Epogen Patent Infringement Case to Open

The drug is already worth billions of dollars and could be worth billions more. No wonder Wall Street will be paying close attention this week as a 3-year-old fight over who is allowed to produce it finally goes to trial. Epogen, a red blood cell stimulator commonly used to treat anemia in kidney dialysis patients, accounted for $1.8 billion in U.S. sales last year for Thousand Oaks-based Amgen Inc., the world’s largest biotechnology company. But a smaller company, Cambridge, Mass.-based Transkaryotic Therapies Inc., or TKT, has found another way to make the protein that makes the drug work. Amgen says TKT is violating the patents it holds on Epogen, but TKT says its process is entirely new and could not have been envisioned when Amgen patented its technique. Now the courts will decide who’s right. The patent infringement case opens in federal court in Boston today. While Amgen puts cloned human genes into hamster ovary cells to produce Epogen, TKT induces human cells to make the protein in a laboratory culture. Its version of the drug, known generically as erytrhopoietin, is now in clinical trials. A pretrial ruling last month probably lessened the chances the case will send shock waves through the biotech industry by exposing other valuable proteins--such as insulin and human growth hormone--to competition from upstart companies who find new ways to produce them. But the issue that most interests the industry is whether Amgen owns the protein or merely one of several processes to make it. On Friday in Nasdaq trading, Amgen shares closed at $62.38; TKT closed at $26.25.