On 7 October 2015 the High Court delivered judgement in D'Arcy v Myriad Genetics Inc [2015] HCA 35.

The decision related to Myriad's patent (686004) on the isolated nucleic acid encoding the BRCA1 mutant polypeptide and to methods of testing for the presence of mutations of the representative BRCA1 gene, and thus an increased likelihood of developing breast or ovarian cancer.  The High Court was asked to decide whether claims 1-3, directed to the isolated BRCA1 nucleic acid, defined patent eligible subject matter (i.e. a manner of manufacture).

The High Court unanimously decided that claims 1-3 did not define a manner of manufacture.  The Court found that, while formulated as claims to a product (i.e. a nucleic acid molecule), the substance of the invention was the information embodied in the nucleotides of the molecule.  The Court decided that the information was an inherent part of the molecule and not created by human action.  The Court did not make any finding with respect to the remaining claims of the patent.

The Commissioner has undertaken a consultation process, considered the feedback received, and finalised her examination practice.

Overview of the consultation process

The Commissioner considered the High Court’s decision. On 16 October 2015 she published the following draft examination practice for public consultation, inviting interested parties to make submissions by Friday 6 November 2015:

Proposed examination practice published on 16 October 2015

Public submissions

The Commissioner received the following non-confidential submissions:

Alphapharm Australia

Baldwins Intellectual Property, New Zealand *

Assistant Professor Wendy Bonython & Assistant Professor Bruce Arnold, University of Canberra

Cancer Council Australia

Mr James Cherry, Freehills Patent Attorneys

Stephen Dolan

Dr Jacinta Flattery-O’Brien and Dr Michael Christie, Shelston IP *

Generic and Biosimilar Medicines Association (GBMA)

Henry Hughes Intellectual Property, New Zealand

The Institute of Patent and Trade Mark Attorneys of Australia (IPTA)

Law Council of Australia

Mr Jensen Mang

Maurice Blackburn Lawyers

Dr Brendan Nugent, AJ Park Attorneys, New Zealand

Adjunct Professor, Luigi Palombi, Murdoch University

Dr Nigel Parker and Dr Victoria Longshaw, Houlihan2 Patent Attorneys

Dr Ana Penteado, Visiting Scholar, Macquarie University

Dr Ian Ross *

The Royal College of Pathologists of Australasia

Dr Grant Shoebridge, Shelston IP *

Dr Ulrich Storz, Michalski Hüettermann & Partner, Germany

The Walter and Eliza Hall Institute of Medical Research


*IP Australia has contacted these individuals and received written confirmation that the submissions are able to be disclosed publically.