On Friday, 30 September 2022, at the Geneva headquarters of the World Intellectual Property Organization (WIPO), the 34th session of Standing Committee on the Law of Patents (SCP) adopted a future work plan for WIPO’s patent committee on patents and health, limitations and exceptions, transfer of technology, and standards essential patents.
On patents and health, WIPO’s member states agreed to the following for the 35th session of the Committee scheduled for 16 October 2023 to 20 October 2023.
At SCP/35, the Secretariat will organize a sharing session among Member States on practices involving licensing of medical technologies for the diagnosis, prevention and treatment of COVID-19, including examples of compulsory and voluntary licensing.
While the kernel of this proposal is sound, it falls short of a more ambitious proposal submitted by Algeria on behalf of the African Group which specifically referenced Articles 30, 31, and 44 of the TRIPS Agreement.
At SCP 35, the WIPO Secretariat will organize a sharing session on State practices involving compulsory and voluntary licensing of medical technologies during the COVID-19 pandemic including the application of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights, namely articles 30, 31 and 44 of the TRIPS Agreement.
Countries including Switzerland and Germany led the charge to delete references to Article 30, 31 and 44 of the TRIPS Agreement in the African Group proposal on future work on patents and health. One hopes the sharing session scheduled for October 2023 will invoke the spirit of the African Group proposal and provide examples of state practice of TRIPS flexibilities, including Articles 30, 31, and 44 as documented here: https://www.keionline.org/wp-content/uploads/KEI-BN-2022-3-TRIPS-Differences-3articles.pdf
As described in KEI Briefing Note 2022:3, Selected differences between Article 30, 31 and 44 of the WTO TRIPS Agreement as regards non-voluntary use of patented inventions,
Article 44 of the TRIPS, on injunctions, is perhaps that place where the U.S. government approach is most clearly consistent, including in particularly, the highly permissive last sentence in paragraph 2, which states that injunctions can be eliminated when a WTO member provide the possibility of declaratory judgments and adequate compensation, two conditions that are available in the U.S. law. In other words, the U.S. approach to government use is not to grant a compulsory license under the Article 31 framework, but to limit the remedies for non-voluntary use to compensation. The “reasonable” compensation standard in U.S. law is certainly to be considered to meet the “adequate” standard in the Article 44.2 of the TRIPS, particularly given the discretion afforded to WTO members by Article 1 of the TRIPS, which provides that “Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.” Using the flexibility in Article 44, a WTO member can effectively create liability rules, which provide the freedom to use patented inventions, subject to an obligation to provide compensation or remuneration to the patent holders.
With respect to WIPO’s sharing session (in October 2023) among Member States on practices involving licensing of medical technologies for the diagnosis, prevention and treatment of COVID-19, including examples of compulsory and voluntary licensing, it would be remiss for the Committee not to consider the robust application of Article 44 of the TRIPS Agreement by the United States of America.
With respect to patents and standards, the Committee agreed to the following:
As proposed in document SCP/34/7 Rev., the Secretariat will organize, at SCP/35, a sharing session by SCP observers, intergovernmental organizations and other relevant stakeholders on their practical experiences on Standard-Essential Patents (SEPs) and Fair, Reasonable and Non Discriminatory (FRAND) licensing related issues.