The surprise decision reinstating Scripps Clinic's Factor VIIIpatent could have a major impact on unresolved patent issuesin the biotech industry.
The U.S. Court of Appeals in Washington on Monday ruled thatScripps Clinic and Research Foundation, Genentech Inc. andChiron Corp. must return to U.S. District Court in San Franciscoto decide the validity and scope of Scripps' patent on FactorVIII.
The appeals ruling provides direction for other patent actionswhile leaving unresolved the crucial issue of whether patentson natural proteins cover recombinant versions.
Based on the decision, litigants can expect to argue their casesin trial because the appeals panel clarified rules that will limitthe use of summary judgments to resolve disputes.
This case "is one of a series in which the Federal Circuit hasspoken quite clearly about the need for the complete absenceof dispute as to material facts" before granting a summaryjudgment, said Walter Buting, chief patent counsel forGenentech.
The appeals court also clarified "best mode" rules in a way thatwill allow patent holders to protect their cell lines.
Best mode requires inventors to reveal the best method forproducing a product. The lower court ruled that Scripps hadviolated best mode by failing to deposit the monoclonalantibody used to purify Factor VIII. The appeals panelreversed that decision in a ruling consistent with its recenterythropoietin patent decision.
As of now, companies don't have to deposit their best cell lines,meaning they can keep them as trade secrets, said WilliamSmith, an attorney at Townsend & Townsend in Palo Alto, Calif.,who represented Chiron early in the case.
The defendants are discussing whether to ask the appeals courtto rehear that decision, said William Anthony, Chiron's leadcounsel.
The central issue that has yet to be decided is whether acompany that isolates a natural protein can claim a patentbroad enough to cover the recombinant version.
Chiron will argue at the upcoming trial that Scripps' patentdoesn't cover recombinant Factor VIII. "You can't leapfrog frompurification of the naturally occurring protein to recombinantFactor VIII," said Anthony. "It's too big a leap in patentcoverage."
A new trial date hasn't been scheduled, but the attorneys don'texpect it to be heard before late this year.
-- Karen Bernstein BioWorld Staff
(c) 1997 American Health Consultants. All rights reserved.