Genetics Institute has asked that all nine members of U.S. Courtof Appeals for the Federal Circuit reconsider the ruling of threeof its judges that invalidated GI's patent for erythropoietin(EPO).

GI claims that the three-judge panel made errors ininterpretation of facts established in the lower court, exceededits authority to review the case and incorrectly imposed theburden of proof on the company.

The panel ruled early last month that GI's patent claims wereinvalid based on the lack of enablement. They said a personskilled in the art could not produce biologically active EPO byfollowing GI's patent.

The stakes in this case are high. Amgen Inc., the winner of thelatest round of the patent battle, estimates its yearly U.S. salesof EPO at $300 million. An Amgen spokeswoman had nocomment on the appeal.

GI and Chugai Pharmaceutical Co. Ltd. of Tokyo argue that theCourt of Appeals for the Federal Circuit (CAFC) overlooked ormisinterpreted the facts used by the District Court to rule thatthe patent was enabling.

For example, the CAFC ruled that GI produced an EPOpreparation that was only half as active as the patent claims. GIsaid that the EPO in question was a preparation about to bepurified. The District Court had agreed with GI.

By concluding that EPO's in vitro activity did not match its invivo activity, the CAFC ruled that the GI patent did not enableone to produce biologically active EPO. The District Court hadconsidered the in vitro and in vivo activities of EPO to besimilar.

GI also said the CAFC did not limit its review to the DistrictCourt decision. GI argues that the CAFC carried out its ownreview of the facts, which, GI said, an appeals court is notsupposed to do.

GI also argues that the CAFC expected GI to prove the patentwas enabling. GI claims that previous court rulings put theburden of proof on the company that questions the patent'svalidity -- in this case, Amgen.

GI and Chugai filed the appeal on March 19, two weeks afterthe CAFC blocked GI from selling EPO in the United States.

GI spokeswoman Clare Midgley said the company cannotpredict when the court will decide on the petition.

-- Carol Talkington Verser, Ph.D. Special to BioWorld

(c) 1997 American Health Consultants. All rights reserved.

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