The High Court is in the process of hearing D'Arcy v Myriad Genetics Inc (Case S28/2015), an appeal from the Full Federal Court concerning the patentability of isolated genetic materials. The patents in question relate to genes known as BRCA1, whose presence is said to suggest an enhanced risk of breast and ovarian cancer in women.
In June 2010 Myriad Genetics Inc filed three patent claims for BRCA1, which help to identify women with an increased risk of developing breast and ovarian cancer. Cancer Voices Australia, in conjunction with Ms Yvonne D'Arcy (a breast cancer survivor), filed an application for revocation of the patents.
The Federal Court rejected Cancer Voices and D'Arcy's application, finding that all three patent claims were, in principle, eligible for patent protection based on the 'manner of manufacture' test.(1) The issue was whether the human intervention required to isolate the genetic material rendered the results eligible for patent protection. The court held that a combination of expansive language regarding the 'artificial state of affairs' requirement(2) and the fact that the isolated nucleic acid did not exist inside the cell meant that the material was patentable. D'Arcy appealed.
In 2014 the Full Court upheld the Federal Court's decision,(3) although for different reasons. The unanimous five-judge decision focused on the structural and functional differences between naturally occurring and isolated forms of DNA.(4) On considering the concept of 'artificially created state of affairs' and the nature of patents as protecting innovations and inventions, the court concluded that the requirements were met.
Myriad ran concurrent litigation in the United States. In Association for Molecular Pathology v Myriad Genetics Inc (USSC 12-398), the majority of the US Supreme Court held that a naturally occurring DNA segment is a product of nature and thus is not patentable solely because it has been isolated.
The United States and Australia have drastically different frameworks – in particular, the US common 'laws of nature' exception requires a court to compare isolated DNA directly with naturally occurring DNA. This is not necessarily dictated by the Australian approach.
In February 2015 the High Court granted D'Arcy leave to appeal the Full Court decision upholding the patentability of isolated genetic material.(5) D'Arcy argued that the isolated DNA was in every relevant sense identical to the naturally occurring DNA. The relevant utility of the isolated DNA was that it possessed the exact same information as the gene in nature (ie, presence of markers).
Myriad argued that to compare the isolated DNA with what is in nature would introduce the US test, which stems from a different legislative context. Myriad also argued that the real question was whether the isolated DNA was artificial. According to Myriad, as the DNA in question had a different chemical (structural) composition and was functionally different, it was artificial in the relevant sense.
It is unclear exactly why the High Court granted leave, particularly given the unanimous judgment of six judges on previous occasions in the Federal Court and Full Court. One possibility is that because the matter is of significant public interest, it should be authoritatively resolved by the High Court. Although the question before the court is narrow and technical, there are significant ramifications for the rapidly developing area of genetics.
The big question is whether isolated forms of what would otherwise be naturally occurring DNA merit patent protection. Some liken genetic markers to natural resources: in much the same way as pre-existing oil and gold deposits are 'discovered', scientists 'discover' genetic markers that are pre-existent in DNA. Arguably, patent law should not protect the finding and extracting of these resources. That said, the results derived from these resources (and perhaps the refining processes themselves) may merit protection.
It is also possible that the High Court is considering whether international conformity with the United States is appropriate, given the international nature of markets and because the United States is a leader in the field. Although the US legal framework is somewhat different from Australia's, counsel for both parties engaged directly with US authorities during the course of their argument; as such, the court will likely consider this issue.
The Institute of Patent and Trademark Attorneys of Australia (IPTA) applied for leave to intervene as amicus curiae, questioning whether the concept of 'patents of inventions' under Section 51(xviii) of the Constitution encompasses isolated genetic material and other materials isolated from nature.
Section 51(xviii) provides that Parliament can make laws for the peace, order and good government of the commonwealth with regard to copyrights, invention and design patents and trademarks.(6)
IPTA's main argument relied heavily on Grain Pool of Western Australia v Commonwealth (2000) 202 CLR 479, in which the High Court held that the rights granted to plant breeders of new plant varieties are a form of patent. Given that living plants fall within the scope of Section 51(xviii), it is likely that biological materials do as well.
When considered in conjunction with Parliament's express exclusion of humans and biological processes for their generation from the act,(7) the only requirement for patentability is the 'artificially created state of affairs' requirement.(8)
The attorney general filed submissions in response to the IPTA application, seeking leave to intervene only if the IPTA application succeeded.
The commonwealth's central argument was that the question in dispute between the original parties could be resolved solely by reference to the Patents Act, and that the court need not engage in the constitutional question. In effect, the commonwealth argued that IPTA had confused its statutory interpretation principles.
The High Court refused to grant IPTA leave to intervene and in so doing avoided having to consider the constitutional issue raised. Instead, the hearing was confined to the dispute between the original parties.
The hearing will continue, with a decision expected to be handed down later this year.
If the High Court upholds the judgments of the inferior courts, there will be an anomalous position between Australia and the United States regarding the patentability of genetic material. The space will be an interesting one to watch.
For further information on this topic please contact Jenni Lightowlers at FAL Lawyers by telephone (+613 9642 2252) or email (firstname.lastname@example.org). The FAL Lawyers website can be accessed at www.fal-lawyers.com.au.
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