The Trips Agreement And Covid-19
The WTO TRIPS Agreement is the most comprehensive multilateral agreement on intellectual property. It provides for certain fundamental principles (such as non-discrimination), sets out the IP system with a view to promoting innovation and the diffusion of technologies for the public good, establishes minimum standards of protection for each of the areas of intellectual property covered by the TRIPS Agreement, contains provisions on internal procedures and remedies for the enforcement of intellectual rights. and submits disputes between members over compliance with TRIPS obligations to WTO dispute settlement procedures. The persistence of the outbreak of the coronavirus clearly shows the importance of sufficiently promoting the research and development of new innovative medicines through exclusivity, but also shows the importance of ensuring the wide availability of these medicines. I propose to consider whether or not the USMCA`s patent provisions relating to the marketing/authorization process for patented medicines, whether or not they offer a viable trade-off between the protection of brand-name drugs (based on research) and the availability of generic (copied) medicines, and what could or should be added to a similar and future agreement on «TRIPSplus». In particular, I would like to propose a «research exception» against offenses, which is similar to the mandatory exception for regulatory review under section 20.47 of the USMCA, and this «research exception,» which is reflected in another «research exception» against foreshadowing. Article 20.6 of the USMCA provides that nothing in the USMCA IP Chapter shall be interpreted and implemented in such a way as to compromise the application of the TRIPS and Public Health Statement. Similarly, Section 20.40 of the USMCA with respect to the rights and obligations set forth in Art. 31 TRIPS or any waiver thereof. Accordingly, the USMCA does not affect or affect the state`s compulsory licensing or use rights or obligations under Article 31 TRIPS or Article 31 bis TRIPS. However, the USMCA requires a specific application of Art. 30 TRIPS (re-evaluated in the USMCA as Art.
20.39 USMCA): Section 20.47 of the USMCA requires a (non-optional) waiver for the regulatory verification of drugs for the sole purpose of generating information to meet marketing authorization requirements. What might be missing in trips and the USMCA, especially given the global COVID-19 situation, is a (mandatory?) Research exception or experimental exception similar to Section 20.47 of the USMCA [Regulatory Review Exception]. Patent holders could be «compensated» for this «research exception» in infringement with a «research exception» against anticipation. This would address the issue of confidentiality and the risk of (pre)publication of clinical trial data that could have a negative impact on the patenting of pharmaceutical products subject to such trials. . . .