Gene patents are alive and well in Australia

In its long-awaited landmark decision, on 15 February 2013 our Federal Court confirmed that isolated genetic/biological material is patentable subject matter in Australia (Cancer Voices Australia v Myriad Genetics Inc. [2013] FCA 65 ).

Gene patents have been the subject of two Senate Inquiries and Private Members’ Bills. In all instances, the arguments in support of prohibiting gene patents have been rejected.

Cancer Voices Australia, a national organization representing cancer patients, and Yvonne D’Arcy, a breast cancer patient, sought revocation of a Myriad Genetics’ patent which is licensed to an Australian-based company, Genetic Technologies. The patent relates to genes used in the diagnosis of breast cancer. It was a “test case” in which Cancer Voices/Yvonne D’Arcy argued that isolated genes/biological material did not constitute patentable subject matter in Australia.

The decision is an important milestone in our case law. It is of special interest internationally given the on-going equivalent proceedings in the US. It is worth noting that, unlike the situation in the US, the patent in suit was not being enforced in Australia at the time the proceedings were commenced. (An earlier attempt to enforce the patent had been disbanded in light of negative publicity.)

Arguments/Findings

The disputed claims of the patent in suit define isolated nucleic acids encoding mutant or polymorphic BRCA I polypeptides linked to breast and ovarian cancer.

Cancer Voices/Yvonne D’Arcy argued that naturally-occurring nucleic acids such as DNA and RNA, even in isolated form, are products of nature and therefore cannot be afforded patent protection.

In considering the issues, the Court emphasised that: “naturally occurring DNA and RNA as they exist in a cell are not within the scope of any of the disputed claims and could never, at least not until they had been isolated, result in the infringement of any such claim”. This statement counters the emotive comments put forward by those in favour of gene patent reform who persistently argued that patentees should not be entitled to own an individual’s genes.

Under Australian law, subject matter eligible for patent protection is defined as a “manner of manufacture” within the meaning of section 6 of the Statute of Monopolies 1624. Accordingly, the Court considered the precedent law in which the definition of a “manner of manufacture” had been examined, in particular the decision of the High Court in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (NRDC).

The Court found that:

  • the concept of “manner of manufacture” has a “broad sweep” intended to encourage developments that are by their nature often unpredictable;
  • a product that consists of an artificially created state of affairs which has economic significance will constitute a “manner of manufacture”; and
  • the relevant state of affairs must be the result of some human intervention.

Most significantly, Justice Nicholas indicated that patentability of the isolated nucleic acids defined in the disputed claims did not turn upon changes that may have been made to the chemical composition of the nucleic acids as a result of them having been isolated. In other words, the patentability of the subject matter considered by the Court related to matter which is identical to that which occurs in nature but is isolated. As such, this decision also seemingly applies to any isolated biological material – for example, peptides and proteins.

Ultimately, it was found that the defined isolated genes constitute an “artificial state of affairs” consistent with a “manner of manufacture” based on the following:

  • Firstly, the High Court in NRDC was deliberate in its use of very expansive language and emphasised the “broad sweep” of the concept involved;
  • Secondly, in the absence of human intervention, naturally-occurring nucleic acid does not exist outside the cell, and “isolated” nucleic acid does not exist inside the cell; and
  • Thirdly, it was considered a mistake and inconsistent with the decision in NRDC for a person whose skill and effort culminated in the isolation of biological material not to be rewarded by the grant of a patent because the isolated material, no matter how practically useful or economically significant, was held to be inherently non-patentable.

It remains to be seen whether the present Federal Court decision will be the closing chapter in the gene patenting debate as it is not yet clear whether the decision will be appealed.