The US Supreme Court has unanimously rejected a number of patent claims made by Myriad Genetics on the isolated forms of two genes, BRCA1 and BRCA2, associated with an increased risk of breast and ovarian cancer. The judgment means that human genes or segments of DNA in their natural form are not patentable in the USA, but allows sythesised DNA to be eligible for patent protection.
A number of Myriad's patent claims were challenged in 2009 in a lawsuit filed by the American Civil Liberties Union (ACLU) and the Public Patent Foundation, representing a group of scientists, patients, and medical associations who argued that their research and ability to help patients was being restricted. The lawsuit stated that a number patent claims were invalid under US patent laws because the genes were 'products of nature'.
Last year, the US Supreme Court sent the case back to the US Federal Circuit Court of Appeals for re-examination (reported in BioNews 651), which upheld Myriad's right to patent the BRCA1 and BRCA2 genes, but denied them the right to patent methods comparing or analysing DNA sequences (reported in BioNews 669).
Now, the Supreme Court has overturned the ruling in part by denying Myriad patent claims on the genes. The court's opinion, delivered by Justice Clarence Thomas, stated that the location and order of the nucleotides existed before Myriad found them. 'Myriad did not create anything', Justice Thomas said. 'To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention', he added.
The court concluded that 'a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated'. It explained that the exception to patentability is needed to prevent the 'tie up' of basic research tools, which would inhibit future innovation. However, the court decided to uphold Myriad's claims on complimentary DNA (cDNA) - synthetically created sections of DNA - because it is not naturally occurring and can only be produced in a laboratory. Myriad has produced cDNA that codes for the BRCA gene.
The judgment says Myriad discovered the location and sequence of the BRCA1 and BRCA2 genes on chromosomes 17 and 13, respectively. This information enabled Myriad to develop genetic tests to detect mutation in these genes and their patents prevented other companies from offering similar tests. Mutations in these genes can significantly increase a person's risk of breast cancer to between 50 percent and 80 percent and to between 20 percent and 50 percent for ovarian cancer.
Sandra Park, a lawyer for ACLU welcomed the decision. 'Today the court struck down a major barrier to patient care and medical innovation', she said. 'Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued'. If others are able to develop genetic tests on the BRCA1 and BRCA2 genes, this could result in lower costs for users. However, the ruling may also discourage investment in the field.
Dr Gareth Williams, a partner at law firm Marks and Clerk, said: 'It would be an understatement to describe this ruling as disappointing news for worldwide biotech research'. 'By declaring isolated forms of human DNA ineligible, it robs genome research companies of a huge commercial incentive to continue researching into DNA', said Williams.
Dr Penny Gilbert, a partner at Powell Gilbert, called it a 'compromise decision'. She said the ruling was not as bad for the biotech industry as predicted because cloned genes could still be patented in certain situations.
The court explained that Myriad is not prevented from patenting 'new applications of knowledge' arising from the BRCA1 and BRCA2 genes, for which the company holds unchallenged patent claims. The court also expressed no opinion on the patentability of genetic codes that have been scientifically altered.
The decision also does not affect so-called 'method claims'. Justice Thomas pointed out that had Myriad 'created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent'. But he acknowledged that the processes used by Myriad to isolate the DNA were well known at the time.
In a statement released after the ruling, Myriad pointed out that it still holds 'more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection' for its BRACAnalysis genetic test.