UK COURT RULES AGAINST AMGEN RIVAL CAN MAKE OWN ANEMIA DRUG.

Byline: Evan Pondel Staff Writer

THOUSAND OAKS - A British appeals court dismissed a patent claim by Amgen Inc. on Wednesday, enabling a competitor to manufacture a drug similar to the biotechnology giant's blockbuster Epogen.

The court overturned an initial ruling, stating that Transkaryotic Therapies' Dynepo, a gene-activated form of erythropoietin, does not encroach on Amgen's patent. Known as Epogen in the United States, Amgen's drug has been among the most successful anemia products for the Thousand Oaks-based company, generating sales of $570 million in the most recent quarter.

``Unfortunately, overturning such a decision sends a message to the industry that it's OK to do whatever you can to bypass someone else's patent,'' said Ronald Renaud, analyst with Bear Stearns in New York. ``And a company shouldn't be able to just come along and make a challenge for the sole reason of getting around a patent.''

In April, the court ruled that TKT's attempt to manufacture and market Dynepo in Europe infringed on Amgen's patent. However, the ruling was appealed, and now the court has voted in favor of Cambridge, Mass.-based TKT. Richard Selden, TKT's president and chief executive officer, said he was gratified by the court's decision, even though it significantly narrows the company's patent.

``Our mission now is to work to bring this important product to patients who need it,'' Selden said in a statement. ``And the court's decision further validates the distinctiveness of TKT's gene-activation technology.''

Though Amgen didn't express concern over the court's ruling, the company could appeal the decision in coming weeks. Jeff Richardson, an Amgen spokesman, said the company will pursue the case contingent on its inherent costs.

``We do know this will probably have little, if any, commercial impact on Aranesp, though,'' Richardson said.

Amgen's Aranesp is already approved in Europe for kidney-failure anemia. Studies have shown that Aranesp can be administered less frequently than other anemia products on the market.

Amgen's scuffle with TKT over one of its patents isn't new. Amgen sued TKT for patent infringement in the United States last year. While the court ruled in Amgen's favor, Richardson said the decision had absolutely no influence on the proceedings in Europe.

Patent infringement has become a highly contested topic in the biotech industry. When ideas that take shape under a microscope are exposed, the biotech community often jumps at the opportunity to surpass the competition.

``Patents are the lifeblood of the industry,'' Richardson said. ``And frequently are challenged.''

Amgen's patent on Epogen expires in 2004. Analysts say the court's recent ruling and the foreseeable demise of Amgen's patent could spark competition.

``So you can say there really is some consequence of the court's ruling, even though it's what happens two years from now,'' said Eric Schmidt, analyst with SG Gowen Securities Inc. in New York. ``And everyone knows this is already a competitive drug market.''

Even so, Schmidt said Amgen shouldn't appeal the court's most recent decision regarding Dynepo. ``It's definitely not worth their time,'' he said. ``Maybe it's a pride thing, but why should they pursue this if it's going to cost them?''

Amgen shares rose 15 cents to close at $45.64, while TKT shares declined 35 cents to close at $38.55 Wednesday.