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AMGEN EPO PATENT DECISION HAS LED TO BIOTECH PATENT FILINGS WITHOUT CELL LINE INFO: SECRECY COULD UNDERMINE FURTHER ADVANCES, G-I ARGUES TO SUPREME COURT

Executive Summary

The Amgen-Genetics Institute erythropoeitin patent fight should be considered by the Supreme Court because of its impact on the disclosure of full information in biotechnology patent applications, Genetics Institute contends in a July 1 writ of certiorari petition to the Supreme Court. Genetics Institute argues that Amgen's failure to deposit with a public repository the specific Chinese hamster ovary cell line used in its recombinant EPO process violates the requirement for patent applicants to reveal their best mode of producing an invention. The two lower court decisions in favor of Amgen have sent a message to the biotech industry, Genetics Institute maintains, that cell lines do not have to be disclosed as part of the patenting process for recombinant products. "Now is the time for the [Supreme] Court to consider this issue, while the commercialization of genetically engineered life forms is still aborning," Genetics Institute declares. As long as the Amgen decisions are upheld, Genetics Institute maintains, "genetic engineering patents will be filed without deposits of the best mode cell lines, and both the public and the 'Progress of the useful Arts' will be shortchanged on the bargain Congress struck" in the best mode provision of the patent statutes. Genetics Institute's cert petition was drafted by a team of constitutional and patent attorneys led by Harvard constitutional law professor Laurence Tribe and his associate Brian Stuart Koukoutchos with Harvard professor (and former U.S. solicitor general) Charles Fried of counsel. Other members of the Genetics Institute legal team are William Lee and Ian Crawford (Hale & Dorr) and Joseph Onek (Crowell & Moring). Quoting a recent biotechnology law trade publication, Genetics Institute states that "the biotechnology industry has quite plainly gotten the message from the [Amgen] decision . . . that genetic engineers need not make the choice between trade secrets and patent protection that the law imposes on all other inventors." The trade publication, a litigation report from the American Intellectual Property Law Association entitled "Biotechnology Practice after Amgen and Scripps," states that "if you have a biotechnology invention involving a product that is made through use of a proprietary bioculture, you can get a patent on the product and keep your proprietary bioculture a secret . . ." If the decision in favor of Amgen's patent by the D.C. federal appellate court is left "uncorrected," Genetics Institute contends, "the legacy of the decision would be cruelly ironic and devastating to the progress of genetic engineering." The irony would stem from the Supreme Court's initial decision in the area of biotech patent law in the 1980 Chakrabarty case, in which the high court found that a genetically engineered living organism can be patented. As part of Chakrabarty, Genetics Institute points out, "the American Society for Microbiology successfully urged this Court to reject a distinction between compositions of matter occurring in nature and those produced in the laboratory by artificial means, precisely because inventors of artificial life forms, if denied patent protection, would refuse to deposit cell lines and thereby stultify research and advancement in genetic engineering." The Amgen decision goes in the face of the arguments in Chakrabarty, Genetics Institute indicates, by giving patent protection and permitting Amgen to keep part of its best mode process secret. In a press statement on the cert filing, attorney Tribe charges that "right now, companies like Amgen can literally patent their cake and eat it too." Genetics Institute is using the spectre of increased secrecy in biotech research and the contradiction of Chakrabarty as attractions to lure the Supreme Court into a review of the Amgen decision. Genetics Institute, however, recognizes the difficulty of its argument by acknowledging that the Supreme Court would have to overturn two decisions in favor of the Amgen patent to reverse the lower court rulings ("The Pink Sheet" March 11, p. 18). The appellate court upheld Amgen's patent with the decision that the firm was not required to deposit a sample of its cell culture line ("The Pink Sheet" March 11, p. 18). That decision appears as the primary target of the Genetics Institute cert petition. Genetics Institute characterizes the appellate decision as a "judge-made rule exempting genetic engineers from the full disclosure requirements that federal patent law imposes on all other inventors." The firm maintains in the cert petition "deposits of genetically engineered hormone-producing mammalian cells should be required unless and until Congress or the appropriate policy-making agency decides otherwise." While the appellate court decision is the primary focus of the cert petition, the Boston District Court previously had found in favor of the Amgen patent application ("The Pink Sheet" Dec. 18, 1989, p. 15). Genetics Institute discounts the first decision, saying "the district court deemed it an 'extremely close' question 'whether the best mode was adequately disclosed in the patent specification.'" The district court, Genetics Institute says, "held that Amgen had fulfilled the best mode requirement because the patent described how to hunt for something like the best mode cells . . ." In addition to the issue of disclosure of cell lines, Genetics Institute also attacks the "salami-slicing" of biotech patients implied by the appellate court decision. That argument could also be of broad significance to the biotech industry if the Supreme Court accepts the cert petition. The court of appeals stated that even if it had found that the best mode standard had been violated by Amgen, it would have only invalidated one part of the company's patent application. Genetics Institute maintains that "Amgen's genetic engineering patent cannot be disaggregated after the fact and upheld piecemeal in the face of Amgen's concealment of "the 'best mode' known at the time to [it] of making and using the invention." Amgen's patent claims for the isolated EPO gene and the vectors for transfecting it cannot stand on their own without the host cells, Genetics Institute argues. The first two parts of the patent "simply cannot be 'made or used'" without the cells, the cert petition argues. Another key element in the court of appeals decision was the overturning of the lower court's finding in favor of a Genetics Institute patent. The basis for that decision was a finding by the appellate court that Genetics Institute had not proven that it could make EPO with a level of activity as described in the patent application. The appellate court cited the activity levels of samples of EPO submitted by Genetics Institute to FDA in its IND application as evidence that the company could not meet its patent description. The cert petition challenges that reasoning with an oblique argument. The petition notes that the IND sample was not necessarily produced by the patented method and, therefore, shows nothing about the enablement of Genetics Institute's purified hormone patent. GENETICS INSTITUTE ON NECESSITY FOR MAMMALIAN CELL LINES TO BE DISCLOSED Excerpted from the July 1 petition to the Supreme Court. References and footnotes deleted; paragraphing added. "[T]he only arguable excuse for the court of appeals' conclusion that organisms created by genetic engineering from a mammal's cells are readily available to any scientist skilled in the art and hence need not be deposited would be the blithe assumption, in the face of the Federal Circuit's own contrary findings, that recreating a specific, novel mammalian cell line is a simple, predictable and straightforward matter of following written instructions -- rather like assembling a bunch of Lego blocks according to the directions on the back of the toy box. Nothing could be further from the truth -- or could better illustrate the folly of judicial legislation in this field. . . . To say scientists [provided with a written description] could 'eventually' produce something akin to Amgen's best mode host cells reveals only a mundane truth about the laws of probability: after all, if you provide enought chimpanzees with typewriters, they will 'eventually' produce something like Hamlet."

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