Genetics Institute Inc. (GI) was issued a U.S. patent Monday coveringpharmaceutical compositions containing erythropoietin (EPO), andTuesday filed a lawsuit in the U.S. District Court of Delaware claimingthat Ortho Pharmaceutical Corp. is violating the patent.GI officials told BioWorld they believe the patent also is being violatedby Amgen Inc., which licenses to Ortho Biotech Inc. the right todistribute EPO in the U.S. under the name Procrit for non-dialysisindications, and in other parts of the world under the name Eprex."We're considering what our approach is going to be regardingAmgen," said Lawrence Stein, GI's vice president and general counsel.EPO, a protein normally produced in very small quantities, stimulatesproduction of red blood cells. Drugs containing EPO are used to treatvarious anemias. The FDA granted its first product license for EPO in1989, to Amgen, of Thousand Oaks, Calif.In 1993, GI earned in "excess of $20 million" in royalties on licensedsales of EPO, said Dennis Harp, GI's director, corporatecommunications. Amgen had 1993 revenues for its EPO product,Epogen, of $587 million.Amgen received its patent, covering the EPO gene, in October 1987,about four months after GI was issued a patent covering purified EPO.What followed was years of litigation that eventually resulted in a May1993 settlement, in which GI paid Amgen $14 million. Another resultwas that GI, of Cambridge, Mass., was enjoined from making, using orselling EPO in the U.S.Tom DesRosier, GI's vice president and chief patent counsel, explainedthat a patent only gives the holder a right to exclude others. It doesn'tgive the holder a right to do what is patented.So that sets up the possibility of a "cross block," whereby eachcompany could block the other from manufacturing and selling EPO inthe U.S."We're certainly prepared to litigate this, but I wouldn't speculate howor on what terms this will be resolved," Stein said. "We believeGenetics Institute made a significant contribution to the developmentand discovery of EPO. The (new) patent recognizes that and entitles usto a reward."Stein said, "We haven't had any discussions with Ortho regarding thispatent, other than a courtesy call telling them a lawsuit had been filed."GI's previous patent was invalidated on a point that involved anumerical claim of specific activity. The new patent describeshomogeneous EPO, but does not make the specific numerical-activityclaim.Clare Castaldo, manager of public affairs for Ortho Biotech of Raritan,N.J., told BioWorld, "We are confident in our position, and we plan tocontinue to supply our customers with EPO." She said Ortho could notcomment further without seeing the suit.Both Ortho Biotech and Ortho Pharmaceutical are affiliates of Johnson& Johnson.GI granted rights to EPO in Japan to Chugai Pharmaceutical Co. Ltd.of Japan, and European rights to Boehringer Mannheim GmbH ofGermany. n

-- Jim Shrine

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