Landmark Gene Patenting Ruling
Landmark Gene Patenting Ruling

On June 12, 2013, the U.S. Supreme Court ruled that human genes cannot be patented, a decision that upsets more than 30 years of U.S. patent law and has wide implications for gene patenting worldwide.  The ruling differentiated between genes (in this case BRCA1 and BRCA2) and synthetic forms of DNA (cDNA). Naturally occurring genes that are isolated are now no longer patentable, while synthetic ones can be patented.  Within hours of the ruling, laboratories across the U.S. announced that they would begin offering tests for the presence of BRCA1 and BRCA2, which previously could only be tested by Myriad (the defendant in the U.S. Supreme Court case).

The issue of gene patenting received a lot of press coverage due to a recent New York Times op-ed by actress Angelina Jolie highlighting her decision to have an elective double mastectomy because of her results from the Myriad test that demonstrated she had a defective BRCA1 gene. The defective gene increases the chance of breast cancer by 80 percent and of ovarian cancer by 50 percent (Lydall, 2013).  In her op-ed, Jolie encouraged all women to take control of health care decisions and to take the test if they have a high risk and can afford to do so (Jolie, 2013). The Supreme Court ruling will allow women across the U.S. to follow her advice, not just for testing breast cancer, but for diseases whose diagnostic tests are controlled by a singular company and whose costs have been prohibitive.

Intellectual property rights and patent decisions are national matters though, so women around the world will need to wait for their own legal rulings on the matter. In Australia, Myriad recently won a ruling by the Federal Court to uphold their BRAC patents. The court ruled that isolating unmodified human genetic material is patentable (George, 2013). In Europe, patenting of genetic material is covered under the Biotech Directive, which is followed by EU states and as well other European countries including Switzerland and Norway. The Biotech Directive allows patenting of biological materials that are isolated from their natural environment or are produced by a technical process (Sharples, 2011). Ethical debates are still being waged in Australia and across Europe about gene patenting and the U.S. ruling may impact future policy decisions.

According to the American Medical Association, 30,000 genes exist and an estimated 20 percent of these genes are patented by private companies, the government and by individuals (Gene Patenting).  This news analysis will examine the arguments for and against gene patenting and will highlight the impact of the U.S. Supreme Court Ruling.

Arguments for and against Gene Patenting

One of the major arguments in favor of gene patenting (and patenting/intellectual property in general) is that it allows corporations and investors to recoup the cost of research and provides them with an incentive to pursue new research as well. Myriad notes they invested years of work identifying the genes, each of which contain a couple thousand nucleotides on chromosomes that contain tens of millions of nucleotides each (Fisher, 2013). Without the incentive of big profits, many corporations may not spend the time isolating individual genes.

On the other side, opponents argue that gene patenting discourages related research and prevents other companies from providing diagnostic tests for these genes. Before the ruling, scientists could not use these genes to develop new tests or find other applications. Myriad’s test, for example, does not perform further data for those who are found to have a “variant of unknown significance.” Thus, individuals who were given that result were unable to legally find a different test that could give them a better answer (Kirchgaessner, 2013).

Myriad had a monopoly on the testing and researching of BRAC genes, allowing them to charge $3000 to $4000 for tests, a prohibitive amount for those who insurances would not cover the test (and for those without insurance). The test might only cost $100 in an open market, so the high ticket price prevented many women from taking advantage of this test that could save their lives (Abad-Santos, 2013).  Biotech companies might argue that the high prices were necessary to recoup investment costs, similar to any drug or medical device.

A second argument against gene patenting is that the patented genes exist naturally, scientists only identified them. For some, such as Justice Thomas, identification alone is not a strong enough argument to receive a patent. Thomas also rejected the argument that separation alone is an act of invention. Australian courts disagreed and ruled that isolation was enough “manufacturing” to lead to a patent. Novel ways of separating genes are patentable in the U.S. though as well as novel ways for applying genes for treatment (Fisher, 2013).

For some, there could be a middle ground. This middle ground could be useful for countries that still allow gene patenting (and not just of synthetic genes). Australian IP expert, Luigi Palombi, argues for the creation of a “genetic sequencing right” that act like a limited property right that rewards discoverers of genetic materials, but does not give them a monopoly on their use. Palombi recommends that the WHO or the Bill and Melinda Gates Foundation play a role in brokering sharing agreements (Dayton, 2013).

Impact of the U.S. Supreme Court Ruling

It is unclear whether the ruling will truly discourage research of new genes because of the loss of the ability to recoup costs through exclusivity or whether the ruling will help the industry thrive because many new companies can offer tests and do research on existing genes. Companies will be able to offer whole genome sequencing as well, which is a whole new area of business. Companies can also remove the gene, chemically alter it and then make money off of it. So there are still many avenues to pursue for revenue generation. The biotech industry is thriving and is expected to grow. In 2012, Americans spent $5 billion on genetic tests and this number is expected to rise to $25 billion in 2021 (Brewster, 2013).

Beyond impact human genetic testing, the ruling may also impact bacterial genes as well as DNA sequencing from animals, viruses, fungi and other natural organisms (Stutman, 2013). According to Nature Biotechnology, 8,000 genes may be at risk because of the Supreme Court ruling and only half of those genes were human genes. The decision may also make it harder to patent things derived from natural products, like drugs from microorganisms and plants (Pollack, 2013). The true impact of the court decision then won’t be known for many years.

Works Cited

Abad-Santos, A. (2013, June 13). Understanding the gene patent ruling: why it’s good news for Angelina Jolie. The Atlantic. Retrieved from: http://www.theatlanticwire.com/national/2013/06/understanding-gene-patent-ruling-why-its-good-news-angelia-jolie/66209/

Brewster, S. (2013, May 29). Will the Supreme Court kill the gene-patent business? Retrieved from: http://gigaom.com/2013/05/29/will-the-supreme-court-kill-the-gene-patent-business/

Dayton, L. (2013, April 19). In Australia, gene patents also subject of High Court struggle. Science Insider. Retrieved from: http://news.sciencemag.org/scienceinsider/2013/04/in-australia-gene-patents-also-s.html

Fisher, S. (2013, June 13). Supreme Court rejects human-gene patents — sort pf. Forbes. Retrieved from: http://www.forbes.com/sites/danielfisher/2013/06/13/supreme-court-rejects-human-gene-patents-sort-of/

Gene patenting. Retrieved from: http://www.ama-assn.org//ama/pub/physician-resources/medical-science/genetics-molecular-medicine/related-policy-topics/gene-patenting.page

George, A. (2013, April 2). Gene patenting: consequences for global health. Chatham House. Retrieved from: http://www.chathamhouse.org/media/comment/view/190565

Jolie, A. (2013, May 14). My medical choice. The New York Times. Retrieved from: http://www.nytimes.com/2013/05/14/opinion/my-medical-choice.html

Kirchgaessner, S. (2013, March 26). Science: custodians of the code. Financial Times. Retrieved from: http://www.ft.com/intl/cms/s/0/6e93c6fa-9180-11e2-b839-00144feabdc0.html#axzz2W7aWiLGd

Lydall, R. (2013, June 14). Angelina Jolie effect has doubled hospital breast cancer checks. London Evening Standard. Retrieved from: http://www.standard.co.uk/news/health/angelina-jolie-effect-has-doubled-hospital-breast-cancer-checks-8659187.html

Pollack, A. (2013, June 14). After patent ruling, availability of gene tests could broaden. The New York Times. Retrieved from: http://www.nytimes.com/2013/06/14/business/after-dna-patent-ruling-availability-of-genetic-tests-could-broaden.html?src=rechp

Sharples, A. (2011, March 23). Gene patents in Europe relatively stable despite uncertainty in the U.S. Genetic Engineering & Biological News. Retrieved from: http://www.genengnews.com/insight-and-intelligenceand153/gene-patents-in-europe-relatively-stable-despite-uncertainty-in-the-u-s/77899385/

Stutman, J. (2013, June 17). Supreme Court denies human gene patents. Energy & Capital. Retrieved from: http://www.energyandcapital.com/articles/supreme-court-denies-human-gene-patents/3515

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