1. Research & Experimental Use of Patented Inventions Brian Opeskin Australian Law Reform Commission AAAS Workshop, Washington DC, 18-19 October 2004

2. AAAS Workshop 18-19 Oct 20042 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)

3. AAAS Workshop 18-19 Oct 20043 Consequences of current position Researchers seldom seek licences Patent holders ignore small-scale infringement Little evidence of impeded research BUT uncertainty & risk

4. AAAS Workshop 18-19 Oct 20044 Which path of reform? Muddle along Guidance from the courts Legislative change International reform

5. AAAS Workshop 18-19 Oct 20045 International legal context Multilateral agreements (TRIPS) –art 27 technology neutrality –art 30 limited exceptions to patent rights Bilateral agreements –Free trade agreements (TRIPS+)

6. AAAS Workshop 18-19 Oct 20046 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

7. AAAS Workshop 18-19 Oct 20047 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

8. AAAS Workshop 18-19 Oct 20048 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?

9. AAAS Workshop 18-19 Oct 20049 Blurred boundaries Upstream-downstream continuum Motives are seldom pure Outcomes not always foreseen Funding promotes commercialisation

10. AAAS Workshop 18-19 Oct 200410 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

11. AAAS Workshop 18-19 Oct 200411 Relationship to other exemptions Private non-commercial use –Community Patent Convention Regulatory review (springboarding) Other specific research exemptions –eg plant breeders rights

12. AAAS Workshop 18-19 Oct 200412 Australian Law Reform Commission GPO Box 3708 Sydney NSW 2001, Australia Ph: +61-2-8238 6333 Fax: +61-2- 8238 6363 Email: patents@alrc.gov.au Website: www.alrc.gov.au