Extension to Therapeutics and Diagnostics in TRIPS Decision

· Notifications of domestic IP laws and regulations

· IP and innovation

· Non-violation and situation complaints

· Technical cooperation and capacity building

· Communication by China requesting consultations with the United States regarding US export control and related measures with respect to certain advanced computing semiconductor chips and manufacturing products, supercomputer items, as well as related technologies and services, destined for or otherwise related to China.

· Instrument of acceptance for the protocol amending the TRIPS Agreement runs until 31 December 2023.

WTO members continued the discussion on whether to extend the TRIPS Decision adopted in June at the 12th WTO Ministerial Conference to COVID-19 diagnostics and therapeutics. At a meeting of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) on 16-17 March, members also provided detailed information on a large number of newly notified laws and regulations and exchanged experiences on cross-border cooperation among Intellectual Property Offices. The Council elected Ms. Pimchanok Pitfield, Ambassador of Thailand, as Chair for the coming year.

Under paragraph 8 of the Ministerial Decision on the TRIPS Agreement, WTO members had agreed to make a decision before 17 December 2022 on whether to extend this Decision to cover the production and supply of COVID-19 diagnostics and therapeutics, confirming members' right to override the exclusive effect of patents and provide greater scope to take direct action to diversify production of these products through clarifications of existing flexibilities and a targeted waiver over the next five years.

Given that consensus was elusive on the extension, the TRIPS Council decided in December last year to recommend to the General Council to postpone the deadline for such a decision. The General Council on 19 December 2022 agreed to this recommendation and resolved to return to the question of the duration of the extension at its next meeting, held on 6-7 March 2023, where members again agreed to keep the issue open for discussion while substantive discussions continue in the Council for TRIPS.

Facilitated by Ambassador Lansana Gberie of Sierra Leone in his last meeting as Council Chair, members reiterated well-known positions on this issue. Developing and least developed country (LDC) members expressed disappointment at the failure to meet the December 2022 deadline set by ministers at MC12. Some members remarked that the extension of the TRIPS Decision was a credibility issue for the WTO, as a solution for vaccines alone was insufficient to make a critical contribution to the lifesaving efforts for COVID-19 patients.

They argued that the concentration of manufacturing contributes to the inequitable rollout of COVID-19 diagnostics and therapeutics, threatening to undo public health gains achieved during the pandemic. These members called for a multilateral solution in the form of a trigger-ready mechanism as part of the preparedness for future pandemics.

Other members urged more evidence and fact-based discussions before taking any decision on the TRIPS Decision extension, noting that further assessment and internal consultations were ongoing to help inform the discussion and address open questions. Some questioned whether an IP-induced access problem existed for therapeutics and diagnostics and warned against any change to the international IP framework without substantial evidence, as this could weaken investment and innovation, risking members' ability to tackle health and other emergencies both now and in the future.

Ambassador Gberie thanked members for a constructive dialogue and called on them to plan well in advance if they want to achieve results and find convergence in the coming months. The next TRIPS Council meeting is scheduled for 14-15 June.

Under the IP and COVID-19 discussion, members considered the Secretariat compilation of COVID-19 related IP measures. The item also serves to continue or initiate work to analyse lessons learned and challenges experienced during the pandemic as indicated under paragraph 24 of the Ministerial Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics, and to address any communications that may be received from members under paragraph 5 of the Ministerial Decision on the TRIPS Agreement. On the latter, the chair noted that thus far no such communication had been received.

Notifications of domestic IP laws and regulations

Under the TRIPS transparency requirement to notify domestic laws and regulations pertaining to intellectual property, the Council received more than 120 new notifications from over 20 different members, most of whom provided detailed information on the legislation they had shared. The Secretariat also introduced its Annual Report on Notifications and other Information Flows which provides the status, tracks submission rates, and identifies trends in members' activities under the TRIPS Agreement's transparency mechanisms.

IP and innovation

Following up on past items on IP and innovation regularly added to the TRIPS Council agenda since 2012, co-sponsors Australia, Canada, the European Union, Hong Kong China, Japan, Singapore, Switzerland, Chinese Taipei, the United Kingdom, and the United States submitted a communication (IP/C/W/697) on "Cross-border cooperation among IP offices." The document highlights that the development of free trade systems and the evolution of information technology have increased the cross-border movement of information, people, services, goods, and monetary funds, increasingly globalizing companies' economic activities.

The communication notes that from the perspective of industrial property, the total number of patent applications filed by innovators worldwide has increased from around one million in the 1990s to more than 3.4 million in 2021. This increasing trend applies also to trademarks and designs, with a record 13.9 million trademark applications and 1.2 million design applications filed worldwide in 2021.

In addition, the numbers of international applications/registrations under the World Intellectual Property Organization's PCT (patent), Madrid (trademark) and Hague (design) systems, as indicators of multilateral industrial property activities, reached record levels in 2021. Even in the midst of the economic downturn caused by the COVID-19 pandemic, the paper indicates, businesses, creators and innovators have remained strongly engaged in industrial property-related activities, helping the world recover from the pandemic in a resilient manner.

In this context, the co-sponsors underlined it is vital for patent applicants that there is an established environment in which they can obtain industrial property rights smoothly and predictably when seeking industrial property protection worldwide. Acknowledging the important role domestic IP offices play in ensuring, promoting and protecting industrial property rights, the co-sponsors underlined that the sharing of cooperative efforts among IP offices in each region and country will serve as a reference for each member to consider future policies and efforts in developing a more globalized industrial property system.

Members highlighted examples of the potential benefits of cooperation between IP offices, the forms of cooperation that would directly benefit users of the industrial property system, and unsuccessful attempts of cooperation. They also shared their views on areas for improvement in the current cooperation efforts among IP offices and their plans to introduce cooperative efforts in the future.

Non-violation and situation complaints

Following up on another MC12 decision, members discussed the longstanding issue of the examination of scope and modalities for non-violation and situation complaints (NVSCs) under the TRIPS Agreement. Ministers adopted in June 2022 a Decision on TRIPS non-violation complaints, directing the Council for TRIPS to continue its examination of this issue and to make recommendations to the 13th Ministerial Conference, scheduled for February 2024. It was also agreed that, in the meantime, members would not initiate such complaints under the TRIPS Agreement.

Members reiterated their well-known positions, which have historically differed on whether such non-violation cases are feasible in the area of TRIPS. Some delegations consider NVSCs essential to maintaining the balance of rights and obligations within the TRIPS Agreement while helping to ensure that legitimate obligations are not circumvented or avoided. Others believe there is no place for the application of NVSCs in IP because of the legal insecurity and curtailment of flexibilities that could ensue and favour their complete ban in the TRIPS area.

Non-violation and situation complaints refer to whether and under what conditions members should be able to bring WTO dispute complaints where they consider that another member's action, or a particular situation, has deprived them of an expected advantage under a WTO agreement, even though no obligation under the Agreement has been violated.

Technical cooperation and capacity building

Ahead of the TRIPS Council meeting, 30 government officials from 18 LDCs attended a workshop aimed at analyzing and strengthening the benefits of the technology transfer transparency mechanism as established under Article 66.2 of the TRIPS Agreement. Article 66.2 calls on developed countries to provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to LDCs in order to enable them to create a sound and viable technological base.

The event allowed participants to enhance their understanding of LDC priority areas for technological development and improve coordination between LDCs and their cooperation partners in support of technology transfer projects, in line with the work and recent developments in various WTO bodies. As part of the workshop programme, some of the participants attended in person the TRIPS Council meeting.

Following requests in past meetings, a dedicated annual workshop, similar to that organized for Article 66.2, is envisaged to enable dialogue on IP-related technical cooperation under Article 67 of the TRIPS Agreement. The WTO Secretariat is planning to organize such a workshop on 12-14 June 2023. The programme will consist of two segments: a two-day workshop segment on 12-13 June, and a final segment, on 14 June, involving participation in the discussions of the TRIPS Council.

Other items

Sharing information on WTO disputes involving the TRIPS Agreement, the chair informed members of the communication by China requesting consultations with the United States regarding US export control and related measures with respect to certain advanced computing semiconductor chips and manufacturing products, supercomputer items, as well as related technologies and services, destined for or otherwise related to China.

The chair also recalled that the current period for depositing the instrument of acceptance for the protocol amending the TRIPS Agreement runs until 31 December 2023. To date, 136 members have accepted the amended TRIPS Agreement. Ambassador Gberie encouraged the 28 remaining members to complete their domestic procedures and deposit their instrument of acceptance with the WTO Director-General as soon as possible.