The TRIPS Agreement and related decisions have the following specific provisions for LDCs:
- General transition period – exemption from applying substantive TRIPS standards until 2021 (article 66.1). LDCs were not required to implement TRIPS standards other than Article 3 (national treatment), Article 4 (MFN treatment) and Article 5 (precedence of WIPO procedures) for a period initially of 10 years from 1 January 1996, then subsequently extended. The latest extension, adopted in 2013, is until 2021 (IP/C/64)
- Exemption from providing protection for pharmaceutical patents, from providing the possibility of filing mailbox applications and from granting exclusive marketing rights until 2033 (IP/C/73 and WT/L/971): LDC members of the WTO are not obliged to protect pharmaceutical patents until 1 January 2033. “The Doha Ministerial Declaration on the TRIPS Agreement and Public Health, adopted in November 2001, exempted LDCs from protection patents and undisclosed information for pharmaceutical products until 1 January 2016. This was given legal effect through a Decision of the TRIPS Council, and another Decision of the General Council that waived the exclusive marketing rights provisions of Article 70.9 for the same period. This transition period was extended until 1 January 2033, or until such a date on which they cease to be an LDC member, whichever is earlier. This decision was complemented by a waiver of the General Council exempting LDCs from the application of mailbox requirements and exclusive marketing rights for the same time period.” (WTO/EIF, 2020).
- Graduation: See WTO/EIF, 2020: Countries graduating before 2021 will need to implement TRIPS standards upon graduation. For countries graduating after 2021, unless new transition periods are negotiated, graduation will have no impact in terms of the general transition period. Unless different solutions are negotiated, graduated countries would have to implement the TRIPS standards in pharmaceuticals starting at their graduation dates. Note that some countries, including Lao PDR, Nepal and Vanuatu, agreed to shorter transition periods during their accession negotiations. “[I]n the area of technology at the end of the transition period graduating LDC members would not normally be required to provide retrospective protection, as patent protection would generally only need to be extended to newly eligible subject matter” (WTO/EIF, 2020).LDCs will be required to apply TRIPS standards and would be subject to the transparency provisions, including the need to notify laws and regulations on intellectual property rights pertaining to TRIPS (Art. 63), notify contact points for the exchange of information on trade in infringing goods (Art. 69), and notify responses to a checklist on enforcement. “They will also be invited to provide information regarding their regime for the protection of geographical indications and the patentability of plants and animals in their territory”. Laws and regulations pursuant to Article 63.2 will be reviewed by the TRIPS Council.
- Waiver from notification requirements for issuing compulsory licenses for exports of pharmaceutical products to LDCs or other countries with insufficient manufacturing capacities in the pharmaceutical sector (article 31 bis of the TRIPS Agreement as amended on 23 January 2017): The Amendment to the TRIPS Agreement, that entered into force in January 2017 ensures that a developing country member or LDC that produces or imports pharmaceuticals under compulsory licences and which is party to a regional trade agreement (RTA) in which half of the members are LDCs can export these pharmaceuticals to other members of the RTA that share the same health problem without any further notification under the system. The use of the special system of compulsory licensing is subject to notification requirements, which include a confirmation by importing members that they have insufficient or no monitoring capacity in the pharmaceutical sector. LDCs are exempt from those requirements as they are presumed to be eligible importing members and to have insufficient manufacturing capacity in the pharmaceutical sector.
- Graduation: “The impact of graduation on the use of compulsory licensing for access to medicines will be limited. Graduated LDCs will remain entitled to use the system of special compulsory licensing to access medicines produced abroad. However, they would have to notify the intention to use the system and in their notifications concerning needed pharmaceuticals they would need to address the existence of insufficient or no manufacturing capacity” (WTO/EIF, 2020).
- Promotion of technology transfer by enterprises and institutions in developed countries (article 66.2 of the TRIPS Agreement): Art. 66.2 establishes that “Developed country Members shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least-developed country Members in order to enable them to create a sound and viable technological base”. A 2003 TRIPS Council decision requires developed country members to submit annual reports on actions in pursuance of this obligation. In 2018, the LDC Group submitted a proposal asking the TRIPS Council to deliberate on the meaning of “incentives to enterprises”.
- Graduation: Graduated LDCs no longer benefit from Article 66.2 The WTO suggests that “graduating LDCs would need to map out which incentives have proven to be the most useful and engage bilaterally with the developed country members granting those incentives” (WTO/EIF, 2020).
The World Intellectual Property Organization (WIPO) provides country-specific intellectual property profiles: WIPO Country Profiles