Gene patents
Gene patents refer to legal protections granted by governments on specific gene sequences or methodologies for their application. Advocates of gene patents argue that they incentivize innovation and investment in scientific research by providing exclusive rights to inventors, thus fostering advancements in medical and genetic technologies. Conversely, critics contend that such patents hinder the open sharing of scientific knowledge, potentially obstructing research and the development of vital medical diagnostic tools and treatments. To qualify for a patent, an invention must be useful, novel, nonobvious, and sufficiently detailed in its application. While naturally occurring products are generally not patentable, modified DNA sequences can be, as they are deemed to be altered beyond their natural state. Significant legal milestones include the 2013 U.S. Supreme Court ruling that human genes cannot be patented, a decision that invalidated over 4,300 existing gene patents. This ruling was pivotal in addressing concerns about the implications of gene patents on healthcare accessibility and scientific progress, while still permitting patents on artificially manipulated genes. The ongoing dialogue surrounding gene patents reflects broader ethical and economic considerations in the biotechnology industry.
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Gene patents
DEFINITION: Patents granted by governments on specific gene sequences or on methods for obtaining or using such sequences
Proponents of gene patents argued that they stimulated research and innovation by rewarding scientific effort and allowing companies to protect their investments in research. Critics, in contrast, asserted that patenting genes prevented the free flow of scientific information and inhibited scientific and medical research, including the development of diagnostic tests and disease treatments.
To be patentable, an idea (or invention or product) must meet four basic criteria: It must be useful (that is, it must have some practical use), it must be novel (not known before), it must be nonobvious (not an idea easily developed by someone trained in the given field), and it must be described in the patent application in enough detail to enable someone trained in that area to use the idea for the stated purpose. In general, products of nature are not considered patentable. Deoxyribonucleic acid (DNA) products were considered patentable because they had been purified or modified in some way not found in nature. In 2005, it was estimated that about 4,300 (or about 20 percent) of human genes had been patented. In 2013, the US Supreme Court ruled that human genes cannot be patented, invalidating the previously granted patents.
In 1977 the University of California applied for patents for insulin and growth genes. In the 1980 case Diamond v. Chakrabarty the U.S. Supreme Court ruled that life-forms modified through are patentable because they have been changed in some way through human intervention and are not likely to be found in nature. The insulin patent was granted in 1982, and in 1987 the growth hormone patent was granted. These patents were awarded following the general patent rule that vaccines and natural products, including hormones, made into useful forms are patentable. Insulin was the first recombinant product approved in 1982 for marketing. Genentech holds the patent for cloned human insulin, which was licensed to the pharmaceutical company Eli Lilly.
In 2009 the American Civil Liberties Union (ACLU) and the Public Patent Foundation (which is affiliated with the Benjamin N. Cardozo School of Law of Yeshiva University) filed a lawsuit in the U.S. District Court of Southern New York against the U.S. Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation, holders of the patents for BRCA1 and BRCA2—genes associated with increased of inherited breast and ovarian cancers. Plaintiffs represented by the ACLU included patients, doctors, universities, and medical associations such as the American College of Medical Genetics. The claim stated that gene patents violate the First Amendment to the U.S. Constitution and patent law because as products of nature, genes should not be patentable. The plaintiffs maintained that gene patents limit scientific research, the free flow of information, and the development of diagnostic tests. The ACLU also noted that the high price charged by Myriad for diagnostic testing to determine a woman’s BRCA1 and BRCA2 gene sequences could prevent women from obtaining genetic testing to determine their risk of cancer.
The case eventually made it before the US Supreme Court, which ruled in June 2013 that human genes could not be patented. The decision invalidated the more than 4,300 gene patents that had already been granted. However, the ruling did allow genes that had been created by manipulation of DNA to be patented, as these did not occur naturally in the human body.
Bibliography
"Can Genes Be Patented?" National Library of Medicine, 28 July 2021, medlineplus.gov/genetics/understanding/testing/genepatents/. Accessed 19 July 2024.
Caulfield, Timothy, Tania Bubela, and C. J. Murdoch. “Myriad and the Mass Media: The Covering of a Gene Patent Controversy.” Genetics in Medicine 9, no. 12 (December, 2007): 850-855.
Gaisser, Sibylle, et al. “The Phantom Menace of Gene Patents.” Nature 458 (March 26, 2009): 407-408.
Holman, Christopher M. “Patent Border Wars: Defining the Boundary Between Scientific Discoveries and Patentable Inventions.” Trends in Biotechnology 25, no. 12 (December, 2007): 539-543.