Court of Delaware has informed the parties he will dismiss the patent litigation Genzyme Corporation (Cambridge, MA) and Mount Sinai School of Medicine brought against Transkaryotic. The order came in response to a motion by Genzyme asking the Court to clarify its recent "Markman" ruling construing the term "chromosomally integrated."

The suit, brought last year, claimed that Transkaryotic's activities relating to Replagal (agalsidase alfa) enzyme replacement therapy for the treatment of Fabry disease infringe one or more claims of United States Patent 5,356,804. The patent is directed to methods of making alpha-galactosidase in mammalian cells, as well as the genetically-engineered cells themselves. Alpha-galactosidase is the enzyme that is deficient in patients with Fabry disease. Genzyme's unextended patent protection expires in October 2011. The patent is exclusively licensed to Genzyme by Mount Sinai School of Medicine.

"We are pleased with the decision that our Replagal product does not infringe their patent ," said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of Transkaryotic. "The fact that the Court decided to dismiss this case before completing briefing on our motions for summary judgment of non-infringement and invalidity confirms our belief that this was a frivolous case. The important thing now is that our time, resources and energy can be focused on improving the lives of patients with Fabry disease."

Genzyme said the court clarified certain claim constructions in its Markman ruling of November 29, 2001, and that based on this clarification, Genzyme will concede non-infringement in its patent lawsuit against Transkaryotic in order to expedite an appeal of the Markman ruling to the Court of Appeals for the Federal Circuit.

Replagal enzyme replacement therapy for the treatment of Fabry disease has been approved in the European Union and several other nations, and is being reviewed by the United States Food and Drug Administration in the United States.

Genzyme General, a division of Genzyme Corporation, is developing Fabrazyme (agalsidase beta), an enzyme replacement therapy for patients with Fabry disease. Fabrazyme is approved in the European Union, and Genzyme is pursuing authorization to market the product in the United States and elsewhere.

Transkaryotic is a biopharmaceutical company dedicated to the development and commercialization of products based on its three proprietary development platforms: Niche Protein products, Gene-Activated proteins, and gene therapy. The company's Niche Protein product platform is based on protein replacement for the treatment of rare genetic diseases, a group of disorders characterized by the absence of certain metabolic enzymes. Transkaryotic's gene activation technology is a proprietary approach to the large-scale production of therapeutic proteins, which does not require the cloning of genes and their subsequent insertion into non-human cell lines. The company's gene therapy technology, known as Transkaryotic Therapy, is focused on the commercialization of non-viral, ex vivo gene therapy products for the long-term treatment of chronic protein deficiency states.