University of Tasmania, Australia

 

Note: This page needs to be updated in light of the recent US Federal Circuit decision. This will be forthcoming in the next few weeks.
 
This page serves as a central repository of information on the Australian BRCA patent lawsuit between Cancer Voices v Myriad Genetics. It contains some commentary but mainly contains links to relevant websites, papers and general issues in patentable subject matter. It also contains links to, and is modelled on Duke University’s BRCA litigation site.
 
For those interested in this litigation but do not have a strong science (genetics) or patent background, the following three introductions will be very helpful. The first is quite short, it is written by Robert Cook-Deegan from Duke University. The second, a little more detailed, is written by Robert Cook-Deegan and Christopher Heaney (access to Annual Reviews (the journal) is needed to access the second introduction). The third is written by the National Cancer Institute (at the National Institute of Health.
 
It is possible to access the official Federal Court website for Cancer Voices v Myriad Genetics here. It contains up to date information on the proceedings. However, it is a deep link so you you have to search for the case. It is easiest to search for the case using its file number: NSD643/2010. To get to the page itself you must also accept some terms and conditions.

Cancer Voices represented by Rebecca Gilsenan of Maurice Blackburn.
Yvonne D'Arcy (personal capacity)

Myriad Genetics Inc represented by Anthony Muratore of Jones Day.
Genetic Technologies Ltd (GTG). As of 30 September 2011, GTG has not been taking any part in the proceedings.

In the early 1990s, researchers from all over the world were searching for genes that correlated with familial breast and ovarian cancer. Myriad Genetics, Inc, in collaboration with the University of Utah, the National Institute for Environment Health Sciences, McGill University and Eli Lilly announced that they had sequenced the Breast Cancer 1 (BRCA1) gene, a breakthrough at the time.
 
In a subsequent US patent, Myriad Genetics, Inc, as the named applicants, effectively claimed the isolated BRCA1 gene, protein, associated mutations and the use of the sequence in diagnostics; this patent is numbered 5,747,282. Through international patent filing, the firm also received Australian patent 686004. Myriad Genetics, Inc has been granted two other patents relating to the BRCA1 gene, 691958 and 691331 and one patent relating to BRCA2, another gene associated with familial breast and ovarian cancer, 773601. There is one other sealed patent in Australia relating to BRCA1, 777341, owned by Gene Logic, Inc. A similar family of patents in the US have been assigned to Myriad Genetics, Inc, but there is no such assignment on the public record in Australia. [These patents can be found by performing a structured number search within the IP Australia AusPat database.]
 
Patent 686004 is the only patent being challenged in the Australian suit. On 6 May 2011 the applicants filed an amended application with the Federal Court, and on 2 June 2011 Myriad Genetics, Inc and Genetic Technologies Ltd filed defences. The hearing commenced on 20 February 2012 and concluded on 24 February 2012.
 
GTG, a small Melbourne-based biotechnology company, is included as a respondent in this litigation because the company holds the exclusive licence to Australian patent 686004 as well as Myriad Genetics, Inc's other Australian BRCA patents and equivalent New Zealand patents. As detailed in Gold and Carbone, GTG has held these exclusive licences since 2002, and is thus the only licensed provider of BRCA1 and BRCA2 testing in Australia.
 
These exclusive licences mean that GTG has the right to exclude others from isolating certain aspects of breast cancer-related genes and from and diagnosing people with a higher inherited risk of breast or ovarian cancer based on comparisons with the claimed gene sequences. By corollary, if people or organisations are found to infringe GTG’s rights then the company can seek financial compensation from them and demand they cease the infringing actions.
 
GTG has, in the past, indicated that the company may institute court proceedings against anybody believed to have infringed the BRCA patents. However, for various reasons, the company has withdrawn from this position. It is also worth noting that, perhaps consistent with the company’s new position on the BRCA patents, GTG has opted to take no further part in the proceedings with Cancer Voices.

A factor precipitating the Australian suit was an analogous suit in the United States. In a first instance summary judgment, Federal District Court Judge Robert Sweet invalidated Myriad Genetics Inc's claims in 5,747,282 and six other US patents. Judge Sweet ruled that claims on DNA molecules claimed unpatentable subject matter, because DNA is an embodiment of genetic information and the claimed molecules are not substantially different from the DNA found in nature.  He also invalidated claims to methods of using the sequences to identify alterations from the "wild type" reference sequences in the genes; this last aspect has not been pursued to date in Australia and could be pivotal.

 
Myriad appealed Judge Sweet’s initial finding to the Court of Appeals for the Federal Circuit (CAFC). Oral arguments were held on 4 April 2011 and can be accessed here. The CAFC decision was handed down on 29 July 2011. All three judges agreed that cDNA was patentable,* and all three agreed that methods to identify alterations from wild type sequences were not patentable. However, on the most contentious issue of isolated genomic sequences, a slim 2:1 majority found them to be patentable. It is a particularly interesting decision for a number of reasons and most of the case is decipherable by non-legal readers; it can be accessed here. Naturally, the decision was appealed to the Supreme Court of the United States (SCOTUS).
 
*(An explanation of the nature of cDNA, gDNA and wild-type sequences is beyond the scope of this web page. Please refer to the introductory references or click on the Wikipedia entries).
 
In what some commentators have described as a ‘surprise decision’, SCOTUS, in the recent case of Mayo Medical Laboratories v Prometheus (Prometheus) has stated that appending conventional steps, specified at a high level of generality, to laws of nature cannot make them patentable. The Prometheus decision did not state anything directly about the patentability of gene sequences, but it does perhaps indicate a different approach in the US to assess whether claims that directly include “laws of nature” are patentable. Subsequently, SCOTUS, instead of hearing Myriad has instructed the CAFC to reconsider it in light of Prometheus.
 
We wait with bated breath.

The Australian case, Cancer Voices Australia v Myriad Genetics, has now been heard and we are awaiting judgment.  In light of the US cases it seems that any prediction may be pure speculation. It is reassuring that the case was argued by two of Australia’s leading IP barristers.

- Richard Gold and Julia Carbone of McGill University and Duke University respectively, have published a case study on Myriad Genetics’ business strategy in different jurisdictions around the world. This case study includes specific references to the use of the patents in Australia.

 
- Summary of Duke University’s empirical study into gene patents and licensing of 10 clinical conditions, ‘The Dangers of Diagnostic Monopolies’ – the article doesn’t require a technical background.
 
- Duke University’s BRCA Patent Suit page.

Various local and international media outlets have covered aspects of the Australian and other international BRCA related cases around the world. Below is a few links; some are more authoritative than others:

-       4 Corners’, ‘Body Corporate’, 6 August 2010.
-       4 Corners’, ‘Patently a Problem’, 11 August 2003.
-       CBS 60 Minutes, segment on Myriad case, 4 April 2010. (US coverage)
-       PBS Newshour segment, 2 April 2010. (US Coverage)

Australian Law Reform Commission Report, ‘Genes and Ingenuity: Gene patenting and human health’, (ALRC Report 99).

Australian Senate, 2010, ‘Inquiry into Gene Patents’ and its report.
 
Australian Senate Enquiry, ‘Patent Amendment (Human Genes and Biological Materials) Bill 2010’.
 
‘Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests’ a report of the Secretary’s Advisory Committee on Genetics, Health, and Society (United States based report).
 
The Australian government recently published a response to the Australian Senate Gene Patents Report, the 2004 Australian Law Reform Commission’s Report No. 99, Genes and Ingenuity, a 2011 Report by the Advisory Council on Intellectual Property, Patentable Subject Matter, and a review of Australia’s patenting system by IP Australia.
 
The content of this website was developed by John Liddicoat and Professor Dianne Nicol at the Centre of Law and Genetics, Faculty of Law, University of Tasmania.