Patent Validity Focus as Amgen Patent Trial Arguments End
Amgen Inc. and smaller rival Transkaryotic Therapies Inc. fought over the validity of patents on the top-selling anemia drug Epogen, as lawyers concluded arguments in a patent-infringement trial that could shape the future of the biotechnology industry.
U.S. District Judge William Young, calling the case a “fascinating legal puzzle,” must decide whether Transkaryotic infringed patents for Epogen, Amgen’s anemia treatment developed by genetically engineering a copy of a human protein.
Transkaryotic’s lawyers argued that Amgen’s patents were obtained without disclosing material information to government examiners and are invalid. Amgen’s attorney countered that Transkaryotic failed to prove that patent examiners were misled.
Shares in Amgen, the world’s largest biotechnology company, rose $2.94 to close at $74.94, and Transkaryotic fell $3.50 to close at $38, both on Nasdaq.
Transkaryotic’s lawyers devoted most of their closing arguments to challenging the validity of the Amgen patents, rather than contesting claims that the patents were infringed.
“Amgen wants to preclude far more than it invented,” Transkaryotic attorney James Haley contended. “That abuses the patent system. It abuses the public and it abuses Transkaryotic.”
Transkaryotic attorneys said Amgen failed to disclose material information to patent examiners, rendering their patents unenforceable. Transkaryotic lawyer Herbert Schwartz said filing notification with the U.S. Patent and Trademark Office--not the examiners reviewing the patent applications--is insufficient.
Amgen argued that Transkaryotic never proved that material information was withheld from examiners.
A victory by Cambridge, Mass.-based Transkaryotic would make it easier for up-and-coming gene therapy companies to challenge the established pharmaceutical companies’ dominance, patent experts say.
“The judge said it’s a legal puzzle and the framework is challenging,” said Robert LeBoyer, an analyst with Leerink, Swann & Co. “But he’s going to have to draw the distinctions and reconcile these opposing points of view.”
Judge Young occasionally interrupted attorneys during closing arguments, to ask his own questions and comment on the case’s complexity. He had warned attorneys Thursday that it may take him some time to reach a decision.
Thousand Oaks-based Amgen is fighting to keep a tight grip on its signature drug Epogen, a version of the human protein erythropoietin. The drug, expected to have U.S. sales of $4 billion in 2000, is given to kidney dialysis patients, who often become anemic, to help stimulate red-blood cell production.
Amgen sued Transkaryotic and Aventis predecessor Hoechst Marion Roussel Inc., saying the companies were infringing five of its patents by developing another version of erythropoietin.
Amgen wants Transkaryotic stopped before its drug goes on the market. Aventis filed last month with U.S. and European regulators for permission to sell a version of Epogen produced using Transkaryotic’s methods.
Transkaryotic, which has yet to put a product on the market, says it didn’t infringe Amgen’s patents because it used a different method to develop erythropoietin.
