By Sharon Terry

Gene patenting is unquestionably controversial today, not in small part due to the ACLU's lawsuit pending against Myriad Genetics and the U.S. Patent and Trademark Office demanding a broad ban on gene patenting. Actually, however, the very term "gene patents" is misleading. Patents are not, and have never been, granted on genes found in a living body. Nor are patents granted simply on the information or code within a DNA sequence. Instead, patents are granted on isolated and purified man-made DNA molecules that do not exist in nature and require a scientist's manipulation to obtain. Simply put, without this manipulation, these isolated DNA molecules would not exist.

For example, a type of isolated DNA molecule that is claimed in many patents, which is called complementary DNA (or "cDNA"), is both structurally and functionally different from genes found in nature. In fact, cDNAs do not occur in nature (nor are they simply purified from nature). Rather, they are produced by making a synthetic copy of an isolated piece of DNA that includes only parts (the protein "coding regions") of the gene found in the body.

Other examples include the short segments of isolated DNA, called probes and primers, which typically consist of only a very small portion of DNA of a total gene. Because of the physical and chemical differences from genes in the body, isolated DNA molecules (such as cDNAs) can be used in numerous ways that genes cannot. For example, isolated DNA molecules can be used: (1) to produce large amounts of human protein in non-human species such as yeast, (2) to identify disease-causing mutations in diagnostic tests, (3) as medical treatments (e.g., gene therapy), and (4) as chemical reagents and research tools to enable new discoveries.

Many of those who oppose the patenting of isolated DNA molecules articulate serious concerns. These concerns include patient access to affordable care, coverage and reimbursement for genetic tests, the availability of second opinion testing, and the appropriate scope of basic research activities that should be beyond the purview of patent holders. We believe that these serious issues need to be addressed thoughtfully. However, a wholesale ban on gene patents, like that sought by the Myriad plaintiffs, would not alleviate these concerns. Rather, such a sweeping, broad-brush approach would cause wide-ranging disruption to research and development for innovative diagnostics and treatments to the detriment of individuals and families in need of medical breakthroughs.

Not only do we believe that gene patents can and should be used in a responsible manner to accelerate medical research, tests, and treatments, we have first-hand knowledge that it can be done. When my two children were diagnosed with a genetic disease called pseudoxanthoma elasticum (PXE), my husband and I worked intensely with a team of scientists to discover the gene associated with the condition. After successfully cloning the gene, we patented its corresponding cDNA and the method for detecting it. The nonprofit organization we founded to be stewards of all that was important to PXE, PXE International, now holds the patent and licenses it for a nominal fee. Although neither I nor the other co-patent holders receive income from the patent, we deliberately chose to patent it in order to ensure (a) broad and affordable availability of the test, (b) that tests are conducted by quality providers, and (c) all test results are added to a mutation database hosted by the National Institutes of Health. Although there is still no treatment, a reliable, accessible test alleviates the typical nine year diagnostic odyssey. The patent on the gene associated with PXE, which enables our mandate for public disclosure of results, focuses and accelerates research and will eventually lead to an effective treatment faster than would a process devoid of the coordination and control offered by the patent.

The law regarding gene patenting, despite being modified somewhat by evolving case law and regulation, has been relatively stable-until the current Myriad challenge. The U.S. Patent and Trademark Office has issued thousands of patents claiming isolated DNA molecules and their uses, and in 2001 (in its patent Examination Guidelines) confirmed explicitly that isolated DNA molecules can be patented. Isolated DNA molecules, as chemical compounds, are eligible for patent protection because they are non-naturally occurring compounds, a product of human activity, and have a distinctive name, character, and use. Therefore, as long as the claimed invention meets all of the statutory requirements for a patent (i.e., it is useful, new, non-obvious, and described adequately in the patent application), a patent covering isolated DNA molecules can be granted. Furthermore, until Myriad, the courts have not previously questioned the patent-eligibility of isolated DNA molecules. Finally, Congress has amended the patent statutes numerous times in ways that reflect its acknowledgement that patents may be granted for isolated DNA molecules and their uses.

The biotechnology industry relies on the well-settled promise of patents covering their inventions, provided, of course, that they meet all of the legal criteria. Biotechnology companies, many of which are very small and very few of which are profitable, rely on patents to incentivize the investment needed for research and development of their products and services. The cost of bringing a commercial biotech product to market, potentially $100 million or more, and the reality that very few research projects make it to market, combine to make innovation in biotechnology difficult at best. Given this, biotechnology companies and their investors will not advance these new technologies without the ability to recoup these costs during the limited time of patent protection. A sudden reversal of this investment-backed reliance on patent protection would be an unprecedented step which would affect not only diagnostics and treatments that rely on these inventions, but would arguably affect a much broader circle of innovative discoveries. For example, isolated DNA molecules are used: (1) to test for infectious agents, (2) to manufacture vaccines, and (3) to produce proteins used as therapeutics, and (4) in screens to identify new drugs. Isolated DNA molecules are also used in agriculture and other diverse industries. Therefore, a ban on "gene patenting" would not simply affect the companies designing genetic tests, but would damage a multitude of industries with wide-ranging products. Taken to its extreme, the arguments for why isolated DNA molecules should not be patent-eligible may be applied to any isolated molecules, such as antibiotics and other pharmaceuticals isolated from natural sources.

A ban on gene patenting would slow down the translational work needed to bring biomedical advances to the individuals who are waiting for new diagnostics and treatments. In addition, such a ban would not remedy the legitimate concerns with diagnostic tests such as their cost and coverage by insurance companies. Therefore, we believe that an unprecedented, wholesale ban on gene patents would not alleviate legitimate concerns and would create greater problems. Let's instead put this considerable energy into alleviating the coverage and reimbursement for diagnostics and therapy morass that will remain untouched by any manipulation of the gene patenting system.        


Compiled with contributions from Ann Waldo.

Sharon Terry, MA, is President and CEO of Genetic Alliance and President of PXE International.

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