Originally published June 15.
By Turna Ray
On the heels of the anti-gene patenting victory in a US District Court by genetic researchers and cancer patients, an Australian patient group has challenged the patentability of DNA.
Cancer Voices Australia, the law firm Maurice Blackburn, and breast cancer patient Yvonne D'Arcy this week took legal action in Australia's Federal Court against four biotech organizations to challenge the legality of gene patents.
The case challenges the viability of Australian Patent No. 686,004, which covers mutations in the BRCA1 gene linked to increased risk of hereditary breast and ovarian cancer. The plaintiffs will argue that the patent, held by Myriad Genetics, Centre de Recherce de Chul in Canada, and the Cancer Institute in Japan and licensed to Genetic Technologies, is invalid.
A US District Court ruled in March that seven patents held by Myriad Genetics on BRCA 1 and BRCA 2 genes are invalid. The case was brought against Myriad, the University of Utah, and the US Patent and Trademark Office by the American Civil Liberties Union and the Public Patent Foundation, on behalf of individual women with cancer, patient groups, doctors, and researchers (PGx Reporter 03/31/10).
Although the legal challenge from Cancer Voices Australia comes after the US District Court's decision, in Australia, the impetus to challenge the patentability of genes has been gathering steam for some time.
At least one year before the ACLU and PUBPAT took on gene patenting in US courts, a debate on the moral issues surrounding gene patenting was brewing in Australia. In 2008, Genetic Technologies asked several Australian labs to stop performing a test for BRCA1 and BRCA2. After the uproar this caused among patient groups and researchers, the company recanted and allowed BRCA testing to continue.
By bringing the lawsuit against Myriad and its licensing partners, "we are hoping to either push or heighten the agenda in this country," John Stubbs, Cancer Voices Australia's executive officer, told Pharmacogenomics Reporter. Industry observers estimate that approximately 400 genes have been patented in Australia.
The case against Myriad and its partners is supported by patent law expert Professor Luigi Palombi from Australian National University. Maurice Blackburn partner Rebecca Gilsenan, as well as barristers David Catterns and Peter Cashman, will try the case on a pro bono basis.
"The patent owner has a right to prevent people from studying and testing for the gene mutation, so gene patents can stifle research, the development of treatments, and access to diagnostic testing," Gilsenan said in a statement. The team will challenge the patentability of genes using arguments similar to those made by ACLU and PUBPAT — namely, that isolated DNA is not substantially different from naturally occurring DNA to meet the requirements for patentability.
"Legal issues in [Australia] are very 'muddy' with no real legal protection for patients and their genes — we want the law in Australia clarified, but it may need some legislative framework to achieve this," Stubbs said in an e-mail.
Australia's Senate was slated to issue a report on the impact of gene patenting earlier this year, but it has been delayed. Stubbs said that following the Senate's investigation, the legislative body could initiate the process necessary to change existing patent law.
Since the US Federal District Court's decision may change in a higher court upon appeal, some experts have wondered whether Cancer Voices Australia is moving too fast to challenge gene patents in Australian courts.
In the European Union, researchers have said they are keeping a close watch on how the gene patenting question plays out in US courts before making any moves. In a previous court challenge of Myriad's patents, several French research institutes had some success in banning certain types of gene patenting, but the structure of the European patent system barred them from broadly challenging gene patents in the way the ACLU and PUBPAT have in the US (PGx Reporter 03/31/10).
After a seven-year legal tussle, the European Patent Office amended one of Myriad's patents (EP 699754) to cover frame-shift mutations, but not missense mutations, in the BRCA1 gene. Shift mutations account for approximately 60 percent of pathogenic mutations in the BRCA1 gene. The narrowed patent, which could not be further contested at the European level after the EPO's 2008 decision, does not, however, “contain claims directed to the BRCA1 gene itself or to mutated forms thereof,” according to the EPO.
Gert Matthijs, head of the molecular diagnostic laboratory at the University of Leuven Hospital in Belgium, previously told Pharmacogenomics Reporter that if the US Southern District Court of New York's initial decision holds up on appeal, it could inspire researchers to take a similar anti-gene patenting case to the European Parliament(PGx Reporter 03/31/10).
Australian supporters of gene patenting, as in the US, will likely argue that there is no evidence that gene patents hinder research and access to tests. One example that may be cited is the fact that Genetic Technologies did not, in 2008, enforce its licenses and allowed BRCA testing to continue in labs that did not hold licenses.
To this, Stubbs counters that the mere existence of gene patents dangles the specter of potential legal challenges, which can deter research on BRCA genes and discourage reporting mutation status to research subjects when studies are conducted by labs without licenses.
"At any time [Myriad and its licensing partners] can close the door on this testing and become a monopoly," Stubbs said. "Cancer patients in this country need protection that this will not occur and we could be talking about the potential to patent any number of genes!"