HHS Secretary Sullivan To Determine If NIH Gene Patent Quest Is Over

The decision on whether the National Institutes of Health should continue its quest for patents on partial human cDNA sequences now rests with Health and Human Services secretary Louis Sullivan. In September, NIH director Bernadine Healy revealed that the agency had received an initial rejection from the United States Patent and Trademark Office (PTO) for the approximately 2,700 partial gene sequences generated by former NIH researcher Craig Venter and others. Then, on October 5, an HHS spokesperson said that Secretary Sullivan would be briefed on the situation by the end of that week, and that he would issue his decision "shortly thereafter" on whether NIH should shelve the patents or respond to objections raised in the PTO rejection and continue with the process. The partial DNA sequences covered in the patents, also known as expressed tag sequences (ESTs), are thought to be useful tools to locate complete gene sequences. But NIH, which saw the possibility that publication of these partial sequences could preclude a later patent on the entire sequence, submitted patent applications. Many in the research community saw the applications as unnecessary and obstructive to progress in the Human Genome Project (Scott Veggeberg, The Scientist, April 27, 1992, page 1). More than five months into the search for a new Human Genome Project (HGP) director, the hunt continues, with the widely acclaimed University of Michigan geneticist Francis Collins reported to be the first choice. Collins and his group are noted for their contribution to the discovery of the defective gene causing cystic fibrosis. While the National Institutes of Health would not confirm Collins's possible selection, sources speaking on condition of anonymity indicate that negotiations are under way. A few problems appear to stand in the way of a Collins appointment. Apparently, Collins does not want to drop his research activities entirely in order to head the genome project and is attempting to reach some sort of accommodation with NIH that might entail splitting his time between Ann Arbor and Washington, D.C. One source says that the salary structure at NIH may also be a problem, especially with President Bush's proposal to decrease federal salaries by 10 percent. Stanford University geneticist Paul Berg, who was himself considered a likely candidate for HGP head, is anxious to see a director for the project named soon, lest it lose support in Congress. Nobel laureate James Watson stepped down as director on April 10, after tangling with NIH director Bernadine Healy over the issue of seeking patents on partial DNA sequences (Scott Veggeberg, The Scientist, May 25, 1992, page 1). "I don't know why it's taking so long to make the appointment," says Berg. Other sources indicate that this and many other decisions in Washington are on hold until after the presidential election. If Arkansas Gov. Bill Clinton is successful in his bid for president there may be a change in the directorship of NIH. Collins would be "ideal" for the job, says Glen Evans, the geneticist at the Salk Institute in La Jolla, Calif., who led a team that recently discovered a defect in chromosome 11 that may cause some types of leukemia. "Collins is probably the most famous and well-respected human geneticist in the country right now. In addition to being a superb scientist, he's a clinician," says Evans. "He's just a wonderful personality in his dealing with people and presentation of science to the lay public." NIH officials and search committee cochairwoman Ruth Kirschstein, director of the National Institute of General Medical Sciences, at press time would not comment on who might be selected and when. In mid-May, NIH set a six-month deadline for completing the search for an HGP director. --S.V. Healy announced the initial pat-ent rejection on September 22 at a Senate hearing--one month after receiving notification from the patent office. "The PTO, in its initial finding, rejected the pending claims, questioning whether the inventions were novel, useful, and nonobvious. It should be noted, however, that these issues are raised by the PTO in well over 90 percent of all patent applications--and that the preliminary finding is typically part of a confidential dialogue with the PTO," Healy told the Senate Judiciary Committee's Subcommittee on Patents, Copyrights and Trademarks. "The PTO contended that the claimed sequences lacked novelty because of the existence of publicly available cDNA libraries, from which the claimed sequences were derived. Taken to its logical extension, however, the PTO's reasoning would deny novelty to virtually all products isolated from expected sources of biomolecules, such as blood, saliva, or tissues. And it would also bring into broad question any gene lying within any available cDNA library." Healy said that the most troubling aspect of the rejection was PTO's denial of claims to full coding portions of some genes because partial sequences previously had been discovered and published. Healy did not reveal, however, whether these completely sequenced genes had been characterized as to function. "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," Healy said. She called for legislative remedies and an international agreement that prior publication of partial sequences not prevent a later patent on fully characterized genes. Healy said NIH's pursuit of these patents will clarify legal issues and determine the "optimal ways to publish the results of their research while using the patent system to maximize the public's benefit from the research that the public supports." Initial Rejection Typical The PTO rejection is not unusual at this early stage, especially in a case that has such implications for researchers and the biotech industry, says Rebecca S. Eisenberg, a University of Michigan law professor and author of a recent article in Science on the gene patent issue (257:903-7, 1992). But whether NIH will be allowed to continue the pat-ent process is doubtful. "It's not clear how much sense this makes to pursue these patent rights in the face of opposition from industry," she says. After all, protection of the domestic biotech industry is one of the main reasons NIH has given all along for pursuing these patents, she says. The Industrial Biotechnology Association (IBA) has now reversed its earlier position supporting the pursuit of patents as an interim policy. In a position paper issued June 10, IBA said: "NIH should not seek patents on either partial genes or gene sequences whose biological function is unknown. Instead, such sequences should be placed in the public domain." IBA says that biotech companies are concerned that if NIH receives patents for partial sequences with unknown function, the companies that undertake "meaningful and costly scientific work" leading to a product may have to obtain a license from NIH. Or, worse yet in IBA members' view, NIH could issue an exclusive license to a competitor. "It is perceived as unfair to permit the Government to exercise complete control over a product to whose development the Government contributed little," according to the IBA paper. Meanwhile, Britain's Medical Research Council (MRC) filed its application in July for about 1,000 partial sequences generated by MRC-funded researchers, but says it did so reluctantly and only in response to the NIH action. "Filing patent applications on partial cDNA sequences is an inappropriate time to file for patents," says Sarah Eccles, a molecular biologist with the MRC's technology transfer office. "If NIH would drop their application ono the basis of the rejection, we would drop ours." Both the Japanese and french governments hadpreviously decided not to file for partial DNA patents, she says. What MRC would like to see is an international agreement resolving this matter. One HHS source indicates that their is strong support for such an agreement, at least at that agency, but he is unclear how the Bush administration feels about the matter. Officials with the vice president's Council on Competitiveness, which is said to be working on a government-wide policy for gene patenting, say they have "no comment" on anything relating to the issue. Speaking for the research community, the American Society for Human Genetics (ASHG) continues to oppose the NIH gene patenting policy. "The ASHG believes that the issuing of patents for EST's is likely to do more harm then good," ASHG president Walter Nance said in May. " An international collaborative venture as bold as the Human Genome Project should not be jeopardized by the possibility of irrevocable damage inflicted by EST patents, the majority of which may never have any demonstrable utility. NIH, however, appears committed to supporting its "interim" gene-patent ploicy -- at least until Sullivan makes a decision. Officials at NIH acknowledge that on Septmenber 25 the filed for patents on aother 4,000 partial gene sequences, but decline to specify what types of genes they were. The majority of the previous sequences were expressed in nerve cells and were generated in the lab of Craig Venter, who has since left to form his own sequencing company, the Institute for Genome Research. "It looks like they [NIH] are going to pursue this as far as they possibly can," says Andrew Kimbrell, an attorney with the Foundation on Economic Trends, a group that is vehemently opposed to patents on living organisms. "They'll go full-speed ahead; it's part of their privatization ideology. They only thing that will stop it will be a change in the White House." Barring a change in presidents, if Sullivan allows NIH to continue on its gene-patenting course, Thomas Friebel, an intellectual property attorney with the firm of Pennie & Edwards in Menlo Park, Calif., predicts: "It's going to be well over a year before there's any resolution." Other, knowledgeable sources say, however, that Sullivan will ultimately be forced to tell NIH to scrap the gene-patent process, mainly because it has no firm legal foundation.

HHS Secretary Sullivan To Determine If NIH Gene Patent Quest Is Over

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