UPDATE: On 17 October 2014, the Secretariat of the World Trade Organization (WTO) circulated an updated WTO airgram WTO/AIR/4358 REV. 1 to its Members following a request by Ukraine. Ukraine requested the addition of an item on “Concerns with Respect to Measures Related to Plain Packaging of Tobacco Products and their Compatibility with the TRIPS Agreement.” This will be discussed under agenda item 13. Given the recent announcement that the WTO panel on Australia’s tobacco plain packaging legislation will not issue its ruling until the first half of 2016, plain packaging advocates may want to take heed of the October 2014 TRIPS Council proceedings. As Reuters recently noted in the piece, No WTO judgment in tobacco packaging dispute until at least 2016,
Both supporters and opponents say such restrictions could spread to alcohol and some foods with high sugar or fat content, making the WTO case far more wide-reaching than Australia’s own tobacco policies.
Many other countries around the world are waiting for the outcome of the case before deciding to adopt similar restrictions on tobacco packaging, although some have lost patience with repeated delays at the WTO and begun legislating.
The following WTO airgram WTO/AIR/4358 REV. 1 (17 October 2014) contains the agenda for the upcoming WTO Council for TRIPS meeting to be held in Geneva from Tuesday, 28 October 2014 to Wednesday, 29 October 2014.
The European Union, Switzerland and the United States made a written request to the TRIPS Council to discuss “Intellectual Property and Innovation: Promoting Awareness; Case Studies.” This item on IP and Innovation will be discussed under agenda item 12. This would mark the 7th time that the United States has tabled an item to the TRIPS Council relating to intellectual property or innovation. The United States first tabled an item on Intellectual Property and Innovation in November 2012 (along with Brazil).
Although each request is for a standalone agenda item, in effect, the US has created a permanent agenda item on innovation and intellectual property at the WTO TRIPS Council. The October 2014 session of the TRIPS Council will be accompanied by an “Innovation Fair” sponsored by the European Union, Switzerland and the United States; please see this piece, 28 October 2014: WTO Innovation Fair on the margins of WTO TRIPS Council review of the Paragraph 6 system, for more details.
The October 2014 session of the WTO TRIPS Council will conduct its annual review of the Paragraph 6 system (which aims to facilitate the export of pharmaceutical products under a compulsory license to countries with insufficient or no manufacturing capacities in the pharmaceutical sector). The annual review of the Paragraph 6 system will be discussed under agenda item 6, “Review under Paragraph 8 of the Decision on the Implementation of Paragraph 6 of the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.”
For some insight into the nature of the TRIPS Council’s treatment of the Paragraph 6 system, here is a selection of previous interventions:
Ecuador, October 2011:
Señor Presidente,
Sobre el tema 5 para debate en el examen anual del funcionamiento del párrafo 6, relativo a las alternativas al uso del sistema del párrafo 6 para lograr el objetivo del acceso a las medicinas, al igual que lo habrán hecho el resto de Miembros, mi país también ha considerado alternativas al uso del sistema del párrafo 6, a través de la recopilación y evaluación de las prácticas de otros países sobre la implementación de los artículos 30, 31 y 44 del Acuerdo de los ADPIC. Prácticas que consideramos son de importancia significativa para que los Miembros de la OMC puedan tomar decisiones de política informadas en su cometido de hacer realidad el espíritu de la Declaración de Doha sobre la primacía de y salvaguarda de la Salud Pública y la promoción del acceso a las medicinas.
Al respecto, permite plantear algunas preguntas relacionadas con las experiencias de otros Miembros de esta organización que demuestran el uso de dichas alternativas:
a. Parecería que el Artículo 31 (k) de los ADPIC facilita derogar las restricciones establecidas en el Artículo 31 (f) de los ADPIC relacionado con las Licencias Obligatorias (CL) para la exportación, cuando un Miembro otorga una LO a fin de “remediar una práctica que ha sido determinada por vía judicial o administrativa como anti-competitiva”. A mi delegación le gustaría tener clarificación del a Unión Europea sobre el otorgamiento de tres LO entre los años 2005 y 2007por la autoridad de competencia de Italia. Mi delegación entiende que Italia hizo uso de la flexibilidad establecida a su favor bajo el artículo 31(k) del los ADPIC en esos casos. Particularmente, a mi delegación le gustaría conocer con más precisión sobre las siguientes LO:
i. En febrero de 2005 la Autoridad de Competencia de Italia (Autorita garante della concorrenza e del mercado) inició una investigación sobre el abuso de MERCK de su posición dominante en el mercado debido a su rechazo a otorgar derechos de licencia respecto de los elementos activos de un antibiótico de MERCK denominado “Imipenem Cilastatina”. El 21 de junio de ese mismo año, la autoridad de competencia italiana otorgó una LO sobre las patentes de MERCK para la elaboración de antibióticos basados en el elemento activo protegido citado. En este caso, existía una patente del producto solo en Italia y no en otros países europeos. La industria de genéricos italiana quería una licencia para producir y comercializar el producto en el resto de Europa, no para el mercado italiano, dónde dicho producto no contaba con protección.
ii. Un segundo caso tiene que ver con el cierre definitivo el pasado 8 de febrero de 2006 de una investigación realizada por la autoridad de competencia italiana respecto del rechazo del Grupo GLAXO para negociar sobre un producto solicitado por Fabbrica Italiana Sintetici SpA (FIS), una empresa química, para producir en Italia un elemento activo de Sumatriptan Succinate, producto usado en la producción de medicinas para la migraña. FIS inicialmente utilizó la LO principalmente para abastecer al mercado de exportación al proveer del producto a empresas genéricas que comercializaban el producto fuera de Italia (por ejemplo en España), país en el que la patente sobre ese producto había expirado. La citada empresa italiana lo hizo fuera del marco del sistema del párrafo 6, que España y otros países Miembros de la UE optaron por excluirse como beneficiarios; y,
iii. El tercer caso, el 21 de marzo de 2007 la Autoridad de Competencia de Italia exigió a MERCK que “otorgue licencias gratuitas que permitan producir y comercializar en Italia el elemento activo Finasteride y medicamentos genéricos relacionados dos años antes de la expiración en el 2009 del Certificado Complementario de Protección”. Finasteride es el elemento activo de una droga comercializada inicialmente bajo el nombre de marca Proscar y Propecia. Este medicamento es utilizado para tratar la hipertrofia de la próstata, el cáncer de próstata y la calvicie masculina. Las LO sin compensación emitías por la autoridad de competencia italiana fueron remedios a los rechazos de MERCK de otorgar licencias sobre sus patentes a los productores de elementos activos farmacéuticos italianos. Nuevamente, se puede apreciar que estas licencias implicaban exportaciones a otros países de Europa, es decir, que no eran principalmente para el consumo en Italia.
Sobre la base de lo anterior y a fin de enriquecer nuestros debates, el Ecuador solicita a la UE si podría dar al Consejo más detalles sobre las LO otorgadas por la Autoridad de Competencia de Italia para exportar a España y otros países Miembros de la UE en relación a los casos sobre MERCK y GLAXO citados, incluyendo, pero no limitado a, procedimientos administrativos, procesos de toma de decisiones y los fundamentos de derecho y de hecho? Igualmente, podría la UE presentar ejemplos de “otros usos bajo el artículo 31(k) del Acuerdo de los ADPIC relacionados con la exportación de tecnologías médicas también?
India, October 2011:
The TRIPS Agreement handles the delicate balance between the exclusive right of the patent holder and the public interest….Articles 30 and 31 do provide such a mechanism. Article 30 is a substantive exception, detailing three criteria for any exception to exclusivity. Article 31, in contrast, is primarily procedural in nature, detailing a list of requirements for a limitation to exclusivity. Taken together, the Articles appear to define the universe of allowed unauthorized use under TRIPS. Similarly Article 44 of the TRIPS agreement does provide some flexibility as far as the State’s right to provide permanent injunction is concerned.
My question is to the delegation of the United States. The question is aimed at accessing the State practices on the application of TRIPS Articles 30, 31 and 44 which may be of importance to our current discussion. My question relates to the application of Article 44 of the TRIPS agreement where the court decides about the injunction when a patent has been infringed.
This is a recent case between eBay, which owns and operates an Internet website that allows buyers and sellers to do transaction in goods and MercExchange. MercExchange alleged that eBay had violated some of its patents and requested the Court to provide permanent injunction. However in this case the US Supreme Court pronounced a landmark judgement which could be relevant to us. In this judgement the Supreme Court held that principles of equity required that the plaintiff in infringement cases satisfy a four-factor test before a court may issue a permanent injunction:
(1) that it has suffered an irreparable injury;
(2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury;
(3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and
(4) that the public interest would not be disserved by a permanent injunction.
Secondly we note that in the case of Edwards Lifesciences vs CoreValve, a compulsory licence was granted for manufacturing a medical device for manufacture in the United States and meant exclusively for the export market.We understand that there have been several such cases in the United States following the landmark Supreme Court judgment in eBay vs MercExchange in the issuance of all compulsory licences. We would request the US delegation to explain to the Members how these cases are not bound by the restrictions on exports under a compulsory license granted under Article 31 of the TRIPS. In fact we feel that these cases and practices in the US can shed light in addressing the present problem of providing access to public health without the complicated mechanism of Para 6.
India, October 2013:
India has always been of the view that the Doha Declaration on TRIPS and Public Health constituted a major landmark in the short history of the WTO because it recognized the primacy of public health needs and the sensitivity of this organization to the problems faced by the poor in the less developed countries.
Along with several other Members, India worked relentlessly for the Decision of August 30, 2003 with the hope that it would genuinely and completely address the problems faced by WTO Members, with insufficient or no manufacturing capacities in the pharmaceutical sector to address their public health problems. It may have sounded prophetic at that time when India voiced certain apprehensions in the GC meeting of August 2003. India sounded a word of caution and while expressing hope that “the results accruing from this mechanism should not be negated by the creation of cumbersome systems that would lead to huge delays in getting medicines across at reasonable cost to those that needed them or discourage Members from using the system for the benefit of the people. In order to make this system successful, a sincere collective effort was required on the part of all Members and the entire pharmaceutical industry.” Regrettably, we have been proven right.
Chair, during the recently held negotiations to extend the TRIPS transition period for the LDCs, we found strong resistance from the developed country Members to provide an indefinite extension till the LDCs graduated to become developing countries. Since the ability of the LDCs to gain access to generic medicines would be directly and severely impaired with the implementation of the TRIPS Agreement, we cannot take seriously any prior or current rhetoric by these Members around Para 6 Mechanism and that these Members are committed to ensuring access to medicines.
Chair, let me also recall that our delegation during the last two Annual reviews in 2011 and 2012, had asked a few questions to some developed country members around the Para 6 mechanism. Regrettably these questions have still remained unanswered. Since the mechanism has been used only once for a single product, in favour of a single country and by a single country during the last several years and since the Members, especially those who would require this Mechanism in future, have several questions, it is necessary that the Council reviews the Mechanism comprehensively by taking into account the views of not only the Members but also all stake holders, including patients, legal experts and civil society organisations. It is therefore pertinent that the Council organises a dedicated workshop on the question of making effective use of compulsory licensing for export under the TRIPS Agreement, including alternatives to the paragraph 6 system involving all relevant stakeholders at the earliest. We are sure that an inclusive approach would help in a better review of the mechanism. Secondly Chair we also understand that a few Members have blocked the consensus required for holding such a workshop. In fact my delegation would urge them to reconsider their position on such a trivial issue to save the lives of thousands of people in the countries lacking manufacturing facilities and also lacking resources to import patented products.
Here below is the airgram in full.
WTO/AIR/4358 REV. 1
2 OCTOBER 2014SUBJECT: COUNCIL FOR TRIPS
THE NEXT MEETING OF THE COUNCIL FOR TRIPS WILL BE HELD IN THE CENTRE WILLIAM RAPPARD ON 28-29 OCTOBER 2014. THE MEETING WILL START AT 10 A.M. ON TUESDAY, 28 OCTOBER.
THE EUROPEAN UNION, SWITZERLAND AND THE UNITED STATES HAVE MADE A WRITTEN REQUEST FOR AN ITEM TO BE PLACED ON THE PROPOSED AGENDA (LISTED AS ITEM 12). IN LIGHT OF THIS REQUEST, THE FOLLOWING ITEMS ARE PROPOSED FOR THE AGENDA:
1. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT
2. REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION
3. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B)
4. RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION ON BIOLOGICAL DIVERSITY
5. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE
6. REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH
7. NON-VIOLATION AND SITUATION COMPLAINTS
8. REVIEW OF THE IMPLEMENTATION OF THE TRIPS AGREEMENT UNDER ARTICLE 71.1
9. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2
10. TWELFTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE IMPLEMENTATION OF ARTICLE 66.2 OF THE TRIPS AGREEMENT
11. TECHNICAL COOPERATION AND CAPACITY-BUILDING
12. INTELLECTUAL PROPERTY AND INNOVATION: PROMOTING AWARENESS; CASE STUDIES
13. CONCERNS WITH RESPECT TO MEASURES RELATED TO PLAIN PACKAGING OF TOBACCO PRODUCTS AND THEIR COMPATIBILITY WITH THE TRIPS AGREEMENT
14. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO
15. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS
16. ANNUAL REPORT
17. OTHER BUSINESSIT IS RECALLED THAT PARAGRAPH 19 OF THE DOHA MINISTERIAL DECLARATION PROVIDES THAT THE COUNCIL, IN UNDERTAKING THE WORK PROVIDED FOR IN THAT PARAGRAPH, SHALL BE GUIDED BY THE OBJECTIVES AND PRINCIPLES SET OUT IN ARTICLES 7 AND 8 OF THE TRIPS AGREEMENT AND SHALL TAKE FULLY INTO ACCOUNT THE DEVELOPMENT DIMENSION.
ANY MEMBER WISHING AN ADDITIONAL ITEM TO BE PLACED ON THE PROPOSED AGENDA IS INVITED TO INFORM THE SECRETARIAT OF THIS SUFFICIENTLY IN ADVANCE SO THAT A REVISED AIRGRAM CAN BE ISSUED TEN CALENDAR DAYS PRIOR TO THE MEETING.
MEMBERS OF THE WTO, OTHER GOVERNMENTS WITH OBSERVER STATUS AND INTERNATIONAL ORGANIZATIONS WITH OBSERVER STATUS ARE REQUESTED TO INFORM THE SECRETARIAT OF THE NAMES OF THEIR REPRESENTATIVES AS SOON
AS POSSIBLE.ROBERTO AZEVÊDO