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U.S. Legal Update: Human genes cannot be patented

Background

When Angelina Jolie revealed that she had undergone a preventative double mastectomy to reduce her risk of developing breast cancer, she inadvertently raised public awareness on the issue of genetic testing. Recent advancements in technology have meant that scientists are able to extract deoxyribonucleic acid (DNA) from human cells so as to isolate specific segments for study.  It is also possible to create DNA synthetically. From an oncology perspective, such advancements have meant that scientists are able to study a particular gene or part of a gene which could be linked to cancer, such as breast and ovarian cancer.

One Utah-based company, Myriad Genetics Inc (“Myriad”) discovered the precise location and sequence of the BRCA1 and BRCA2 genes, mutations that can substantially increase the risks of breast and ovarian cancer. Shortly after this discovery, Myriad obtained a number of patents. Under the U.S. Patent Act, patents are permitted to be issued to “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter” (35 U.S.C. section 101). Myriad’s patent gave it exclusive right to conduct BRCA testing in order to isolate an individual’s BRCA1 and BRCA2 genes.

Recent developments

On 13 June 2013, the Supreme Court of the United States1  held that isolated human genes such as BRCA1 and BRCA2 could not be patented (“Myriad Case”). The Court held that Myriad’s patent claim fell within the law of natural exception, which states that the “laws of nature, natural phenomena and abstract ideas” are “basic tools of scientific and technological work”2  that lie beyond the domain of patent protection. The Supreme Court found that Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. Myriad’s principal contribution was uncovering the precise location and genetic sequence of the gene mutation and isolated it from the surrounding genetic material; however, such a discovery, despite  being groundbreaking or innovative, does not by itself satisfy the threshold contained under the U.S. Patent Act.

Implications for the future

In its decision, the Supreme Court of the United States repeatedly noted that the proceedings did not relate to any method claims. Had Myriad created an innovative method of manipulating genes whilst performing a BRCA test, the Court noted that it could possibly have sought a method patent. However, the processes used by Myriad to isolate the BRCA1 and BRCA2 genes were well understood and widely used by geneticists.
The price of the Myriad BRCA test usually costs more than $3,000 which made it inaccessible to some women. Dr Harry Ostrer, one of the petitioners in the Myriad Case, said that following the Court’s decision, the price of the test “should come down significantly” and would naturally “have an immediate impact on people’s health”3.

BRCA testing in Australia

In Australia, the methods of detecting the BRCA gene and treating BRCA associated disorders are patented. The BRCA1 and BRCA2 genes can only be detected with a specialised blood test and the availability of the procedure and the criteria by which the test is offered varies across Australia.

The High Court of Australia is currently considering a case similar to the Myriad Case, brought by the lobby group, Cancer Voices, which is seeking to challenge the Melbourne-based Genetic Technologies, the company which has been granted the exclusive licence in Australia by Myriad to its BRCA1 and BRCA2 patents. Genetics Technologies have reportedly stated that it has no intention of enforcing its patents BRCA1 and BRCA2 in Australia, which would effectively force the genetic testing into private laboratories and out of the public system4. In any event, the gene patent in Australia expires in 2014.


1 Association for Molecular Patholohy et al v Myriad Genetics, Inc et al, 569 U.S. (2013)
2 Mayo v. Prometheus, 566 U.S. ___ (2012)
3 Adam Liptak, ‘Human genes can’t be patented: Supreme Court’, Sydney Morning Herald, 14 June 2013.
4 Natasha Robinson, ‘Radical risk reduction’, The Australian  <http://www.theaustralian.com.au/news/features/radical-risk-reduction/story-e6frg6z6-1226643398339>, 16 May 2013.

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