On 15 October 2012 the Australian Government announced a review of pharmaceutical patents, with a particular focus on pharmaceutical patent term extensions. In announcing the review, the Parliamentary Secretary for Industry and Innovation, Mark Dreyfus, stated that the Australian Government was "taking practical steps to ensure access to affordable medicines while fostering innovation and research". Mr Dreyfus also said that "concerns have been raised about a number of aspects of pharmaceutical patents, including bringing generic pharmaceuticals to market and the effect of patent terms on innovation".

Terms of reference for the pharmaceutical patent review panel

The purpose of the review is to evaluate whether the patent system is effectively balancing a number of objectives, in particular the timely access to generic medicines, the fostering of innovation, and support for employment in research and industry. The panel appointed to carry out the review has been instructed to have regard to the following issues in making its recommendations to the Government:

  • Issues that impact on competition in the pharmaceutical industry, for example, the ability of generic medicines to enter the market.
  • Issues around fostering innovation and bringing new pharmaceuticals to market.
  • The importance of the patent system in providing employment and investment in research and industry.
  • The impact of pharmaceutical patent provisions on Government health expenditure.
  • International approaches to extensions of term for pharmaceutical patents.
  • Australia's obligations under international agreements (including free trade agreements and World Trade Organisation agreements).
  • Australia's position as a net importer of patents and medicines.

The pharmaceutical patent review panel

The panel appointed to carry out the review will be chaired by Mr Anthony Harris, a former New South Wales Auditor-General and Parliamentary Budget Officer. He will be assisted by Professor Dianne Nicol, Associate Dean of Research, Law Faculty at the University of Tasmania, and Dr Nicholas Gruen, the CEO of Lateral Economics. None of the panel members has any experience in the research based pharmaceutical industry, or in the biomedical research field. However, Dr Gruen has previously consulted to the generic pharmaceutical company, Hospira, and has previously advocated for amendments to Australian patent law to allow the manufacture of drugs in Australia for export during the normal term of an Australian pharmaceutical patent. Accordingly, in view of the make up of this panel, it will be particularly important for research based pharmaceutical companies, Universities and research institutes carrying out biomedical research, to engage with this review to ensure that their views are heard and considered.

Public submissions for pharmaceutical patent review deadline

The panel has been asked to provide a final report to Government by April 2013, and accordingly there is little time for consultation with stakeholders and consideration of submissions. It is anticipated that the panel will soon issue some form of consultation paper and invite public submissions, however at this stage the time period for such submissions is not clear. Based on other reviews currently being carried out on behalf of the Australian government in the patent area, and the short period for the preparation of the report to the Government, stakeholders are only likely to be provided with a short time period for making submissions.

Reaction to pharmaceutical patent review

Obviously the announcement of the review has been welcomed by the Generic Medicines Industry Association (GMiA). According to their press release they believe "inappropriate extension of patents and the granting of inappropriate patents cost the national economy dearly and should be guarded against. The patent system should not support trivial patents that extend patent exclusivity to products that do not deliver a health benefit." Medicines Australia, representing the research based pharmaceutical industry, has also issued a press release suggesting that the Government's review "should consider the compelling case to extend the patent life of innovative medicines". They also indicated that "extension to the patent life for health technologies like pharmaceuticals was important because of regulatory and investment processes consumed user patent life."

While we applaud the optimism of Medicines Australia, we are concerned that it is unlikely that the Australian Government would consider the new provision of additional patent term beyond the 5 year patent term extension currently available. However, the review may represent an opportunity to correct some anomalies in the patent term extension legislation, one of which became evident in the decision of the Full Federal Court of Australia in H Lundbeck A/S v Alphapharm Pty Ltd1   in which Lundbeck was denied a patent term extension in respect of its enantiomeric anti-depressant product, escitalopram (marketed as LEXAPRO), on the basis that the earlier registration of its racemic product, citalopram, constituted the first registration of a product containing the enantiomer. This was despite a finding that the patent covering the enantiomer was novel over an earlier disclosure of the racemic product. The review may also represent an opportunity to put forward a case for paediatric pharmaceutical extensions in line with those provided for in Europe and for the removal of the requirement for patentees to submit research and development expenditure information under s76A.