Myriad Genetics – Naturally occurring gene sequences outlawed in the US

Friday 14 June 2013

The Supreme Court in the US yesterday handed down a long awaited decision as to the patentability of naturally occurring gene sequences.

The case hinged on whether gene sequences associated with BRCA1 and BRCA2 (indicators for the predisposition of breast and ovarian cancer) should be patentable. For Myriad Genetics, the holder of the patent, it was an important case as they sell lucrative tests to physicians. It is a highly emotive issue and Angelina Jolie’s recent mastectomy after being tested positive for the BRCA gene mutation has only highlighted the importance of these tests in the prevention of disease.

There have been several arguments that as these genes exist in nature that they should not be patentable. James Watson – one of the founders of the structure of DNA was even asked to provide a brief to the court on the subject and he believed that naturally occurring sequences should not be protected by patents.

The Supreme Court stated that “genes and the information they encode are not patent eligible… simply because they have been isolated from the surrounding genetic material”. Whilst this decision is a game-changer, the court was clear to make the distinction that the decision did not affect the patentability of modified or synthetic sequences (complementary DNA (cDNA) sequences were given a special mention as still patentable). Neither did the decision involve method claims for new applications of knowledge about sequences of genes.

This decision now invalidates a huge swathe of gene sequence patents in the US and potentially opens up the market for gene chips for testing individuals for numerous conditions. Previously, such chips would have been difficult to produce due to so many different parties owning patents for individual gene sequences and no industry-led cross-licensing arrangement to allow exploitation. It will be interesting to see if the courts in other countries will also be willing to ban patents for naturally occurring gene sequences and this US case will no doubt now open up the debate in Europe.

If you have any concerns regarding how this decision will impact your patent portfolio, please contact Simon Bradbury or your usual Appleyard Lees contact.

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