Issyk Kul, May 27 and 28, 2014 Regional Seminar on the multilateral legal framework and practice of patent protection in the pharmaceutical field Product.

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Issyk Kul, May 27 and 28, 2014 Regional Seminar on the multilateral legal framework and practice of patent protection in the pharmaceutical field Product and Process Patent Protection after the TRIPS Agreement Marco M. ALEMAN Acting Director, Patents Law Division, WIPO

Product patents Product patent: protect a product as such, e.g. an apparatus, a device or a chemical compound

Process patents Process patent: series of steps or acts, for performing a function or accomplishing a result

Example: Patent protection available for pharmaceutical products Product (compound per se/composition of matter) - compounds: patentable if they’re novel and industrially applicable(even only as intermediates in the preparation of other compounds) - compounds: if unknown structure patentable defining its properties or how the compound is made (product by process claim) - composition: sometimes can be claimed when the invention is really a new compound or a new use of an old compound Process (methods for manufacturing the product) First and second medical use

TRIPS Agreement. Transition Periods Obligation to implement the TRIPs provision within a determined deadline set in the Treaty Article 65.2 TRIPs (General transition Period) Article 60.4 TRIPs (products patent protection to areas of technology not so protectable within the country when the TRIPs entered into force) Art patent protection for pharmaceutical and agricultural chemical products

General Transition Periods Date of entry into force of the TRIPS Agreement: 1st January st January 1996: 1st deadline 1st January 2000: deadline for developing countries/countries in transition (5 years of General Transition Period) 1 January 2006: deadline for LDCs (10 years of General Transition Period)  extended up to July 1, Adoption entry 1 y to 5 y GTP 10y GTP New GTP of TRIPS into force implement for developing for LDCs for LDCs countries/transition

Pharmaceutical products No obligation to implement Sections 5 and 7 of part II of the TRIPs or to enforce the rights thereto up to 2005 (for developing countries) or 2016/2021(for LDCs) Establishment of an Exclusive Marketing Rights (EMR) system during this special transnational periods (but: LDCs not obliged to constitute it)

Transition Periods %