Transfer Pricing Associates

US Supreme Court Rules on Human Genome

post Tuesday August 20, 2013

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The complex nature of patents and what is actually able to be patented has been a long running debate and will likely continue for the foreseeable future. The United States Supreme Court recently ruled on a long standing question regarding the possibility of patenting portions of the human genome and DNA.

The company that was involved in the case before the US Supreme Court was Myriad Genetics. Myriad Genetics is a leader in the diagnostic testing market of various gene mutations. The two primary genetic mutations that Myriad is widely known for is the testing of BRCA1 and BRCA2. These two mutations have been linked to increased risks of breast cancer and ovarian cancer. Myriad owns a substantial patent portfolio that deals directly with Myriad’s diagnostic testing of these mutations.

At issue in the case against Myriad was §101 of the United States Code 35 on Patents, that an invention is not a naturally occurring phenomenon, or "product of nature".  This key subject was at the heart of the debate over the patent portfolio owned by Myriad. Ultimately, the Supreme Court ruled that “Myriad did not create or alter either the genetic information encoded in the BRCA1 and BRCA2 genes or the genetic structure of the DNA. It found an important and useful gene, but ground-breaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry”. Additionally, the Court ruled that cDNA, a synthetic type of DNA that matches with a gene sequence, is protected under §101.  

There are compelling arguments on each side of the table. Some groups argue that the ruling was a victory for scientific freedom and future development and access to medicine and civil liberty. While some organizations praised the ruling, others, like the American Intellectual Property Law Association (AIPLA), proclaimed that the lack of protection offered for the testing portion of Myriad’s patent portfolio will discourage investment in further research and bio-technology.

One thing is clear from this ruling, that there will be continued battles over similar issues and that the ruling handed down from the Supreme Court has answered few questions, but could potentially guide the near-term future of patents in the realm of the human genome.

Source: Mondaq

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