On 7-8 August 2013, the Department of Trade and Industry (the DTI), Republic of South Africa and the World Trade Organization (WTO), in close collaboration with the World Health Organization (WHO) and the World Intellectual Property Organization (WIPO) will hold a National Workshop on Intellectual Property and Public Health in Pretoria. Leading experts from these intergovernmental organizations, Roger Kampf (WTO), Dr. Peter Beyer (WHO) and Marco Aleman (WIPO) will address a host of topics including the determinants of prior and post patent grant (definition of patentable subject matter, patent examination and review procedures), flexibilities post patent grant (exceptions and limitations, regulatory review exception, compulsory licenses), socially responsible licensing and special compulsory licences for export of medicines.
In the context of domestic efforts to militate South Africa to incorporate public health safeguards into its national legislation, one wonders what type of technical advice will be provided by the WTO, WIPO and WHO at this workshop.
For example, in the discussions on compulsory licensing, one would hope that the technical assistance experts from the WTO, WIPO and WHO would distinguish between compulsory licenses that are granted under the procedures of Part II of the TRIPS Agreement concerning patent rights, and judicial compulsory licenses under Part III of the Agreement, concerning the remedies for infringement of these rights. For example, the most commonly used mechanisms for obtaining a compulsory license in the United States are those associated with Part III of the TRIPS, including in particular Article 44 of the TRIPS. Under the structure of the TRIPS Agreement, Article 44 judicial compulsory licenses are not subject to the restrictions that exist for Article 30 and 31 of the TRIPS, an issue not explored in the experts reports.
As put forth in KEI’s February 17, 2013 statement on the Nexavar India compulsory licensing case,
We note that Article 44 of the TRIPS Agreement provides for judicial discretion in granting injunctions to prevent such infringement under Article 44.1,…It also permits for broader limits on injunctions under Article 44.2, which provides for the possibility of eliminating the possibility of obtaining an injunction when certain conditions are met with regard to compensation or remuneration. Notably, in the United States, there is a rapidly expanding use of such flexibilities in decisions where injunctive relief is denied by a judge under the new standards for injunctions set out by in eBay v MercExchange, 547 U.S. 388 (2006), or in various United States statutes including 28 U.S.C. §1498 in the customs statute and 35 U.S.C. §271(3)(2) which places restrictions on injunctions in cases involving early working of patents or failures to provide competitors with relevant information on patents for biologic drugs.19. In the case of the aforementioned statutes, the United States takes advantage of the ability to grant compulsory license rather than enforce injunctions for infringement, under the policy space provided by Article 44 of the TRIPS Agreement. Article 44.2 provides that
Notwithstanding the other provisions of this Part and provided that the provisions of Part II specifically addressing use by governments, or by third parties authorized by a government, without the authorization of the right holder are complied with, Members may limit the remedies available against such use to payment of remuneration in accordance with subparagraph (h) of Article 31. In other cases, the remedies under this Part shall apply or, where these remedies are inconsistent with a Member’s law, declaratory judgments and adequate compensation shall be available.
20. Where injunctions are not enforced and the remedy is limited to payment of remuneration, the effect is a compulsory license under Article 44 rather than Article 31 of the TRIPS Agreement. This type of compulsory license, also known as a “judicial compulsory license,” is common practice in the United States and has been granted for a wide range of patented products, including, for example, for medical devices.
Consequently, one would hope that this national workshop would discuss state practice involving the compulsory licensing of medical technologies, including the application of TRIPS Articles 30, 31 and 44 particularly in the light of the eBay precedent set forth in the United States.
The agenda is reproduced below.
INTELLECTUAL PROPERTY AND PUBLIC HEALTHNATIONAL WORKSHOP
Organized by the Department of Trade and Industry, Republic of South Africa
and the WTO Secretariat,
in close collaboration with the WHO and WIPO SecretariatsPretoria, 7-8 August 2013
Draft Programme
(each session to include appropriate time for discussion)________________________________________________
Wednesday, 7 August 2013
08h30 Registration of Participants
09h00 – 09h30 Opening of the Workshop
Speakers: Host Country Representative
Mr Roger Kampf, Counsellor,
Intellectual Property Division, WTOTheme I: Flexibilities and Policy Options in the IP System to Address Public Health Needs
09h30 – 10h30 Determinants Prior and Post Patent Grant:
– Definition of Patentable Subject Matter
– Patent Examination
– Review ProceduresSpeakers: Ms Elena Zdravkova, Senior Manager Registrar of Patents, Companies and Intellectual Property Commission, South Africa
Mr Marco Aleman, Deputy Director, Patents and Innovation Division and Head, Legislative and Policy Advice Section, WIPO
Dr. Peter Beyer, Senior Advisor, Department of Public Health, Innovation and Intellectual Property, WHO
Mr Roger Kampf, WTO10h30 – 11h00 Coffee Break
11h00 – 12h00 Flexibilities Post Patent Grant:
– Exceptions and Limitations
– Regulatory Review Exception
– Compulsory LicencesSpeakers: Mr Roger Kampf, WTO
Mr Marco Aleman, WIPO
Dr Peter Beyer, WHO12h00 – 12h30 Socially Responsible Licensing Policies
Speaker: Dr Peter Beyer, WHO
12h30 – 14h00 Lunch Break
14h00 – 15h15 Special Compulsory Licences for Export of Medicines
Speaker: Mr Roger Kampf, WTO
15h15 – 15h45 Coffee Break
Theme II: Putting the IP System into the National Perspective
15h45 – 16h30 IP Flexibilities Viewed from a User’s Perspective
Speaker: Mr Danie Dohmen, Partner, Adams&Adams
Mr Stavros Nicolaou, Senior Executive, Strategic Trade Development, Aspen PharmacareEnd of day Side Event: Presentation of WHO-WIPO-WTO Study on “Promoting Access to Medical Technologies and Innovation”
Thursday, 8 August 2013
09h00 – 09h45 Domestic Implementation and Use of Flexibilities to Create Synergies Between Public Health and IPRs: Issues under Consideration
Speaker: Mr McLean Sibanda, Chief Executive Officer,
The Innovation Hub, PretoriaTheme III: Regulatory and Compliance Issues in the Field of Public Health
09h45 – 10h30 The Relationship Between Regulatory Approval and the Intellectual Property System
Speakers: Dr Peter Beyer, WHO
Mr Roger Kampf, WTO
Mr Marco Aleman, WIPO10h30 – 11h00 Coffee Break
11h00 – 11h30 National Perspective
Speaker: Representative from South Africa
11h30 – 12h30 Mechanisms to Combat Counterfeit Medicines
Speaker: Dr Peter Beyer, WHO
Mr Roger Kampf, WTO12h30 – 14h00 Lunch Break
Theme IV: Specific Issues at the Crossroad Between Public Health, IP and Trade
14h00 – 14h30 Competition Policy and Rules
Speakers: Dr Thapi Matsaneng, Education and Advocacy Coordinator, Advocacy and Stakeholder Relations, Competition Commission, South Africa
14h30 – 15h15 Traditional Medicinal Knowledge and Intellectual Property
Speakers: Mr Tom Suchanandan, Director, Advocacy and Policy Development, Department of Science and Technology, South Africa
15h15 – 16h00 Interface Between Tobacco Control, Intellectual Property and Trade
Speakers: Dr Peter Beyer, WHO
Mr Roger Kampf, WTO16h00 – 16h30 Closing Session
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