The recent news that Angelina Jolie tested positive for the BRCA1 mutation and has consequently undergone a prophylactic double mastectomy to guard against developing breast cancer has increased the intensity of the spotlight on the gene patent debate currently playing out in both the United States Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc, and in the Full Federal Court of Australia in Cancer Voices Australia v Myriad Genetics Inc.

In April 2013, the US Supreme Court heard arguments in relation to the patentability of isolated human genes, which are claimed in patents held by Myriad Genetics, Inc. A decision by the Supreme Court is expected in June 2013. Earlier this year, we reported on the landmark decision of the Federal Court that confirmed the patentability of isolated nucleotide sequences (genes) in Australia. This decision is currently under appeal. For more information, refer to the article at the following link.

http://www.shelstonip.com/news_story.asp?m=2&y=2013&nsid=265

The reporting of the gene patent debate in the popular press has heavily centred on the provocative ethical quandary: should a company be entitled to own a person’s genes? However, a point that seems lost on the proponents of gene patent reform is that gene patents do not confer ownership of anyone’s genes because they are directed to isolated gene sequences not gene sequences that exist in humans. This point was clearly made in the Myriad Federal Court decision in Australia where the Court emphasized that: “naturally occurring DNA and RNA as they exist in a cell are not within the scope of any of the disputed claims and could never, at least not until they had been isolated, result in the infringement of any such claim”. This statement clearly counters the emotive comments put forward by those in favour of gene patent reform who persistently argue that patentees should not be entitled to own an individual’s genes.

Much less attention has been given to a consideration of the benefits of gene patents which allow for investment in innovation that is required to bring a product to the public. Specifically, Myriad invested 200 million dollars in raising doctor awareness about hereditary breast and ovarian cancer in addition to the money invested in developing the BRCA tests and characterizing a patient’s susceptibility to developing cancer. For taking these risks and providing a test that will potentially save women’s lives, Angelina Jolie included, Myriad’s pioneering work has been attacked on the basis of flawed ethical arguments. Without patent protection it is arguable as to whether the BRCA predictive tests for hereditary breast and ovarian cancer would have been commercialized and thus made available to the public.