On 13 June 2013 the Supreme Court of the United States released its decision in Association for Molecular Pathology v Myriad Genetics Inc, 569 US 12-398, finding that human genes cannot be patented. The case is an important decision on an issue at the intersection of intellectual property law and ethics. The Court’s unanimous decision could have significant international consequences for medical research and related biotech industries.
Myriad Genetics Inc (Myriad) is a molecular diagnostic company which discovers and commercialises tests to assess a person’s risk of developing a disease.1 The company discovered the precise location and sequences of BRCA1 and BRCA2 genes. If these genes mutate, they significantly increase the risk of breast and ovarian cancer. This knowledge had the potential for tremendous commercial value through the commercialisation of tests for these cancers. Myriad obtained several patents which would give it the exclusive right to isolate a person’s BRCA1 and BRCA2 genes and would give it the exclusive right to synthetically create a specific form of what is known as “composite DNA” (cDNA), being BRCA cDNA.
Several parties challenged the validity of those patents, including the Association for Medical Pathology, a number of universities, patient advocacy groups and individual cancer patients. They argued that the patents were invalid because they did not cover patentable inventions under Title 35 of the United States Code regarding patent law.2 Because the patents covered products of nature, they were invalid.
The Supreme Court decision was preceded by a number of controversial hearings and decisions.3 The preceding Federal Circuit decision provided that isolated DNA which does not exist alone in nature can be patented, but other inventions relating to diagnosis were not patentable.
The decision: genes are not patentable
A unanimous Court found that, because the BRCA1 and BRCA2 genes are a product of nature, their mere isolation does not justify the recognition of a valid patent.
Myriad submitted details of the extensive processes that resulted in the discovery of the genes, but the Court held that extensive effort is an insufficient criterion of patentability. Ascertaining the locations of the genes did not constitute a new composition of matter. Further, although the process of isolation of the genes covered by the patents involved the severance of chemical bonds that bind the molecules together, this was not enough to support the patents. The patents focused on the genes themselves, rather than this process, and the genes themselves were found to be not patentable.
In making this finding, the Court applied a part of the United States Code which has a close analogue in Australia. Under the Patents Act 1990 (Cth), “human beings, and the biological processes for their generation, are not patentable inventions”.4
…but the mixed finding probably maintains the monopoly on the BRCA test
The Court found differently in regards to Myriad’s cDNA patents. Although cDNA is a form of DNA, and DNA does occur naturally, cDNA itself does not occur naturally. By way of further background: DNA contains matter referred to as “nucleotides”. In nature, strands of DNA include nucleotides known as “exons” and other nucleotides known as “introns”. In the case of cDNA, a lab technician removes the introns. cDNA is more compact; it contains only exons.
The Court held that because cDNA is not a product of nature, it does not present the same obstacles to patentability. Significantly, this finding provides that Myriad’s particular test for the gene which utilises cDNA is patentable. 250,000 of the tests are performed each year. A notable recent recipient of Myriad’s BRAC Analysis test was Angelina Jolie.5
Lavan Legal comment
The decision finds a middle ground between two powerful arguments.
On the one hand, there is a strong economic argument for the recognition of property rights in respect of discoveries, even where those discoveries concern the human body. The protection of intellectual property supports the commercialisation of the subject matter, which incentivises research and innovation.
Against this, there is a strong argument that some things should not ever be the subject of intellectual property rights. Australia recognises this with the “human beings” exception in section 18 of the Patents Act 1990 (Cth). Research becomes either expensive or impossible for everyone other than the owner of the intellectual property rights and so once the discovery is made, further innovation and research is stifled. Further, there is an ethical argument that is well-supported in many sections of the community that, irrespective of the economics of the situation, human beings, and any part of a human being, should never be capable of ownership.6
By denying that genes could be the subject of patents, the case is a landmark affirmation of the second category of arguments. This will open the door for the development of new cancer tests and will reduce their cost. By protecting the cDNA patents, the Court affirmed the former category of argument. Myriad’s development of that process was clearly a scientific innovation and one driven by commercial motives. The decision may not be entirely satisfactory to either “camp”, but it provides a commendable compromise. It continues the incentives for companies to engage in research, but opens up the competition and allows others to attempt to solve these important problems.
1 Myriad Genetics, Myriad (14 June 2013) Myriad Genetics <http://www.myriad.com/>.
2 35 USC §101.
3 Decisions of: the United States District Court for the Southern District of New York, the United States Court of Appeals for the Federal Circuit, the US Supreme Court and the Federal Circuit again.
4 Patents Act 1990 (Cth), s 18(2).
5 See eg: Bill Mears, Court: Human genes cannot be patented (14 June 2013) CNN <http://edition.cnn.com/2013/06/13/politics/scotus-genes/index.html>.
6 Eg the Catholic Church. See also: Michael Sandel, What Money Can’t Buy: The Moral Limits of Markets (Allen Lane, 2012).