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IP law in a global perspective. TRIPS patent standards. TRIPS patent standards. Section 5 of Part II (Articles 27-34). Article 27(1). Patentable subject matter; make patents available for; Product and/or process patents In all fields of technology. Article 27(1).
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IP law in a global perspective TRIPS patent standards
TRIPS patent standards • Section 5 of Part II (Articles 27-34)
Article 27(1) • Patentable subject matter; make patents available for; • Product and/or process patents • In all fields of technology
Article 27(1) • Patentable subject matter; • Invention is new; • Involves an inventive step; and • Capable of industrial application. • A right of priority (12 months) is incorporated by reference to Article 4 Paris Convention
Article 29 • Disclosure obligations (’sufficiency of disclosure’) • Person skilled in the art
Article 62 • Formal requirements concerning acquisition and maintenance of patents (all categories of intellectual property protected in TRIPS) • Article 12 Paris Convention incorporated
Article 27(1) • Non-discrimination based on: • Place of invention • Field of technology • Imported or locally produced • (see examples in Handbook p. 102)
Article 27(2) • Excludes inventions contrary to ordre public or morality • Protect human, animal or plant life or health or to avoid serious predjudice to the environment (see Handbook p. 103) • Condition; ’commercial exploitation’ • Article 4quarter Paris Convention
Article 27(3)(a) • Excludes patentaility of: • (a) (1) Diagnostic, (2) therapeutic and (3) surgical methods for the treatment of humans and animals • (b) (1) Plants and animals and (2) essentially biological processes for their production; … …however patent protection for (1) microorganisms and (2) non-biological and microbiological processes are required (Article 27(3)(b))
Article 27(3)(b) • Patent protection for plant varieties or an ’effective sui generis system’, or a combination • UPOV
Article 27(3)(b)… • …further sets out a review process in the TRIPS Council regarding protection for plants and animals, traditional knowledge and biodiversity
Article 27(3)(b)… • Plant variety protection • Paragraph 19 of the Doha Declaration (’outstanding implementation issues’) broadened the review to cover TRIPS-CBD relationship; TK and folklore.
Article 28 • Rights conferred: • (a) products: prevent making, using, offering for sale, selling, or importing (compare Article 6 on exhaustion). • (b) process: using process; using, offering for sale, selling, or importing products obtained by the process
Article 34 • Burden of proof for process patents • Two options
Article 28(2) • The right to assign, or transfer by succession the patent, and to conclude licensing agreements (’property’)
Permissible exceptions • (1) Exhaustion (Article 6) • (2) Limited exceptions (Article 30) • (3) Compulsory licenses (Article 31)
Article 30 (’limited exceptions’) • must be ’limited’; • must not ’unreasonably conflict with normal exploitation of the patent’; and • must not ’unreasonable prejudice the legitimate interests of the patent owner, taking into account the legitimate interest of third parties’ • (examples, Handbook p. 109)
Article 30 • Canada – Pharmaceutical Patents • Robert Howse, ‘The Canadian Generic Medicines Panel: A Dangerous Precedent in Dangerous Times’, Journal of World Intellectual Property (2000): 493-507.
Article 31(’compulsory licensing’) • Article 5A Paris Convention • (a) authorization of such use shall be considered on its individual merits;.. • (f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use’
Access to medicines case • Doha Declaration on TRIPS and Public Health (2001) • 30 August 2003 Waiver Decision (implementation of Paragraph 6 to Doha) • Ministerial Decision 6 December 2005 on amendment • Still pending amendment to TRIPS
Doha Declaration • Article 5(c) • Article 6 regarding members with insufficient or no manufacturing capacitites in the pharmaceutical sector; mandate to TRIPS Council
Follow-up • Extension of transition periods for LDC’s (Handbook, Annex 9-10) • Solution to ’Para. 6 problem’
30 August 2003 Waiver Decision • Implementation of Para. 6 Doha Declaration • Waives Article 31(f) and (h)
Ministerial Decision 6 December 2005 on amendment • Protocol amending TRIPS
Formal amendment to TRIPS • Article 31bis
Article 32 • Revocation/forfeiture (must be subject to an opportunity for judicial review)
Article 33 • Term of protection; 20 years