For an overview of LDC-specific transition periods with regards to intellectual property under WTO rules see this page. 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.
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. ↩
How to use the mechanism
The following text can be used to notify relevant parties that an LDC intents to use the Paragraph 7 mechanism:
Certification of non-implementation and non-enforceability of patents and data protection in respect of pharmaceutical products
Download the Word file of this text here.
Whereas: 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.
The TRIPS agreement originally put down significant hurdles for the effective use of compulsory licensing for the supply of medicines to countries without sufficient medicines production capacity. This was because article 31(f) of TRIPS restricted compulsory licensing to predominantly for the supply of the domestic market. In other words, issuing a compulsory licence to produce medicines mostly for export was not compliant with TRIPS. As a result countries that relied on importation to give effect to a compulsory licence were at a disadvantage compared to those with production capacity. This problem was recognised in 2001 by the Doha WTO ministerial conference that took a decision to find an “expeditious solution” to the problem. This became known as the Paragraph 6 mechanism after the section of the Doha declaration that addressed the issue. Since 30 August 2003, a waiver to Article 31(f) has been in place that allows WTO Members to issue compulsory licences specifically for export to address needs notified by other countries under the system. The waiver formed the basis for a permanent amendment of the TRIPS Agreement (Article 31bis) which came into force on 23 January 2017 and replaces the waiver. For more details, see here.