Subject: Can Superpig Be Patented? -- Biotech Firms Face Thorny Issues Date: Published: 2/25/86 142 lines Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. Biotech Firms Face Host of Thorny Issues In Seeking to Secure Commercial Rights --- By David Stipp Staff Reporter of The Wall Street Journal Can superpig be patented? Although bigger, better, genetically engineered farm animals are still just twinkles in researchers' eyes, that question may soon have to be answered. Scientists have already applied for patents related to "supermouse," a rodent outfitted with rat genes that dwarfs its normal kin. As the biotechnology industry begins to reap commercial rewards, companies are becoming increasingly aggressive about patenting inventions and protecting trade secrets. At stake are the rights to products potentially worth hundreds of millions of dollars and recognition for making major scientific breakthroughs. But efforts to secure commercial rights in the fast-evolving industry have raised a host of tricky questions that may take years to answer. Some issues, such as whether animals can be patented, are unprecedented. Others are old questions with new twists. For example, some companies are pondering how to prove ownership of their genetically engineered microorganisms if a competitor steals them. Moreover, corporate theft itself has new dimensions. Anecdotes abound about scientists, usually unnamed, who have visited competitors' laboratories and tried to filch potentially valuable microbes by picking up stray ones on clothes, shoes or even chewing gum. Biotechnology companies rarely need to steal microorganisms to benefit from their competitors' efforts, though. Many of the companies sprouted from universities fewer than 10 years ago and have retained academic ways, including remarkable openness about their work. Consider the case of two Hybritech Inc. scientists, Richard Bartholomew and Robert Wang. According to a suit filed by the San Diego-based company against Monoclonal Antibodies Inc. of Mountain View, Calif., the two scientists discussed crucial details of their work while riding in a car pool with another scientist, Gary Wada, who later joined Monoclonal. Hybritech charged in the suit that the conversations helped Mr. Wada assemble a prototype of Hybritech's main technology, used in disease diagnosis, for Monoclonal "in just one month." Monoclonal denied that it was aided by the car-pool conversations, and a federal district court ruled in its favor. Hybritech is appealing. Some researchers complain that the scientific tradition of openness is being perverted as companies try to clamp down on trade-secret leaks. But biotechnology executives disagree: Researchers measure success by their published discoveries, and "to keep these brilliant scientists happy, we have to let them publish their research," says Hubert Schoemaker, president of Centocor Inc. in Malvern, Pa. Partly because of the openness, many companies are moving toward commercialization of such major products as interferon, a naturally occurring substance with promise as an anti-cancer drug. That situation will probably generate a rash of patent fights, which, in turn, may result in patent-office hearings "that could drag on for years," says Jorge Goldstein, a Washington, D. C., patent attorney. The legal wrangling could compound problems the U. S. patent office has keeping up with the novelties bubbling out of biotechnology's cauldron. Indeed, the office is currently processing some 5,700 biotechnology patent applications, up 46% from a year ago, says a patent official. The average processing time for a biotechnology patent is about 31 months, compared with 22 months for all patents. Biotechnology companies often remain in legal limbo concerning rights to their work even after they patent it. The scope of many biotechnology patents is unclear, partly because they cover complex biological processes that are hard to describe precisely and sometimes aren't well understood, says Robert Benson, a Chicago patent attorney. And major uncertainties surround patents for living creatures. Some issues have been resolved, though. Since 1980, patent-law changes have allowed microorganisms and plants to be patented. Animal patents are just around the corner, say patent attorneys. But such patents raise knotty questions. For example, even microorganisms are generally too complex to describe precisely in patent applications, so viable samples must be deposited with a microbe storage laboratory before patents are granted. Does that mean companies will have to deposit herds of supercows to receive patents for them? Numerous uncertainties will probably be hashed out in patent-infringement suits during the next few years. The legal battles are expected to be particularly hard fought because scientific reputations, as well as rights to key products and processes, will be at stake. The kind of intense personal rivalry that is often behind such suits is illustrated by an imbroglio between research teams at the National Cancer Institute and at the Pasteur Institute of France. In December, the French institute charged in a lawsuit filed in U. S. claims court in Washington, D. C., that NCI researchers relied on the French researchers' discoveries to develop a blood test for AIDS, acquired immune deficiency syndrome. The blood test, a biotechnology breakthrough, won a patent last year, and the French claim they should receive a share of royalties from the test. However, the case has become a cause celebre, not because of the money at stake (an estimated $5 million annually in U. S. royalties), but because its outcome will help to establish who discovered the AIDS virus -- a discovery that may win a Nobel Prize. A central issue in the AIDS dispute is whether the U. S. researchers benefited significantly from virus specimens provided to them by French scientists. Such questions are increasingly likely because microorganisms are to biotechnology what integrated circuits are to electronics. And keeping microbes out of competitors' hands can sometimes be tricky. Bernard Dixon, contributing editor of Biotechnology magazine, says he knows of a case in which a scientist tried to pick up useful microorganisms in a competitors' laboratory by surreptitiously placing a piece of sticky tape on a centrifuge while touring the place. Another scientist, Royston Clowes of the University of Texas at Dallas, tells of a group of researchers whose request for a sample of a kind of virus isolated by a rival was rejected. So they planned to culture the virus from the rejection letter itself, on the assumption that the microbes were floating in the air where the letter was written. Mr. Clowes adds that before the plan could be executed, the virus became widely available. Largely to document cases of microbe theft, BioTechnica Ltd. of Cardiff, Wales, is developing technology that it claims can "fingerprint" microorganisms. Products based on the technology to identify proprietary bacteria and plant cells should be available in about six months, says a BioTechnica spokesman. Patents are pending. 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