Isolated Nucleic Acids are Patent Eligible in Australia

Wednesday 25th June 2014
Article written by: Harriet Tregonning

Last year, the Federal Court of Australia confirmed that isolated naturally occurring nucleic acid sequences are patent eligible subject matter.  The landmark decision affirms the long standing practice of granting claims to isolated nucleic acid sequences in Australia.

The applicants opposed to the patenting of human genetic material have since lodged an appeal against the ruling with the Full Federal Court of Australia: a decision on the appeal is expected later this year.

Cancer Voices Australia Pty Ltd v Myriad Genetics Inc

In Cancer Voices Australia Pty Ltd v Myriad Genetics Inc [2013] FCA 65 the Federal Court considered the validity of Myriad’s claims to isolated nucleic acid sequences encoding the BRCA1 gene.  BRCA1 is associated with breast and ovarian cancers.  The applicants argued that Myriad’s claims to the BRCA1 gene were invalid, on the basis that isolated nucleic acid sequences are a product of nature, and do not constitute a “manner of manufacture” as required under the Australian Patents Act 1990.  No other grounds of invalidity were pleaded.

In his decision, Justice Nicholas ruled in favour of Myriad, finding that the claims in question were valid because isolating the BRCA 1 gene from the human body required human intervention.

The Australian position is contrary to the stance taken by the US Supreme Court in the U.S equivalent case Association for Molecular Pathology v Myriad Genetics Inc (2013) 569 U.S. 12-398.  Where the US Supreme Court found that isolated human genes are ‘products of nature’ and are not patent eligible subject matter, the Australian Federal Court found them to constitute an ‘artificial state of affairs’ that provides a new, useful, and economically significant effect.

Justice Nicholas provided three reasons for his finding that isolated nucleic acid sequences are an ‘artificial state of affairs’:

  1. The High Court of Australia, in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252, the leading Australian case regarding patent eligible subject matter, intended for the concept of “manner of manufacture” to be broad and inclusive.
  2. The extraction and purification steps that result in isolated nucleic acid sequences involve human intervention.  Unlike the US Court of Appeals for the Federal Circuit, Justice Nicholas did not find that the patentability turned on changes to the chemical composition of the nucleic acids; rather it turned on this human intervention.
  3. The isolation of the nucleic acid may be the result of significant intensive intellectual effort, and it would be illogical and inconsistent with the purposes of the Patents Act if that effort were not rewarded.

Appeal to be heard shortly

An appeal of the Australian decision has been heard by the Full Federal Court and is expected to be decided shortly.

Justice Nicholas stated that he did not consider the decision of the US Supreme Court to be helpful, as the law in Australia is different to that of the US.  This refers to the creation of judicial exceptions to patent eligible subject matter in the US, as compared to the broad interpretation of the statutory requirements in Australia.

Isolated nucleic acids are also patent-eligible in New Zealand

Isolated nucleic acid sequences remain patent-eligible subject matter in New Zealand. Like Australia, the New Zealand courts follow the test set out in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 when considering patent eligible subject matter. While a case challenging the patent eligibility of isolated human genes has yet to be heard in in New Zealand, it is likely that the New Zealand courts would follow the decision of the Australian Federal Court.

Need more information?

Contact a member of our team:

Contact us

Baldwins' eNewsletter

Sign up to our monthly newsletter