The right of companies such as Myriad Genetics Inc to control access to genes which they have patented remains a subject of contention.
The recent Australian Federal Court decision supporting Myriad Genetics Inc's ownership of patents on the genes BRCA1 and BRCA2 will not remain uncontested.
On March 4, 2013, the law firm Maurice Blackburn lodged documents to appeal Justice Nicholas's decision. Cancer Voices Australia has already launched a petition asking the government to change patenting laws. Thus Myriad Genetics patents operating in Australia are still under challenge.
Within the United States the situation is similar. On May 12, 2009, the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) filed a lawsuit charging that Myriad Genetics' patents on two human genes associated with breast and ovarian cancer (BRCA1 and BRCA2) are unconstitutional and invalid. The suit charges that the patents stifle diagnostic testing and research that could lead to cures and that they limit women's options regarding their medical care. In November 2012, the Supreme Court granted the plaintiffs' cert petition and agreed to hear argument during the current session on the patentability of human genes. As of February, 2013, the issue remains unresolved.
Within the next two years, Myriad Genetics patents on genes BRCA1 and BRCA2 will expire and thus the impediments these patents are said to impose to further research and medical treatment will be largely removed. Within Australia the issue is even less acute. For Australian genetic researchers, the patent's effect will be mitigated because in 2012 the country's parliament introduced an 'experimental use defence', whereby researchers investigating a patent's subject matter, or related areas, cannot be found to infringe the patent.
Despite these factors which would seem to reduce the influence of the Myriad Genetics patents, Myriad Genetics has retained control of the data generated by its control of diagnostic tests. Critics have complained that even when the company's patents expire, its control of this database will continue to act as a brake on research.
The larger issue is not Myriad Genetics gene patents but those of the other biotech companies with gene patents. Thus the fate of the Myriad Genetics cases before the courts in both Australia and the United States is the precedents they will set.