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Basic Features of the Multilateral Systems of Patents

and Regulatory Test Data

Development Dimensions of Intellectual Property Rights

Hanoi Foreign Trade University, 15 & 16 December

2008

Christoph Spennemann, Legal Expert Intellectual Property Team

Division on Investment and EnterpriseUNCTAD

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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

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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)

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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

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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)

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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

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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

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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

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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

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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

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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)

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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

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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)

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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?

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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

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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

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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

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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

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Contact

Christoph SpennemannLegal ExpertIntellectual Property TeamDivision on Investment and Enterprise (DIAE)UNCTADE-mail: Christoph.Spennemann@unctad.orgTel: ++41 (0) 22 917 59 99Fax: ++41 (0) 22 917 01 94http://www.unctad.org/tot-ip