WIPO Patent Committee Asked To Discuss UN High Level Report On Access To Medicines 13/12/2016 by Catherine Saez, Intellectual Property Watch Leave a Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)The World Intellectual Property Organization patent law committee is a unique international forum where discussions about the patent system are held. The committee meeting this week is a display of different views of developed and developing countries on how the patent system is expected to meet their needs. The 25th session of the Standing Committee on the Law of Patents (SCP) is taking place from 12-15 December. Re-elected SCP Chair Bucura Ionescu of Romania There has been a longstanding divide in perspective about the patent committee between the developing countries, which say they are seeking to protect their policy space to address their development needs such as public health, and developed countries which are interested in refining the system to make it more efficient. As agreed at the last session of the SCP in June, the agenda [pdf] includes five topics upon which delegates agreed to discuss. These are: Exceptions and limitations to patent rights; quality of patents, including opposition systems; patents and health; confidentiality of communications between clients and their patent advisors; and transfer of technology (IPW, WIPO, 30 June 2016). This choice of topics reflects the divergent interests of WIPO members about the work of the SCP. Developing countries are generally interested in exceptions and limitations, patents and health, and tech transfer, while developed countries would prefer the committee to concentrate on patent quality, including international work sharing, and the confidentiality of communications between clients and their patent advisors. Another topic on the agenda is a proposal [pdf] by the Group of Latin America and Caribbean countries (GRULAC) on the revision of the 1979 WIPO Model Law for Developing Countries on Inventions. The agenda includes a number of sharing sessions during which member states are expected to discuss their national experiences. Limitations and Exceptions At the last session of the SCP, members agreed that the WIPO secretariat would organise a compilation of information regarding practical experiences of members and observers of the SCP on the effectiveness of exceptions and limitations to patent rights in addressing development issues, and the challenges associated with those exceptions and limitations. Contributions were provided by: Guatemala [pdf], Canada [pdf], the Dominican Republic [pdf], the United Nations Conference on Trade and Development (UNCTAD), World Trade Organization (WTO), Innovation Insights [pdf], Intellectual Property Owners Association [pdf] (IPO) and Third World Network [pdf] (TWN). According to the meeting document [pdf], which provides a summary of contributions, some members had already submitted information for a previous session of the SCP. The submissions in their entirety are available on the SCP electronic forum. UNCTAD, for example, in its submission [pdf], found that “it may be stated that patent exceptions and limitations, while available in domestic law, are often unclear in scope and therefore difficult to make operational.” The WTO meanwhile focused [pdf] on the WTO-WIPO-World Health Organization trilateral study on the intersections of public health, IP and trade in the promotion of access to medical technologies and innovation. WTO particularly targeted a flexibility in the TRIPS Agreement which it is pushing to be approved, known as the Paragraph 6 system, which is intended to facilitate the exportation of generic medicines to developing countries that lack production capabilities. Brazil’s Experience During the “sharing session,” on 12 December, Brazil talked about compulsory licences, under which governments are permitted to allow affordable generic production of medicines if brand-name prices are too high and the patent-holder declines to negotiate. In 2007, Brazil issued “its first and only compulsory licence to date,” for the antiretroviral efavirenz, the Brazilian delegate said. “The underlying intention was to guarantee that HIV patients receive appropriate treatment by the Brazilian Public Health System,” he said. However, he added, “In spite of strictly following the requirements contained in the national and international legal framework, the Brazilian Government faced legal disputes in national courts, which were initiated by the owner of the patent. Those disputes, however, were not successful.” A limitation included in the Brazilian law (Article 43, subsection II of the Brazilian Industrial Property Law) allowed Brazilian public laboratories to work on the manufacturing of the generic drug, he said. Article 43 states that “patent rights do not extend to acts carried out by unauthorized third parties for experimental purposes, in connection with scientific or technological studies or researches.” “Its goal is to maintain the incentives for research and studies by third parties, thus allowing the progress of science and technology,” the delegate said. “The owner of the efavirenz patent, however, initiated legal proceedings in order to challenge the public laboratories. Yet again, the Brazilian Courts held that the limitation is fully compliant with the relevant legislation,” he said. That led to a decrease of the price of efavirenz from US$1.59 to US$0.45 per tablet, he said. “Recent cases in other countries have shown that exceptions and limitations are inherent to the patent system regardless of the level of development of the country. As an example, news by media outlets state that last August the German Federal Patent Court issued a compulsory licence covering the antiretroviral drug raltegravir, marketed under the name Isentress,” following an emergency procedure, he remarked. A 2010 Brazilian proposal [pdf] in respect of exceptions and limitations to patent rights, and in particular the elaboration of an exceptions and limitations manual, to serve as a reference to WIPO members, was supported by several countries in their opening statements. UN Secretary General’s High-Level Panel on Access to Medicines Invited The African Group and the Asia and Pacific Group – a majority of the WIPO membership – both mentioned their wish that the report of the UN Secretary-General’s High-Level Panel on Access to Medicines be discussed at the SCP. This view was also shared by non-governmental organisations taking the floor on the first day of the session. For example, Médecins Sans Frontières (MSF, Doctors Without Borders) said that WIPO contributed to the formulation of the High-Level Panel report through its expert advisory group and they urged WIPO and its member states to “take full consideration of the analysis and recommendations provided by the report in the future work of the committee.” MSF urged WIPO to “take concrete steps in assessing the health impact of trade agreements and rejecting the proposals of TRIPS-plus provisions on intellectual property.” MSF also called on WIPO to address the lack of transparency in patent information concerning medicines, vaccines and diagnostics, and establish disclosure requirements for International Non-proprietary Names (INN) in patent applications. “The High-Level Panel Report explicitly recommends WIPO to ‘establish and maintain publicly accessible databases with patent information status and data on medicines and vaccines’,” the MSF representative said. Finally, MSF asked that WIPO provide public health-oriented technical assistance, with concrete follow-up, on public health safeguards in member states’ patent laws. The Third World Network also urged the SCP to initiate discussions based on the report and in particular that WIPO develops, with other stakeholders, an international database including INN, dates of grant and expiry. Image Credits: WIPO Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related Catherine Saez may be reached at csaez@ip-watch.ch."WIPO Patent Committee Asked To Discuss UN High Level Report On Access To Medicines" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.