27 June 2016
KEI statement on exceptions and limitations to patent rights
In relation to limitations and exceptions, we recall Brazil’s prescient submission, document SCP/14/7 (tabled in January 2010) which called attention to the lack of policy coherence in a world where in certain international fora, countries endorse the use of compulsory licensing to promote access to medicines for all, and in separate fora, criticize developing countries for actually considering or issuing such compulsory licenses.Paragraph 15 of the Brazilian submission noted:
15. During the post WTO period, after a long period of negotiations, the government of Brazil decided in May 2007 to sanction the compulsory licensing of an antiretroviral drug in order to address urgent public health problems. Our country then suffered an intense campaign led by some international actors [to discredit us], as if it was ignoring the rules agreed by all WTO Members, with which we fully complied.
In November 2015, the United Nations Secretary-General Ban Ki-moon convened the High-Level Panel on Access to Medicines with the objective of reviewing and assessing “proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.
If the compulsory licensing of medicines is truly supported, it should not be subject to bilateral and unilateral trade pressures. This Committee should address what role if any can WIPO play in addressing this lack of policy coherence.
In developing modules on state practice for limitations and exceptions, the International Bureau should examine how certain countries, such as the United States, implement limitations and exceptions to remedies associated with the exclusive rights of patents, with a focus on the flexibilities found in Articles 44.1 and 44.2 of the TRIPS, including cases where non-voluntary authorizations to use patents replace injunctions to enforce exclusive rights. (See for example, the U.S. Supreme Court decision eBay v MercExchange, or 28 USC 1498).
In addition, we would like to draw the Committee’s attention to the United States’ Affordable Care Act, which created a limitation on remedies for infringement of patents when a company selling a biologic drug failed to provide timely disclosure of patents to potential suppliers of biosimilar products.
In conclusion, we support Brazil’s call for the WIPO Secretariat to create a compilation of court cases related to exceptions and limitations to patent rights.