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

2. 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

3. 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)

4. 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

5. 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)

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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)

12. 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

13. 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)

14. 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?

15. 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

16. 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

17. 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

18. 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

19. Contact Christoph Spennemann Legal Expert Intellectual Property Team
Division on Investment and Enterprise (DIAE)
UNCTAD
Tel: ++41 (0)
Fax: ++41 (0)