The US Supreme Court has today dealt a blow to the worldwide biotech industry by declaring that inventions deriving from isolated human DNA cannot be patented. After months of speculation, it handed down its decision in the Association for Molecular Pathology, et al. v Myriad Genetics case, which sought to establish if Myriad’s patents on the BRCA1 and BRCA2 genes, which increase susceptibility to breast cancer, were valid. The Court also ruled that because it is not a naturally occurring product, complementary DNA (cDNA) remains patentable.

Although other researchers have been able to study the genes since Myriad’s patents were filed in 1995, the intellectual property rights held by the Salt Lake City-based molecular diagnostic company mean that only it can commercialise the use of the genes , together with genetic testing for the presence of BRCA1 and 2 mutations (also protected by the patents). Other parties would have to obtain a license from Myriad to do so.

In 2009, a federal court suit was filed against Myriad by a group of plaintiffs, including the Association for Molecular Pathology, the American College of Medical Genetics, and the America Civil Liberties Union, claiming that Myriad’s patents had stifled research and were invalid due to covering naturally-occurring products (human genes). This decision from the Supreme Court is definitive and follows a series of referrals and appeals between the United States District Court (for the Southern District Court of New York) and the US Court of Appeals.

Dr. Gareth Williams, Cambridge-based European Patent Attorney and Partner at Marks & Clerk, comments:

“It would be an understatement to describe this ruling as disappointing news for worldwide biotech research. It represents a volte-face in the approach to intellectual property rights around genetics and its effects will be felt well beyond US borders.

“By declaring isolated forms of human DNA patent ineligible, it robs genome research companies of a huge commercial incentive to continue researching into DNA. This research is vital if we are to develop effective DNA-based treatments or diagnostics for diseases like cancer or inheritable illnesses.

“The decision goes against a recent equivalent in the Australian courts, which declared isolated DNA to be patentable. The US Patent and Trademark Office has granted patents on DNA for over ten years now and the European Patent Office has also continued to grant gene patents. We may now see other jurisdictions like the UK and Europe following in America’s footsteps by refusing future patents on DNA-derived inventions and revoking existing ones.

“The finding that merely isolating a natural product does not create a patentable invention could have ramifications far beyond gene patents. In the future, this could potentially lead to challenges against patents on naturally occurring antibodies or therapeutics, which may be argued to fall within this exception.

“The only consolation in this judgment is that the Court held that cDNA is patentable subject matter. cDNA is generated in the lab by converting the intermediate molecules made during gene expression back into DNA. As a consequence, they do not exist naturally and differ in sequence from the naturally occurring gene. This leaves hope for the industry that useful diagnostics and therapeutics may be derived from such patented cDNA. However, it may prove to be valueless in the end if consumers and competitors are still free to use the natural gene sequence.

“In combination with other recent rulings from the US courts, this indicates there is a strong feeling within the US Supreme Court that the scope of patentable subject matter must be reined in. The Prometheus ruling severely curtailed the scope of patents on personalised medicine and now we see claims on isolated DNA, which is often a key element of such therapies, being held invalid. This is a double whammy for the biotech industry.”