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The Supreme Court gene patenting decision – sparking questions for the UK?

14
Jun
2013
Posted on 14 June, 2013 by Eva Sharpe
The breast cancer susceptibility (BRCA) genes hit the headlines earlier this year with Angelina Jolie’s public announcement of her decision to have a preventative mastectomy after finding that that she was at high risk of breast and ovarian cancer. The genes are back in the spotlight this week, after yesterday’s US Supreme Court ruling over whether human genes can be patented.

Genes have been patented for around 30 years and around 20% of human genes have already been patented, so what is new in this case?

In yesterday’s decision, the Supreme Court ruled that in the US, DNA that has been isolated from the human body is no longer eligible for patenting. They ruled that ‘a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated’.

Which sounds quite simple, but they then went on to say ‘[complementary DNA] cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring’ which complicates things.

When the decision was announced yesterday it took a while to work through the consequences, and even investors seemed initially confused, with Myriad’s shares rapidly rising following the decision, followed by drop which seems to have been attributed to investors thinking through the implications for the company.

It is going to take some time to resolve exactly what the consequences of the decision are. Myriad Genetics hold exclusive rights under patents covering the BRCA genes in the US, effectively giving them a monopoly on genetic testing for BRCA. As isolated genomic DNA can be used in some genetic tests, this ruling opens up the possibility for other companies to use isolated patient DNA to test for BRCA mutations. This decision could potentially mean that alternative cheaper tests can be developed, widening access to healthcare in the US.

But how does this relate to gene patenting in the UK? The US Supreme Court decision only applied to the patents held in America so this won’t affect the patents held here directly. UK patent claims which cover isolated DNA are still valid here. Our rules are governed by the EU Biotech Directive which says that in the EU ‘biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention event if it previously occurred in nature’.

But just because human genes are eligible for patenting here, it doesn’t automatically follow that all isolated human genes can be patented. All patent applications also have to meet the legal criteria of being ‘novel’, ‘inventive’ and ‘having a use or application’ and the number of new patents on isolated DNA sequences has dropped ever since the publication of the human genome project.

With this in mind it is the older patents (which were generally broader in scope) that are most likely to be affected by this Supreme Court decision. Myriad’s BRCA patents expire in the next few years anyway, and so although the decision will have some impact on Myriad Genetics and BRCA testing, the decision is really a landmark case looking at gene patenting more widely, and opening debate about the implications for other isolated natural products like proteins.

It’s worth noting though that in a similar case earlier this year, The Federal Court of Australia made the opposite decision and affirmed the patent eligibility of isolated DNA molecules under Australian law. *This decision has been appealed so we are waiting to see whether this goes the same way as the Supreme Court ruling.

With both Australia and the US reopening this old issue, I will watch with interest to see whether Europe follows suit.

*Updated 17.06.13

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policy SCOTUS BRCA
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