15 February, 2013

Federal Court of Australia Affirms Patentability of Isolated Nucleic Acids

Federal Court of Australia Affirms Patentability of Isolated Nucleic Acids

The Federal Court of Australia today handed down its decision in the case of Cancer Voices Australia & Anor v Myriad Genetics Inc & Ors. The presiding judge, Justice Nicholas, identified the issue in the case as one “of considerable importance”, framing the question to be decided as whether a “valid patent may be granted for a claim that covers naturally occurring nucleic acid that has been isolated”.

Justice Nicholas answered that question in the affirmative.

Although the patent includes 30 claims, it was only claims 1 to 3 that were in dispute. Claim 1 of the patent is: [an] isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19. Claims 2 and 3 are dependent claims extending only to DNA. The challenge to the claims was solely on the basis that they include non-patentable subject matter. In particular, the applicants contended that each claim comprises “isolated” nucleic acid that is not materially different to the nucleic acid that occurs in nature.

Under Australian law, other than specific exclusions of certain subject matter, the question as to what constitutes patentable subject matter is answered by reference to section 18(1)(a) which asks whether the invention “is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies”. The leading case on that point is the decision of the High Court of Australia known as NRDC. Following that decision, Justice Nicholas observed that “a composition of matter may constitute patentable subject matter if it consists of an artificial state of affairs, that has some discernible effect, and that is of utility in a field of economic endeavor”.

Justice Nicholas’ decision identifies three considerations influential in leading to his conclusion that isolated nucleic acids are patentable. First, that the High Court in NRDC was “deliberate in its use of very expansive language” to emphasise the “broad sweep" of patentability. Secondly, the importance of “isolated” in that the claim is to a nucleic acid that is the product of human intervention. Third, that it would “lead to very odd results if a person whose skill and effort culminated in the isolation of.. an isolated DNA sequence could not be rewarded by grant of a patent because the [subject matter]… was held to be inherently unpatentable”.

Importantly, the decision emphasises that patentability of isolated nucleic acids “does not turn upon what changes have been made to the chemical composition of such substances as a result of them having been isolated”, thereby making it clear that there is no requirement for changes in chemical composition of the claimed nucleic acid.

The patentability of gene sequences has received close attention in Australia over recent years, with several government-appointed inquiries having been held. Justice Nicholas’ decision makes reference to the Australian Government Response of November 2011 to the Reports of three of those inquiries, that response specifically accepting the recommendation of the Australian Law Reform Commission that the Patents Act not be amended to exclude genetic materials from patentable subject matter. The decision also makes reference to the Senate Committee Report into a parliamentary Bill introduced in 2010 which sought to exclude from patentability biological materials, defined in that Bill as including DNA and RNA, Justice Nicholas noting that the Report recommended the Senate not pass the Bill (which has now lapsed).

The decision identifies that one of the “main arguments” raised against the patentability of isolated DNA sequences is the impact that such patents may have on future research, for example in diagnostic and therapeutic technologies. In making this observation, Justice Nicholas noted the “significance” of a recent amendment to the Patents Act, which introduced an explicit statutory exemption from infringement for research and experimental activities. Thus, under new section 119C of the Act “[a] person may, without infringing a patent for an invention, do an act that would infringe the patent apart from this subsection, if the act is done for experimental purposes relating to the subject matter of the invention”. Inclusive provisions in the Amended Act illustrate the scope of “experimental purposes” and include “improving or modifying the invention”. Section 119C applies in relation to acts done on or after 16 April 2012 in relation to patents granted before, on or after that date.

Whilst the decision may again lead to calls for legislative change it does make clear that isolated nucleic acids sequences are currently patentable in Australia.

The deadline by which either party may appeal the decision to the Full Federal Court is 21 days from the date of the decision.

For more information, please contact: Dr. Martin O'Brien

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