TRIPS-Compliant Alternatives for Overcoming Intellectual Property Barriers to COVID-19 Countermeasures

Abstract

In the aftermath of the recent WTO Ministerial Decision on the TRIPS Agreement (adopted June 17, 2022), there may be some confusion about the many options that countries have for overcoming intellectual property barriers to allow alternative production, distribution, and use of COVID-19 countermeasures. Of course, visibility into the patent landscape for particular products is essential to understanding freedom to operate in terms of products, ingredient, and manufacturing processes, and that work is complicated, though aided by the Medicines Patent Pool MedsPaL and VaxPaL databases and work done by other researchers on COVID-19 vaccine and therapeutics patents. Overcoming patent barriers on ingredients will not be a significant barrier if existing, patent- owning/licensed suppliers have adequate supplies and will sell at an affordable price. If compulsory licenses need to be issued that cover export/import sources of ingredients, the process for gaining freedom to operate becomes that more difficult.

Jamie Love has previously written a cogent analysis of many of these alternatives, saying that the then proposed TRIPS Decision was only the fifth best alternative. This brief analysis summarizes some of the alternatives he discussed but lays out a fuller and broader description of alternatives. The new Decision’s plus-and-minuses for the most part compare negatively to the described alternatives which include: (1) Article 73 national security declarations, (2) Article 31(k) competition-based licenses, (3) Article. 44.2 judicial licenses on patents and trade secrets, (4) an Article 30 production- for-export exception to Article 31(f), (5) Article 6 parallel importation of countermeasures produced under a compulsory license, (6) regular non- predominate export under Article 31, (7) Article 31 bis licenses, (8) an Article 39.3 exception to allow disclosure of manufacturing-related data, and (9) an Article 39.2 public interest/public health exception to trade secrets/confidential information.

Keywords: WTO, TRIPS Agreement, patent, vaccine, COVID-19, trade countermeasures