See also the following essays in Medium:
- The proposed WTO agreement on intellectual property and COVID 19 vaccines should not require that authorizations of non-voluntary use of patents list all patents covered, Medium, March 17, 2022.
- The Quad WTO proposal on COVID 19 and TRIPS proposal is tied for the 5th best option for exports, Medium, March 20, 2022.
Ed Silverman of Stat has a story on the QUAD deal on TRIPS.
Ed links to a document which sets out the proposal (see below).
It is a very limited and narrow agreement. It only covers vaccines, it limits “eligible members” to developing countries, and only those who exported less than 10 percent of world exports in 2021 (China is excluded).
Countries are required to follow Article 31 of the TRIPS, which of course, is an existing and not a new flexibility, but with “clarifications” and a partial waiver of 31.f.
The clarifications are actually new obligations on countries that do not presently exist in Article 31. With the exception of the partial waiver of paragraph f in Article 31 (exports to “eligible countries”), the agreement makes Article 31 more restrictive and burdensome. In other words, outside 31.f, the agreement makes Article 31 worse.
For example, there is a new obligation to identify all patents covered by the authorization, something not required now in TRIPS, and not even the practice in the United States for 28 U.S.C. 1498(a) cases. There is a new obligation to notify the WTO of use of the waiver, something not required for compulsory licenses in general.
Particularly galling given that the agreement concerns vaccines is that only the 3rd paragraph of Article 39 is addressed, and the concession is essentially a statement of existing flexibilities. The Article 39 provisions most relevant to trade secrets and manufacturing-know are paragraph 1 and 2, and they are not included.
Overall, this agreement will be welcomed by PhRMA members, if it ends the conversation about IP and the pandemic at the WTO.
Here is the text published by Stat:
TRIPS COVID-19 solution (the outcome of the quadrilateral discussions at the end of last week, to be presented to WTO Members)
1. Notwithstanding the provision of patent rights under its domestic legislation, an eligible Member1 may limit the rights provided for under Article 28.1 of the TRIPS Agreement (hereinafter “the Agreement”) by authorizing the use of patented subject matter2 required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic, in accordance with the provisions of Article 31 of the Agreement, as clarified and waived in paragraphs 2 to 6 below.
2. For greater clarity, an eligible Member may authorize the use of patented subject matter under Article 31 without the right holder’s consent through any instrument available in the law of the Member such as executive orders, emergency decrees, government use authorizations, and judicial or administrative orders, whether or not a Member has a compulsory license regime in place. For the purpose of this Decision, the ” law of a Member” referred to in Article 31 is not limited to legislative acts such as those laying down rules on compulsory licensing, but it also includes other acts, such as executive orders, emergency decrees, and judicial or administrative orders.
3. Members agree on the following clarifications and waivers for eligible Members to authorize the use of patented subject matter in accordance with paragraphs 1 and 2:
(a) With respect to Article 31(a), an eligible Member may issue a single authorization to use the subject matter of multiple patents necessary for the production or supply of a COVID-19 vaccine. The authorization shall list all patents covered. In the determination of the relevant patents, an eligible Member may be assisted by WIPO’s patent landscaping work, including on underlying technologies on COVID-19 vaccines, and by other relevant sources. An eligible Member may update the authorization to include other patents.
(b) An eligible Member need not require the proposed user of the patented subject matter to make efforts to obtain an authorization from the right holder for the purposes of Article 31(b).
(c) An eligible Member may waive the requirement of Article 31(f) that authorized use under Article 31 be predominantly to supply its domestic market and may allow any proportion of the authorized use to be exported to eligible Members and to supply international or regional joint initiatives that aim to ensure the equitable access of eligible Members to the COVID-19 vaccine covered by the authorization.
(d) Eligible Members shall undertake all reasonable efforts to prevent the re-exportation of the COVID-19 vaccine that has been imported into their territories under this Decision. All Members shall ensure the availability of effective legal remedies to prevent the importation into their territories of COVID-19 vaccines produced under, and diverted to their markets inconsistently with, this Decision.
(e) Determination of adequate remuneration under Article 31(h) may take account of the humanitarian and not-for-profit purpose of specific vaccine distribution programs aimed at providing equitable access to COVID-19 vaccines in order to support manufacturers in eligible Members to produce and supply these vaccines at affordable prices for eligible Members. In setting the adequate remuneration in these cases, eligible Members may take into consideration existing good practices in instances of national emergencies, pandemics, or similar circumstances.3
4. Nothing in Article 39.3 of the Agreement shall prevent a Member from taking measures necessary to enable the effectiveness of any authorization issued as per this Decision.
5. For purposes of transparency, as soon as possible after the adoption of the measure, an eligible Member shall communicate to the Council for TRIPS any measure related to the implementation of this Decision, including the granting of an authorization.4
6. An eligible Member may apply the provisions of this Decision until  years from the date of this Decision. The General Council may extend such a period taking into consideration the exceptional circumstances of the COVID-19 pandemic. The General Council will review annually the operation of this Decision.
7. Members shall not challenge any measures taken in conformity with this Decision under subparagraphs 1(b) and 1(c) of Article XXIII of the GATT 1994.
8. No later than six months from the date of this Decision, Members will decide on its extension to cover the production and distribution of COVID-19 diagnostics and therapeutics.
1 For the purpose of this Decision, an “eligible Member” means any developing country Member that exported less than 10 percent of world exports of COVID-19 vaccine doses in 2021.
2 For the purpose of this Decision, it is understood that ‘patented subject matter’ includes ingredients and processes necessary for the manufacture of the COVID-19 vaccine.
3 This includes the Remuneration Guidelines for Non-Voluntary Use of a Patent on Medical Technologies published by the WHO (WHO/TCM/2005.1)
4 The information provided shall include the name and address of the authorized entity, the product(s) for which the authorization has been granted and the duration of the authorization. The quantity(ies) for which the authorization has been granted and the country(ies) to which the product(s) is(are) to be supplied shall be notified as soon as possible after the information is available
James Love. US Mobile is +1.202.361.3040. http://twitter.com/jamie_love, http://keionline.org/jamie