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Criticized for issuing gene-related patents that seem to describe discoveries more than inventions, the U.S. Patent and Trademark Office in Virginia is on the verge of releasing new examination guidelines that raise the bar for patentability. While the new guidelines will make it more difficult to patent genes, PTO Director Q. Todd Dickinson has also recently stressed that his office awards such patents based on solid legal precedent — despite the objections from medical groups and others who feel that patenting genes is unethical and not in the public’s best interest. The new guidelines are largely supported by the biotech community and will require applicants to be more specific in describing what a gene actually does. “One simply cannot patent a gene itself without also clearly disclosing a use to which that gene can be put,” Dickinson told the House Judiciary Subcommittee on Courts and Intellectual Property on July 13. “As a result, we believe that hundreds of genomic patent applications may be rejected by the U.S. PTO, particularly those that only disclose theoretical utilities.” For the past six months, interim guidelines on genomic patenting have been in place. Dickinson said the final version, expected to be released this fall, is unlikely to differ significantly. As for the 6,000-odd gene patents already issued — 1,000 of them for human genes — Dickinson told Rep. Zoe Lofgren, D-Calif., “If there is a problem here — and it’s not clear if there is or is not — it’s the courts’ job to look at the patents.” Some of the first patents on human genes, which date back to the late 1970s, aroused little controversy because they were so clearly linked to the cause or treatment of specific diseases, such as anemia, and involved years of laboratory work. But with the expansion of efforts to clone and sequence human DNA, a rush for patents ensued. Currently, more than 20,000 applications related to genes are pending at the PTO. To meet the utility standard, the PTO in the past required only that DNA serve as a molecular probe — a property attributable to most human DNA, according to Harold Varmus, president of Memorial Sloan-Kettering Cancer Center in New York and director of the National Institutes of Health in Maryland from 1993 to 1999. The result? “Some of the issued patents have seemed very broad in their claims,” he told the IP subcommittee. “Other issued patents appear to cover many possible gene functions that were only speculative at the time of submission, thereby allowing the patent holder to claim title to applications that became known only after extensive additional studies by others.” Earlier this year, for example, Human Genome Sciences Inc. was granted a patent on a gene that was later discovered to be the entryway for the AIDS virus to infect cells. While Varmus said the revised guidelines are “an improvement,” he argued that the bar still may not be high enough. “Overly enthusiastic protection of intellectual property, too early in the process of product development, can impede the delivery of public health benefits,” he said. But biotech industry representatives staunchly defended the importance of patents to their companies and future medical advances. “Patents are an absolutely fundamental requirement for commercial success in our industry,” testified Dennis Henner, senior vice president of research for Genentech Inc. in South San Francisco “We feel the PTO has done a good job walking this tightrope.” Henner added, “We believe it is important for the PTO to not hesitate in rejecting those applications that seem to raise questions.” Neither Celera Genomics, located in Rockville, Md., nor the publicly funded Human Genome Project, which jointly announced the completion of a “rough draft” of the human genome in June, has sought to patent the genome itself, although Celera has filed provisional applications for thousands of individual genes. WORDS OF PRAISE As for the IP subcommittee, its members had nothing but praise for the PTO and made it clear that Congress — for the time being, at least — has no plans to tackle legislation on such a sensitive subject. “You really do quite a wonderful job,” Lofgren told Dickinson. “Congress should not be passing much legislation in this area.” John Conyers Jr., D-Mich., conceded that he was “scared to death” of the direction that gene patenting is headed. “We’ve made animals. We’ll make people soon,” he said. Still, neither he nor any other committee member challenged the PTO’s policy of issuing patents on genes. Yet, in the 50 public comments received by the agency on revising the utility guidelines, many writers found the practice deeply objectionable. “Genes are not inventions so we do not understand why the PTO is issuing patents for human genes and sequences,” wrote Abbey Meyers, president of the National Organization for Rare Disorders, a federation of 140 nonprofit health groups based in New Fairfield, Conn. “How can the PTO allow a person or company to patent genes that have existed since the beginning of time?” The College of American Pathologists, headquartered in Northfield, Ill., also opposes the patenting of genes. “Because information about gene sequences is so fundamental to understanding specific diseases,” the group argues, “patent holders can essentially gain ownership of diseases through patents.” But, as Dickinson testified, courts have held for half a century that isolated and purified products of nature may be patented, culminating with the Supreme Court’s 1980 decision, Diamond v. Chakrabarty. The high court found that genetically engineered bacteria were patentable, ruling that the inventor’s discovery “is not nature’s handiwork, but his own; accordingly, it is patentable subject matter.” Randal Scott of Palo Alto, Calif.-based Incyte Genomics Inc. echoes this point, stressing that, while genes have been around as long as humans, no one before has been able to use them to diagnose, cure, or predict diseases. “Companies like Incyte Genomics have isolated, purified, sequenced, and discovered a commercial utility for genes and put them into commercially useful formats for development of drugs and diagnostic tests,” he testified. Henner of Genentech agreed, and told the committee that increased PTO scrutiny is the best way to regulate the burgeoning industry. “In our opinion, the question of whether patents should be made available for gene inventions is not an issue that needs to be revisited,” he said. “The proper focus for discussions on gene patenting is not on the question of whether patents should be granted on genes, but, rather, the question of when it is appropriate to grant such rights.”

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