Not the Breast Outcome for Myriad Genetics

The United States and Australia share some pretty significant legal differences.

For example, rigid gun control laws in Australia compared to the constitutional right to bear arms in the United States, the right to gay marriage in the United States compared to Australia’s archaic position that love should exist only between a man and a woman (seriously?) and the fact that a claimant may be entitled to punitive damages in the United States, whereas such damages do not exist in the land Down Under. However, despite these core legal differences, as of October this year, these two nations are now unified on a very important legal principle: in both jurisdictions, my (and your) genetic information is not patentable. And thank goodness for that.

A brief background for you: Myriad Genetics, a world leading molecular diagnostic biotechnology company, held a patent for many years over BRCA1 and BRCA2 (commonly called the “breast cancer genes”) in Australia and the United States. We all have these genes, however some people more than others are susceptible to developing cancer by virtue of these genes, and specifically breast and ovarian cancer. On May 12 2009, in the United States, a group of plaintiffs led by the American Civil Liberties Union filed a lawsuit against Myriad Genetics alleging that the patents they held over these “breast cancer genes” were invalid and unconstitutional (see Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al 569 U.S. 2013). Similarly in Australia, in a suit filed in 2010 by Yvonne D’Arcy (a cancer survivor) and Cancer Voices Australia, the plaintiffs challenged Myriad Genetics’ patent over the “breast cancer genes” on the grounds that their procedure was not a patentable invention within the meaning of the Patents Act 1990 (Cth). Both proceedings against Myriad Genetics proceeded to the highest courts of both the United States and Australia, and despite the laws regarding gene patentability being at odds at times, in the end both jurisdictions have upheld the same legal principle.

So, what was the result? On June 13 2013, in a unanimous decision, the United States Supreme Court held that human genes are not capable of being patented. In delivering the words of the court, Justice Thomas stated:

“Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

However, the court did find that as Myriad Genetics had also created synthetic forms of the genes, those particular genes could be patentable. In principle, the Court reasoned that:

“[Myriad Genetics] found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy [this inquiry].”

Then following suit, on 7 October this year in a landmark decision, the High Court of Australia (the High Court) also unanimously held that an isolated nucleic acid (that is, the coding for a BRCA1 protein) was not a “patentable invention” (see D’Arcy v Myriad Genetics Inc & Anor [2015] HCA 35). This decision of the High Court reversed the February 2013 decision of the Full Federal Court of Australia (see D’Arcy v Myriad Genetics Inc [2014] FCAFC 115), which found that Myriad Genetics had a valid patent on the isolated gene (and its mutations and physical utilization of the sequence) for diagnostic purposes. The Full Federal Court found that the act of isolating the gene mutation rendered it a “human invention.”

Why do we care about these decisions? The World Health Organisation estimates that there were approximately 14 million new cases of cancer and 8.2 million cancer related deaths in 2012. Of those statistics, deaths relating to breast cancer accounted for approximately 521,000 deaths. Detection of the BRCA1 and BRCA2 genes is found to assist with diagnosing particular cancers, for example, ovarian and breast cancer. Considering these staggering numbers, it would seem that at a basic level, the more people working on the diagnostics of the “breast cancer genes,” the closer we will get to finding a cure to these deadly diseases. But sadly, up until these legal decisions, it was only Myriad Genetics who held the patent to these natural genes.

On its face, it seems absurd to permit a corporate body to have ownership of a patent over genes in my body, and for that corporate party to be the only body permitted to work on those genes, research those genes and perform diagnostic testing on those genes, to the exclusion of all others. Continuing to allow that legal position would be to allow the stunting of medicine and disease research. Perhaps now, these outcomes across two large jurisdictions will see the beginning of researchers worldwide working on such human genes without fear of infringing patent, without other legal or moral ramifications and perhaps the decisions may also result in less litigation in the sphere of patents that are sought for purely diagnostic testing purposes. After all, we want the breast of the breast working on these genes.

Emma Bechara is an L.L.M. candidate, 2016, at NYU School of Law.