WIPO Patent Law Committee Looks At Health, Quality

Discussions carried out at the World Intellectual Property Organization patent law committee this week reflect strong interest for the subjects but from different angles. Topics such as how patents may affect access to medicines are favoured by some countries, while others view patents as the main enabler of innovative new products. Some find collaborative work between patent offices primordial, while others worry that it could be harmonisation in disguise. Proposals are not lacking about activities to be conducted in the committee but countries need to agree on those which meet their common goals. [Update: the committee finished early with an agreement on future work. Story to come shortly.]

The 26^th session of the WIPO Standing Committee on the Law of Patents (SCP) is taking place from 3-6 July.

At the last session of the SCP, in December, no agreement could be reached on the future work of the committee, in particular, according to sources, because of the request of some countries that the SCP address the recommendations of the United Nations Secretary-General’s High Level Panel on Access to Medicines (IPW, WIPO, 16 December 2016).

It was then decided to revert to the previous approved work programme and to the five topics, which were selected then, as featured in the agenda [pdf] of the 26^th session: 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.

Limitations and Exceptions

According to WIPO, “While the granting of exclusive patent rights is considered as an incentive for investment in innovative activities and the production of knowledge, allowing the enforcement of the full scope of the exclusive rights in all circumstances may not always meet the ultimate goal of the patent system to enhance the public welfare.” Certain limitations and exceptions to patent rights are thus used by countries to provide balance between the interests of the right holders and the public.

The African Group this week underlined the challenges faced by developing countries and least developed countries to implement exceptions and limitations to patent rights.

Paraguay for the Group of Latin American and Caribbean countries (GRULAC) mentioned a January 2010 proposal [pdf] by Brazil on exceptions and limitations to patent rights, in particular the third phase of the proposal which suggests the elaboration of an exceptions and limitations manual to serve as a reference to WIPO members. Brazil further explained that the manual should include the description of various exceptions and limitations, and goals and challenges experienced by countries in implementing those exceptions and limitations.

Indonesia, Iran, Tunisia, South Africa, Senegal, and India also supported the concept of an exceptions and limitations manual.

The concept of a handbook or manual was opposed by Group B (developed countries), as the group considered a document presented as a manual would prejudge its content.

Quality of Patents, Work Sharing

The WIPO secretariat, as instructed by the SCP, circulated a questionnaire for member states at the beginning of the year containing two elements. The first was how each member state understands the term “quality of patents,” and the second one on the implementation of cooperation and collaboration between patent offices in search and examination of patent applications. Some 57 members and two regional patent offices responded to the questionnaire.

The secretariat provided a document [pdf] on the responses on the quality of patents, and a document [pdf] on the responses to the questions on cooperation and collaboration between patent offices.

According to the secretariat document summarising the answers about patent quality, no legal definition of that term seems to exist. The document also explains that two main concepts emerged from the responses. The first concept is that the term quality of patents relates to the quality of a patent itself, and the second concept is “that the term is understood in the context of the patent grant process within the IP offices.”

The document summarising the answers about the cooperation and collaboration between patent offices states that the responses show extensive cooperation between IP offices at the bilateral, regional and international levels. “They can be between the offices of developed countries, between the offices of developed and developing countries or between those of developing countries,” it said.

In general, developed countries are very supportive of collaboration between IP offices and work sharing as an essential tool in the quality of patent, in particular because it increases the capability of offices in their prior art searches.

In June 2016, Spain tabled a proposal [pdf] on Additional Studies on the Assessment of Inventive Step, which was supported by a number of countries. The Spanish proposal envisages a study or a series of study on the concept of inventive step and its evaluation “since patent professionals agree that this is the patentability requirement of most difficult assessment.”

Some developing countries have underlined in the past and again this week that there is a lack of definition of what quality of patents actually means. For example, Senegal, on behalf of the African Group, said patentability criteria can be implemented in various ways, depending on national legislations, and cooperation between IP offices does not always guarantee the quality of patents.

Work sharing also raised concern in the past, and also this week, among some countries as an attempt at harmonising the patent system. That was the case of countries such as Brazil, Iran, and Argentina, which said every patent office should grant of refuse patents based on national patent legislation.

A developing country source told Intellectual Property Watch that work sharing is an interesting tool but only one of them.

Patents and Health

This week, the SCP considered a new proposal [pdf] by Canada to conduct a review of existing research on patents and access to medical products and health technologies. Also still considered is a 2011 proposal [pdf] by the United States on patents and health.

The Canadian proposal suggests that the review be undertaken by the WIPO secretariat in consultation with the World Health Organization and World Trade Organization, and that it should cover the period 2005-2016. The review should include topics such as the relationship between patent protection and the affordability and availability of medical products and health technologies. The review should also include 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. Several countries supported the proposal.

The 2011 US proposal details a work programme including a presentation by the WHO on the availability of generic medicines in developing countries and least developed countries (LDCs), and on the non-patent barriers to availability of safe and effective medicines. Also foreseen in the US proposed work programme is a comprehensive study on the positive impact of patent systems in providing lifesaving medicines to developing countries.

The SCP also considered a study [pdf] provided by the WIPO secretariat on 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 for public health purposes.

Commenting on the study, Senegal for the African Group regretted that the document does not express all concerns of the group, as for example, the delegate said the study does not examine the affordability of medicines.

Indonesia, on behalf of the Asia and Pacific Group, said the UN High-Level Panel on Access to Medicines is not mentioned in the study, while a number of the panel’s recommendations are directly addressed to WIPO, and called for the SCP to explore them. South Africa and Ecuador concurred.

Several countries mentioned the June 2016 proposal [pdf] of the African Group for a WIPO work programme on patents and health, as the way forward.

The proposal contains three elements: “(i) the elaboration of studies to be commissioned by the WIPO Secretariat, following consultations with the Member States at the SCP, from renowned independent experts; (ii) information exchange among Member States and from leading experts in the field; and (iii) the provision of technical assistance to Member States, and particularly developing countries and LDCs, in relevant areas, and building upon work undertaken in the first two elements of the work program.”

Japan for Group B said IP protection is crucial for the development of new medicines and that it is important to focus on other factors which hinder access to medicines, such as inadequate financing of health systems, lack of adequate medicinal facilities, and reliable procurement system, lack of infrastructure, and conflicting interests. The Japanese delegate said the African Group proposal contains elements to which the group could not agree, such as the report of the High-Level Panel on Access to Medicines.

Brazil suggested that the Medicines Patent Pool make a detailed presentation on its database MedsPal, the medicines patents and licences database, as the delegate said this is a very useful tool for IP offices. That suggestion was supported by a number of countries, such as Chile, Switzerland, Canada, and Argentina.

Elise De Geyter contributed to this story.

 

Image Credits: WIPO