TWN Info Service on Intellectual Property Issues (Dec16/03)
14 December 2016
Third World Network

Developing Countries Prioritize “TRIPS Flexibilities” in WIPO’s Patents Committee

Sangeeta Shashikant (Geneva): Developing countries emphasized the importance of “flexibilities” within the patent system to address development challenges and achieve public policy objectives and called for more discussion on several different flexibilities within the patent system as the 25th session of the WIPO Standing Committee on Patent (SCP) began its proceedings. 

The SCP is meeting in Geneva from 12th to 15th December. As part of its agenda, the SCP will be undertaking discussion on exceptions and limitations (E&L) 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. 

In their opening statements, developing countries emphasizedinter alia further action on exceptions and limitations (E&L) and having a work programme on opposition systems. Brazil called for implementation of the third phase of its proposal on E&L (SCP/14/7) i.e. the development of anon-exhaustive manual on E&L as a reference for WIPO Members. 

Developing countries also strongly recommended discussion on the UN Secretary General’s High Level Panel on Access to Medicines Report (UNHLP report) and called for implementation of its recommendations. 

There were also calls for WIPO to recognize disclosure of International Non-proprietary Names (INNs) in patent applications as well as for a study on Article 29.2 of the TRIPS Agreement which allows WTO Members to require patent applicants to provide information about the applicant’s corresponding foreign applications and grants. 

GRULAC’s proposal to revise the 1979 WIPO Model Law for Developing Countries on Inventions (SCP/22/5) was also supported by developing countries, many of whom also stressed that the agenda item should be given equal importance as the other substantive agenda items. 

Developed countries, on the other hand in their opening statements stressed on the subject of work-sharing in the context of quality of patents and developing soft law on the subject of confidentiality of communication between clients and their patent advisors. The former topic has raised concerns among developing countries that the  aim of promoting work-sharing is to further the patent harmonization agenda. The latter subject concerns the question whether patent attorneys should have the right to resist requests from authorities to disclose IP advice rendered by them to their clients in their professional capacity. 

Regional & Country Statements

Indonesia on behalf of the Asia and the Pacific Group stressed on the importance of  “flexibility” in domestic patent laws for policy planners to craft, amend or delay domestic patent laws in accordancewith national development priorities and social and economic realities. 

It said that the SCP was very important in creating a balance between the rights of patent owners and the larger public interest particularly in the area of public health, technology transfer and patent related flexibilities.  

It said that SCP/25/3 (on “Practical Experiences on the Effectiveness of, and Challenges Associated to, Exceptions and Limitations”) provided valuable information about how E&L are not being utilized to their fullest extent despite their presence on paper in most developing countries and LDCs, and the constraints that prevent their optimum use. 

“These submissions […]clearly indicate the need to ensure WIPO’s technical assistance in designing of national patent laws or national IP strategies take these constraints into consideration and provide assistance on how developing countries can overcome such constraints and make full use of the available flexibilities”, it added. 

The Group called for the SCP to explore discussion based on the UNHLP report adding that the WIPO study on the constraints faced by developing countries and LDCs in making full use of patent flexibilities and their impacts on access to affordable especially essential medicines in developing countries and LDCs must involve the UNDP which facilitated the UNHLP.                                                    

It also called on the WIPO Secretariat to address the question about the feasibility of disclosure of International Non-proprietary Names (INNs) in patent applications where theapplicant knows it.    

The Group supported SCP having a work programme on opposition systems that could, comprise a questionnairesurvey on the different kinds of opposition mechanisms available in a country, the procedures and modalities for their use, constraints in using the opposition system effectively and how such opposition systems could be strengthened and their constraints removed.                                             

It also stressed that the SCP should arrive at a common understanding on what is meant by “quality of patents” – does it mean efficiency of patent offices in disposing patent applications, or does it mean the quality of patents granted that is how toensure that patent offices do not grant patents of questionable validity”. It called on the WIPO Secretariat to provide regular information to Member States about the outcome of patent applications in different jurisdictions as well as outcomes of opposition procedures.

It further called on the Secretariat to conduct a study on the extent to which Article 29.2 of TRIPS is implemented in different countries and how its broader use may be promoted to improve patent quality. Article 29.2 of TRIPS Agreement states that a Party to the TRIPS Agreement may require patent applicants to provide information about the applicant’s corresponding foreign applications and grants. 

Nigeria on behalf of the Africa Group expressed hope that the SCP would reach agreement on a more ambitious future work program that is transparent, balanced and progressive; aligns with the development agenda recommendations; takes into account the different levels of development of WIPO Member States; and aims to foster amore accessible patent system. 

It stressed on the subject of patents and health, in particular its proposal (SCP/24/4) and the findings and recommendations of the UNHLP report. 

Brazil expressed hope that the SCP discussions should focus on the role of the patent system in fostering innovation and promoting social, economic and technological development, taking into account the different levels of national conditions, as well as the priorities and goals of each country. In this sense, “one-size-fits-all” approaches would lack the flexibility necessary for the adaptation of each country’s legal framework and practices in light of their individual socio-economic goals, it added.

It stressed progressing to the third phase of its proposal on E&L, i.e. the elaboration of a non-exhaustive manual regarding exceptions and limitations to patent rights. Progress on the subject would be in the benefit of all countries, particularly developing countries, it added. 

On patents and public health, Brazil stressed that providing access to health and medicines at affordable prices is part of the Agenda 2030, agreed by the Members of the United Nations by consensus. More recently, the High-Level Panel commissioned by the United Nations Secretary General has raised additional aspects to beconsidered during the discussion of this item, it further said. 

Civil Society Statements

The Third World Network (TWN) noted that developing countries often face undue political and economic pressures to dissuade them from using the flexibilities that could protect public health, adding that the UNHLP report recommends that governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of countries to use TRIPS flexibilities. 

It further said that often patent monopoly is justified as a tool for promoting innovation, however more and more evidence suggests that patents can have negative effects on innovation. According to the UNHLP report: “Public health-sensitive intellectual property rules and mechanisms can help address the misalignment between pro-driven innovation models and public health priorities”, adding that nobel laureate Prof. Joseph Stiglitz has also recently said: “ The patent system, TRIPS, is not about innovation. It is abut monopoly profit”. 

It called on the SCP to initiate discussions based on the UNHLP report which specifically recommends that: “WIPO in collaboration with stakeholders to develop an international, easily searchable database which should include: (1) standard internationalcommon names for biological products; (2) international non-proprietary names for products, either as known at the time of application or after the granting of a patent; and (3) dates of grant and expiry”. 

Médecins Sans Frontières (MSF) called on the SCP to explore policies to facilitate access to affordable medicines and implement public health safeguards in their patent laws. It also called on the SCP to take full consideration of the analysis and recommendations of the UNHLP. 

It highlighted that the issue of access is particularly difficult in middle-income countries. Today, a third-line treatment regimen for HIV is priced over 17 times more than the lowest price of first-line treatment, because patent and regulatory barriers block generic competition and the wide availability of more affordable generic sources, it added. Countries that legitimately use compulsory licences remain under tremendous political pressure, as we saw with Colombia earlier this year, who had the threat of withdrawing international support for the peace process used as a political bargaining chip against the Colombian government’s attempt to curb the high price of medicines, it further said. 

MSF proposed that the SCP should take concrete steps to assess the health impact of trade agreements and reject the proposals of TRIPS-plus provisions on intellectual property, which have a detrimental impact on access to medicines.  It in particular highlighted proposals in the ongoing Regional Comprehensive Economic Partnership (RCEP) agreement, which involves 16 countries in the Asia-Pacific region. 

Second, it proposed that the SCP address the lack of transparency in patent information concerning medicines, vaccines and diagnostics, and establish disclosure requirements for international non-proprietary (INNs) names in patent applications. 

It noted the steps taken by WIPO in providing new chemical search functionality in the PATENTSCOPE database, but that further steps are needed in implementing the full recommendations of the UNHLP report.  Disclosure of INN names should also be a normative requirement in patent applications, it further said.  

MSF also highlighted the challenge of patent evergreening. It highlighted the UNHLP report recommends WIPO cooperate with other multilateral organisations and UN bodies, to “support governments to apply public health sensitive patentability criteria”, and to “strengthen the capacity of patent examiners at both national and regional levels to apply rigorous public health-sensitive standards of patentability taking into account public health needs.” 

It urged WIPO to implement UNHLP recommendations in its future work, and to review and improve its technical assistance to member states with a better aligned approach offacilitating access to medicines and innovation. 

Knowledge Ecology International (KEI), a US based organization raised issue concerning government rights in patented inventions, when the government funds or partly funds the research.

The United States, like many other countries, retains certain rights in patents for inventions when it funds the research. This includes world-wide royalty free rights to practice or have practiced on its behalf, an invention, KEI said. 

KEI suggested that WIPO create an instrument that would create reciprocal rights in government funded inventions, so that countries that were members part of such an agreement would agree to the terms and modalities under which they could share access to government funded inventions.

It referred to a recent situation whereby a generic drug manufacturer in Canada asked the U.S government to use those rights in order to export a generic version of the prostate cancer drug Enzalutamide, which is sold under the brand name of Xtandi, to countries with a per capita income less than one third of the US, including South Africa and Chile. The US government rejected the request, for now, but also indicated that it wanted to consider such requests within a broader policy framework.

On the UNHLP, KEI encouraged the SCP to consider the report, and in particular, its recommendations on transparency and delinkage of R&D costs from product prices, an important topic that has implications for the practical implementation of patent protection for medical inventions, as well as the norms concerning patents.