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AMGEN EPO INJUNCTION IS STAYED BY U.S. APPELLATE COURT

Executive Summary

AMGEN EPO INJUNCTION IS STAYED BY U.S. APPELLATE COURT in a last-minute action on April 17. Under the order, D.C. Appeals Court Judge Helen Nies found that "Amgen has demonstrated that numerous, complex, and substantial legal questions exist" and that "on the basis of the public interest, the scales tip in the favor of a stay [pending appeal]." The decision suspends a March 14 injunction order issued by Boston Federal Court Judge William Young that would have required Amgen to offer a cross-licensing agreement to Genetics Institute and withdraw its objections before FDA to the marketing approval of Chugai-Upjohn's Marogen ("The Pink Sheet" March 19, p. 12). In her order, Judge Nies said that the court was only deciding whether the injunction should be stayed and chose not to address the "conditions" set by the lower court. The decision to stay the injunction, Nies said, was based on two considerations: Amgen's "chances for success on appeal" and "equities as they affect the parties and the public." The appellate court, for the time being, agreed with Amgen's position that the "public interest" supports a stay of the injunction pending appeal of the larger patent case. "We, like the district court, discern an 'overriding' public interest in the continuing production of EPO during the appeal period," the order states. * The appellate court order was issued minutes after Amgen had been ordered again on April 17 to comply with the conditions set for a stay of injunction in a hearing before Judge Young. Under Young's order, Amgen was to have tendered a cross-licensing agreement to Genetics Institute by 5 p.m. April 18 and asked FDA to remove Epogen orphan exclusivity as an obstacle to Chugai-Upjohn's marketing of Marogen by May 18. Although Amgen officially had not tendered an agreement by April 17, the company had indicated to Judge Young that it was willing to enter into the cross-licensing agreement with Genetics Institute. In addition, Amgen apparently was ready to withdraw its objections to FDA's granting approval to Marogen. In a draft of Judge Young's order filled out but never filed by the company, Amgen said it was ready to comply with that provision of the court order. The high court also denied a request by Genetics Institute that would have required Amgen to make monthly deposits equal to its profits from Epogen sales in an escrow account in the event Judge Young's order was vacated. The court said that it would entertain motions from either party to expedite briefing in the case. Genetics Institute said it is reviewing the appellate decision to determine how to proceed. The company has at least two options -- either to request a review of the Nies decision or seek an appeal of Boston Federal Court Magistrate Patti Saris' Dec. 11 decision that upheld the validity of certain claims of Amgen and Genetics Institute's patents and found other claims to be invalid.
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