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AMGEN/GENETICS INSTITUTE EPO PATENT INTERFERENCES DECLARED

Executive Summary

AMGEN/GENETICS INSTITUTE EPO PATENT INTERFERENCES DECLARED by the U.S. Patent and Trademark office (PTO), Genetics Institute announced in a May 17 press release. Genetics Institute said it "received notice that the U.S. Patent and Trademark Office has declared two patent interferences between Genetics Institute and Amgen relating to erythropoietin (EPO)," the release states. PTO initiated the two patent-blocking procedures on May 9. According to the release, the first interference relates to "the DNA sequence encoding EPO [corresponds] to Claim 2 of Amgen's issued U.S. Patent '008 and a pending patent application by Genetics Institute" The second interference concerns Amgen's and Genetics Institute's pending applications and "relates to the method of making active EPO by growing genetically engineered mammalian host cells," Genetics Institute said. The companies have until Aug. 9 to file preliminary motions and notice of filing preliminary statements. A date has not been set for the interference proceedings. In October 1987, Amgen was granted its patent, now subject of the interference proceedings, for the DNA sequence encoding EPO, the host cell, and the viral vector involved in the process of making EPO. In July 1987 Genetics Institute received a patent, not involved in the interference, for a method of purifying EPO and purified EPO. Amgen has a distinct advantage in the first interference because it filed its patent application for EPO's DNA sequence in November 1984, two months before Genetics Institute. However, the patent office has determined that information submitted by Genetics Institute "is deemed sufficient to demonstrate that [Genetics Institute] would be prima facie entitled to judgment on the basis of priority with respect to the effective filing date of the patent of [Amgen]." In a press statement, Genetics Institute said the proceedings were initiated because it was "able to sufficiently demonstrate conception of the inventions before" Amgen's filing date. The question as to which company owns the rights to the EPO-manufacturing process remains a crucial point of contention because both patents are pending. Genetics Institute filed for a process patent for EPO in January 1985; Amgen's filing date was October 1987. The patent office may automatically call an interference when application filing dates for similar patents are more than six months apart. G.I. asserted that the proceedings give the company the opportunity to take a stab at invalidating Amgen's right to produce EPO in the U.S. "These proceedings now give us the formal opportunity to prove that G.I. scientists were the first legal inventors of recombinant DNA technology for production of EPO," G.I. patent attorney Bruce Eisen said in the press statement. Amgen and Genetics Institute are currently locked in reciprocal patent suits in Massachusetts and California. A hearing date of Aug. 7 has been set in the Massachusetts dispute. Given the timetable for filing motions with the patent office, it is anticipated that interference proceedings may follow soon thereafter. Amgen is also in arbitration with its EPO marketing partner, Ortho, over breach of their 1985 agreement. A hearing date in that dispute has been set for Aug. 10. Amgen is still awaiting FDA approval of its EPO product Epogen for anemia associated with chronic renal failure. Approval has been delayed by a court-ordered filing of Ortho's data on predialysis patients. Although FDA approval has been considered imminent for some time, the agency's recent insistence that EPO be approved for broad chronic renal failure rather than Amgen's end-stage renal disease indication may further delay approval, as well as jeopardize the drug's orphan status ("The Pink Sheet" May 15, p. 5).
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