Dear Chairman,
Congratulations to the Chair and the Vice Chairs for their elections.
KEI is an NGO that focuses on new thinking about innovation, and also the protection of consumers.
Our comments will focus on the proposal by Brazil to address the SCP work program on patent limitations and exceptions, as set out in SCP/14/7.
KEI supports all of the elements of work set out in paragraphs 25 to 27 of SCP/14/7, which we see as logical and useful steps to begin an empirically based discussion of patent limitations and exceptions, focused on practical concerns.
To this end, and considering also the several reports already prepared by the Secretariat, KEI would like to discuss four issues:
First, with respect to access to medicines, Brazil has called attention to the lack of policy coherence in a world where at one moment 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. If the compulsory licensing of medicines is truly supported, it should not be subject to bilateral and unilateral trade pressures. What role if any can WIPO play in addressing this lack of policy coherence? Perhaps the countries most committed to bilateral and unilateral trade pressures could be asked to elaborate the rationale and criteria they use to punish countries that simply try to carry out the mandate of paragraph 4 of the Doha Declaration of TRIPS and Public Health, and to explain why they believe such pressures are in fact consistent with the Doha Declaration on TRIPS and Public Health and the WHO Global Strategy on Public Health, Innovation and Intellectual Property, as set out in WHA61.21. We agree also with Venezuela that the SCP should consider issues such as the treatment of goods in transit, for cases where products with different patent landscapes move in international trade.
Second, KEI suggests in developing information on state practices, the SCP focus on way that some countries, such as the United States, implement limitations and exceptions to remedies associated with the exclusive rights of patent, 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)
Third, negotiators for 38 countries are meeting, in secret sessions in Mexico this week to consider a new trade agreement on the enforcement of intellectual property rights. We do not know if this secret agreement will address the enforcement of patents. If so, the SCP should ask the countries involved to make the negotiating text of the ACTA public, so its ramification for the patent system can be discussed at the next meeting of the SCP. KEI also strongly objects to the lack of transparency of the ACTA negotiations, and the degree to which the voices and interests of consumers and many developing countries have been marginalized in the ACTA negotiation.
Four, with respect to patents on standards, KEI endorses the proposals for WIPO to consider a protocol on disclosures of assertions of patent rights as they related to proposed standards. These include suggestions that a failure to constructively disclose assertions of patent rights in a standard should eliminate remedies to enforce the patent, against relevant implementations of that standard. Such a protocol, perhaps within the PCT or a standalone instrument, would make it easier to develop standards, including the open standards that are increasingly important for innovation.