Basic Features of the Multilateral Systems of Patents and Regulatory Test Data s

Overview of presentation Protection of Patents under the Paris Convention, TRIPS Agreement and US – Vietnam Bilateral Trade Agreement (BTA) Protection of Regulatory Test Data under the TRIPS Agreement and the BTA Conclusions

Patents under the Paris Convention Paris Convention for the Protection of Industrial Property (1883) As compared to Berne Convention (copyright): less detailed, only broad principles to address increased patenting activity under foreign jurisdictions National treatment (Art 3) Right of priority (Art 4) Independence of patents (Art 4bis) Compulsory licensing (CL) to prevent patent abuses (Art 5A)

Patents under the TRIPS Agreement Major shift in international patent law: detailed provisions on patents and other IPRs Mandatory minimum standards of protection Right to choose method of implementation Introduction of most-favored nation (MFN) treatment into IP law Patents available for all areas of technology

Minimum standards Members in domestic implementation of TRIPS rules must not go below minimum standard of protection but they may provide higher protection (« TRIPS-Plus ») Example: minimum term of patent protection = 20 years from filing date Increasing number of FTAs with TRIPS-Plus provisions Example: US – Vietnam Bilateral Trade Agreement (option to extend patent term in some cases)

Right to choose method of implementation (1) By statute, adminitrative regulation, or allowing direct applicability of TRIPS By creating special IP courts or by leaving this up to ordinary courts By providing operational language for TRIPS provisions E.g. patent available for invention that is new, inventive & industrially applicable TRIPS « flexibilities »  major importance to address local policy priorities

Right to choose method of implementation (2) India – Mailbox Case (WTO Appellate Body/AB), 1997 Controversy re India’s implementation of TRIPS patent provisions (transition period until 2005) India: WTO panels should not interpret a Member’s domestic law, as Members are free to choose way of implementation AB: rejected this view WTO panels & AB may interpret domestic law to the extent necessary to assess TRIPS compliance Freedom to choose implemenation does not equal right to self-certify TRIPS compliance

Art 27 Non-discrimination Members must make patents available without discrimination for any inventions (products or processes) in all fields of technology e.g. no exclusion of pharmaceuticals as to place of invention whether imported or locally produced

Optional exclusions from patentability Inventions against ordre public; morality; human, animal, plant life or health; environment Methods of medical treatment Plants & animals Incl biological processes for production of plants & animals But not micro-organisms and non-biological production processes Plant varieties: either patent or sui generis system (UPOV or others) or combination thereof

Patentability requirements Novelty anything not available to public prior to the date of patent application Inventive step (non-obviousness) anything not obvious to person skilled in the art on date of patent application, having regard to prior art (=existing knowledge) Industrial application (utility) any invention that may be manufactured or used in any commercial activity need for an industrial product

Art 28 Rights conferred (1) Product patents: making, using, offering for sale, selling, or importing the substance Process patents: Using the process (method-of-making) Using, offering for sale, selling, or importing product directly obtained by process (method-of-use)

Art 28 Rights conferred (2) Product patents are wider than process patents If process patent: competitor may reverse engineer end product and re-assemble it through different process Infringement proceedings: Burden of proving difference of process must be put on defendant in certain cases If product patent: no re-assembly of product through different process, as substance as such is protected

Exceptions to granted patent rights (1) General exception clause (Art 30 TRIPS) Three-step test comparable to copyright Exceptions are limited (step 1) No unreasonable conflict with normal exploitation of patent (step 2) No unreasonable prejudice to legitimate interests of patent owner, taking into account legitimate third party interests (step 3)

Exceptions to granted patent rights (2) Canada - Patent Protection of Pharmaceutical Products WTO Panel Non-discrimination also applies to Art 30 exceptions But differentiation for bona fide purposes does not amount to « discrimination » Leeway to provide differential treatment if justified by public health purposes?

Art 31 Compulsory licensing (CL) Authorization by the government of a third party to use an invention without the consent of the right holder « Government use » if third party acts on behalf of the government TRIPS contains list of procedural rules Members free to determine substantive grounds for CL Exception FTAs, incl US – Vietnam BTA: no CL for patent abuse not amounting to antitrust violation

Art 39 Protection of Regulatory Test Data Data submitted to drug regulatory authorities (DRAs) for marketing approval purposes Pharmaceutical or agrochemical test data TRIPS authorizes different approaches: Data exclusivity  DRA may not rely on original data for examination of subsequent submissions (USA; EU countries) Unfair competition approach  no exclusivity  reliance by DRA on original data  speeds up market entry of generic competitors

Protection of Regulatory Test Data under the BTA BTA Article 9(5), (6): exclusivity conferred upon pharmaceutical and agrochemical test data No approval of generic products (medicines) based on originator test data Term of exclusivity: normally not less than five years from date of approval granted to data originator

Conclusions Paris Convention only laid down some general principles of international patent law TRIPS Agreement represents a major shift: minimum standards of patent protection Patentable are all areas of technology Members maintain some flexibility of implementation FTAs/BTA take away some of this flexibility in the area of patents & test data protection

Contact Christoph Spennemann Legal Expert Intellectual Property Team Division on Investment and Enterprise (DIAE) UNCTAD E-mail: Christoph.Spennemann@unctad.org Tel: ++41 (0) 22 917 59 99 Fax: ++41 (0) 22 917 01 94 http://www.unctad.org/tot-ip