by Damon Gupta
The U.S. case challenging the validity of gene patents is moving to the next step in the U.S. legal system. Myriad Genetics has filed a notice of their intent to appeal the Southern District of New York’s decision invalidating patent claims on the BRCA1 and BRCA2 gene sequences and methods of determining the existence of mutations associated with breast cancer, of which Myriad is the exclusive licensee. The Court of Appeals for the Federal Circuit will be next in line to hear the case and determine whether to affirm or deny the lower court’s decision.
The validity of gene patents is also being challenged in Australia, and Myriad is a party to the lawsuit. June 8, 2010, Rebecca Gilsenan, an attorney with the Maurice Blackburn law firm, filed a lawsuit pro-bono on behalf of applicants (plaintiffs), Cancer Voices Australian, an advocacy group for all cancer patients in Australia, and Yvonne D’Arcy, a Brisbane woman diagnosed with breast cancer who could not afford BRCA1 testing by the exclusive licensee of the challenged Australian gene patent.
The suit was filed against the patent owners — Myriad, Centre de Recherce de Chul (a Canadian research organization), and The Cancer Institute (a Japanese research organization) — and Genetic Technologies Limited (GTL), an Australian based biotechnology company that holds the exclusive license to the gene patent on the isolated BRCA1 gene, which gives GTL a monopoly over BRCA1 testing in Australia. Gilsenan, the plaintiff’s attorney argues that the BRCA1 gene patent is invalid because “isolated genetic material is a discovery of a naturally pre-existing substance, not an invention, and therefore, is unpatentable.” Gilsenan is concerned about the effects of patenting genes arguing that gene patents compromise patient healthcare “by bottlenecking competition necessary to drive or maintain prices at low levels, encourage innovation, and improve testing quality.”
The Australian gene patent case is set for a directions hearing on July 8, 2010. In a directions hearing the judge determines how to proceed and what items or steps are necessary to have the case ready for hearing. After the directions hearing, the defendants must prepare a “Defense to the Application” form, which is analogous to a defendant’s answer to the complaint in the U.S. legal system.
Participants in the gene patent debate in the U.S. will be watching the case as it progresses through the Australian courts. An Australian Court’s decision is not binding on a U.S. court, but they could use some of the arguments presented in the Australian case. As biotechnology IP attorney and law professor at the University of North Carolina, John Conley notes, the U.S. Supreme Court has shown an increase in citing to foreign courts.