The latest in the legal battle over erythropoietin (EPO) has Amgen Inc.filing a lawsuit asking that a new Genetics Institute Inc. patent bedeclared invalid, presumably preempting a legal strike by GeneticsInstitute.Amgen's complaint, filed Monday in U.S. District Court inMassachusetts, follows the issuance of a patent to Genetics Institute onJune 20 covering homogenous EPO. Amgen holds a patent, coveringthe EPO gene, which was issued in 1987, about four months afterGenetics Institute got its patent covering purified EPO. Years oflitigation resulted in a 1993 decision enjoining Genetics Institute frommaking or selling EPO in the U.S.But the June 20 issuance of patent No. 5,322,837 gave GeneticsInstitute new ammunition. The following day it sued Amgen licenseeOrtho Pharmaceutical Corp., and said it was considering what action itwould take against Amgen, of Thousand Oaks, Calif. (See BioWorldToday, June 23, 1994, p. 1.)"We are seeking to have the court declare that any dispute over the[5,322,837] patent was entirely resolved by prior litigation and thatGenetics Institute cannot assert any patent rights relating tohomogenous EPO against Amgen and its licensees," said ThomasWorkman, Amgen's vice president, secretary and general counsel.Dennis Harp, director, corporate communications for Cambridge,Mass.-based Genetics Institute, told BioWorld: "This is an attempt ontheir part to try to have the patent declared invalid before we initiate asuit against them. There's nothing in this complaint which is surprising.We expected as much from Amgen."There's nothing that prevents us from suing them," Harp said. "Thisaction by Amgen may increase the likelihood that we do that."Amgen's complaint said it "seeks a declaration of its rights and otherlegal relations under reasonable apprehension of a threat of unlawfulpatent enforcement by Genetics Institute." It seeks declaratoryjudgment of patent non-infringement, invalidity and unenforceabilityagainst Genetics Institute's homogenous EPO patent.David Kaye, Amgen's manager of product communications, toldBioWorld that "we had ongoing discussions with (Genetics Institute),which I can't elaborate on, except to say we had reasonableapprehension" that a lawsuit was forthcoming.The issuance of Genetics Institute's patent, which differed from itsoriginal patent in that it didn't have a numerical claim of specificactivity, opened up the possibility of a "cross block" with Amgen inwhich each company could block the other from making and sellingEPO in the U.S. A patent doesn't give the holder a right to do what ispatented; it only gives the holder a right to exclude others.The legal debate over EPO, a protein that stimulates production of redblood cells, extends into Europe and involves affiliates of bothcompanies.Ortho, a Raritan, N.J., subsidiary of Johnson & Johnson, distributesEPO in the U.S. under the name Procrit for non-dialysis indications,and in most of the rest of the world under the name Eprex.Cilag AG, a Johnson & Johnson subsidiary, is challenging GeneticsInstitute's patent in Europe before the Opposition Division of theEuropean Patent Office. In July, in an early stage of the challenge, theoffice upheld Genetics Institute's claim covering homogenous EPO.Genetics Institute granted EPO rights in Japan to ChugaiPharmaceutical Co. Ltd. of Japan, and European rights to BoehringerMannheim GmbH of Germany. Kirin Brewery Co. Ltd. of Tokyo hasrights to Amgen's EPO in Japan, and shares rights in China. n

-- Jim Shrine

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