Who owns you?
Mar 2013 |Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65
This decision is one of the earliest judicial assessments worldwide in relation to intellectual property entitlements of human tissue.
Introduction
In Cancer Voices Australia v Myriad Genetics Inc1, the Federal Court of Australia [New South Wales District Registry] (the Court) was called upon to determine whether the consequences of isolating deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from a human cell constituted patentable subject matter.
The Court considered whether such an isolation process resulted in:
- a "manner of manufacture" under the Patents Act 1990 (Cth) (the Act);
- the creation of "an artificial state of affairs" that caused a "discernible effect" to arise;
- a "mere discovery" rather than a "patentable invention"; and
- a "product of nature".
This represents a landmark decision as it is the first Australian case to consider the patentability of isolated genes and has significant effects on future research.
Facts
Cancer Voices Australia (a national organisation that represents people affected by cancer)2 and Yvonne D'Arcy (a survivor of breast cancer) (the applicants) commenced proceedings against Myriad Genetics Inc and Genetic Technologies Limited (the researchers). The applicants sought declarations and orders revoking patent claims lodged by the researchers (disputed claims). The subject patent included a total of 30 claims. The disputed claims related to tangible materials (rather than genetic information) and an isolated chemical composition.
The subject patent described the field of the invention in the following terms:
"The present invention relates generally to the field of human genetics. Specifically, the present invention relates to methods and materials used to isolate and detect a human breast and ovarian cancer predisposing gene (BRCA1)".3
[Our emphasis]
The isolation process involved removing naturally occurring DNA and RNA from the cell and separating it from other components comprising the cell.
The applicants submitted that the disputed claims did not constitute a "manner of manufacture" under section 18(1)(a) of the Act, and consisted of "non-patentable subject matter" because the isolated DNA and RNA were "products of nature". The applicants relied on evidence that considered naturally occurring nucleic acid and isolated nucleic acid, and established that the differences between the two states of nucleic acid were neither significant nor material. The applicants did not make any submissions with respect to the disputed claims lacking novelty, inventive step, utility or the fair basis.
The researchers submitted that the disputed claims were valid because the subject patent involved "an artificial state of affairs" that caused a "new and useful effect that [was] of economic significance".4 The researchers also relied on evidence that established there were chemical, structural and functional differences between isolated nucleic acid and the naturally occurring nucleic acid from a cell extracted from a human body.
Relevant legislation and case law
Section 18(1)(a) of the Act states that:
"…an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies".
Section 6 of the Statute of Monopolies enables patents to be granted for "the sole working or making of any manner of new manufacture".5 The Court identified that the terms "manner of manufacture" and "manner of new manufacture" enabled it to consider legal principles developed in case law rather than "qualify for patent protection".6
The Court primarily considered the principles established in the case of National Research Development Corporation v Commissioner of Patents7 (NRDC case). The patent in the NRDC case involved the chemical composition (herbicide), which was to be used on the eradication of weeds. The Commissioner of Patents objected to the patent on the basis that it involved "the mere use of known substances" that did "not result in any vendible product".8 The High Court found in favour of the National Research Development Corporation in that it invented "a new and inventive use of a known chemical composition".9
In the NRDC case, the High Court itself had considered the decision of Re GEC's Application10 and its concept of a "vendible product". The High Court stated that a "manner of manufacture" would exist when a product creates "an artificial state of affairs" of "economic significance". The same principle applies to a process whereby the process creates a "discernible effect". In the present case, the applicants conceded that the subject patent satisfied the element of "economic significance".
In the NRDC case, the Commissioner of Patents also objected to the patent on the basis that it related to processes which relied on the "operation of natural laws or the natural properties of the materials involved" and that such processes were not "independent of the discovery itself".11 The High Court considered the case of Genentech Inc's Patent12 that confirmed a discovery was not patentable, however found that a patentable invention would be created when a discovery enables an inventor to inform others on how to use the discovery. The High Court also considered the case of Funk Bros. Seed Co. v Kalo Inoculant Co.13 that established "the work of nature" and "laws of nature" exist in all patentable subject matter, and that such terms will not assist when determining what constitutes a "manner of manufacture".
In the present case, the applicants relied on the case of American Cyanamid Company v Upjohn Company14 which involved a patent for a new antibiotic. In that case, the parties did not consider whether isolating a strain from a micro-organism constituted a "manner of manufacture". The applicants also relied on the case of Kirin-Amgen15 which involved the patentability of a naturally occurring protein. The applicants specifically relied upon Lord Hoffmann's judgment, which stated that isolated protein "was not new".16
Decision
Justice Nicolas observed:17
- The principles in the NRDC case must be applied when determining whether "a composition of matter"18 constitutes a "manner of manufacture"; and
- Patentable subject matter will exist when "a composition of matter" entails "an artificial state of affairs" (that is an outcome of human intervention), with a "discernible effect" that is of commercial value.
In relying upon the following considerations, Justice Nicolas found that "an artificial state of affairs" is created when isolating DNA and RNA:19
- In the NRDC case, the High Court highlighted the importance of broadly considering the concept of a "manner of manufacture";
- Human intervention is required to isolate DNA and RNA, as the DNA and RNA found in the human cell must be extracted and purified before it becomes an isolated product; and
- A person who exercises skill and effort to isolate DNA and RNA should be independently rewarded by being granted a patent. "Odd results" will arise if isolating DNA and RNA,"no matter how practically useful or economically significant, was held to be inherently non-patentable".20
The Court dismissed the applicants' claim (thus allowing the researchers the grant of their patent) and ordered the applicants pay the researchers' costs.
Impact
This is the first case in Australia to find that isolated genes are protected as patentable subject matter. The impact of the decision will have significant consequences on future research concerning serious and chronic illness.
Competing considerations were carefully weighed in the assessment made by the Court, being that of the commercial incentive of encouraging research and the social utility of access to the outcomes.
The potential is for a market to be created in which private companies will own the intellectual property associated with specific isolated genes, once a patent is granted in their favour. Those companies will control the uses associated with those entitlements and this may well result in competing researchers being financially impeded in their ability to access critical information.
As against this, any lack of product protection to private researchers (with a corresponding risk to their return on investment) may amount to a disincentive to invest significant funds in research. In turn, this may create a monopolised market.
It is important to note that the applicants may appeal the Court's decision. Cancer Voices Australia are currently petitioning for the Patent Act 1990 (Cth) be amended so it expressly excludes "human genetic material" from being a patentable subject matter.21
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1 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 (CVA).
2 http://www.cancervoicesaustralia.org/
3 CVA at [56].
4 CVA at [7].
5 As cited in CVA at [79].
6 CVA at [79].
7 National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252.
8 NRDC case at p 261 as quoted in CVA at [83].
9 CVA at [83].
10 Re GEC's Application (1943) 60 RPC 1.
11 NRDC case at p 259 as quoted in CVA at [89].
12 Genentech Inc's Patent [1987] RPC 553.
13 Funk Bros Seed Co. v Kalo Inoculant Co. (1948) 333 US 127.
14 American Cyanamid Company v Upjohn Company [1971] RPC 425.
15 Kirin-Amgen [2005] RPC 169.
16 Kirin-Amgen [2005] RPC 169 at [132] as quoted in CVA at [98].
17 CVA at [101] and [102].
18 CVA at [101].
19 CVA at [107] - [109].
20 CVA at [109].
21 http://www.cancervoices.org.au/images/0/03/Gene_Patent_Petition_to_House_of_Representatives.pdf.
