The enlarged bench of the Full Federal Court of Australia has unanimously confirmed that isolated genetic/biological material does represent patentable subject matter in its long-awaited landmark decision in D'Arcy v Myriad Genetics Inc [2014] FCAFC 115 (5 September 2014).

The decision contrasts with that of the US Supreme Court in Molecular Pathology v Myriad Genetics Inc which unanimously held that naturally occurring DNA sequences are products of nature and not patent eligible merely because they have been isolated.

The Australian Full Federal Court decision is the latest chapter in the gene patent debate in Australia which has involved two Senate Inquiries, proposed changes to the legislation via Private Members’ Bills and a primary Federal Court decision. In all instances, including this latest Full Federal Court decision, the arguments in support of prohibiting gene patents have been rejected.

The relevant law

Under Australian law, eligible patentable subject matter is defined as a “manner of manufacture” within the meaning of section 6 of the Statute of Monopolies. Accordingly, the Court considered the precedent set for patentable subject matter in Australia by the High Court decision in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (NRDC) in relation to the definition of a “manner of manufacture”.

The issues and arguments

The disputed claims of the subject patent define isolated nucleic acids encoding mutant or polymorphic BRCA I polypeptides, which are linked to breast and ovarian cancer. The submission made on behalf of the appellant (Yvonne D’Arcy) are summarised as follows:

  • There is nothing “artificial” in an isolated nucleic acid which is the subject of the claims in question; 
  • The isolated nucleic acid of the claims is precisely the same as the naturally-occurring nucleic acid; and
  • The claims relate to the discovery of human biological material or “laws of nature”, which are not patentable.

The respondents contended that the claims were to a product that consists of an artificially created state of affairs providing a new and useful effect that is of economic significance. The respondents also contended that isolated nucleic acid differs from nucleic acid found in a human cell chemically, structurally and functionally.

Findings and Conclusion

The Court emphasised that this case was not about policy, moral or social issues. Rather, the case was about whether, under Australian law, the challenged claims of the Myriad patent are directed to patent eligible subject matter.

The Court considered a number of principles in reaching its conclusion as follows:

  • patentability boundaries must encompass the development of science and technology and human ingenuity; 
  • human intervention that creates an artificial state of affairs that has some discernible effect is essential; 
  • expressions such as “the work of nature” or “the laws of nature” are not found in the statute; nor are they useful tools of analysis.

The Court also noted that the Australian Parliament had considered and specifically declined to exclude purified and isolated gene sequences from the scope of patentable subject matter.

The Court also addressed the decisions made by a number of the US Courts in relation to the corresponding US Myriad patent. Specifically, the Court rejected Judge Bryson’s metaphor (made in his dissenting view in the decision of the US Court of Appeals for the Federal Circuit) likening an isolated nucleic acid to a branch snapped off a tree. The Court stated that the chemical and physical makeup of an isolated nucleic acid renders it not only artificial but also different from its natural counterpart.

The Court also stated that the isolation of a nucleic acid leads to an economically useful result – in this case, the treatment of breast and ovarian cancers and that this is surely what was contemplated by a manner of new manufacture in the Statute of Monopolies.

In relation to the US Supreme Court decision, the Federal Court stated that it is difficult to reconcile the Supreme Court’s endorsement of the reasoning in Chakrabarty, with its rejection of isolated nucleic acid as eligible for patentability. The Federal Court stated “with respect, the Supreme Court’s emphasis on the similarity of ‘the location and order of the nucleotides’ existing within the nucleic acid in nature before Myriad found them is misplaced. It is the chemical changes in the isolated nucleic acid which are of critical importance, as this is what distinguishes the product as artificial and economically useful”.

The Federal Court’s view was that following Chakrabarty and NRDC, the isolated nucleic acid has ‘markedly different characteristics from any found in nature’; Myriad did not merely ‘separate that gene from its surrounding genetic material’. Myriad’s claim, properly considered is not, as the US Supreme Court considered, concerned ‘primarily with the information contained in the genetic sequence [rather than] with the specific chemical composition of a particular molecule’.

Ultimately, it was found that the isolated nucleic acid has resulted in an artificially created state of affairs for economic benefit which is patent eligible subject matter.

It is not clear at this stage whether the decision will be appealed to the High Court of Australia. We will keep you promptly informed of developments. Shelston IP are the attorneys responsible for prosecution of the Myriad patent that is the subject of this dispute.