Court puts DNA R&D in a spin

US Supreme Court muddies the test tube waters with compromise decision on gene patenting

The US Supreme Court’s consideration of Association for Molecular Pathology v Myriad Genetics was attracting attention in biotechnology circles long before Angelina Jolie had a double mastectomy based on the results of a BRCA1 genetic test.

In the US, the test she underwent costs around $3,500 (£2,200) and is only available from Myriad, which had filed a series of patents directed to the breast cancer susceptibility genes BRCA1 and BRCA2. In May 2009 several of these were challenged by a group of doctors, scientific institutions and advocacy groups, arguing the claims to the genes were invalid. They alleged the company had used its patents to keep others from providing alternative, cheaper tests.

After losing at district court level and then succeeding on appeal, Myriad’s claims came before the  Supreme Court, which focused  on the issue of whether DNA and genes could be patented at all.

Myriad’s opponents argued that patents should not be granted for any DNA sequences since they were “products of nature”. Myriad contended that the act of severing the chemical bonds in a chromosome to isolate DNA was sufficient to alter the molecule from its natural state, thereby rendering it patent-eligible. In any event, claims to complimentary DNA (cDNA) – a man-made construct created during the cloning process and not identical to the gene in nature – should, they argued, be capable of patent protection.

In the end the court rendered a compromise decision that held that “isolated” DNA is not patentable, but that synthetically created DNA, including cDNA, is. This followed the position taken by the US Solicitor General in an amicus brief, arguing against the longstanding US Patent Office practice of granting patents for “isolated” gene sequences. That will now need to change and the -validity of patents happily granted by the US Patent Office may  be at risk. This is quite a slapdown for an industry where much of the funding for R&D is raised on the basis of patent protection, given that it often takes years of testing before there is any hope of return on investment.

However, the decision is narrow enough that patent claims can be drafted to protect inventions involving man-made variants or uses of genetic sequences. Hence, it remains to be seen whether this decision will have the draconian impact on the industry predicted by some.

So where does this leave gene patents in the UK? The US decision is not precedential, and the issue of  patenting has been addressed in an EU directive implemented in the UK over 10 years ago. Not surprisingly, the directive had a troubled gestation, but was thought necessary to harmonise patent law in an industry considered commercially important. It makes clear that a gene sequence isolated from its natural environment or produced by means of a technical process may be patented, even if identical to that which exists naturally.

The way forward for biotech patentees seems more clear here than in the US, where the Supreme Court has created myriad uncertainties.