First Witness Takes Stand in Amgen Biotechnology Patent Case.

Byline: Ronald Rosenberg

May 16--A Whitehead Institute scientist yesterday gave U.S. District Court Judge William Young a primer on biotechnology as he took the stand as the first witness in the patent infringement lawsuit between Amgen Inc. and Transkaryotic Therapies Inc. of Cambridge.

The non-jury trial is being closely watched by Wall Street and the biotechnology community to see how far patents can reach covering a natural substance found in the body and how new, lower-cost manufacturing processes could affect the most profitable biotech drugs.

The suit, which began more than three years ago, stems from TKT's claim that it has found an alternative way to make Epogen, a red-blood cell stimulator developed by Amgen -- and the world's best-selling biotech drug with worldwide sales of nearly $4 billion.

Amgen, based in Thousand Oaks, Calif., has become the nation's largest biotech company because of its success developing and selling Epogen. The company is suing both TKT and its partner, Aventis SA, one of the largest European pharmaceutical companies, for allegedly violating five Amgen patents for Epogen.

Harvey Lodish, a widely regarded professor of biology and bioengineering at the Massachusetts Institute of Technology who runs a 30-person research laboratory at the Cambridge-based Whitehead Institute, testified on behalf of Amgen.

In his testimony on the underlying technology of Amgen patents, he explained, with questioning from Amgen lead attorney Lloyd R. Day Jr., the structure of erythropoietin (EPO). The drug is the human hormone that Amgen developed to treat anemia in people suffering from advanced kidney disease, under the brand name Epogen.