Pharmaceutical patents review

On 15 October 2012, the then Parliamentary Secretary for Innovation, the Hon Mark Dreyfus QC MP, announced a review of pharmaceutical patents.

Terms of reference

The review evaluated whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation and supporting employment in research and industry.

Central to this was the analysis of the pharmaceutical extension of term provisions of the Patents Act 1990 (s.70).

The review also considered whether there is evidence that the patent system is being used to extend pharmaceutical monopolies at the expense of new market entrants. In doing this, the review considered how patents for new formulations are granted, considered the treatment of new methods of manufacturing and new uses of known products, the impact of contributory infringement provisions and the impacts of extending patent monopolies on entry of generic pharmaceuticals into the market.

In conducting the review and making recommendations the panel considered:

  • the availability of competitively priced pharmaceuticals in the Australian market
  • the role of Australia's patent system in fostering innovation and hence to bringing new pharmaceuticals and medical technologies to the market
  • the role of the patent system in providing employment and investment in research and industry
  • the range of international approaches to extensions of term and arrangements for pharmaceutical inventions
  • Australia's obligations under international agreements (including free trade agreements and the World Trade Organisation agreements)
  • Australia's position as a net importer of patents and medicines.

Conduct of the review

A public consultation process was conducted as part of the review.

Panel members were: 

  • Mr Tony Harris, former NSW Auditor-General and Parliamentary Budget Officer, as Chair
  • Professor Dianne Nicol, Associate Dean, Research, Law Faculty at the University of Tasmania
  • Dr Nicholas Gruen, CEO of Lateral Economics.

 

The current government has made the final report available in response to stakeholder interest.

The panel released its Draft Report on 2 April 2013. Written responses to the report closed at 5pm on 30 April 2013.

The panel released a Background and Suggested Issues Paper on 21 November 2012. Submissions closed on 21 January 2013. Public hearings were held in Canberra, Sydney and Melbourne on 11, 12 and 15 February 2013 respectively.

Public Submissions

We received 40 non-confidential submissions on the Draft report and 38 non-confidential submissions on the Issues Paper. Copies of these submissions are available here.

  • Dr. Robin Pope and Dr. Reinhard Selten
  • Professor Stephen Duckett
  • Dr. Mary Osborn
  • Consumers Health Forum of Australia
  • Japan Pharmaceutical Manufacturers Association (JPMA)
  • AbbVie
  • F. Hoffman La-Roche and Roche Products Pty Limited
  • American Chamber of Commerce in Australia (AMCHAM)
  • Amgen Australia Pty. Ltd.
  • Professor Andrew Christie, Dr. Chris Dent, Professor Peter McIntyre, Dr. Lachlan Wilson and Professor David Studdert
  • Anna George
  • AusBiotech
  • Bristol-Myers Squibb Company
  • Consumers Federation of Australia
  • Dr. Hazel Moir
  • Eli Lilly Australia Pty Ltd
  • Federation internationale des conseils (FICPI)
  • The Australian Federation of Intellectual Property Attorneys (FICPI Australia)
  • GlaxoSmithKline Australia
  • International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
  • The Institute of Patent and Trade Mark Attorneys of Australia (IPTA)
  • Japan Intellectual Property Association (JIPA)
  • Medicines Australia
  • Pfizer Inc.
  • Pharmaceutical client of Davies Collison Cave
  • Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Research Australia
  • Sanofi-Aventis Australia Pty Ltd.
  • Starpharma Pty Ltd
  • U.S. Chamber of Commerce
  • Biotechnology Industry Organization (BIO)
  • Merck Sharp & Dohme (Australia) Pty Limited
  • Monash University
  • The Australian Group of the International Association for the protection of Intellectual Property (AIPPI)
  • Alphapharm Pty Limited
  • Generic Medicines Industry Association Pty Ltd
  • The Intellectual Property Committee of the Business Law Section of the Law Council of Australia (IPC)
  • Novartis Pharmaceuticals Australia Pty Ltd
  • Baker IDI Heart and Diabetes Research Institute
  • The Australian Fair Trade and Investment Network (AFTINET), The Public Health Association of Australia (PHAA), The Australian Federation of AIDS Organisations (AFAO), The Asia Pacific Network of People Living with HIV (APN+) and Palliative Care Australia

We received the following non-confidential submissions for the Issues Paper:

  • Japan Intellectual Property Association (JIPA)
  • Dr. Charles Lawson
  • AusBiotech
  • Dr. David Lim and Prof V Bruce Sunderland
  • The Institute of Patent and Trade Mark Attorneys of Australia (IPTA)
  • Interpat
  • Merck Sharp & Dohme (Australia) Pty Limited
  • AbbVie
  • H. Lundbeck A/S (Lundbeck)
  • Japan Pharmaceutical Manufacturers Association (JPMA)
  • Consumers Health Forum Of Australia
  • Pfizer Australia Pty Ltd
  • GlaxoSmithKline (GSK)
  • Pharmaceutical Society of Australia
  • CSL Limited
  • The Australian Fair Trade and Investment Network (AFTINET), The Public Health Association of Australia, The Australian Federation of AIDS Organisations, The Asia Pacific Network of People Living with Aids (APN+) and The Palliative Care Association of Australia
  • Vimala Srinivasan
  • The Australian Group of the International Association for the protection of Intellectual Property (AIPPI)
  • Monash University
  • Cancer Voices Australia
  • The Australian Federation of Intellectual Property Attorneys (FICPI Australia)
  • Novartis Pharmaceuticals Australia Pty Ltd
  • Amgen Australia Pty Ltd
  • Medicines Australia
  • Civil Liberties Australia – Attachment 1, Attachment 2 and Attachment 3
  • Mundipharma Pty Limited
  • Roche Products Pty Limited
  • American Chamber of Commerce in Australia
  • The Intellectual Property Committee of the Business Law Section of the Law Council of Australia (IPC)
  • Bristol-Myers Squibb Company
  • Dr. Hazel V J Moir
  • The Walter and Eliza Hall Institute of Medical Research
  • Janssen-Cilag Pty Limited
  • AlphaPharm
  • Generic Medicines Industry Association Pty Ltd (GMiA)
  • Bristol-Myers Company (BMS) and Sanofi
  • Medicines Australia
  • Centre for Adaptive Behaviour and Cognition, Max Planck Institute for Human Development