Centocor Inc.'s lead product, CentoRx, has come under attack just as ithas moved within striking distance of FDA review. On Thursday,Genentech Inc., of South San Francisco, announced that it has filed apatent infringement complaint against Centocor for infringing its"Cabilly patent," which covers basic scientific methods used toproduce chimeric antibodies.Ongoing discussions "at the highest levels of both companies" overwhether or not Centocor's manufacture of CentoRx infringes onGenentech's patent have apparently broken down, although Centocorspokesman Tim Cost said his company had no idea that this was thecase. "Considering our historically positive relationship withGenentech, we were disappointed with this filing," said Cost.Last December, Centocor filed a product licensing application (PLA)with the FDA for approval to market CentoRx for adjunctive use inangioplasty procedures. The product, an anti-platelet monoclonalantibody, will be marketed by Eli Lilly & Co., of Indianapolis, Ind.,and manufactured by Malvern, Pa.-based Centocor, if it wins FDAapproval. The two companies will split profits. In early April, resultsfrom CentoRx's pivotal Phase III trail were published in the NewEngland Journal of Medicine and Lancet.CentoRx has been one of the driving forces behind Centocor's long,slow recovery from a major disappointment with its first therapeuticdrug, Centoxin for the treatment of sepsis. Centoxin was rejected bythe FDA and withdrawn from the European market after a clinical trialsuggested the drug was more harmful than placebo.Cost said he has no idea what immediate impact the Genentech lawsuitmay have on his company's manufacture of CentoRx. The companyhas been stockpiling supplies of the drug in preparation for possibleFDA review and subsequent market launch."We've been aware of the Cabilly patent [Cabilly is the surname of theinventor] for several years and it's been extensively reviewed bothinside the company and by outside counsel," Cost told BioWorld. "Wedo not believe we've infringed any claims nor do we believe that wehave used the technology covered under this patent." Cost said thatCentocor pays licensing fees to Stanford and Columbia Universities,which have both "innovated in the mammalian expression of chimericmonoclonal antibodies.""As a technology-based company, we certainly respect intellectualproperty when we use the technology of others," he said.Genentech spokeswoman Laura Leber said that the Cabilly patent isbroad and well-known, covering antibody technology related tochimeric immunoglobulin compositions, expression vectors andmethods. She said that Genentech has licensed the patent to 12companies, including some biotechnology companies. She declined tolist the firms or what they pay in licensing fees.The Cabilly patent, U.S. Patent No. 4,816,567, was originally filed in1983 and granted in 1989. Although CentoRx has been in developmentfor years, Genentech spokespersons were unable to comment on whythe company chose to file a lawsuit at this time."We need to review the paperwork before we decide what to do next,"said Cost. "Any reasonable business transaction is possible."Centocor's infamous brush with biotechnology litigation can't be ahappy memory: the company spent roughly $12 to $13 million in a1991 patent battle with XOMA Corp. of Berkeley, Calif. (which alsospent a comparable sum). It lost the suit and neither company's sepsisdrug ever made it to the U.S. market.

-- Lisa Piercey Washington Editor

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