Pharma Patents

A step to the left, a step to he right, shake it all about. Alongside the Productivity Commission's review of compulsory licensing of patents (and after reviews by ACIP) the Australian government has announced a review of pharmaceutical patents, presumably reflecting debate in Europe about the 1992 Supplementary Protection Certificate (SPC) regime, ie short term extension for pharmaceuticals of patent protection, questioned in the Medeva decision. (Section 70 of the Patents Act 1990 (Cth) provides for 5 year extension for pharma inventions beyond the 20 year term for a standard patent)

The review is to be undertaken by a three member panel: Tony Harris (former NSW Auditor-General) as Chair, Professor Dianne Nicol (Associate Dean, Research, Law Faculty at the University of Tasmania) and Nicholas Gruen (CEO of Lateral Economics and last mentioned in this blog regarding the fatuous Government 2.0 report).

The review will involve consultation with stakeholders and public submissions.

The Terms of Reference indicate that

The review will evaluate 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 will be an analysis of the pharmaceutical extension of term provisions of the Patents Act 1990 (s.70). The review will also consider 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 will consider how patents for new formulations are granted, consider 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. 

Should such evidence be found, the review should provide an assessment of the subsequent impact on competition, innovation and investment.

The panel is expected to provide a final report to Government in early 2013.

In conducting the review and making recommendations the panel is to have regard to:

• 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