On 30 June 2016, the 24th session of the WIPO Standing Committee on the Law of Patents (SCP) agreed to an ambitious work program on patents and health, exceptions and limitations to patent rights, quality of patents, transfer of technology and confidentiality of communications between clients and their patent advisors.
On patents and health, the Committee agreed to the following:
- A sharing session among Member States on national experiences relating to use of health-related patent flexibilities for promoting public health objectives or the challenges thereof with a view to explore the issues to be examined in a study to be submitted to SCP/26.
- The study to be submitted to SCP/26 will be prepared by the Secretariat, consulting with independent experts, the WHO and the WTO, and will examine the constraints faced by developing countries and LDCs in making full use of patent flexibilities and their impacts on the access to affordable especially essential medicines for public health purposes in developing countries and least developed countries (LDCs).
- Further discussion on the feasibility study on the disclosure of International Nonproprietary Names (INN) in patent applications and patents (document
SCP/21/9), specifically where the INN is known to applicants at the time of filing. Members and regional patent offices are invited to make presentations in order to clarify the issues and their concerns. The Secretariat is invited to make a presentation on the PATENTSCOPE Chemsearch which facilitates patent search using the INN.
As a consequence, the WIPO secretariat is charged with preparing a study, in consultation with independent experts, the WHO and the WTO in examining the constraints faced by developing countries and least developed countries (LDCs) in making “full use of patent flexibilities” to secure access to medicines. One wonders if this WIPO study will take into account the formidable political pressure countries such as Brazil, Colombia, India, South Africa and Thailand have faced in using TRIPS flexibilities. At the 26th session of the SCP (in 2017), the WIPO secretariat is convening a session where countries will exchange experiences in state practice “relating to use of health-related patent flexibilities for promoting public health objectives or the challenges thereof.” (Source: SCP/24/5)
On exceptions and limitations, the Committee’s program of work includes:
- The Secretariat will prepare a document, compiling information to be submitted by members and observers of the SCP, regarding their practical experiences on the effectiveness of, and challenges associated to, exceptions and limitations, in particular in addressing development issues.
- A sharing session among Member States on case studies, including court cases, on those exceptions and limitations that have proven effective to address development issues and/or economic strengthening.
This followed the tumultuous 23rd session of the SCP (December 2015) when negotiations collapsed as member states failed to reach common ground on a host of topics ranging from patents and health, work sharing and the confidentiality of communications between clients and their patent advisors. As Intellectual Property Watch (IP-Watch) reported in December 2015, No Future Work Programme For WIPO Patent Law Committee; Questions On Development Orientation,
“The African Group voice said the proposed work programme lacked ambition and in particular failed to touch upon access to information and knowledge, economic growth and development. The Nigerian delegate speaking on behalf of the African Group said the group considered priorities to be: patents and health, limitations and exceptions to patent rights, technology transfer, and the quality of patent including opposition systems.” (Source: IP-Watch, 6 December 2015, No Future Work Programme For WIPO Patent Law Committee; Questions On Development Orientation, http://www.ip-watch.org/2015/12/06/no-future-work-programme-for-wipo-patent-law-committee-questions-on-development-orientation)
The Committee’s program on work sharing (in the context of quality of patents) proved a stumbling block for Iran at SCP 23 in December 2015:
79. The Delegation of Iran (Islamic Republic of) reiterated that it could not go along with work sharing, which was a bilateral or trilateral issue. It stated that without having a precise definition of the concept of patent quality, work sharing would not be workable between national offices. In its view, work sharing was a matter of procedure which fell outside the mandate of the SCP as a substantive committee. The Delegation therefore requested the deletion of item (2)(ii) regarding work sharing. The Delegation further noted that it could not go along with the future work regarding the confidentiality of communications between clients and their patent advisors, and requested that the words “with respect to cross-border aspects […] in cross-border issues” be removed. Furthermore, the Delegation requested that the Committee hold informal consultations with each regional group plus two or three, since some regions had difficulty in reaching a unified position. In its opinion, it was difficult for countries to raise their concerns and positions in the plenary.” (Source: SCP/23/6)
In December 2015, the Chair had proposed the following text on work sharing (which did not meet consensus):
(i) The Secretariat will circulate a Questionnaire prior to SCP/24 for comments from Member States and regional patent offices, which contains the following elements:
- how each Member State understands “quality of patents”; and
- implementation of work sharing and collaborative activities between patent offices, including experiences, their impacts, exchanging search strategies, tools to share information and capacity building needs in the area of work sharing.
At SCP 24, the Committee reached consensus by adroitly avoiding the offending phrase – “work sharing” – and replacing it with “cooperation and collaboration”; this deft move untangled the Gordian knot that blocked consensus on the Committee’s work on patents and health, exceptions and limitations to patent rights, quality of patents, transfer of technology and confidentiality of communications between clients and their patent advisors.
A key topic the Standing Committee on the Law of Patents (SCP) will have to address in the future is the revised African Group proposal on a WIPO work program on Patents and Health, presented to the Committee on 30 June 2016. The African Group proposal provides a holistic approach to patents and health and endeavors to make WIPO more responsive to recent developments in public health including:
1) Challenges to public health …. including pandemics such as the Ebola virus that gravely affected Africa in 2014-15, 2) the Zika virus in the Americas and the Caribbean, for which there currently is no cure, 3) the serious threat of Anti-Microbial Resistance (AMR), 3) the need for new ways to finance and incentivize Research and Development (R&D), 4) the 2015 revision to the WHO Model List of Essential Medicines which included expensive, patented medicines to treat cancer, HIV and tuberculosis, 5) the establishment of the United Nations High-Level Panel on Access to Medicines, 6) the WTO extension of the transition period under Article 66.1 of the TRIPS Agreement for LDC Members for Certain Obligations with Respect to Pharmaceutical Products (6 November 2015) and 7) the adoption of the Sustainable Development Goals (SDGs). (Source: SCP/24/4)
In addition, the African Group submission proposes that WIPO establish a nuanced, technical assistance module on compulsory licensing:
Development of a technical assistance module that explicitly demonstrates the difference between compulsory licenses that are granted under the procedures of Part II of the TRIPS Agreement, concerning patent rights, and those granted under Part III of the Agreement, concerning the remedies for infringement of those rights. This module would explain both approaches, and focus on the flexibilities afforded to both systems, noting that 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 Agreement.
In terms of policy coherence, the African Group proposed the following:
14. Appoint a balanced Working Group or Task Force to study and synthesize the reports and recommendations from the HLP and commitments in the WHO GAP, in relation to the patent system; and to consider how the SCP can contribute to advancing the innovation and health related SDGs.
15. At a half-day Information Exchange session during SCP 26, invite the UN Special Rapporteur on the Right to Health to present the report to the Human Rights Council on Intellectual Property Rights and Access to Medicines. Also invite WHO to present WHO CEWG and GAP reports, and the Co-Chairs of the UN HLP to share their views on the HLP’s objectives and findings.
16. Organize a technical workshop on state practice involving the compulsory and voluntary licensing of medical technologies, including the application of TRIPS Articles 30, 31 and 44.
17. Periodic information exchange on the margins of the SCP, involving leading experts, on identified development-oriented issues related to patents and health.
18. WIPO development of an international patent register, in consultation with Member States and the support of WHO, for essential medicines to facilitate determination of the patent status of a medicine internationally, including those for communicable and non-communicable diseases. Currently, there is no efficient or accurate way to determine the patent status of medicines, including those on the WHO Model List of Essential Medicines. This lack of transparency in the patent status of essential medicines (and other medicines) negatively affects efforts of governments and procurement agencies to negotiate terms and conditions of access to medicines.
The African Group proposal provides WIPO a comprehensive road map to address patents and health; the question remains as to whether industrialized countries will accept this ambitious work program.