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Patents are often involved in public health policy discussions, and are considered by some as playing a major role in the escalating prices of new medicines, creating access issues. The World Intellectual Property Organization committee on patent law this week is discussing the issue and is holding information sessions by the Medicines Patent Pool, World Health Organization, and the World Trade Organization.

The 27th session of the WIPO Standing Committee on the Law of Patents is taking place from 11-15 December. The agenda adopted on 11 December is here [pdf]. A tentative schedule [pdf] for the week was published on 11 December.

The last session of the SCP in July agreed to a work programme for this session, divided into five subjects: 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.

Opening the session, WIPO Director General Francis Gurry mentioned the recently published annual World Intellectual Property Indicators (WIPI) [pdf] (IPW, WIPO, 6 December 2017). With 11.8 million patents in force in the world in 2016, and a steadily growth rate in patent applications around the world, the work of the SCP is particularly important.

“Who is looking at the international dimension,” said Gurry, “and the way in which patent systems fit together, and the appropriate rules framework for that inventive activity which is intensifying all the time? [T]he answer really is you.”

The issue of patents and health “continues to occupy much of the time of the committee,” he remarked, and said presentations would be provided by the WTO and the WHO on the issue of the availability of generic drugs in developing countries and least-developed countries (LDCs).

Gurry also mentioned the partnership between WIPO and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) establishing the Patent Information Initiative for Medicines (Pat-INFORMED) (IPW, WIPO, 17 October 2017), seeking “to give the legal status of patents.” The initiative had been requested for “quite some time by the non-governmental community, in particular,” he said, adding that the initiative would facilitate the procurement of medicines around the world. The full database is expected to be available in the course of 2018, he said.

He also underlined the importance of the issue of client-attorney privilege, as rising patent applications also increases the possibility of litigation, in particular multi-jurisdictional litigation.

The SCP elected Dámaso Pardo, president of the Argentina National Institute of Industrial Property (INPI), as chair. The vice chairs are: Adrian NEGOIŢĂ, director, Patents and Innovation Support Directorate, State Office for Inventions and Trademarks (OSIM), Romania, and Serkan ÖZKAN, industrial property expert, Turkish Patent and Trademark Office (TURKPATENT), Turkey.

Role of Bolar Exception

Following a decision at the July session of the SCP, the WIPO secretariat prepared a document [pdf] dealing with the role of a regulatory review exception in obtaining marketing approval for pharmaceutical products by a regulatory authority (IPW, WIPO, 6 July 2017). The exception is also known as the “Bolar exception,” after a 1984 United States case (Roche Products Inc. v. Bolar Pharmaceuticals Co. Inc. 733 F.2d 858).

The document explains that pharmaceutical products cannot come into the market without marketing approval from a competent regulatory authority. Requirements for obtaining such marketing approval depend on many factors, but in general, it says, an applicant is required to submit information on the product requiring the production and testing of its samples, which could be considered an infringement of the patent, if the applicant is not the patentee.

If a third party cannot use the patented invention to obtain regulatory approval prior to the expiration of the patent, market entry of competitive products, such as generics, would be delayed, says the document. To avoid this situation, many patent laws provide for a regulatory review exception.

The document describes the regulatory review exception, its objectives and goals, the regulatory review exception and the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the challenges faced by member states in implementing the exception, and the results of the national/regional implementation. The document also includes a compilation of various legal provisions on the exception in an appendix. A summary of the draft reference document is also available [pdf].

Among challenges faced by member states in implementing the exception, the document says two types of challenges have been recognised by some member states. The first relates to the uncertainty about the scope of the exception, and the second is the lack of awareness about the exception among potential users who might benefit from it. Other factors may affect the use of the regulatory review exception, such as the lack of production capacity of generic medicines in the country, the document says.

Use of Flexibilities

The WIPO secretariat, following a request made in July, produced a supplement [pdf] to a study submitted in July about constraints faced by developing countries and LDCs in making full use of patent flexibilities and their impacts on access to affordable medicines, in particular essential medicines. The supplement was to be constructed with inputs from member states.

For example, the document presents the submission of the Ministry of Health of Colombia describing “the difficulties and pressures it had experienced in taking administrative steps to issue a declaration of public interest in order to issue a compulsory license” in 2015.

The document also says a comment prepared by the International Treatment and Preparedness Coalition Latin America and the Caribbean and submitted by the Civil Society Coalition addresses the challenges it faced in Guatemala in relation to the application for a compulsory licence.

According to the document, the low number of compulsory licence grants may however not necessarily relate to constraints on its use but may also be due to the fact that some pharmaceutical products are not patented in some countries.

Review Patent Protection and Access to Medicines

Canada submitted a revised version [pdf] of its previous proposal for a review of pre-existing analysis and research on the topic of patent protection and access to medical products and health technologies. Switzerland sponsored [pdf] the Canadian proposal.

Canada proposes that the review cover studies from 2005 and 2016, and be carried out by WIPO in consultation with the WHO and WTO secretariats.

The review would cover topics such as the relationship between patents and other related issues and: the affordability of medical products and health technologies; the role of the IP system in incentivising and promoting the development of new medicines and health technologies, and in ensuring the supply of quality products; and the role and performance of compulsory and voluntary licensing mechanisms and patent pools in facilitating the affordability and availability of medical products and health technology.

Patents, Access to Medicines, High Level Panel

Most delegations taking the floor on 11 December underlined the importance of access to safe and affordable medicines.

Indonesia for the Asia and Pacific Group, said the United Nations Secretary General’s High Level Panel on Access to Medicines (High Level Panel) “specifically explored the policy incoherence between IP, trade and human rights and has made a number of recommendations in this regard,” remarking that some of those recommendations were addressed to WIPO. Indonesia requested that the SCP initiate an exploratory discussion based on the High Level Panel report.

Senegal for the African Group underlined global health challenges such as the lack of universal health coverage, antimicrobial resistance, viral hepatitis, HIV/AIDS, and neglected tropical diseases and said those challenges need close cooperation between different actors in the field of trade, IP, health and research. The SCP and WIPO have a central role to play according to their mandates to ensure universal and transparent access to resources and information in developing countries and least-developed countries and to assist member states in appropriately using these and meeting the challenges of public health, the delegate said.

Senegal remarked on its proposal [pdf] tabled in June 2016 suggesting the establishment of a working group or a task force to study and synthesise the report and recommendations from the High Level Panel. The delegate said obstacles to access to medicines linked to the IP system should be identified, as well as solutions.

In its statement, India also referred to the High Level Panel and suggested that a study group be set up with all stakeholders to identify constraints linked to access to medicines and suggest solutions.

India called for a revision of the 1979 WIPO Model Law on Patents, underlining the fact that this model law was framed at a time when many developing countries and LDCs were not WIPO members or just “fresh entrants.”

Any further work concerning patents and health should reflect a balanced approach taking into account the various factors relevant to patents and health, Estonia said on behalf of the European Union in its opening statement. Later on 11 December, the EU delegation said the EU remains committed to increase access to affordable medicines, but underlined the fact that the current innovation model has delivered consistent progress, and key new treatments.

Switzerland for Group B (developed countries) said both innovation and access are important in the field of patents and health. The patent system is a key incentive for the development of medical products, the delegate said. The protection of IP rights, including patents, serves as incentive and enhance the availability of new medicines for all, he said. It is important to keep in mind the full context and not only focus on one particular element. The lack of access to medicines can be influence by many factors, such as the lack of trained health professionals, the lack of health infrastructure, conflicting policies, lack of supply chain management, retail mark-ups, and tariffs, he explained.

Group B could not support the African Group proposal, in particular on the High Level Panel, the delegate said, as the panel was not a member-driven process and does not reflect their positions, nor was it endorsed by them. The High Level Panel report cannot be a basis for discussion, the delegate said.

Brazil said that innovation encouraged by the patent system produced a number of “important technologies that have improved health outcomes significantly worldwide.” However, it is also vital to achieve the 2030 United Nations Sustainable Development Goal of improving the health and well-being of all people at all ages, the delegate said.

Significant gaps persist in health, innovation and access, he said, adding that according to the WHO and the World Bank, some 400 million people worldwide lack healthcare, including access to medicines, vaccines, and medical devices, and three-quarters of them live in middle-income countries.

The SCP is the most appropriate forum for UN member states to discuss and try to find ways to ensure the patent system provides the most meaningful contributions to public health priorities, he said. Brazil said it supports the African Group proposal.

[Note: for further discussion on the role of WIPO in public health issues, see the book, Balancing Wealth and Health, eds. Ruth Dreyfuss and Cesar Rodriguez-Garavito, particularly the chapter by Harvard Prof. Ruth Okediji entitled, “The Missing Role of WIPO.”]