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Executive Summary

Biogen's U.S. interferon patent covers "all production of recombinant alpha interferons," the company asserted in a July 23 press release. The release announced issuance of the 17-year monopoly rights for recombinant alpha interferon by the U.S. Patent and Trademark Office. The patent states that Biogen's invention focuses on "rDNA molecules and their use in producing interferon-like polypeptides," specifically, DNA molecules expressed in "appropriate host organisms." The patented molecules "are characterized by DNA that codes for polypeptides having an immunological or biological activity of human interferon." According to the patent, these rDNA molecules "may be used in the production of polypeptides useful in antiviral and antitumor or anticancer agents." The patent document adds-that "the methods of this invention should allow the production of these polypeptides in amounts and by methods hitherto unavailable." Biogen has licensed the worldwide rights to its alpha interferon patents to ScheringPlough, which has developed the product under the trade name Intron A. Schering has applications pending for use of alpha interferon against three forms of cancer, and one NDA for use against the common cold. The patent (No. 4,530,901) gives Biogen "the right to exclude others from the manufacture, use or sale of recombinant alpha interferons in the U.S.," the company press release asserted. In May, Schering reached an agreement with Roche, the other major drug firm with an alpha interferon NDA pending at FDA, whereby both companies would refrain from taking patent infringement actions in court against one another and instead compete in the marketplace with their alpha interferon products. The agreement covered the Roche patents, as well as those arising from Roche's collaboration with Genentech for recombinant alpha interferon. However, under the agreement, both Schering and Roche will protect their patent rights in the case of a third party attempting to enter the market. Biogen Begins Effort To Enforce Patent Rights With Suit Against Boehringer Ingelheim In Austria The Schering-Roche agreement has no effect on either firm's regulatory or administrative challenges to each other's patents. Roche, which announced in March that it had been issued a patent in the U.S. for its purification of leukocyte interferon, has argued that its discovery takes precedence over Biogen's initial cloning and expression of the protein, and that Biogen's patent should not apply to Roche's product, Roferon A. "This latest action signifies the strength of the Biogen research position, and points up the logic of why Roche would agree to be a party to the recent business agreement reached between Roche and Schering-Plough," Schering stated in response to the Biogen announcement. "We have always believed that the Biogen patent position was very strong. We entered the recent agreement with Roche as a business decision, believing that it would be better to compete in the marketplace than in the courts." The release noted that Biogen holds a similar patent from the European Patent Office, issued in 1984. That patent covers the manufacture and sale of rDNA alpha interferons in major markets on the continent. Roche is challenging the European patent. Biogen has already initiated legal action to enforce its European patent rights. On July 19, the company announced that it had filed suit against "an unlicensed seller of an interferon product in Austria." According to the release, the infringing product is an eyedrop containing a recombinant alpha interferon for the treatment of herpes simplex virus keratitis. Filed in Vienna, the complaint names Boehringer Ingelheim Zentrale GmbH and two of its subsidiaries as defendants.

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