1. TRIPS Flexibilities P. Roffe ICTSD Bellagio, October 2007

2. 2 The relative importance of flexibilities The minimum standards of TRIPS The Doha Declaration of 2001 The WHO and IGWIG process Two main issues: 1. Which flexibilities 2. Their implementation

3. 3 Which flexibilities? o Patent and related fields o A lot has been said and written o A possible typology o Pre and post grant o UNCTAD current work

4. 4 Pre grant o Use of transition periods in case of LDCs -2013 waiver -2016 waiver o Administrative observations and opposition procedures (could adopt post grant oppositions) o Patentable subject matter -Role of patent examiners -Exclusions from patentability (27.2 and 27.3.a TRIPS) -Definition of invention (treatment of new uses, new chemical entities) o Patentability criteria (novelty, inventive step, industrial application). Narrow or wide interpretations o Options outside the patent system in cases of incremental innovations: utility models, compensatory liability regimes o Patent claim construction: delimiting the boundaries of the invention o Disclosure of patented inventions: in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art

5. 5 Post grant Exceptions to patent rights (scientific research, experimental use; bolar or regulatory exception; medical treatment or medical practitioner) Parallel imports Compulsory licensing -Doha regime Control of patent abuses and anticompetitive licensing practices Protection of clinical test data -Misappropriation -Data exclusivity (FTAs) -Cost sharing

6. 6 Implementation General principle: freedom to determine the appropriate method of implementation within own legal system and practice Pre-conditions Political will Right policies and institutions in place Human resources for their implementation Administrative Judicial

7. 7 Implementation International cooperation Role of bilateral donors Roles of WIPO, WTO, WHO The WIPO Development Agenda