BRCA1

The ruling overturned biotech company Myriad Genetics’ patent on genes with links to breast and ovarian cancer. The ruling also affirmed in part and reversed in part the decision of the US Court of Appeals for the Federal Circuit.

Composite DNA patentable

The Court has agreed that synthetically created exons, strands of nucleotides known as composite DNA (cDNA), are patentable. However, the ruling found that, “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated but cDNA is patent eligible because it is not naturally occurring.”

Myriad Genetics’ patents overturned

In the case, respondent Myriad Genetics discovered the precise location and sequence of two human genes, BRCA1 and BRCA2, mutations of which can substantially increase the risks of breast and ovarian cancer. This knowledge allowed Myriad to determine the genes’ typical nucleotide sequence, which, in turn, enabled it to develop medical tests useful for detecting mutations in these genes to assess a patient’s cancer risk.

Myriad obtained a number of patents, now overturned, which conferred sole rights to isolate an individual’s BRCA1 and BRCA2 genes, based upon its discovery.

The case does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.

Isolation of an individual’s genes

Dr Luigi Palombi, author of Gene Cartels: Biotech Patents in the Age of Free Trade, who works at the Centre for the Governance of Knowledge and Development at The Australian National University, commented on the case in an interview with the Australian Science Media Centre (ASMC). He said the decision is to be welcomed. “It removes 30 years of uncertainty over the patenting of biological materials existing in nature and deals a blow to the semantics over the word ‘isolated’.

“According to the Court, merely isolating genetic material from the human body does not render the genetic material patentable subject matter. The Court also make it clear that, while cDNA is patentable subject matter, if the genetic sequence housed in the cDNA is ‘indistinguishable’ from the information in the natural DNA, that cDNA is also not patentable subject matter. In other words, before genetic material is patentable, the genetic sequence housed in that material must be distinguishable from what exists in nature.”

Commercial monopolies over genetic mutations

The ASMC also interviewed Professor Ian Olver, CEO of Cancer Council Australia, who said the decision addresses the issue of commercial monopolies over genetic mutations that are vital to cancer prevention, diagnosis and treatment.

“If there had been greater clarity on the issue back in 2008, the Australian licensee for the BRCA1 and BRCA2 patents would not have been able to demand public laboratories cease conducting the tests. Eventually, the patent enforcement claim was withdrawn, but there was, and still is, nothing in Australian law to prevent commercial interests trying to monopolise the use of genetic materials.

“The US Supreme Court’s ruling paves the way for Australia’s federal parliament to change the Patents Act and clarify that human genetic materials are not inventions and are not patentable. We welcome innovation in medical research, which should be rewarded by a robust patents system. However, discovery and isolating genetic material is not innovation. The US Supreme Court’s decision is a landmark ruling that provides a clear precedent for Australia.”