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

AAAS Workshop Oct Where are we now? Research exemption widely assumed to exist Legal basis varies between countries Uncertainty about existence & scope –no statute, no caselaw (Australia) –no statute, but caselaw (US, Canada, NZ) –statute and developing caselaw (Europe)

AAAS Workshop Oct Consequences of current position Researchers seldom seek licences Patent holders ignore small-scale infringement Little evidence of impeded research BUT uncertainty & risk

AAAS Workshop Oct Which path of reform? Muddle along Guidance from the courts Legislative change International reform

AAAS Workshop Oct International legal context Multilateral agreements (TRIPS) –art 27 technology neutrality –art 30 limited exceptions to patent rights Bilateral agreements –Free trade agreements (TRIPS+)

AAAS Workshop Oct Comparative laws & practices Scientific research, patenting & commercialisation are global activities Attention to patent laws & practices of major industrialised countries Attention to proposed reforms about experimental or research use

AAAS Workshop Oct Generic or specific exemption? TRIPS Agreement –technology neutrality required –bona fide differentiation allowed Patent system is a generic system Must justify exceptionalism –identify areas (genetics?) –demarcation

AAAS Workshop Oct Scope of an exemption Researchers purpose, intention –commercial, scientific, altruistic Research outcome, effect Nature of researcher –commercial, not-for-profit Nature of the activity –Research on or with the invention?

AAAS Workshop Oct Blurred boundaries Upstream-downstream continuum Motives are seldom pure Outcomes not always foreseen Funding promotes commercialisation

AAAS Workshop Oct Defence or exemption? Defence: –Infringement + immunity from liability –Researcher has burden of proof Exemption: –No infringement; use outside scope of patent holders exclusive rights –Patent holder has burden of proof

AAAS Workshop Oct Relationship to other exemptions Private non-commercial use –Community Patent Convention Regulatory review (springboarding) Other specific research exemptions –eg plant breeders rights

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