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GENE SEQUENCE PATENTS: NIH HAS THREE TO SIX MONTHS TO RESPOND TO PTO’s INITIAL REJECTION OF NIH’s FILINGS, DIRECTOR HEALY TELLS SENATE HEARING

Executive Summary

NIH has up to six months to appeal the U.S. Patent and Trademark Office's initial rejection of the government's patent applications for 2,375 complementary DNA sequences discovered as part of the human genome mapping project. The PTO's action, issued Aug. 20, addresses whether NIH's applications meet initial requirements that a patent application must cover inventions that are novel, nonobvious and useful. National Institutes of Health Director Bernadine Healy, MD, told the Senate Judiciary/Patents Subcommittee Sept. 22 that NIH has three months to respond and can request and extension to six months. HHS and NIH are now discussing "whether or not we will continue the dialogue with the patent office," Healy explained. She added that the agency's outside patent counsel has indicated that "this is a customary part of the process and indeed it is very optimistic that most of the concerns raised in the preliminary patent office finding can be met." The NIH director stressed that NIH is using the applications to foster open public discussion of gene patenting issues. The Senate hearing was convened to discuss ethical concerns related to gene patenting. Sen. Hatfield (R-Ore.), another hearing witness, had earlier this year proposed a moratorium on the patenting of genetically-engineered organisms, partly to allow time for Congress to set up an ethics advisory group ("The Pink Sheet" Sept. 21, T&G-7). Asked by Subcommittee Chairman DeConcini (D-Ariz.) to comment on the moratorium proposal, Healy said such a moratorium could be "particularly dangerous" in the gene research field -- which is "moving so quickly that if you had a five-year moratorium you would be basically declaring the patent system not applicable to genetic material." Even though HHS and NIH have not formally decided how to proceed with the cDNA patent applications, Healy reviewed some of her concerns about PTO's response. From a "policy standpoint," the NIH director commented, "the most troubling proposed rejection in the [patent] examiner's action deals with the issue of 'nonobviousness.' That is, whether the information can be readily determined from what is in the public domain, as for example in a scientific publication." Of concern is the "rejection of claims to full coding portions of some genes that [former NIH researcher Craig Venter] had discovered with between 400 and 500 base pairs because of prior publication of small DNA sequences -- only 15 base pairs long -- that were in common with these newly disclosed full coding regions of genes in the Venter application. Indeed, this was a major concern that led NIH to file for patents -- namely, dumping sequence information on thousands of genes into the public domain might jeopardize later obtaining patents on the full gene or a gene fragment with apparent function." In retrospect, Healy added, "the NIH filing was a highly appropriate protective action. The PTO's position here suggests the need to at least consider a legislative remedy and international agreement that the prior publication of partial gene sequences not preclude a subsequent patent on the full genes and/or partial genes with known function. Attention to this issue should be a matter of some urgency," she added. Chairman DeConcini asked Healy to focus on the ethical issues of gene patenting. Healy replied that "there are certain situations that are so ethically odious that I'm even embarrassed to bring them up, like the notion of patenting a human being." In another example, Healy posed the question: "Is it ethical for someone for a period of time to have intellectual property rights to control a powerful human hormone that everyone in this room has circulating in their body -- erythropoietin?" The U.S. government and legal system have "said that it is ethical for a time to ascribe to Amgen or some company patent protection on that particular hormone for the greater good of getting that hormone developed so that it could be used for patients with chronic renal failure who have terrible problems with anemia," the NIH director observed. Healy suggested that it is "important" to define these ethical questions in terms of "very specific and concrete issues," and she suggested that generally the "benefits probably outweigh the risks" for the patenting of genes or gene fragments. From a "personal view," Healy said she "might have more trouble with the ethical issue of patenting a living animal." Yet, in cases where a transgenic animal might be used to obtain a life- saving hormone, Healy suggested that a patent might be ethical "if that's the only way we can get the investment to produce that animal and produce that product that would save lives." Healy stated that NIH probably would not enforce any potential cDNA patents except in unusual cases such as when an exclusive license might be required to encourage development of a treatment for an orphan disease. Sen. Hatfield focused his testimony on a proposal to establish a permanent advisory body to make policy recommendations on ethical issues to Congress. Hatfield suggested that this proposal might be accomplished by resurrecting the congressional Biomedical Ethics Board. The board was established by law in 1985 but never got off the ground, in large part because the selection of advisors bogged down over such questions as their views on fetal tissue research and abortion. Sen. Domenici (R-N.M.) told the committee that Hatfield's concerns "are well-founded" but contended that they could be addressed through existing programs. For example, he noted, rules governing the National Center for Human Genome Research require that 3% to 5% of the program budget be used to study the social implications of genetic research. Genentech VP David Beier outlined principles on the gene patenting issue endorsed by both the Industrial Biotechnology Association and Association of Biotechnology Companies, including strong support for the patenting of genes and genetically- engineered organisms. The trade associations believe it is appropriate for NIH to seek patents on gene sequences with known functions so as to facilitate technology transfer, although it is "not clear" yet whether patents should issue for gene sequences whose function is unknown. IBA and ABC encourage the continuing dialogue between NIH and PTO, and the associations support exclusive licensing by NIH as appropriate to encourage commercial development of gene technology. DeConcini, Hatfield and Labor and Human Resource Committee Chairman Kennedy (D-Mass.) wrote to the congressional Office of Technology Assessment Sept. 8 to request a review of gene patenting issues. Areas to be explored, the senators specified, include what "constitutes patentability of human DNA sequences"; the legal arguments for and against such patenting; the ethical implications of "ownership of naturally occuring human DNA sequences"; and the "increasing trend to file early patents" on research by the Human Genome Project and how this trend affects the research enterprise of the federal government, universities and biotech companies. In addition, the senators asked whether current technology transfer laws are "adequate, too confining, [or] too open."
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