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US Supreme Court Mulls Patenting of Human Genes

By BiotechDaily International staff writers
Posted on 10 Dec 2012
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The US Supreme Court (Washington DC, USA) will soon decide whether companies can patent human genes, which could reshape medical research and the fight against various diseases.

The case in question involves patents filed by Myriad Genetics (Salt Lake City, UT, USA) on two breast cancer (BRCA) predisposition genes for which the company has developed a specific test that identifies mutations on these genes that are associated with much greater risks of breast and ovarian cancer. The American Civil Liberties Union (New York, NY, USA) challenged those patents, arguing that genes could not be patented, and in March 2010, a US district judge agreed and invalidated the patents, stating that “DNA's existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body or the information it encodes.”

However, the US Federal Appeals Court reversed that decision in 2011, claiming Myriad's genes can be patented because the isolated DNA has a markedly different chemical structure from DNA within the body. Later on, the US Supreme Court invalidated that decision and sent the case back to the lower courts for rehearing. The decision came after the Supreme Court unanimously threw out patents on a Prometheus Laboratories (San Diego, CA, USA) test that assists doctors to set drug doses for autoimmune diseases like Crohn's disease, saying, “The laws of nature are unpatentable.”

However, in August 2012, the US Federal Circuit Court once again upheld Myriad's patents, leading to the current review. It is expected that in this round before the Supreme Court, the justices' decision will likely resolve an ongoing battle between scientists who believe that genes carrying the secrets of life should not be exploited for commercial gain, and companies that argue that a patent is a reward for years of expensive research that moves science forward.

“It's wrong to think that something as naturally occurring as DNA can be patented by a single company that limits scientific research and the free exchange of ideas,” said Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project.

Myriad’s company's lawyers responded, according to court papers, that without being able to patent and profit from their work, the company would not be able to fund the type of medical breakthroughs doctors depend on. The company also said that deciding now that genes cannot be patented would throw into chaos current research and profits structures for drug-makers, and medical research companies, who have been granted more than 40,000 DNA-related patents from the US Patent and Trademark Office in almost 30 years.

Related Links:

US Supreme Court
Myriad Genetics
Prometheus Laboratories

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