Hoffmann-La Roche Inc. expressed confidence Friday that therejection of the claims of its alpha interferon patent by the U.S. Patentand Trademark Office (PTO) will be overturned, but others weren't sosure."We're concerned about it, yes, but we also feel we have a strongposition," Darien Wilson, manager of public policy andcommunications for Roche, told BioWorld. "We do plan to file aresponse within the time period," which is 60 days from May 6.The patent, No. 4,503,035 (also called the '035 patent), covers purifiedhomogenous alpha interferon. The Nutley, N.J., company has separatepatents on recombinant alpha interferon, as does Schering-Plough,which has a cross-licensing arrangement with Roche that was agreed toin 1985. Terms of that agreement were not made public.The PTO's rejection of the patent claims for the homogenous form ofalpha interferon, originally filed on Nov. 24, 1978, centered on theapplication's absence of amino acid sequencing information.Sequencing data subsequently was published (by the inventors). Andthat data was incorporated into a filing more than a year after theoriginal _ on Dec. 26, 1979 _ according to PTO examiner HowardSchain, opening a window for his determination of prior art.Dennis Tramaloni, patent litigation counsel for Roche, told BioWorldhe questions what he calls the examiner's new standard that "you'renot entitled to a protein until you have its entire amino acid sequence,"and said the PTO was "throwing the inventors' literature against them.We have a variety of counterpositions," Tramaloni said, "and disputehis legal theorizing."David Stone, an biotechnology analyst with Cowen & Co., had twoobservations: "This decision, even if its ultimately upheld, does notnecessarily radically alter the commercial landscape for the alphainterferon market," given that the recombinant version is the dominantproduct, and the nature of other interferon patents that would remain ineffect. And, Stone said, "The rejection by the examiner will be thesubject of further discussion between Roche and the patent office," andan unfavorable decision likely would result in a Roche appeal.Ultimate rejection of the patent claims would alter the playing field forcompanies paying Roche a royalty or those that plan to use alphainterferon, such as Amarillo Cell Culture Co. Inc., which has clinicaltrials ongoing to test low-dose natural interferon-alpha applied to oralmucosa.Ed Sherwood, president and CEO of the Texas company, toldBioWorld he looks forward to the possibility of a relationship withRoche down the road. But he also sees the possibility of legal battlesover the product he gets from Hayashibara Biochemical LaboratoriesInc., a Japanese firm that successfully defended itself in a three-yearalpha interferon infringement suit brought by F. Hoffmann-La RocheLtd. in Tokyo District Court."This is clearly a serious setback for Hoffmann-La Roche, and apositive thing for us," Sherwood said. "We have always maintainedthat what we're doing, and what we plan to do, does not infringe the'035 patent. But we recognize in the real world that would not preventthem from bringing suit against us."While we feel confident that we would ultimately win, it would cost alot of money," Sherwood said.Roche's Wilson said the patent remains in force while the re-examination is pending with the PTO, and that legal staffs representingbiotechnology firms will know to recommend that they hold off anydevelopment plans until the issue is resolved."We don't think there's going to be a flurry of activity from othercompanies going out to manufacture interferon," Wilson said. "We'reconfident this rejection is going to be removed." n

-- Jim Shrine

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