Judge Rules for Amgen Patents

Times Staff Writer

Amgen Inc. won a widely watched patent dispute Friday over an anemia drug that brings it $2.4 billion a year in sales.

In a 290-page decision, U.S. District Judge William Young found that the patents covering Amgen’s Epogen were valid and that two patents dealing with the drug’s production had been infringed by Transkaryotic Therapies Inc. and its partner, Aventis Pharmaceuticals Inc.

The result of the ruling in Boston, coupled with earlier decisions, is that four Amgen patents on Epogen have been found “valid, enforceable and infringed,” said spokeswoman Christine Cassiano, a spokeswoman for Thousand Oaks-based Amgen. “Obviously we’re quite happy with this decision. It’s a vindication for us on our patents.”


Used to treat anemia in patients with kidney failure, Epogen is Amgen’s brand name for a genetically engineered version of erythropoietin, a natural protein that spurs red blood cell production.

Transkaryotic’s version of erythropoietin, called Dynepo, is produced using human cells, while Amgen uses hamster cells. Amgen had raised concerns that had Transkaryotic prevailed, it could use the same technology to copy virtually any biotech drug.

Transkaryotic spokeswoman Justine Koenigsberg said the Cambridge, Mass.-based company would appeal: “Certainly we’re disappointed by the decision. We do continue to believe we don’t infringe any valid Amgen patents.”

Michael J. Astrue, president and chief executive of Transkaryotic, said in a statement that Young’s decision “misreads the law, discourages innovation, exports biotechnology manufacturing jobs overseas and denies patients in the United States an important alternative product.”

Aventis, based in Strasbourg, France, couldn’t be reached for comment.

Transkaryotic is trying to establish manufacturing in Europe for Dynepo, with the goal of launching it by early 2006, Koenigsberg said.

The company appealed a 2001 ruling by Young that Amgen had proved that three of its patents covering Epogen were “valid, enforceable and infringed.”


Last year, a federal appeals court said it agreed with the lower court’s ruling that Transkaryotic’s Dynepo infringed two Amgen patents. But it said Young had misapplied the law when he declared the Amgen patents valid and returned the case to the court in Boston.

Friday’s ruling provides reassurance to investors worried about the future of Amgen and its top-selling drug in the face of competition from generic drugs and other products, said Geoffrey C. Porges, an analyst with Sanford C. Bernstein & Co.

“It does solidify Amgen’s intellectual property position in advance of the competitive threat” from other drug makers, Porges said. The next big hazard, he said, looks like it is Swiss drug maker Roche’s product Cera, which it is “likely to try and bring to market in 2007 or 2008.”

Amgen also sells a newer anemia drug, Aranesp, which brought the company $1.5 billion in sales last year.

News of the ruling came just as stock markets were closing.

Shares of Amgen rose $1.22 to $55.22 in regular trading and was up 26 cents more in after-hours trading. Transkaryotic closed down 48 cents to $16.79 and was unchanged after hours. Both are listed on Nasdaq. Aventis rose $2.32 to $84.44 on the New York Stock Exchange.