Least Developed Country Members (LDCs) of the WTO benefit from transition provisions related to pharmaceutical products and processes with regard to the implementation of certain sections of the TRIPS Agreement.
Paragraph 7 of the Doha Declaration on TRIPS and Public Health removed the obligation for LDCs to comply with Section 5 and 7 of Part II of TRIPS, which relate to patents and the protection of undisclosed pharmaceutical test data, including any obligation to enforce rights arising from these provisions. In practice, this means that LDCs are allowed to not grant or enforce pharmaceutical product patents and not provide test data protection.
Some LDCs that are WTO Members have chosen to grant patents and/or protect test data through the grant of market exclusivity for a certain period. Such patents and market exclusivity need not be enforced pursuant to the transition extension. Therefore, LDCs have maximum flexibility in the purchase and supply of low cost generic medicines.
The extension of the ‘pharmaceutical transition period’ was originally set to expire on 1st January 2016, but has been further extended to 1st January 2033 (or earlier in case a particular country ceases to be in the LDC category).
There is no guidance from WTO regarding the certification of the non-grant or enforceability of patents and test data protection by Least Developed Countries. The text below provides a model for such certification, on the understanding that the legal situation in each country should be assessed in the light of its domestic legislation and constitution.1
The model certification has been helpful in the purchase and supply of generic medicines for the treatment of HIV. For more information see this chapter on uses of the Doha Declaration in Ellen ‘t Hoen’s book, in particular the section on the LDC Waiver.
Certification of non-implementation and non-enforceability of patents and data protection in respect of pharmaceutical products
Further to Paragraph 7 of the Declaration on the TRIPS Agreement and Public Health adopted by the WTO Ministerial Conference on 14 November 2001 (WT/MIN(01)/DEC/W/2) and Council for TRIPS Decision IP/C/25, the WTO Council for TRIPS decided on 6 November 2015 (IP/C/73) that Least Developed Country Members of the WTO need not implement, apply or enforce patents and test data protection with respect to pharmaceutical products until at least 1 January 2033.
The [insert title of government official] hereby confirms that:
(a) patents and test data protection with respect to pharmaceutical products shall not be granted or deemed enforceable within and with respect to [insert country name] at least until 1 January 2033;
(b) importation, manufacturing, use, sale, and offering for sale of pharmaceutical products may be conducted by any party complying with the relevant medicines regulations, notwithstanding any patents which may have been granted or test data protection (including related grants of regulatory marketing exclusivity) which may be applicable with respect to those products; and
(c) patents and test data protection rights (including related grants of regulatory marketing exclusivity) may not be enforced by holders thereof within and with respect to [insert country name] with regard to any actions by the government or third parties undertaken during the period extending at least until 1 January 2033.
1. The text is adapted from: Carlos M. Correa, Guide for the application and granting of compulsory licences and authorization of government use of pharmaceutical patents. WHO/PHI/2009.1, 2009, World Health Organization. ↩