Patents on human genes continue to cause controversy in the academic and popular press. A recent decision in Australia (1) has reaffirmed the patentability of isolated human DNA in that jurisdiction, reigniting the debate on the appropriateness of such patents and their potential to negatively affect access to healthcare.
Following the race to identify and isolate genes associated with hereditary breast cancer, patents associated with the BRCA1 and BRCA2 genes were granted in a number of jurisdictions. These patents are controlled by Myriad Genetics, which has pursued a business of model of monopoly for the provision of genetic tests for breast cancer, preventing a broader range of providers from offering the test.
This business model and the aggressive patent enforcement strategies of Myriad were broadly condemned, and caused some anxiety in the medical community and the wider public. The Myriad patents were challenged in opposition proceedings in Europe, and were ultimately upheld, although significantly narrowed in scope (2). More recently, the patents have been challenged in the USA (3) and in Australia.
Concerns about these patents have a number of strands, but the primary objection is in relation to patient access to diagnosis and medical treatment. The rhetoric suggests gene patents equate to reduced access — whether due to the likelihood of patents to increase costs and limit provision to a single or small number of test providers, or because of the potential negative effects of patents on test quality and validation (4,5).
The decision by the Federal Court of Australia in favour of Myriad addresses the question of whether a valid patent may be granted for a claim covering a naturally occurring nucleic acid that has been isolated. However, it does not relate to whether 'method of diagnosis' patents are valid. This is in contrast to the US Myriad case, which addressed both issues (6).
The question for the Australian court was whether isolated DNA amounts to a 'manner of manufacture'. The court made clear that DNA and RNA existing within cells of the human body cannot be the subject of a valid patent. However, and consistently with precedent in other jurisdictions, isolated DNA and RNA are to be treated differently, and can constitute the matter of a valid patent. In the Australian context, this is because they fulfil the criteria of a 'manner of manufacture'. Specifically, they constitute 'a product that consists of an artificially created state of affairs which has economic significance' (1).
The issue of whether a 'product of nature' can constitute a 'manner of manufacture' was also dealt with by the court. Importantly, it emphasised that it is not required to consider whether a composition of matter is a product of nature for the purpose of deciding whether it constitutes patentable subject matter. According to the court, 'the real problem lies in knowing, or rather not knowing, what degree of human intervention is necessary before it can be concluded that the requisite artificial state of affairs exists' (1).
The court made the point that the disputed claims are not to genetic information per se, but rather tangible materials. Much of the opposition to gene patenting arises from concern over the perceived nature of gene patents claiming a monopoly over the 'storehouse of genetic information' (1). The Australian court has drawn a clear distinction between the claims to tangible materials and any informational value that they may encompass.
This decision is perhaps unsurprising, as the Australian court has followed other major jurisdictions in reaffirming the patentability of isolated nucleic acids. If the US Supreme Court denies patentability to isolated DNA in its decision later this year, this will place the USA at odds with Europe and Australia in its interpretation of this question.
Upholding the patentability of isolated DNA is consistent with traditional principles of patent law, which draw a distinction between substances as they occur in their natural state (unpatentable), and those which have been isolated by human intervention (patentable in that isolated form). To deny the patenting of isolated DNA would require the reformulation of these patent law principles, and such reformulation would have potentially far reaching consequences in other fields of technology, such as pharmaceuticals.
An alternative approach would be to treat genetic material as different to other substances and make an exception on that basis. However, such an approach would be a form of genetic exceptionalism, and difficult to justify logically.
The main motivation for challenges to the Myriad patents in all jurisdictions appears to be in relation to patient access to genetic testing. However, it is not clear that overturning patents on isolated genes is the best means of addressing such concerns.
Firstly, overturning all gene patents may have unintended consequences for innovation in other fields where gene patents may play an important role, such as the development of therapeutic compounds. Secondly, overturning product claims to isolated DNA would not affect 'method of diagnosis' claims, which may present more of an obstacle to patient access to genetic testing (7). Such a change to the law might therefore prove largely ineffective at addressing this concern. Instead, a more appropriate and targeted solution to concerns about patient access to diagnosis should be adopted, such as a specific exception to infringement for diagnosis (5,8).