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Primer: Background Information About Gene PatentingWhat is a patent? A patent is a grant issued in the name of the United States Patent and Trademark Office (PTO). A patent "confers the right to an applicant to exclude others from making, using, or selling an invention in the United States" and its territories for 20 years from the application filing date. (If a patent was applied for prior to June 8, 1995, the term of these exclusive rights extends 17 years from the application filing date.) The goal behind granting exclusionary rights to an inventor is to protect the time and money that an individual or company may put into the development of an invention. This guaranties that only the applicant of a patent has the opportunity to produce and market an invention for the term of the patent, and is seen as essential to encouraging investment in and development of new products. Patents are also granted to motivate invention and promote disclosure as patentees must teach the world how to practice the invention in exchange for patent rights. The exact nature of the rights conferred by a patent is a point of confusion. The key to these rights is in the words "right to exclude" in the phrase quoted above. A patent does not grant the rights to make, use, sell or import an invention. A patent only grants the right to exclude others from making, using, selling or importing the invention. Since the patent does not grant the right to make, use, sell, or import an invention, the patentee's own right to do so depends upon two things. The rights of others (does someone else hold a patent with prior rights over the new product?) and whatever general laws might be applicable (is the product or its use legal and safe?). A patentee, merely because he/she has received a patent for an invention, is not thereby authorized to make, use, offer for sale, or sell, or import the invention if doing so would violate any law. Technically, therefore, if Congress were to pass a law prohibiting the patenting of genes, gene patents would be invalidated. Realistically, however, this would be infeasible because the federal government would then have to compensate holders of already issued patents for their losses, which would be astronomically expensive. Gene patent revocation would also be unlikely because patents are viewed as necessary to spur private investment in genetics, genomic medicine, and biotechnology. For an invention to be patented, it must meet three conditions. It must be considered new, non-obvious to those working in the applicable field, and it must be useful. Whether and how the discovery of particular gene sequences meet these conditions is a matter of tremendous debate. An invention will not be considered new or novel in the PTO if the invention was known of, used or being offered for sale by others in this country, or patented or described in a printed publication in this or a foreign country, before it was invented by the person applying for the patent. In the realm of genetic patenting, novelty is most clearly seen from the viewpoint of supporters of gene patents when considering transgenic organisms. In transgenic modification, a gene or segment of genetic material is transferred between species of organisms. A gene typically found in the bacterium Bacillus thiurengenesis that codes for the production of a toxin, for instance, is spliced into the DNA of corn to produce crop plants with a built in pesticide. No naturally occurring species of corn have this ability, so therefore this corn is viewed as new. In the case of the Harvard onco-mouse, a mouse bred with cancer for use in research, the genetic manipulation performed on the organism was sufficient for the PTO to classify the entire animal and its offspring as the invention of the researchers who developed it. The condition of novelty becomes more clouded when looking at attempts to patent single genes. If the gene is simply sequenced (its chemical structure is described), and isolated from its natural environment (the chromosomes of the organisms in which it occurs), does it represent something new? Such an isolated form of these genes is not known to be found anywhere in nature, and it seems that isolation may be a key distinction in determining whether a not a patent can be granted on a single gene. There is a long history of allowing patents to be granted on "products of nature" (including chemicals and bacteria) that have been isolated or purified because purified objects of nature do not, obviously occur naturally and therefore represent "new" condition. To meet the non-obvious requirement, an invention must be sufficiently different from existing inventions so that, at the time of application, the invention would not have been obvious to a person of ordinary skill in the field. The policy behind this requirement is that patents should only be granted for real advances, not for mere technical tinkering or modifications of existing inventions. While the PTO often makes the determination as to whether an invention is non-obvious, the standard is actually set in the courts and is only applied by the PTO. The courts can overrule the PTO in litigation. A last condition requires inventions to be a product of human invention. This is perhaps the most controversial aspect of the patenting life debate. The heart of this issue revolves around the distinction between an invention and a discovery. For instance, no one would expect an individual to be granted a patent on a material discovery such as minerals or crude oil, because they are pre-existing products of nature. However, an individual who creates a product from such discoveries may correctly be given credit as the inventor of something new. Why are gene patents controversial? Opponents of gene patenting have argued that genetic material exists as part of a natural heritage and that no amount of manipulation can confer upon such material the status of a human invention. Supporters of gene patenting contend that the only manner in which a gene can be sequenced (structurally described) is through the formation of a copy, and that such a copy constitutes an isolated and purified invention. How will gene patents affect scientific research? There is a stereotype of scientists as individuals motivated purely by the search for objective truth. In pursuit of these truths they engage in think tanks and peer review, freely publishing their findings to ensure a high standard of objectivity in their own work. This free flow of information is seen to benefit scientific progress by enabling others in the field to build on previous work. Whether patents will limit the cooperation among researchers apparently depends on the risks perceived by the patent owners. A patent on a DNA sequence provides the owner with exclusionary rights over the "tangible DNA molecules and constructs, but does not prevent anyone from perceiving, using and analyzing information about what the DNA sequence is." In theory, the owner of a gene that has the potential to be useful in the diagnosis or treatment of a disease should be willing to freely share access to the gene. In doing so, the patent holder is in a position to profit from this sharing. This could be strong motivation for researchers to patent as many genes as possible and to make access to these genes as easy as possible. In such a system, we would expect genetic research to be both highly competitive and open to the sharing of ideas and information. There is some evidence that "…patent holders tend not to enforce their rights against basic scientific uses…" but with more and more educational institutions applying for patents, research by other organizations, even pure research, might be seen as competition. By contrast, individuals concerned with DNA sequencing will often face risks greater than the benefits provided by the exclusionary rights provided by a patent. As genetic sequences are uncovered, they can often be used as starting points for future discoveries. Having a patent on a sequence alone opens the door for other researchers to "scoop" new patents on the proteins a sequence might code for, or potential uses of the sequence. In this arena, researchers would benefit from playing their cards close to their chests in order to prevent such an infringement. At least early in the process of genetic sequencing, then, we can see how channels of communication between researchers might shut down. "University scientists who might otherwise be colleagues in the scientific enterprise became business competitors jockeying for commercial advantage. Moreover, there soon was a greater willingness to suppress or distort research, several peer-reviewed studies have shown. Scientists became less willing to share critical research tools and bio-materials. Old habits of openness and collegiality gave way to non-disclosure agreements and material transfer licenses." How will genetic patents affect the standard of medical care? "One of the controversies surrounding issuance of patents covering naturally occurring mutations, the occurrence of which correlates with an increased risk of developing disease, is the belief that they will be used to prevent doctors from practicing medicine. Some fear that patents on fragments of DNA might also impede basic research due to complicated licensing webs." The fear mentioned in the statement above is founded in the same belief system that argues gene patents will hinder "pure" scientific research by limiting the ease with which information is shared. At its core, medicine is science, so this should not be surprising. What is surprising is that with concern over the increasing cost of medical care, the biotech industry used the very argument leveled against them to oppose the granting of genetic patents to the National Institutes of Health (NIH). How will the commodification of genes and organisms affect the ongoing process of scientific research? Will the granting of patents on individual genes have an overall negative or positive For Additional Reading References
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