Amgen v. Roche: U.S. Court Scheduled Discovery Phase

Patent infringement suit filed by Amgen has advanced to Discovery phase following the order from the U.S. District Court in Boston which denied Roche’s motion to dismiss Amgen’s patent lawsuit against it. The Court has not made any determination as to Amgen’s claim that C.E.R.A. infringes its patents, and Roche remains confident that it does not infringe any of Amgen’s patents. The Court has set a Nov. 6 deadline for Roche to answer Amgen’s compliant. However, the Court order does not impact Roche’s efforts to seek regulatory approval from the U.S. FDA or other health authorities for its investigational Continuous Erythropoietin Receptor Activator (C.E.R.A.) for the treatment of renal anemia including chronic kidney disease patient on dialysis and not on dialysis. Earlier in November 2005, Amgen Inc., the world’s largest biotechnology company, sued Roche Holding AF, alleging the Roche’s experimental anemia drug C.E.R.A. infringes Amgen’s patents. The lawsuit reveals that C.E.R.A. contains erythropoietin (or EPO), a human protein that forms the basis of Amgen’s anemia drug – Epogen. Amgen complaint seeks an order to prevent Roche from making or selling C.E.R.A. in the U.S. Currently, C.E.R.A. is in the final stage of human tests needed for regulatory approval. C.E.R.A. is so called “pegylated” drug, designed to be longer-acting by attaching a polyethylene glycol molecule. The lawsuit alleges that Riche infringes six U.S. patents on products and pharmaceutical compositions, and processes for making EPO. Amgen seeks a declaration by the Court that Roche’s importation, use, sale or offers to sell a pegylated version of recombinant human erythropoietin infringe Amgen’s patents.