1. Durban, South Africa January 29 to 31, 2013 Topic 17: Research and Regulatory Review Exception Regional Seminar for Certain African Countries on the Implementation and Use of Several Patent-Related Flexibilities REPUBLIC OF SOUTH AFRICA

2. TRIPS - The Research and Regulatory Review Exceptions Thu-Lang TRAN WASESCHA Counsellor, Intellectual Property Division WTO Secretariat Tran Wasescha- January 2013 WIPO-DTI Regional Seminar for Certain African Countries on the Implementation and Use of Several Patent-Related Flexibilities Durban, South Africa, 29-31 January 2013

3. “Background” Any exclusive right in terms of property has exceptions (balance of rights and obligations, balance of interests) The patentee has the (negative) right to prevent others from using his patented invention without his authorization. The patent is not a blank check. Too difficult to agree on a list of exceptions or limitations, which exist in many laws: not only conceptual but also variations in terms of scope

4. Wording on exceptions and limitations: a comparison Copyright: Article 13 (cf. Article 9 (2) of the Berne Convention on rights of reproduction) «Members shall confine limitations or exceptions to exclusive rights to certain cases which do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holder.» Case US - Section 110(5) US Copyright Act WT/DS160/R and arbitral award on losses WT/DS160/ARB25/1 Patents: Article 30 «Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with the normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties. Case Canada – Pharmaceutical patents 2000 WT/DS114/R

5. The three-step test in Article 30 Article 30 - Exceptions to rights conferred – Members may provide exceptions which shall be limited shall not unreasonably conflict with a normal exploitation of the patent shall not unreasonably prejudice the legitimate interests of the patent owner. Canada-Pharmaceutical Patents (WT/DS114/R) – steps are cumulative – clarified interpretation of individual steps

6. The three-step test in Article 30 Regulatory review exception: the panel’s decision – Marketing authorization process for generics; requirement to produce a batch of products f- which could be considered as infringing a patent of the original producer – Possible delay of market entry of generic versions – Canadian law authorizes generic competitors to use the patented invention for purposes of regulatory review – Compatible with TRIPS Article 30 [However, stockpiling is not compatible] Adoption of regulatory review exception by some countries Scope varies: pharmaceuticals only, or any other areas requiring marketing authorization

7. Les exceptions aux droits exclusifs Private use Use for teaching purposes, etc. Research exception – See WIPO’s presentation – Useful exception for patent protection of plant varieties (cf. plant breeder’s exception under UPOV Convention)? Regulatory review exception, etc.

8. The perfect triangle Public - society IPR holdercompetitors

9. 9 Consult our website www.wto.org Other questions to: n thu-lang.tranwasescha@wto.org; tel.: +41 22 739 57 05; # 3024 thu-lang.tranwasescha@wto.org