Least Developed Countries Table WTO Proposal to Extend Pharma Patents Transition Period, Waiver
The WTO’s poorest members tabled a proposal in late February for extending their transitional period for enforcing global trade rules protecting pharmaceutical patents and clinical data, along with a related waiver involving patent protection and exclusive marketing rights for pharmaceutical and agricultural chemical products.
The move is set to kick off discussions among the WTO membership toward the potential renewal of these pharmaceutical-specific exemptions, which are otherwise set to expire on 1 January 2016.
However, the proposal may also raise renewed questions about how this deadline relates to a separate 2013 decision extending until 2021 the transition period for least developed countries (LDCs) to apply the provisions of the WTO’s Agreement on Trade-Related Aspects of Intellectual Property (TRIPS). This extended transition period does not apply to Articles 3, 4, and 5 of TRIPS, which refer to national treatment, most-favoured-nation (MFN) treatment, and multilateral agreements on the acquisition and maintenance of protection.
Bangladesh presented the proposal on behalf of the LDC Group at a 24 February meeting of the TRIPS Council. Sources familiar with the meeting noted that the discussion on the proposal was brief, given that it was raised under “other business” rather than as a formal agenda item.
The proposal is expected to be discussed in more detail at the next meeting of the TRIPS Council, currently scheduled for 9-10 June.
Currently, WTO members that are considered to be LDCs under the UN classification are exempted from having to implement the provisions of the TRIPS Agreement relating to the protection of pharmaceutical patents and clinical data notably to enable their access to low-cost generic antiretroviral treatments given the high prevalence of HIV in some LDCs.
A 2002 decision by the WTO General Council – the organisation’s highest decision-making body outside of the ministerial conference – had approved the existing extension to 1 January 2016, and was part of the process to implement the 2001 Doha Declaration on the TRIPS Agreement and Public Health.
The latter document specifically states in its final paragraph that LDC members of the WTO “will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these sections until 1 January 2016.”
Furthermore, the 2001 ministerial declaration says, this decision does not prevent LDCs from seeking other transition period extensions as outlined under Article 66.1 of TRIPS.
The new proposal requests that the transition period for least developed countries (LDCs) remain in force for as long as those countries considered LDCs remain least developed countries.
Citing the health burdens that result from high rates of HIV and non-communicable diseases such as cancer, the proposal says that it is “imperative” for the WTO’s poorest members to “retain maximum policy space to enable them to confront their health burdens with effective and affordable strategies.”
For instance, the proposal quotes a 2011 technical brief by the Joint United Nations Programme on HID/AIDS that suggested that “without extension of the transition period, access to antiretroviral therapy and other medicines in LDCs will face real changes,” noting that this could also lead to a reversal in the progress that has been made so far in accessing such medicines in least developed countries.
Waiver extension requested
LDC members have also requested a waiver for implementing their obligations under Articles 70.8 and 70.9 of the TRIPS Agreement, which deal with the protection of existing subject matter for pharmaceutical and agricultural chemical products.
A previous waiver agreed in 2002 by the General Council for Article 70.9 must be reviewed annually until it terminates on 1 January 2016.
Article 70.8 of the TRIPS Agreement permits inventors to submit applications for patents even in cases where there is no patent protection, in a provision sometimes known as the “mailbox” given that it essentially stores such applications.
A WTO member shall “apply to these applications, as of the date of application of this [TRIPS] Agreement, the criteria for patentability as laid down in this Agreement as if those criteria were being applied on the date of filing in that member, or where the priority is available and claimed, the priority date of the application,” according to paragraph (b) of that provision. The following paragraph then discusses how patent protection will be provided once the patent is granted.
Article 70.9 refers to those products covered under 70.8, and specifically involves the granting of exclusive marketing rights for five years in cases where a government has approved the marketing of a pharmaceutical or agricultural chemical product in that transition period, subject to certain conditions.
The LDC Group has asked for the waiver on both provisions to be extended for as long as a WTO member remains a least developed country.
Relationship with 2013 decision
One question that the proposal is likely to raise is how these deadlines – and the proposal to extend them – relate to a separate decision taken at the WTO nearly two years ago.
In June 2013, WTO members agreed to extend the transition period for LDCs to implement the overall TRIPS agreement until July 2021. The extension, according to the same decision, noted that it was “without prejudice to the Council Decision of 2002” on the extension of the LDC transition period for “certain obligations with respect to pharmaceutical products” that expires in 2016.
The LDC Group in that instance had also originally requested for the extension to last so long as a member was a least developed country, a move that had been met with resistance from some other WTO members. In the end, the extension was granted until 2021 following negotiations with the rest of the global trade body’s membership. (See Bridges Weekly, 13 June 2013)
Some observers have stressed that one way forward for LDCs could consist in seeking a declaratory or interpretative statement from the TRIPS Council and General Council that the 2013 extension covers pharmaceutical patents, regulatory data, and exclusive marketing rights, including non-enforcement, and that further action regarding the 2016 medicines extension is therefore not necessary.
Some experts also argue that continuous extension of such waivers may perpetuate a disconnect between LDCs and the international IP system – and that as a result, LDCs’ integration in the global knowledge-based economy would be deferred, leading to limited technology transfer and investments.