Pharma Session 4. Carlos R. Olarte

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1 Pharma Session 4 Double Jeopardy: Policy-Based Examination of Patent Validity Proposals for Patent Examination by Health Authorities in other Jurisdictions Carlos R. Olarte

2 Agenda Colombia (and Andean Community) Bolivia (and Andean Community) Paraguay South Africa 2

3 ALIFAR Declaration, 13 May 2015 ALIFAR insta a los gobiernos de América Latina a priorizar regulaciones como la Anuencia Previa, prevista en las legislaciones de Bolivia, Brasil y Paraguay 3

4 Colombia: Law 1753/2015 Article 70. Patents and compulsory licenses. The Ministry of Health and Social Protection (MSPS) may file before the Superintendence of Industry and Commerce (SIC [the Colombian Patent Office]), within a period of sixty (60) days after the date of publication of the patent application, non-binding technical considerations relative to the patentability of patent applications that are of its interest. 4

5 Colombia: Law 1753/2015 General comments Considerations have to be «technical» and «relative to the patentability»; in theory, this requires considerations to be tied to regular patentability requirements (e.g. novelty, inventive level, industrial applicability, support, enablement) Considerations are not binding on the CPO MSPS could already file an opposition like anyone else Considerations are free, but the MSPS does not become a party in prosecution (an opposer does) 5

6 Colombia: Law 1753/2015 General comments Any modification of Andean IP law (Decision 486) e.g. adding requirements or modifying who is the competent authority to review and decide patentability requirements - would clearly violate Andean law Compare: obligation requiring Health Ministry to review patent-related issues runs counter to reason expressed by many governments to shun «linkage» (MoH is not designed to review patent scope) 6

7 Bolivia: Supreme Decree 29004/2007 Domestic law requiring prior health authority consent for patent applications covering pharmaceutical products and processes Violates Andean Decision 486 No Andean Non-Compliance action initiated 7

8 Bolivia: Supreme Decree 29004/2007 ARTICLE 2. (PRIOR CONSENT).... shall mean the concrete mechanism to determine whether the content and scope for which protection is sought in the patent application do not interfere with the right to health and access to medicines. ARTICLE 3. (GRANTING OF PATENTS). The granting.. shall depend on the Prior Consent given by the Unit of Medicines and Health Technology UNIMED. 8

9 Bolivia: Supreme Decree 29004/2007 ARTICLE 4. (COMPETENT ENTITIES). : (a) the National Intellectual Property Service SENAPI, responsible for analyzing the requirements for the award (b) The Unit of Medicines and Health Technology UNIMED, main responsibility is to issue Prior Consent... ARTICLE 5. (RESPONSIBILITY). : (a) SENAPI, following the award of an invention patent, shall refer the relevant procedure to UNIMED. (b) when the result of the Prior Consent is positive, UNIMED shall [give] the grounds for the result of the Prior Consent. If negative, UNIMED shall [give] the grounds for the refusal. 9

10 Paraguay: Law 2593/2005 Creates an obligation to request a technical opinion from the Health Ministry. Not clear if this opinion is binding and if the scope of the opinion excludes typical patentability requirements. Article 25.- In cases of patents for pharmaceutical products, the Directorate of Industrial Property [Patent Office] must request a technical opinion from the Ministry of Health and Social Welfare for it to take a position concerning the product or procedure, within the scope of its competence. 10

11 South Africa: Draft Natl IP Policy 2013 Published in the Government Gazette, Vol. 579, 04 September 2013, No Still under discussion by ZA government Favorably cites at p. 14 the ANVISA prior consent system as a potentially useful mechanism and recommends information sharing (database connectivity) between ZA patent office and health authority. 11

12 Gracias! Carlos R. Olarte 12