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Executive Summary

BIOGEN ALPHA INTERFERON EUROPEAN PATENT REMAINS IN EFFECT PENDING APPEAL of a decision by the Opposition Division of the European Patent Office to revoke the patent. Biogen announced in a Dec. 12 release that it intends to appeal the patent board division's oral decision to the Technical Board of Appeals of the European Patent Office after the Opposition Division issues its written opinion, expected in three to six months. Biogen noted that its patent remains in effect until then. If another company markets an alpha interferon product in the interim and if the patent is reinstated, that company could be liable for patent infringement, Biogen said. Biogen reported that the Opposition Division, which consists of four patent examiners, "objected to the scope of certain claims" for Biogen's recombinant alpha interferons. "Because the rules of the European Patent Office require either total acceptance of all claims within a patent or revocation of the patent, the Opposition Division indicated it intends to revoke the patent," Biogen stated. Biogen explained that it submitted a sample of the strain from which its alpha interferon is developed as part of its patent application. The European Patent board decided that Biogen's patent claim should be limited to only what is in that sample strain; any difference from that strain would not be covered under Biogen's patent. The release notes that the oral decision does not affect the company's patent position in the U.S. Biogen obtained a U.S. interferon patent covering "all production of recombinant alpha interferons" in July 1985. The firm also said the European patent is not necessary for Biogen licensee Schering to market Intron A interferon alfa-2b. Schering's agreement with Roche also remains in effect. The two firms agreed in May 1985 not to sue each other for patent infringement of their respective leukocyte interferon products. The agreement did not affect efforts to file and enforce patents for alpha interferon. In 1984 Roche challenged the European Patent Office's issuance of a patent to Biogen for cloning and expressing alpha interferon. The final decision on Biogen's patent, the first to go through the European Patent Office, could set a precedent for the entire biotechnology industry. Europe has thus far taken a narrow view of what a patent covers in contrast to U.S. patent interpretation. For example, a federal appeals court recently upheld a Hybritech patent covering a method of using monoclonal antibodies in immunometric assays for detection and monitoring of physiologically significant conditions.

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