Intellectual Property - Patenting of Human Genes
D'Arcy v Myriad Genetics Inc  HCA 35
Can a human gene be the subject of a patent? This tricky ethical and legal dilemma was recently examined by the High Court of Australia in the matter of D’Arcy v Myriad Genetics Inc  HCA 35. Although providing three separate reasons for judgment, the Court unanimously rejected the notion that isolated, DNA or RNA is a patentable invention as a “manner of manufacture” within the meaning of section 6 of the Statute of Monopolies1 and upheld the appeal by Yvonne D’Arcy.
Myriad Genetics Inc (an American molecular diagnostic company) is the holder of patent number 686004. That patent makes 30 claims relating to methods and materials used to test for and identify mutations or polymorphisms in the gene which codes for the production of the BRCA1 protein which are known to dramatically increase the risk of that patient developing breast and ovarian cancers. Myriad Genetics Inc also holds an Australian patent in respect of BRCA2, and both patents are exclusively licensed to Genetic Technologies Limited (the Second Respondent).
Given there is up to an 85% risk of developing breast cancer and up to a 50% risk of developing ovarian cancer if a woman carries both the BRCA1 and BRCA2 genes, these patients may choose to undergo a preventative mastectomy and/or hysterectomy before any cancer has a chance to occur.
The difficulty for patients, and the rationale behind the commencement of proceedings by Ms D’Arcy and Cancer Voices Australia (a consumer advocacy group and the Second Appellant), is that claims 1 to 3 of the Myriad patents extended to include the “isolated nucleic acid” DNA and RNA containing one or more mutations or polymorphism. Put simply, Myriad claimed to own the isolated BRCA1 and BRCA2 genes as products, rather than any process for isolating those genes, and thus also claimed the right to restrict any testing for those genes to those services offered by Myriad and its licensees, at a cost that is beyond the means of some patients (for example, US patients are required to pay more than $US3,000.00 for Myriad’s BRACAnalysis test).
At first instance before Justice Nicholas and on appeal before the Full Federal Court, Myriad’s claims to the isolated genes were upheld. In so doing, the Court placed considerable emphasis on the decision of National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (NRDC) and whether the Myriad claims result in the creation of “an artificial state of affairs”.
In a joint decision, Chief Justice French and their Honours Kiefel, Bell and Keane observed that the phrase “an artificial state of affairs” in NRDC was not intended to be a formulaic definition of manner of manufacture (given the Court “had already denounced the idea of an exact formula”2) and that to focus on this phrase ignores the question of whether the claimed product (in this case the isolated genes) fits into the existing concept of manner of manufacture. If not, it is not simply enough to ask whether the claimed product or process results in an artificially created state of affairs; rather, a number of relevant issues must be considered, including but not limited to:
- 1.Whether patentability of the invention would produce negative effects on innovation;
- 2. Whether patentability of the invention might negatively affect activities beyond those formally the subject of the exclusive rights granted to the patentee;
- 3. Whether patentability of the invention would require the court to assess conflicting and important public and private interests and purposes;
- 4. Whether patentability of the invention might enhance or detract from the coherence of the law relating to inherent patentability;
- 5. How patentability of the invention might place Australia in the international community; and
- 6. Whether patentability of the invention would be better left to the legislature.3
In any event, their Honours agreed with the submission of Ms D’Arcy that the information in the isolated DNA and RNA is the same as that which exists in a person with the mutations or polymorphisms for which they are being tested and, particularly given the very large size of the relevant class of isolated genes claimed in the patent, it is likely that if the claims were “properly the subject of a patent, the patent could be infringed without the infringer being aware of that fact”.4
Their Honours Gageler and Nettle took a slightly different approach, focussing on their finding that the genes which Myriad sought to patent were mere discoveries. Their Honours observed that “the BRCA1 gene is a naturally occurring phenomenon [and] it is not patentable in itself”.5 Her Honour Justice Gordon expanded on this approach by pointing out the boundaries of the class of product claimed by Myriad cannot be delineated (and therefore no single product is identified) and, while Myriad can exploit the applications of the knowledge it has discovered, it cannot monopolise the information in and of itself.
You can read the judgment in its entirety via AustLII.
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1 That Statute of Monopolies being the Imperial (English) Act of that name passed in 1623 as more fully defined in the Dictionary to the Patents Act (1990) (Aust), Schedule 1.
2 D’Arcy v Myriad Genetics Inc  HCA 35 (7 October 2015) .
3 Ibid .
4 Ibid .
5 Ibid .