WTO TRIPS Council Looks At IP And The Public Interest, Importance Of Research Exemption 28/02/2018 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)A relatively new topic of discussion at the World Trade Organization committee on intellectual property is the relationship between intellectual property and the public interest. This week, WTO delegates discussed the application and benefits of a regulatory exception to IP rights allowing earlier entry of generics to the market, known as the Bolar exception. The committee also heard about a request from least-developed countries (LDCs) to improve technology transfer measures that developed countries have the obligation to provide under WTO rules. World Trade Organization The Council for the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) met on 27 February. This is the second of two articles from the event. For this meeting of the TRIPS Council, Bolivia, Brazil, Chile and South Africa proposed an item [pdf] on IP and the public interest and in particular the use of the regulatory review exception, also known as the “Bolar exception,” which was supported by China. The so-called Bolar exemption enables generic medicine producers to get ready to enter the market as soon as patents expire, the document tabled by the four proponents explains. Without this exception, generic manufacturers “would be blocked from undertaking the trials required for regulatory approval, taking months, perhaps years, to obtain such approval,” which would equate to extending the protection of the patent owner. India, Brazil, South Africa Say Bolar Not Limited to Health India explained that the application of the Bolar exceptions is technology and sector agnostic, according to its statement. “While the application of the exception is technology neutral, it has been of particular benefit in ensuring early availability of more affordable generic medicines which in turn has positively affected access to medicines and treatments,” it said. Bolar exceptions have an important link with compulsory licensing, the Indian statement said, and the absence of such exceptions “can severely affect the ability of a country to effectively utilize compulsory licence provisions.” In India, the Bolar exceptions “played a vital role in the entry of a more affordable generic of a cancer drug” in 2012 when the Indian Patent Office issued its first-ever compulsory licence on a drug used to treat kidney and liver cancer. The South African Patents Act was amended in 2003 to include Section 69A, introducing a Bolar type exception, according to the South African statement. As in India, the exception is not limited to pharmaceutical products, but applies to any invention in any field of technology. The main feature of Section 69A is that it permits a generic manufacturer of pharmaceutical, veterinary or agricultural products “to obtain registration of generic equivalents of patented products with the registration authorities in South Africa, prior to the expiration of the relevant patent.” South Africa, which is reviewing its IP laws, is discussing whether the Bolar exception should be extended to a broader category of activities, such as early experimental research, according to the statement. “Some stakeholders advocate an approach as exemplified by the US. Patent Act regulatory review exception, which covers both regulatory review and early research (e.g., pre-clinical) pathway,” it said. The South African statement mentioned the World Intellectual Property Organization “WIPO Lex,” providing national IP laws and international agreements, as a valuable resource for countries not having implemented the exception yet, and seeking to have examples of sound regulatory practices. The South African delegate also noted the December meeting of the WIPO Standing Committee on the Law of Patents (SCP) during which the WIPO secretariat was requested to review a draft reference document on exceptions regarding acts for obtaining regulatory approval from authorities (IPW, WIPO, 15 December 2017). In Brazil, the Brazilian delegate said, the regulatory review exception lies in the Industrial Property Law (Article 43, paragraph 7). The use of the exception is not limited to the health industry, he said in his statement. Brazil underlined two potential challenges for the full implementation of the exception. The first is access to the chemical compounds necessary for the production of the active pharmaceutical ingredient, and the second is the insufficient disclosure of the invention as contained in the patent application “creating an obstacle for the reproduction of the invention even by an expert in the field.” “The Bolar provision is one of the key tools to ensure an efficient and balanced patent system by safeguarding against the artificial extension of patent protection,” he said, adding “It is a very useful health-related patent flexibility for promoting public health objectives and maintaining dynamic competition between companies.” According to a source on background, El Salvador, Costa Rica, Chile, Singapore, China, and Indonesia took the floor to argue that use of the Bolar exception has allowed finding the right balance between IP right holders and users. Switzerland, EU, US, Praise Regulatory Exemption Too Switzerland in its statement recognised the importance of the discussion. Public interest is fundamental to Switzerland, the delegate said, adding that the current system of IP protection should and does integrate a balance between private and public interests, it said. Switzerland introduced the Bolar exception in 2008 into its patent law. Because marketing approval procedures might reduce the duration of the patent term, Switzerland partially compensates patent owners for their time lost due to regulatory requirements, the Swiss statement said. The EU welcomed the constructive tone of the paper submitted by the four proponents. According to the EU statement, the compatibility of the Bolar exception with the TRIPS agreement is one example demonstrating the flexibilities allowed by the TRIPS agreement “to the benefit of research for new pharmaceutical products” and earlier entry to market for generics. A regulatory review exemption was introduced into EU law in 2004 by Article 10(6) of Directive 2004/27, amending Directive 2001/83 on the Community code relating to medicinal products for human use, the statement said. The EU, however, would be cautious “in supporting a too broad interpretation of the regulatory review exemption, that could amount to weakening the underlying IP rights for other purposes, such as for industrial policy reasons.” The background source said the United States noted that IP and patents should not be viewed as intrinsic barriers to access. Factors outside the IP system, such as pricing and procurement policies, taxes, tariffs, also play a role in higher costs for consumers and health systems. LDCs Ask for Stricter Implementation of Tech Transfer Duty The Group of Least-Developed Countries (LDCs) submitted a document [pdf] requesting developed countries to fully implement their technology transfer requirements under WTO rules. The proposal of the group was presented by Haiti during the TRIPS Council yesterday, according to sources. At issue, according to the LDC communication, is how developed countries follow their obligation of transfer of technology according to paragraph 2 of TRIPS Article 66. In particular, the group said in the document that there is a lack of clarity in notifications on the nature of incentives, and whether such incentives result in technology transfer to LDCs (IPW, WTO/TRIPS, 23 February 2018). EU Sees Good Will but Limiting Factors; US Unsupportive The European Union said its member states take their commitments and obligations under Article 66.2 “seriously and fulfil them.” Technology transfer is often one component of a more complex project, the EU said in its statement. “The acquisition by LDCs of a sound and viable technological base does not indeed depend solely on the provision of technology or equipment, but also on acquisition of know-how, management and production skills, improved access to knowledge sources as well as on adaptation to local economic conditions,” it said. One of the most important pre-conditions of technology transfer is the improvement of the absorption capacity of LDCs, the EU said. In their efforts to promote tech transfer, EU members are limited by the fact that they do not own the “vast majority” of technologies in sectors such as energy, water, and agriculture. “It is clear that the private – and particularly the commercial – sector is nowadays the main source of technologies,” it said. Another limiting factor, the EU representative said, is that EU governments “cannot force the private sector to transfer its technologies. Incentives can therefore only take the form of encouragement, promotion and facilitation.” According to a source, the United States said it cannot support the terms of the LDC proposal because the US does not have a clear understanding of the perceived problem. The LDC proposal would undermine longstanding and beneficial reporting requirements, the US representative said. WTO developed country members submit annual reports on actions taken or planned in pursuance of their commitments under Article 66.2, following a 2003 TRIPS Council decision [pdf]. The US representative added that technology transfer can proceed most effectively if it is based on voluntary and mutually-agreed terms by the involved parties, and not terms recommended or favoured by the TRIPS Council, the source said. Japan said the annual workshop to discuss Article 66.2 could be a useful platform for a practical evidence-based discussion on the issue, according to the source. Brazil said the capital is analysing the proposal of the LDC Group, and said it could be a good basis for advancing discussions, a Brazilian source told Intellectual Property Watch. According to a source, Bangladesh, Haiti, and Benin clarified that they are not asking to force the private sector to transfer technology. However, the notifications of developed countries make reference to technical assistance projects and programmes, but do not detail the incentives provided nor specify that the purpose of the incentive is to encourage the transfer of technology to LDCs. A developing country source told Intellectual Property Watch, that for them, the LDC proposal lacked concrete measure proposals. CBD Left at the Door by US Opposition According to several sources, once again several countries, such as India, China, Chile, and South Africa asked for a briefing of the UN Convention on Biological Diversity at the TRIPS Council. Australia said it was open to the briefing, and Canada said it does not oppose it. The United States opposed such a briefing, sources said. Image Credits: Catherine Saez 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 email@example.com."WTO TRIPS Council Looks At IP And The Public Interest, Importance Of Research Exemption" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.