Amendments To Australia’s Intellectual Property Laws

On 19 March 2014, the Intellectual Property Laws Amendment Bill 2014 (Cth) (the Bill) was introduced into parliament.

Most substantively, the Bill seeks to introduce a compulsory licensing scheme for pharmaceuticals and to take steps to unify the Australian and New Zealand patent examination regimes. In principle, these proposals appear largely uncontroversial. At a policy level, providing a mechanism to facilitate the supply of pharmaceuticals to foreign countries in need seems entirely reasonable. The proposed steps to unify the Australian and New Zealand patent examination regimes also seem reasonable — at least from the perspective that the agreement between Australia and New Zealand to actually do so has, it seems, already been made.

As always, however, it will be interesting to see how well the proposed amendments actually achieve these goals, and whether any unintended consequences ensue.

Overview of proposed amendments

At a high level, the Bill proposes amendments to:

  • the Patents Act 1990 (Cth) to introduce compulsory pharmaceutical licensing provisions in compliance with the TRIPS Protocol (Schs 1 and 2);
  • the Plant Breeder’s Rights Act 1994 (Cth) to provide the Federal Circuit Court with jurisdiction over infringement matters (Sch 3);
  • facilitate a unified Australia and New Zealand patent attorney profession and patent filing and examination processes (Sch 4); and
  • remove document retention provisions and correct errors arising from the last amendments made to the Patents Act (Sch 5).

Arguably, the most substantive proposals are those in respect of compulsory pharmaceutical licensing and unification of the patent attorney profession and patent prosecution for Australia and New Zealand.

Compulsory licensing provisions in respect of pharmaceuticals

In 2005, theWorld Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) was amended to introduce compulsory licence provisions in respect of pharmaceuticals. At a general level, these provisions provide for compulsory patent licences for the purposes of manufacturing and exporting vital medicines to countries in need.

As stated in the Explanatory Memorandum (the EM) to the Bill:

The Aim of the Protocol is to encourage patent owners to either practice price differentiation, and provide medicines to least developed and developing countries in need at affordable prices, or to issue voluntary licences to generic manufactures to provide medicines at affordable prices. If a patent owner is unwilling to do this, then the Protocol provides a mechanism to force the patent owner to issue a compulsory licence.1

Australia is a signatory to the TRIPS Agreement. However, it is yet to comply with its obligations in this regard.

A broad objective considered in the lead-up to the Bill was that of providing countries in need with medicines while at the same time supporting innovation and maintaining current expenditure on foreign aid (compliance with the TRIPS Agreement was not itself an objective). The options considered to meet the objective were to:

  1. take no action;
  2. give the Federal Court power to grant and amend licences;
  3. give the Commissioner of Patents power to grant and amend licences; and
  4. increase funding for relevant aid programs.

On their face, options (1) and (4) do not appear to meet the objective, so it is perhaps unsurprising that they were not recommended. Based on government and public consultations, conferring the power to grant a compulsory licence on the Federal Court was found more palatable than conferring such power on the Commissioner of Patents, leading to option (2) being recommended.

Against this background, Schs 1 and 2 of the Bill propose amendments that allow an application to be made to the Federal Court for an order requiring the patentee of a patented pharmaceutical invention (PPI) to 78 intellectual property law bulletin April 2014 grant a compulsory licence to exploit the invention “to the extent necessary for the purpose of manufacturing a pharmaceutical product in Australia for export to an eligible importing country”.

If implemented, these provisions will expand Australia’s existing compulsory licence provisions, which provide the Federal Court with power to grant a compulsory licence where the reasonable requirements of the public with respect to a patented invention have not been satisfied or where a patent owner contravenes the restrictive trade practices provisions of Australia’s Competition and Consumer Act 2010 (Cth).

Australia and New Zealand Single Economic Market initiative

Australia and New Zealand have a long history of cooperation in economic and trade relationships. This history has seen the progressive integration of policies, laws and regulatory regimes — with the most recent initiative being to create a seamless trans-Tasman business environment: the Single Economic Market (SEM) initiative.

In pursuit of the SEM initiative, Sch 4 of the Bill proposes two broad changes: the implementation of a trans-Tasman patent attorney regime and the provision of a more unified approach to patent filing and examination.

Australia and New Zealand patent attorneys

In 2013, Australia and New Zealand agreed to establish a single regulatory regime for patent attorneys. New Zealand has agreed that the framework will be based on Australia’s existing regulatory regime. Consequently, the amendments proposed in the Bill focus on administrative facilitation rather than substantive changes to the requirements and procedures governing the Australian patent attorney profession.

To facilitate the trans-Tasman regulatory regime for patent attorneys, the Bill proposes amendments that create a unified registration process, register, code of conduct, disciplinary process, and regulatory bodies for Australian and New Zealand patent attorneys.

Patent applications and examination

Turning to patent filing and examination, the Bill puts forward amendments to allow Australian patent applica tions to be filed at and examined by the New Zealand patent office.

Fundamentally, this is achieved by amending the Patents Act to allow the Australian Commissioner of Patents to delegate “any or all” of the Commissioner’s powers and functions to a New Zealand patent official. Under this approach, the intention is that existing administrative and judicial review procedures will remain available irrespective of whether an Australian or a New Zealand patent office official makes a decision.

New Zealand has also made changes to facilitate the SEM initiative. Under the Patents Act 2013 (NZ), many aspects of New Zealand patent law have been aligned (at least at the legislative level) with Australian patent law.This includes procedural conformity in a number of areas (such as the manner in which examination proceeds, when patent publication occurs, and the ability to request re-examination of a patent), as well as alignment in several substantive areas (such as the prior art base, utility requirements and support requirements).

The conformity is not, however, universal. For example, at the fundamental level of what constitutes patent-eligible subject matter, the only express exclusion under Australian legislation (for standard patent applications) is human beings and biological processes for their generation. In addition to this exclusion, however, New Zealand legislation excludes methods of diagnosis practised on humans, plant varieties, computer programs “as such”, and methods of treating humans by surgery or therapy. Contrasting with the last of these exclusions is Australia’s 2013 High Court decision of Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd,2 in which the ability to patent methods of medical treatment was confirmed.

1 Explanatory Memorandum to the Intellectual Property Laws Amendment Bill 2014 (Cth), p 10 at [12].

2 Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1; 103 IPR 217; [2013] HCA 50; BC201315312.

This article was first published in LexisNexis' Australian Intellectual Property Law Bulletin, vol. 27, no. 3, 2014.

Topics:  Australia, Pharmaceutical, Pharmaceutical Patents

Published In: Civil Procedure Updates, Intellectual Property Updates, International Trade Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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