Statement of Knowledge Ecology International (KEI) to the WIPO Standing Committee on the Law of Patents (SCP): Patents and Health
7 December 2011Thank you Mr. Chair. Knowledge Ecology International has submitted its written comments on patents and health which can be found in WIPO document SCP/17/INF/3.
In November 2001, the World Trade Organization (WTO) Ministerial Conference in Doha, Qatar adopted the Doha Declaration on the TRIPS Agreement and Public Health affirming that the “TRIPS Agreement does not and should not prevent members from taking measures to protect public health.” This landmark declaration marked a watershed moment in global trade governance, by singling out public health and in particular, health technologies, from other trade-related issues. The Doha Declaration reiterated that health technologies are not just another commodity and may be differentiated from other inventions as underscored by paragraph four of the Declaration,
the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.The Doha Declaration was precipitated by a request made by the African Group in April 2001 for the WTO to hold a special session of the TRIPS Council to clarify the relationship between intellectual property and access to medicines. In its request, the African Group observed,
[a]s the recent upsurge of public feelings and even public outrage over AIDS medicines has shown, there is now a crisis of public perception about the IPR system and about the role of TRIPS which is leading to a crisis of legitimacy for TRIPS.
Whilst this storm is raging outside the WTO, and legitimately so, we as Members inside the WTO cannot shut our eyes and ears. Each of us, from developing and developed countries, must respond, and respond adequately and appropriately.
Nearly ten years on from Doha, it is perhaps appropriate that the African Group and the Development Agenda Group (DAG) tabled their paper on a work program for patents and health (SCP/16/7) at the 16th session of the Standing Committee on the Law of Patents (SCP) with the over-arching objective that the, “patent system should be consistent with fundamental public policy priorities, and in particular the promotion and protection of public health”.
To preface our contribution on patents and health, we observe that recommendation 14 of WIPO Development Agenda (http://www.wipo.int/ip-development/en/agenda/recommendations.html) states:
Within the framework of the agreement between WIPO and the WTO, WIPO shall make available advice to developing countries and LDCs, on the implementation and operation of the rights and obligations and the understanding and use of flexibilities contained in the TRIPS Agreement.
We note that technical assistance experts often fail to distinguish between compulsory licenses that are granted under the procedures of Part II of the TRIPS, concerning patent rights, and those granted under Part III of the TRIPS, concerning the remedies for infringement of those 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 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. Consequently, we support the African Group/DAG request for the International Bureau to
Organize a technical workshop on state practice involving the compulsory licensing of medical technologies, including the application of TRIPS Articles 30, 31 and 44.
KEI supports the African Group/DAG proposal for the International Bureau to “commission a framework study by independent experts” to document state practice on compulsory licensing including the provision of empirical data on the royalty rates set in each case and an “examination on the extent to which countries use exhaustion of rights to allow parallel trade in medicine”.
In addition, under the mandate of recommendation 14, we request the International Bureau to undertake technical studies on the following:
• Current implementation of Paragraph 7 of the Doha Declaration on TRIPS and Public Health, regarding patents in LDCs,
• The methods of implementing Paragraph 6 of the Doha DeclarationAnother issue of concern is the increasing attempt by developed countries to lower patentability criteria and increase protections for patent right holders at the expense of public health through bilateral and plurilateral free trade agreements. These new standards often go well beyond the requirements of the WTO TRIPS Agreement and can fail to adequately incorporate the Doha Declaration. For example, the United States is currently negotiating a regional free trade agreement known as the Trans-Pacific Partnership Agreement with a diverse group of developed and developing countries. The United States proposed intellectual property text would lower standards for patentability and require patents on subject matter explicitly exempted by Article 27 of TRIPS, including for plants, animals, diagnostic, therapeutic and surgical methods. Additionally, the United States proposal would increase the monopoly power of patent holders through mandatory patent term extensions, exclusive rights in regulatory test data, and patent linkage. The provisions of the United States proposal will predictably delay entry of generic competition into the market and harm access to affordable medicines. Also of particular concern is the intention that the standards set in the Trans-Pacific Partnership Agreement be extended to a wider group of countries than those currently involved in the negotiations. Creation of new global patent norms should not occur through non-transparent bilateral or plurilateral trade agreement negotiations.
The US proposal also seeks to eliminate any form of pre-grant opposition to patents and would allow only post-grant procedures. Pre-grant opposition can serve to improve patent quality and reduce the granting of spurious patents. The elimination of pre-grant opposition systems benefits the patent holder and can increase the costs of challenging patents, even those that never should have been granted.