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TWN Info Service on Intellectual Property Issues (Feb14/06)
7 February 2014
Third World Network

WIPO: South push for work programme on patents and health
Published in SUNS #7736 dated 5 February 2014

Geneva, 4 Feb (Alexandra Bhattacharya) -- Developing countries successfully called for a work program on patents and health at the World Intellectual Property Organisation (WIPO) that acknowledges patents as a possible barrier to access to medicines.

This call was strongly made when developing countries shared experiences on their use of health-related intellectual property flexibilities during the agenda item on Patents and Health at the 20th session of the WIPO Standing Committee on the Law of Patents (SCP).

They urged the SCP, a WIPO committee "dedicated to the progressive international development of patent law", to continue with a work program on this issue in the face of visible reluctance from major developed countries.

The 20th session of the SCP met in Geneva on 27-31 January 2014.

Intensive and hectic informal consultations on the future work of the Committee, where the work program on Patents and Health was one of the main sticking points, resulted in a decision in which the Secretariat would prepare two studies for the next session of the SCP: (i) a feasibility study on the disclosure of International Non-Proprietary Names (INNs) in patent applications and/or patents [as found in 8(c) of the African Group/DAG proposal (SCP/16/7)]; and (ii) a study on the role of patent systems in promoting innovative medicines, and in fostering the technology transfer necessary to make generic and patented medicines available in developing countries/least developed countries [this is based on the US proposal (SCP/17/11)].

(DAG is the Development Agenda Group comprising a number of developing countries that champion the integration of development into WIPO's work.)

The third element of the decided future work program also stated that at the next SCP session, "the potential of a study on the implementation of flexibilities concerning different types of exhaustion of rights in Member States and its contents will be discussed".

This is based on 8(b) of the African Group/DAG proposal. During the plenary discussion on 31 January, Brazil particularly expressed disappointment about the "downgrading" of this element.

(Exhaustion of rights relate to the legal right to import patented medicines marketed at cheaper prices in other countries.)

The issue of Patents and Health has been on the agenda of the SCP since the 16th session when the African Group/DAG submitted a detailed proposal (SCP/16/7) for a work plan in this area which would ensure that the SCP discussed substantively the issue of patents and public health, and drew up a work programme which would assist countries to adapt their patent laws and make full use of the patent flexibilities, in accordance with public health needs and in compliance with international obligations.

However, the implementation of the elements of the proposal has been consistently blocked by Group B (comprising developed countries). Thus, although the sharing session on countries' use of health-related patent flexibilities was a step in the right direction, particularly in light of recent revelations in South Africa regarding the pharmaceutical industry's campaign to undermine the country's new IP policy and the remarks by Bayer CEO on access to medicines in India, there are still concerns regarding the long-term work plan in the SCP on the issue.

The elements of the DAG and African Group proposal (SCP/16/7) call for the Committee to undertake the following:

(i) Commission a framework study by leading independent experts to examine the challenges and constraints faced by developing countries and least developed countries (LDCs) in making full use of the public health- related patent flexibilities both in the pre-grant and in the post-grant stage.

This study should also include: (a) component on the law and practices with regard to compulsory and government use licenses in WIPO Member States; (b) An examination on the extent to which countries use exhaustion of rights to allow parallel trade in medicine; (c) An assessment of the benefits of mandatory disclosure of International Non-Proprietary Names (INNs) in the abstract or title of patent applications; and (d) Conduct a cost-benefit analysis of the admissibility of Markush claims (broad patent claims that may apply to a broad range of compounds).

(ii) Information exchange among Member States and from leading experts in the field including inviting the UN Special Rapporteur on the Right to Health to make a presentation; experience sharing sessions on countries' use of patent flexibilities for promoting public health objectives; organising a technical workshop on state practice involving the compulsory licensing of medical technologies and developing a database on the patent status in WIPO Member States of relevant diagnostic tools and medicines for at least 10 non-communicable and communicable diseases.

(iii) Provision of technical assistance to Member States, and particularly developing countries and least developed countries (LDCs), in relevant areas, and building upon work undertaken in the first two elements of the work program.

The full text of the African Group/DAG proposal (SCP/16/7) is available here:
http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_7.pdf

At the seventeenth session of the SCP, the United States of America submitted a counter-proposal (SCP/17/11) to the Africa Group-DAG joint proposal on patents and health.

The US proposal focused on activities on issues such as conducting a study on the positive impact of the patent systems in providing medicines to developing countries and argues that alternative approaches such as voluntary licensing and tier pricing are preferred to use of flexibilities in providing availability of medicines.

Below are highlights of the SCP discussion on patents and health.

COUNTRIES' EXPERIENCES ON THE USE OF HEALTH-RELATED IP FLEXIBILITIES

Algeria, on behalf of the African Group, said that the Group believed that WIPO must strengthen its commitment and involvement in this area, building on current activities to achieve the international goals set in this area. In this context, the DAG/Africa Group proposal covered a work program which aimed to assist Member States, particularly developing countries and least developed countries, to adopt and adjust their patent systems in order to take full advantage of the flexibilities in the international patent system to promote their policies on public health.

Algeria further noted that at present, WIPO undertook a number of activities, on its own and with other international organisations, and through technical assistance, on which Member States can provide only limited input and there was a need for Member States to provide more guidance. While some of these activities have been beneficial for developing countries, there have been serious concerns raised on some other activities and their development orientation from a public health perspective has been questioned.

Therefore, having the topic of patents and public health on the SCP agenda would allow SCP members to provide guidance to WIPO on its work on this issue, and to discuss national experiences, Algeria said. It further stated that the sharing session on countries' use of health-related patent flexibilities would offer the opportunity to exchange experiences on the use of health-related patent flexibilities, and on the challenges to their use.

Algeria said that the African Group had taken note of the US proposal and recalled that this proposal, though interesting, may guide the discussions in the SCP on issues that were not related to patents and hence were outside the mandate of this committee. It hoped that this proposal would not depart the discussion from its main objective, namely to enable developing countries and least developed countries to take advantage of the flexibilities in the international patent system for their need in public health.

Algeria, in its national capacity, noted that its legislation had taken into account the balance which should exist between the right of the holder and public interest and the law recognised flexibilities in particular through compulsory licences in health and nutrition. It described the patent system in Algeria, noting that to date there had not been problems in implementing exceptions and limitations and with respect to drugs, no exceptions and limitations had been used. It proposed that work in the SCP should be able to examine whether there should be legal aid in this respect.

India noted the need to bear in mind the proposals currently on the table, and particularly supporting the DAG/African Group proposal (SCP/16/7). It stated that this proposal was a work program which wanted to enhance the capacities of Member States to adapt the patent regime for public health concerns.

It recalled Paragraph 5 of the Doha Declaration on TRIPS and Public Health (2001) which reaffirmed the right of all WTO members to grant compulsory licences and to determine the grounds under which the licences could be granted. It noted that Para. 5 (d) of the Doha Declaration also reaffirmed that each WTO Member State was free to establish its own exhaustion regime (Article 6) and in this context a Secretariat study on exhaustion would be useful.

India further expressed concerns regarding the admissibility of Markush claims and also supported the use of International Non-proprietary Name (INN) in patent searches. It reiterated that the detailed discussion of specific health-related flexibilities was well within the mandate of the SCP.

(INN is the official non-proprietary or generic name given to a pharmaceutical substance, as designated by the World Health Organisation. The DAG/Africa Group proposal calls for an assessment of the mandatory disclosure of INNs in the title or abstract of patent applications which would enable an easier identification of the generic name of the medical product subject of the patent application.

(Markush claims include a general formula with multiple options that allow for the protection, under a single patent, of up to several millions of molecules. The admission of patents with such claims leads to a rather complex situation when it comes to pharmaceuticals, because a single patent may potentially limit or block research and development on, and the commercialisation of, an extremely large number of products.)

Pakistan welcomed the discussion on IP and health and said that IP should not inflate prices and put the price of health beyond the reach of developing countries.

Japan, on behalf of Group B, said that although it recognised the importance of this agenda item, however,  the  mandate of the Committee should be respected, and there was a need to be cognisant of the work of other WIPO committees and other IGOs.

Japan further said that patents provided important incentives for the development of medicines and this was an important context when considering the relationship between patents and health. It added that the SCP should proceed in a "balanced" manner and that all policymaking should be evidence-based.

Kenya said that members of the African Group have been keen to avail themselves of the "flexibility of derogating from the substantive provisions of several bilateral, plurilateral and multilateral arrangements in order to take necessary measures to protect human, animal or plant health".

In sharing Kenya's experience in the use of health-related flexibilities, it provided an overview of the East African Community (EAC) Regional Intellectual Property Policy on the Utilisation of Public Health-Related WTO-TRIPS Flexibilities and the Approximation of National Intellectual Property Legislation. This aims  to guide the EAC Partner States on how their national intellectual property legislation should be adjusted in order to enable them to fully utilise the Public Health-related WTO-TRIPS Flexibilities. It underlined that the EAC Partner States undertake to reject any attempts, both at national, regional or international level, which may hinder their full utilisation of the TRIPS flexibilities.

Kenya also noted that national legislation had provisions on most of the flexibilities which had been helpful in facilitating access to affordable medicines. For example, in 2001, upon coming into force of the Kenyan patent law, significant reduction of prices of medicines was witnessed which may be attributed to the flexibilities incorporated in the law. It also referred to the challenges in the implementation of the flexibilities and underlined the need for the patent system to be supportive of public health policies - a position which Kenya sought "to retain in any discussions or negotiations relating to patents and health including those under the SCP".

Kenya also referred to a number of documents from various forums whose findings and recommendations could enrich and inform the SCP process with regard to patents and health and in this context, it requested the Secretariat to make them easily accessible on the WIPO website.

These documents included: (i) The 2002 report of the UK Commission on Intellectual Property Rights entitled "Integrating Intellectual Property Rights and Development Policy"; (ii) The 2002 WTO and WHO joint report on WTO Agreements and Public Health; (iii) The 2003 report of the WHO Commission on Intellectual Property, Innovation and Public Health (CIPIH); and (iv) The 2012 WIPO, WTO and WHO joint report on Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade.

Zambia noted that medicines were not like any other commodity and there was a need for a balanced and sustainable approach. It said that experiences had shown that IP flexibilities were not easy to implement. It added that the issue of public health required all stakeholders to share information on patent flexibilities and the issue needed to be taken forward in a "practical, balanced and sustainable" way.

Iran said that WIPO, as a UN agency, had the mandate to address the subject of patents and health and in this regard the work program of the SCP should examine possible impediments posed by the current system (in terms of Member States making full use of flexibilities).

In reference to the proposal of the US in this area, it noted that WIPO did not have a mandate to discuss "Falsified and other substandard medicines" (as found in the US proposal SCP/17/11) and a process on this issue was currently underway within the context of the WHO SSFFC (Member State Mechanism on Substandard/ Spurious/Falsely Labeled/Falsified/Counterfeit medical products).

Zimbabwe noted that only one flexibility - compulsory license - had been utilized in the country and there was a need for technical assistance for "flexibilities to see the light of day."

South Africa stated that its government had been busy working on its National Policy on IP which focused "heavily on health and on reform in the treatment of medical patents in order to address the particular health challenges faced by South Africans on a daily basis".

It said that the recent leak on the multinational pharmaceutical industry's move to undermine the South African government's efforts to reform its IP policies was "unfortunate to say the least", as one of the major objectives of this policy was to contribute towards the protection and promotion of public health and access to medicines in particular.

It referred to the statement by the Director-General of the Health Ministry, Malebona Precious Matsoso, during the WHO Executive Board meeting the week before, who had said that "this is not the first time South Africa has been under attack even in the face of the most devastating HIV/AIDS and TB co-morbidities. Our former President, the late Nelson Mandela, was the first respondent to the legal challenge".

South Africa further said that as the country moved towards promoting competition, levelling the playing field and adopting an IP policy which would enable South Africa to fully utilise the flexibilities provided for in the TRIPS Agreement, there was a need for support and not have Pharma companies conspiring to undermine our efforts. It underlined that "Such action should be strongly condemned."

In this context, it was imperative that the SCP should substantially discuss the issue of patents and public health as well as draw up a work program that assists countries to adapt their patent laws and make full use of the patent flexibilities in accordance with public health needs. This was in line with the African Group/DAG proposal  (SCP/16/7) in this area.

Argentina reminded the committee that the TRIPS Agreement gave the right to Member States to establish their own standard for the "inventive step" requirement (one of the criteria for granting a patent). It noted further that the WHO had also stated that patents may have influence on access to medicines and had encouraged the use of flexibilities under the TRIPS Agreement. It believed that it was very important to develop a study on the TRIPS flexibilities and their implementation and the African Group/DAG proposal was a step in the right direction.

Greece, on behalf of the European Union, was of the opinion that any further work should reflect a balanced approach taking into account various factors of relevance to patents. It expressed its support for the US proposal.

Belarus said there were currently plans to revise its legislation to make it "better balanced" both in the protection of patentees' interest and also to have an improved health system. It noted that the experience of other countries was important in this context and was following the example of other countries such as India.

Japan said that denying the contribution of the patent system in enhancing public health would prevent the development of medicines in the future. It added that any work undertaken in the Committee, including on flexibilities, should not shift the "balance".

The US, in its intervention, provided an overview of the flexibilities found in US patent law, particularly noting the 1984 Hatch-Waxman Act which had resulted in a balanced approach that had both promoted innovation in new medicines and also generic drugs. It also referred to US 35 USC 271 which provides a research exemption especially relevant to drugs.

Knowledge Ecology International (KEI), a US-based NGO, said that developed countries such as Greece and Spain were considering the use of compulsory licenses on patents for expensive cancer drugs. Germany, the United States, Belgium, Canada and France have all issued or considered compulsory licenses of patents on medical devices and diagnostics.

It said that in considering the work program on health and patents, the SCP needed to identify specific activities that are relevant to the challenges governments face, including those with ageing populations, budget deficits and escalating healthcare costs. It added, "Some government delegations seem intent on blocking any work that could weaken drug company monopolies. This is wrong - wrong for developing countries, and also wrong for countries with developed economies."

Referring to the US proposal (SCP/17/11), KEI said that it was "basically a defence of the worst abuses of the patent system in the field of health - even as courts in the United States have issued compulsory licenses on at least four medical devices in recent years and recently abolished patents on certain gene patents."

Medecins Sans Frontieres (MSF) expressed concern that WIPO was not quickly addressing its mandate in providing technical assistance to countries "to enable them to design and reform patent laws through the use of public health flexibilities." It was also concerned that developing countries continued to face difficult challenges in balancing intellectual property, public health and access to medicines in national patent laws.

It further noted that the recent events in South Africa had demonstrated the willingness of multinational pharmaceutical companies to secretly undermine a legitimate patent law reform process - the very sort of reform that WIPO should support - that could lead to the improvement of generic competition and promotion of access to medicines.

MSF urged: (i) the SCP to take concrete steps in adopting the African Group/DAG proposal - (SCP/16/7), and (ii) Member States of developing countries to increase information sharing and technical support to one other in the context of patent law reform that promotes public health.

The Third World Network (TWN) expressed support for the African Group/DAG proposal (SCP/16/7) and underlined that access to medicines was one of the critical elements to ensure the enjoyment of the right to health.

It referred to the session of the Human Rights Council and the recently concluded session of the WHO Executive Board, both of which had adopted resolutions containing operational paragraphs which encourage Member States to use the TRIPS flexibilities to ensure access to medicines. Similarly, discussions in the context of the UN post-2015 development agenda as well as deliberations on sustainable development goals also flag access to medicines as an important issue.

TWN urged the Director-General of WIPO to either not engage or to disengage from pharmaceutical companies and their associations who are involved in the efforts to block use of flexibilities, and for the Member States to condemn the efforts of the pharmaceutical industry to undermine the use of TRIPS flexibilities and their disregard for human rights. It hoped that the deliberations would identify the constraints faced by developing countries to effectively and efficiently use flexibilities in their  patent law to ensure access to medicines.

A summary document of the interventions made by the Member States will be posted on the SCP Forum on the WIPO website.

DISCUSSION ON FUTURE WORK REVEALED DIVERGENCES

Preliminary discussions on the future work of the SCP on the issue revealed that wide divergences on the future work persist. Developing countries were in favour of taking forward elements from the African Group/DAG proposal (SCP/16/7) whereas Group B called for a "balanced" approach which should focus on both "innovation and access" and supported the US proposal on the table.

The African Group stated that the US proposal included elements which were outside the mandate of the SCP, particularly noting that a study on the positive impact of patents on the access to medicines would prejudge the outcome and would not be objective.

The exchange of views was based on the Chair's attempt to zone in on "priorities"
as a way of ascertaining future work.

There was a particularly detailed and rigorous exchange of views regarding possible studies on: (i) An assessment of the benefits of mandatory disclosure of International Non-Proprietary Names (INNs) in the abstract or title of patent applications; and (ii) A cost-benefit analysis of the admissibility of Markush claims (broad patent claims that may apply to a broad range of compounds) as found in the African Group/DAG proposal.

 


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