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Executive Summary

BIOTECH PROCESS PATENTS ARE BEING REVIEWED MORE SLOWLY than protein patents at the Patent Office, Chiron President Edward Penhoet, PhD, indicated at a Prudential-Bache health care R&D conference Sept. 22 in New York. "The short-term problem comes from the fact that within the U.S. Patent Office there are basically two different sections dealing with biotechnology-related problems," he said. "Section 150 deals with proteins, and that group seems to be moving more rapidly and issuing more patents than Section 120, which is the group grappling with recombinant DNA and the patents covering processes." As examples, Penhoet cited the recent issuance of a patent to Genetics Institute for erythropoieitin (EPO) "based on essentially one purification step of a large body of prior knowledge," and Chiron's Factor VIII litigation, where "there was some enabling technology performed by the Scripps Clinic" in purifying the protein. "These patents are issuing from the section of the U.S. Patent Office that deals with proteins and the recombinant production patents are behind," he noted. "I think that what we will see over the next two years or so is that those two should begin to converge and there will be some sort of equity in terms of the two sides, that is, purification of proteins and their production. We are in a stage right now that for the next couple of years there is going to be a fair amount of confusion about how these patents relate to one another." Concurring with Penhoet's analysis was Philip Whitcome, Amgen Director of Strategic Planning, whose company leads in the development of EPO and plans to file a Product License Application in December. "It is our conclusion that when properly construed and properly interpreted, this [Genetics Institute] patent will relate primarily not to recombinant material, but material derived from urine," he said. "After all, it is unlikely that if we were the first to clone and express the gene, the first to put it in clinic, the first to report any type of clinical response in patients, the first to file a PLA and probably the first on the market, that we did not also have a pretty good position with respect to patentability." A second reason for the current state of patent confusion, according to Penhoet, is that early patent tests so far have taken place outside the U.S. For example, a U.K. court is hearing the Burroughs Wellcome/Genentech dispute over TPA. "I think although the patents are issuing more rapidly in Europe, Europe has a much weaker patent stance than the U.S., so I would expect to see much stronger patents issuing in the U.S. and that coverage in the U.S. is likely to be more substantial," he emphasized. "I think it would be dangerous to extrapolate from the European experience to say the U.S. Patent Office is likely to act in the same way and that the patent rules are likely to be the same (as) established in European cases."

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