Thursday, June 13, 2013

US Supreme Court rules that isolated human genes are not patentable

Thursday, June 13, 2013

In a ruling that is sure to send reverberations around the world of intellectual property law, the US Supreme Court unanimously ruled that isolated human genes are not patentable.

More specifically, the Court found that the BRCA1 gene was not patentable subject matter in the very recent decision of Association for Molecular Pathology v. Myriad Genetics, Inc.

This ruling is remarkably timely, as public awareness of this aspect of patent law has never been higher. Hollywood film star Angelina Jolie recently announced that she underwent a double mastectomy in response to the results of a DNA test that identified her as having a mutation in her BRCA1 gene - which indicates an increased susceptibility for developing breast cancer. Public debate is heated with respect to the patenting of human genes.  The BRCA1 gene had been patented by Myriad Genetics, a company based out of Utah. Myriad provides BRCA1 screening test at a cost of approximately $3000, which raises access to medicine issues. Can an average woman afford Myriad’s BRCA1 test?

In coming to its unanimous decision, the US Supreme court noted that although Myriad found an important and useful gene, it was also undisputed that Myriad did not alter the gene in any way. As such, Justice Thomas wrote that "separating that gene from its surrounding genetic material is not an act of invention."

It is important to note that the Supreme Court distinguished the patentability of complimentary DNA molecules (“cDNA”) in determining that “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived," and accordingly, "cDNA is not a 'product of nature' and is patent eligible under §101." §101 of the Patent Act defines the eligible subject matter for a patent in the US.

Moreover, the Supreme Court explicitly noted that it was not ruling on the patentability of methods or applications of knowledge involving the BRCA1 and BRCA2 genes. Rather, the Court found that it was "merely hold[ing] that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material."

Check back with MBM’s blog for analysis and updates regarding this exciting and  landmark ruling and the Canadian context with respect to human gene patenting.

By: Adam Tracey