Research & Experimental Use of Patented Inventions Brian Opeskin Australian Law Reform Commission AAAS Workshop, Washington DC, October 2004

AAAS Workshop Oct Functions of ALRC Statutory body established in 1975 Functions: to inquire and report Projects not self-selected Terms of reference given by government Wide variety: 70 reports in 30 years Carries out investigations independently Report to Commonwealth Parliament

AAAS Workshop Oct Context of ALRC Inquiry Previous report on genetic information (ALRC 96, 2003) Follow on inquiry into gene patents TOR: Impact of gene patents on –health care –research & its commercialisation –biotechnology industry Duration: Jan June 2004

AAAS Workshop Oct Inquiry process Advisory committee of experts Research – national, international Targeted consultations >70 Formal written submissions >119 Public consultation documents –Issues paper 27 –Discussion paper 68

AAAS Workshop Oct Final Report – ALRC 99 Released 31 August recommendations Directed to 17 bodies Not self-executing Under consideration by government

AAAS Workshop Oct Implementation rates

AAAS Workshop Oct Is there a research use exemption in Australia? Widely assumed to exist No express defence in the Patents Act Is it implied by definition of exploit? Case law is outdated

AAAS Workshop Oct Clarify existence of exemption Amend Australian Patents Act to create new exemption –avoids under-investment in research –cleaner IP for researchers –better valuation of patent holders IP –no costly litigation

AAAS Workshop Oct Scope of exemption A researcher should be able to use a patented invention to study or experiment on the subject matter of the invention: –study must be the sole or dominant purpose –commercial motive does not affect the exemption

AAAS Workshop Oct Other attributes of exception Study & experimentation, not research Closer to European model in CPC Not limited to gene patents Exemption, not a defence Any study already permitted under the Patents Act is preserved

AAAS Workshop Oct Other ways to facilitate research Limit the scope of patent rights OR improve the way patented inventions are worked? –model licence agreements –industry initiatives (patent pools) –education programs for researchers –compulsory licensing (crown use)

AAAS Workshop Oct Australian Law Reform Commission GPO Box 3708 Sydney NSW 2001, Australia Ph: Fax: Website: