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Legal Affairs Gene Patents Continued from page 8 The Supreme Court took Judge Bryson's dissent and made it the basis of its decision, holding the isolated genes unpatentable under Section 101 of the patent statute. The opinion characterized the claimed invention as being the discovery of the information in the DNA, rather than the chemical isolation of the molecule that uses the "information" in the biochemical process of protein synthesis. The opinion states that "separating [a] gene from its surrounding genetic material is not an act of invention." In a key passage that goes to the heart of the Court's opinion, the Court states, "Myriad's claims [are not] saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule (emphasis added). Myriad's claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA." Rather, the Court concludes that Myriad's invention is the discovery of the genetic information in the code embodied in the gene and present in both the natural and isolated DNA, therefore the identity of information renders the nonnatural molecule to be categorized as a product of nature and patent ineligible. Myriad's invention is not just the discovery of the location and sequence of the BRCA1 and BRCA2 genes that code for specifc polypeptides, but their chemical isolation. To state that a claim for a DNA molecule is not a claim for a chemical composition is nonsense. It is a claim for a chain of nucleotide base pairs, a molecule whose utility resides in the genetic code embodied in the molecule. The molecule is admitted to be "nonnaturally occurring" and yet is called a product of nature! To a chemist, this is incomprehensible, as Judge Lourie recognized and the other judges and justices could not. Implications If it should now be the law that patent eligibility of a molecule with a defned chemical structure, whether DNA or otherwise, is determined by whether or not the "information" in that structure is the same as the "information" in a related naturally occurring molecule, this has far-reaching implications. For example, if the "information" in an antibody is its antigen-binding specifcity, then any antibody fragment that retains the same antigen-binding specifcity would be patent ineligible. Similarly, if the "information" in an enzyme is its substrate specifcity, then any portion of the enzyme molecule that re- Stop burying your head in the sand. Beware of the hidden danger of mycoplama contamination. Mycoplasma Control Whoever said "what you can't see can't hurt" didn't know a thing about mycoplasma. 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The reductio ad absurdum of this principle renders thousands of chemical compositions unpatentable under Section 101 merely because they function in the same way as naturally occurring molecules from which they merely differ by the "noninventive" process of making and breaking of chemical bonds. Chemistry, it would seem, is no longer a sophisticated science but a mere prosaic manipulation that, while not magic, is child's play to one of ordinary skill in the art. Perhaps some Nobel prizes should now be revoked because their recipients merely made or broke chemical bonds to produce other molecules, apparently not activity for which great honor is warranted. The Supreme Court's decision has been widely touted as being a boon to research, especially for cancer patients, because of the high cost and limited availability of the patented test using the BRCA1 and BRCA2 genes. A note of caution: Myriad spent years of effort and millions of dollars determining which portions of the approximately 80 millionbase-pair-long chromosome 17 and the 114 million-base-pair-long chromosome 13 represent the portions coding for polypeptides that are found in people with a signifcantly higher likelihood to develop breast or ovarian cancer and not in those lacking that gene. It has attempted to recover this investment by patenting the isolated DNA used in its test for cancer vulnerability and charging a high price for the test. If other companies can now piggyback on that costly labor and charge a much lower price for the test, how many other companies will make similar investments and efforts if patent protection is now unavailable? Some companies will still do the research but may keep the results secret, resulting in wasted effort and resources by others trying to duplicate their achievements. The patent system, requiring full disclosure in return for a limited period of exclusivity, was intended to avoid such waste and delay in making scientifc progress in medicine and other disciplines. A patent on a new chemical composition must disclose how to make and use it. If this valuable information is kept secret, biochemical science is retarded and wasteful duplication takes the place of rapid advances. I have been a professor of organic chemistry for nine years and a patent practitioner in the chemical, pharmaceutical, and biotechnological arts for 36. Judge Lourie's opinion should have been adopted by the Supreme Court. I cannot accept a Supreme Court decision that trivializes chemistry and elevates biological "information" over chemical structure in patent law, and that usurps the role of Congress and creates a new class of patentineligible subject matter by judicial fat. I hope that other patent practitioners with chemical training, as well as other chemists, biochemists, and biotechnologists will agree.