WASHINGTON -- The U.S. Court of Appeals brought new life toScripps Clinic's anti-hemophilia blood Factor VIII patent onMonday when it ruled that Scripps, Genentech Inc. and ChironCorp. must return to District Court to decide the patent'svalidity.
The ruling reversed summary judgments, made by the U.S.District Court of Northern California between 1987 and 1989,that had effectively invalidated the Scripps patent.
"Encumbered by the summary nature of the (District Court)proceedings, neither scientific nor evidentiary truth has riseneasily to the surface," said the appeals panel in returning thecase to the lower court.
The U.S. Court of Appeals of the Federal Circuit ruled on nineissues, five of which it returned to the District Court.
A major issue in this case is whether a patent holder who wasthe first to purify a natural protein can block from themarketplace companies that produce its recombinantequivalent without a license.
As early as 1983, Scripps claimed that both Genentech andChiron were infringing Scripps' patent when they producedFactor VIII using recombinant methods. Both Genentech andChiron argued there was no infringement, since the Scrippspatent covered the purification of natural Factor VIII.
Factor VIII is a large blood-clotting protein found in the blood.About 20,000 people in the United States suffer fromhemophilia A, a disease caused by the absence of Factor VIII.Many hemophiliacs have contracted the AIDS virus frommultiple blood transfusions. Therefore, several companies,including Cutter Labs (which licensed Genentech's technology),Chiron and Baxter Health Care (which licensed GeneticsInstitute's clone), are developing recombinant-derived FactorVIII.
The Court of Appeals ruling showed that "the Zimmermanpatent is alive and well again," Scripps' attorney William S.Feiler told BioWorld. Theodore S. Zimmerman is one of the co-inventors of the Scripps patent that issued in November 1982.Scripps applied for and received additional Factor VIII productclaims in a 1985 reissue patent. Joining Scripps in prosecutingand defending the patent were Revlon Inc. and Rhone PoulencRorer. Revlon originally held a license to the patent beforeselling its rights to Rorer.
Genentech spokesman Jack Murphy said the company'sattorneys were reviewing the 41-page ruling and would nothave a comment until today. Chiron also declined commentuntil today. Genetics Institute said that it is not in litigationwith Scripps over the Factor VIII patent.
-- Carol Talkington Verser, Ph.D. Special to BioWorld
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