Info Service on Health Issues (Aug15/01)
South stress balanced approach to patents for public health and development
Geneva, 4 August (Mirza Alas) – Developing countries stressed the need for a balanced approach to patents to ensure public health and development interests at the 22nd session of the Standing Committee on the Law of Patents (SCP) of the World Intellectual Property Organization (WIPO).
The SCP 22 took place on 27-31 July at the WIPO headquarters in Geneva.
Developing countries called for the balanced approach in their general statements during the opening of the SCP that was delayed due to the differences among Member States over the proposed agenda. The formal session of the SCP resumed at 3 pm on 27 July after agreement was reached on the agenda through informal discussions that lasted during the morning and the lunch break.
The differences over the agenda were due to the lack of consensus on the SCP’s future work program that emerged at SCP 21. The 21st session agreed to discuss only two studies on inventive step and disclosure requirements at the 22nd session. However, the agenda item listed as “other issues” the following: Exceptions and limitations to patent rights; Patents and health; Confidentiality of communications between clients and their patent advisors and Transfer of technology.
Developing countries expressed their concern on listing these issues under the agenda item “other issues” instead of having them as stand-alone agenda items as in the previous SCP sessions. The compromise was worked out listing all five issues including the studies under the heading “five issues”. Further, the proposal of the Group of Latin American and Caribbean countries (GRULAC) for the revision of the WIPO Model Patent Law was listed under “other issues.”
Member States had an opportunity to provide general views on the agenda that was then approved. Developing countries emphasized the importance of capacity building in developing countries, technology transfer and the examination of exceptions and limitations to enhance developing countries ability to balance the use of patents as well as reiterated the importance of the WIPO Development Agenda program. Many delegations expressed their support for the proposal presented by Brazil on behalf of the GRULAC on a revision of the current 1979 WIPO Model Law for developing countries on inventions which dates from 1979 and does not include important developments in intellectual property such as the TRIPS agreement.
Developed countries on the other hand emphasized the need for a work program on quality of patents and on a work-sharing platform for this end that would, they argued, contribute to the harmonization of process and therefore improve the quality of patents. However, there is no agreed definition among Member States of “quality” which made the current discussions move in different directions under the same apparent topic.
(There are concerns among developing countries and public interest observers that the work sharing among patent offices as proposed by developed countries would actually lead to harmonization of standards and practices in the examination and grant of patents that would undermine the flexibilities available in the TRIPS agreement with regard to national sovereignty to determine the scope of patent protection. Thus such harmonization would compromise the development and public health needs of developing countries.)
Below are the highlights of some interventions from WIPO Member States.
Nigeria on behalf of the African Group stated that it recognizes the instrumental role of the SCP in building knowledge, understanding the application of various patent related norms and effective use of the international patent system. However, Nigeria pointed out that SCP’s activities “include enabling factors encapsulated in the Development Agenda Recommendations, with the objective of enhancing patent related uses for social, technological and economic development and noted their disposition to actively engage within the SCP, on identified issues that support the objectives of the region, giving due regard to the different levels of development of WIPO Member States”. It stressed that the “policy space for Member States will therefore be of utmost relevance in SCP discussions and their outcomes”.
Further, Nigeria emphasized the need for enhanced discussion and activities in the area of Exceptions and Limitations to Patent Rights, Patent and Health, and Technology Transfer. On Quality of Patents, including their opposition systems.. The statement also supported also supported the GRULAC proposal on the revision of the 1979 WIPO Model Law for Developing Countries on Inventions.
Pakistan on behalf of the Asia Pacific Group (Japan is not part of the Group) stressed the need for balanced discussions on all topics on the agenda. It stated that, “ The work of this committee is critical in balancing the rights of patent owners and public interest particularly in the area of public health, technology transfer and patent flexibilities. It is essential to find the right balance between patent rights and the right to health in light of the differences in the levels of social, economic and technological development among members, TRIPS flexibilities and respect for intellectual property law and the needs of all Member States”. It further stated that the balanced approach to patents “not only allow governments, especially in resource-constrained countries, with the necessary policy space to meet health needs but also promote further innovation”.
Brazil on behalf of GRULAC stated that it was “important for Member States to learn from each other’s experiences and practices under these two topics. While acknowledging similar practices in some countries, it is important to recognize that IP policies and legislation should address national economic and scientific issues as well as development concerns”.
Brazil noted that the topic of “inventive step” has a key role in national innovation systems, and therefore is an important flexibility provided by the TRIPS Agreement. It also noted that “Sufficiency of disclosure is a crucial component of the patent system’s function of technology dissemination and, therefore, a tool for technology transfer from developed to developing countries.”
In the light of the discussions on exceptions and limitations in the 21st session GRULAC stressed that the “Secretariat prepares an analysis of those exceptions and limitations that have proven effective to address development concerns”. GRULAC also proposed the development of a non-exhaustive manual on this topic, as a reference to Member States of WIPO contained in the Brazil proposal that was submitted at the 14th Session of the SCP.
[The proposal contained the following three phases: Phase I on Exchange of information on national and regional laws on exceptions and limitations, and experience of implementing such laws, including jurisprudence. Phase II on Investigation of what exceptions and limitations are effective to address development concerns, and conditions for their implementation. Phase III on Elaboration of a non-exhaustive manual on exceptions and limitations as a reference for WIPO Members. Again at the 19th session of SCP Brazil made a proposal to operationalise Phase II of the proposal i.e. WIPO should analyse the exceptions and limitations which are most commonly used in each of the 10 clusters in the questionnaire and present this analysis. ]
Recalling its statements in the last two sessions for a complete revision of the 1979 WIPO Model Law on Inventions and the draft decision proposed by GRULAC regarding the revision of the Model Law, Brazil said, “Such a document should take into account the international legal landmarks, such as the WTO Agreements, and the WIPO Development Agenda Recommendations. GRULAC urged all delegates to go through this document and recognize that it is outdated and does not serve the purpose intended”.
India in its statement stressed that “the development of patent system and use of patent rights should operate in a balanced and an objective manner, which should meet the goal of providing the protection for the moral and material interests of inventors, and at the same time, should assist the development aspects of the society as well”.
On the quality of patents India said that, “the quality of examination needs to improve substantially in conformity with the policy objective of a country so as to not create huge social cost of granting patents to insignificant improvement, which only leads to litigation and create barriers for the dissemination of knowledge and transfer of technology”.
India rejected the proposals on work sharing as a solution to clear backlog of the patent applications and stated that, “Rather the sharing of work of other offices could weaken the examination process and capability of patent offices in the developing countries. Thus, steps should be taken to build capacity among patent offices of the developing countries for enabling them to perform their quasi-judicial functions, according to their national laws, in the best manner possible. Work sharing should not become an area for norm setting in the future”.
In order to provide life-saving drugs at affordable prices India stated that there is a “need not only to study TRIPS flexibilities and effective implementation or utilization of compulsory licensing provisions under Patent Law, but also to study the impact of grant of compulsory licenses and consequential impact on availability and prices of patented drugs”.
India also supported the demands to commission a “feasibility study on the disclosure of International Nonproprietary Names (INN) in patent applications and/or patents and on the issues of a study related to Markush formulae and the huge impediment created by them in healthcare industry by creating mysterious cobweb of unreal compounds to be discovered in future thus stifling innovations in the field of technology”.
On the issue of transfer of technology, India pointed out that the “protection and enforcement of patent rights should promote technological innovation and transfer of technology (achievable by patent specifications independent of any know-hows) in the country where the rights are protected; thereby providing the mutual advantage to producers as well as to users of technological knowledge. In order to create balance of rights and obligations, the protection and enforcement of patent rights vis-à-vis technological content of patent specifications should be conducive for the socio-economic developments of the country.”
Iran underscored that “the deliberation on exceptions and limitations, technology transfer, and patents and health, would help the committee to better understand the challenges encountered by developing countries in their economic and social development and explore ways to better adapt the patent system to meet the needs of their national development. In this context, the international harmonization of patent laws without giving due account to the differences in the levels of social, economic and technological development would not benefit all Member States”.
China stressed that the “different national situation and levels of development mean focus on different interest. All parties will need to show more flexibility and cooperation spirit to cover the topics of interest of all the Member States. Improving capacity building of all offices, meaningful work sharing and the ability to better prepare patent applications will enhance quality. Using the flexibilities of the patent system will serve to promote technology transfer and the social value of the patent system”.
Japan on behalf of Group B (developed countries) emphasized that SCP has the responsibility to provide a venue of technical discussions on substantive patent law. Japan also noted that not much progress has been achieved in this forum so far and that it is very important to continue the substantial and technical forum and the studies were very important in that direction.
Japan observed that it is necessary to properly understand what patents are and what patents should be so it is important to build a core understanding, and the studies prepared by the Secretariat are very useful in that regard and there is need to continue the technical discussions on those studies. Also, Japan noted that there should be discussions on what this committee should do in the future. International work sharing and collaboration is one of the critical issues.
On the confidentiality on communications Japan underlined the importance of cross border aspect and the need to respond to the demand on this topic from the business world.
Luxembourg on behalf of the European Union emphasized the importance of work sharing and collaboration as well as the need to discuss confidentiality of communication. Further it regretted that in the last SCP there could not be an agreement on the future work program and hoped that the work program at SCP 22 would be able to maintain the balance of the interests of all Member States. The EU also stressed the need to move forward on the work-sharing proposals and said, “Investing time in this topic will enhance international cooperation and ensure and enhance the quality of patent systems to all”.
On the GRULAC proposal, the EU said this will imply substantial amount of time that will need to be dedicated by SCP and a new balance on the topics under discussion will need to be found. The EU emphasized that a revision on the Model Law should not touch on the interpretation of TRIPS provisions.
Belarus on behalf of Central Asia and Eastern Europe stated the importance of this forum for patent law. All the issues are important. Currently the issue at hand is patent law and this will allow for a more balanced and effective patent system. On inventiveness and disclosure, the discussions should be practical in nature and enhance the exchange of information and experience. Further it observed the importance of resolving issues on patents and health and transfer of technology and concession of patent rights. It also stressed the use the patent system to solve social problems.
Médecins Sans Frontières (MSF) reminded the SCP that, “2014 and 2015 had witnessed a number of increased public health challenges at a global scale facing many Member States of this Committee. A number of examples are worth highlighting. For instance, the Ebola crisis last year further demonstrated the failure of the patent-centric innovation system in biopharmaceutical sectors. To offer another example, the increasing epidemic of hepatitis C has become a challenge to both developed and developing countries, while the medicines are priced out of reach of many. In addition, the newly revised World Health Organization (WHO) Model List of Essential Medicines has included new medicines treating hepatitis C, cancer and drug-resistant TB. All of these new medicines remain under heavy patent thickets and would present concerns for many Member States in this Committee in getting access”.
MSF called on this Committee and the Member States to keep connecting patent discussion with social reality; to not discuss normative issues in isolation from prominent social impacts such as those related to health; and to recognize the increasing public health challenges facing many Member States of the Committee and to make concrete progress on the proposal of public health and patents.
Finally, MSF asked the Committee to continue working on the issue of mandatory disclosure of International Nonproprietary Names (INN), which was not concluded in the last session. MSF believes that disclosure of INN remains crucial for public health agencies and non-governmental organizations to effectively monitor public health-sensitive patents at an early stage. We also feel that the requirement of INN disclosure would help to direct more rational filing behaviors of the applicants and help to prevent abuse of the patent system.
Third World Network remarked that 22nd Session of the Standing Committee on the Law of Patents is taking place exactly after the 20th year of the TRIPS Agreement.
During the last twenty years there is plenty of evidence to show that the TRIPS Agreement has failed to fulfill its promises especially in the context of addressing developmental challenges of developing countries.
The almost universal protection of product patent regime has failed to deliver on both innovation and access. There is no substantial increase in the R&D outcomes with regard to health products to meet the unmet health care needs of developing countries. Similarly, the patent monopoly is blocking access to affordable medicines and incapacitates both developing and developed countries to fulfill their obligation on the right to health. The exorbitant prices of Hepatitis C oral antiviral drugs are a case in point.
Against this background, TWN recalled the main findings on patent contained in a declaration titled “Declaration on Patent Protection: Regulatory Sovereignty Under TRIPS” by worldwide experts convened by Max Plank Institute for Innovation and Competition on the occasion of the 20th anniversary of the TRIPS Agreement. The Max Plank statement stated that “ the “historically unprecedented numbers of patents filings and grants” create problems such as backlogs at patent offices, patent thickets, market entry barriers and increased litigation that ultimately generate impediments to research and commercialization. The result is rising costs of monitoring patents and legal uncertainty, limiting the economic freedom of market participants, which in turn affects consumer welfare and distorts competition. Thus “the overall social benefits of innovation are reduced while an imbalance emerges between those able to cope with the resulting insecurities and related costs, such as multinational enterprises with their own patent departments, and those who cannot, such as small and medium sized enterprises or individual inventors”.+