Info Service on Intellectual Property Issues (Nov14/01)
WIPO Patent Committee to discuss critical issues on patents and public policy
Geneva, 3 November (TWN) – The Standing Committee on the Law of Patents (SCP) is to discuss critical issues on patent and public policy including exceptions and limitations, patent and health and technology transfer.
The 21st session of the SCP of the World Intellectual Property Organization (WIPO) is taking place on 3-7 November, Geneva. It will also discuss issues such as quality of patents and the confidentiality of communications between clients and attorneys.
[The SCP was established in 1998 as a forum to discuss issues, facilitate coordination and provide guidance concerning the progressive international development of patent law including the harmonization of national laws and procedures. However, the overt attempt to harmonise the patent law is on backburner due to resistance form the developing countries.]
The work program of the SCP was adopted at the 20th session of SCP, which was held on 27-31 January 2014. The 21st session is expected to discuss the following issues along with new documents.
The discussion on exceptions and limitations to patent rights will focus on the following documents: obtaining regulatory approval from authorities (SCP/21/3); compulsory licensing and/or government use (SCP/21/4 and SCP/21/5); exceptions and limitations relating to farmers’ and/or breeders’ use of patented inventions (SCP/21/6); and exhaustion of patent rights (SCP/21/7).
These documents have been prepared without evaluating the effectiveness of those exceptions and limitations. However, the documents cover practical challenges encountered by Member States in implementing the abovementioned exceptions and limitations.
A half-day seminar will be held on exceptions and limitations on 3 November (3-6 pm). This seminar was proposed by Brazil at the 19th Session of the SCP held on 25-28 February 2013 (SCP/19/6).
As per the agenda the Secretariat is to make a presentation on the exceptions and limitations on the abovementioned topics. This will be followed by a panel discussion on the “Effectiveness of exceptions and limitations when addressing developing country concerns and how national capacities affect the use of exceptions and limitations”. The panellist are: Mr. Carsten Fink (Chief Economist, WIPO), Ms. Margaret K. Kyle, (Professor, MINES ParisTech, France), Ms. Jayashree Watal (Counsellor, Intellectual Property Division, World Trade Organization). The panel discussion will be followed by a presentation of case studies on the use of exceptions and limitations by Member States.
The discussions on patents and health will focus on three new documents. First, the 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 (SCP/21/8). Secondly, the feasibility study on the disclosure of International Nonproprietary Names (INNs) in patent applications and/or patents (SCP/21/9). Thirdly, a document on the potential of a study on the implementation of flexibilities concerning different types of exhaustion of rights in Member States.
The deliberation on technology transfer will focus on an updated document (SCP/21/10). This document is expected to incorporate further practical examples and experiences on patent-related incentives and impediments to transfer of technology from Member States and observers of the SCP, in particular from least developed countries, taking into account the dimension of absorptive capacity in technology transfer.
The quality of patents discussions are based on the existing documents and an information sharing discussion among Member States regarding experiences on international work sharing and collaboration. Developing countries have reasonable apprehension about the proposals made by developed countries on the quality of patents because many of these proposals are covert attempts for the harmonisation of patent law.
The Secretariat is expected to produce two studies for the 22nd session of the SCP. The first study focuses on a study on inventive step that contains the following elements: the definition of the person skilled in the art, methodologies employed for evaluating an inventive step and the level of the inventive step. The second study focuses on sufficiency of disclosure that contains the following elements: the enabling disclosure requirement, support requirement and written description requirement. These studies are supposed to be simply factual information without analysis or recommendation.
[The developed countries’ proposals are in the following documents: SCP/19/5 REV: Proposal of the Delegation of Spain and other Member States of the European Union for the Improvement of Understanding of the Requirement of Inventive Step; SCP/19/4: Proposal by the Delegation of the United States of America regarding Efficiencies of the Patent System; SCP/17/7: Proposal by the Delegation of Denmark; SCP/17/8: Revised Proposal from the Delegations of Canada and the United Kingdom.]
The deliberation on confidentiality of communication between client and attorney will be based on an existing document. However, there will be a seminar on the confidentiality of advice from patent advisors scheduled for 3-6 pm on 5November. It will begin with a presentation from the Secretariat followed by two panel discussions. The first panel will focus on patent advisors’ perspectives from Mr. Steven Garland (Smart & Biggar/Fetherstonhaugh, Canada), Mr. Pravin Anand (Anand and Anand, India), Mr. Jeffery Lewis (Patterson Belknap Webb & Tyler, United States of America), Mr. Wouter Pors (Bird & Bird, Netherlands). The second panel will focus on clients’ perspectives from Mr. Hans B L๖chle (Head Global Intellectual Property of the Schindler Group, Switzerland) Ms. Manisha A. DESAI, Assistant General Patent Counsel, Eli Lilly and Company, Indianapolis. The last session will focus on perspectives of Member States.
The apprehension about the confidentiality of communication between the patent attorney and client has the potential to create legal protection to prevent the full disclosure of the invention by preventing the discovery of documents.
Exceptions and Limitations
The exceptions and limitation discussions were initiated at the SCP on the basis of a proposal by Brazil at the 14th session of the SCP on 25-29 January 2010. Brazil’s proposal contains the following three components:
“The first phase shall promote the exchange of detailed information on all exceptions and limitations provisions in national or regional legislations, as well as on the experience of implementation of such provisions, including jurisprudence. The first phase shall also address why and how countries use – or how they understand the possibility of using – the limitations and exceptions provided in their legislations. The second phase shall investigate what exceptions or limitations are effective to address development concerns and what are the conditions for their implementation. It is also important to evaluate how national capacities affect the use of exceptions and limitations. The third phase shall consider the elaboration of an exceptions and limitations manual, in a non-exhaustive manner, to serve as a reference to WIPO Members”. (SCP 14/7.)
Brazil brought much more clarity on the second component of the original proposal though a subsequent proposal submitted at the 19th session of the SCP on 25-28 February 2013 (SCP/19/6). This subsequent proposal asked the Secretariat “to take into account public policy objectives and society needs as a whole, including, inter alia, development needs, public health goals and competition”. Further “it should also consider the obstacles Member States found when implementing such” exceptions and limitations.
The discussions on the exceptions and limitations on patents are mainly expected to inform WIPO Member States, especially developing countries, to use these exceptions and limitations (flexibilities) to achieve public policy objectives in key areas like health, environment, food etc. Further, these discussions are also expected to change the way WIPO looks at exceptions and limitations and to enhance the capability of developing country Member States to use the limitations and expectations. WIPO often ignores the importance of the use of limitations and exceptions to patent rights and instead stresses the need for patent protection. Often this is coming out of a vested interest to serve the interests of patent owners and also increase the organization’s revenue through the facilitation of filing of patent applications under Patent Cooperation Treaty (PCT) at the cost of public interests.
Developed countries maintain a double standard on the use of limitations and exceptions; while developed countries use the limitations and exceptions in their domestic law they discourage developing countries from doing it. Some developed countries often exert political pressure as well as unleash propaganda tactics using international media to prevent developing countries from using limitations and exceptions such as compulsory licenses in order to protect the commercial interest of their industry.
Patent and Health
The work program on patent and health is the result of a joint proposal from the Africa Group and the Development Agenda Group (DAG) at the 16th session of the SCP on 16-20 May 2011 (SCP/16/7). The proposal has 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 least developed countries (LDCs), in relevant areas, and building upon work undertaken in the first two elements of the work program.
On studies, the original proposal contains the following studies by leading independent experts:
“(a) A component on the law and practices with regard to compulsory and government use licenses in WIPO Member States. Such a study will also provide as detailed information as possible, as to Member States that have issued or that have attempted to issue compulsory and government use licenses, the details of the license issued, the challenges faced as well as the impact on public health. This should also include the provision of empirical data on the royalty rates set in each case.
(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. This would enable an easier identification of the generic name of the medical product subject of the patent application.
(d) Conduct a cost-benefit analysis of the admissibility of Markush claims (broad patent claims that may apply to a broad range of compounds). It could be worthwhile to analyze whether such claims based merely on theoretical inference can be considered to satisfy the criteria for patentability.”
Due to opposition from developed countries, mainly from the Group B countries, there was no progress in this proposal. It was only at the 20th session of the SCP that agreement was reached to prepare two studies under this program. First is a study the feasibility study on the disclosure of INNs in patent applications and/or patents (SCP/21/9). Second is a document on the potential of a study on the implementation of flexibilities concerning different types of exhaustion of rights in Member States. The 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 and Least Developed Countries” is carried out at the request of the USA.
Unlike the original proposal these studies are carried out by the Secretariat. Further, no agreement was reached to start the work program on element two and three under the joint proposal. Element two on information contains a proposal to invite the UN Special Rapporteur on the Right to Health, to present his report to the Human Rights Council on Intellectual Property Rights and Access to Medicinesthe. The third element on technical assistance contains a proposal: “Flowing from the outcomes of the studies and information exchange as contained in elements I and II above, the WIPO Secretariat, in consultation with Member States, should develop targeted technical assistance programs”.
The developed countries that are part of Group B are systematically blocking the adoption of the working program contained in the joint proposal.
Transfer of Technology
The technology transfer document for the discussion at the current SCP session is an updated version of a paper prepared by the Secretariat and submitted at the 14th session of the SCP as per the decision of the 13th session. This document was revised and resubmitted at the 17th session. Again, the 20th session instructed the Secretariat to prepare a document to collect further practical examples and experiences on patent -related incentives and impediments to the transfer of technology from Member States and observers of the SCP, in particular, from least developed countries, taking into account the dimension of absorptive capacity in technology transfer.
The main issue with regard to the Secretariat study is their reluctance in recognising barriers created by patents to facilitate technology transfer on fair and equitable terms. Generally speaking, the Secretariat in the past has taken a view that a patent itself facilitates the technology transfer and exceptions and limitations in the patent system are enough to facilitate technology transfer. Further, WIPO does not carry out any technical assistance for developing countries to navigate the barriers created by patents so as to facilitate the technology catching up process in those countries.
In contrast, the United Nations Committee on Development Policy (CDP) recognised the negative aspect of patents on technology transfer in its 2013 submission to the Economic and Social Council (ECOSOC) on the role of science, technology and innovation whichstated: “… there have been revived concerns about the negative effects of the current IP system and recognition that the IP system needs to evolve to foster dissemination of technology, including by allowing countries to have room to tailor their own national IP system to their specific development needs. In this regard, patent based regimes are not necessarily compatible with the technological development stage of many developing countries and may deter innovation in these countries” (http://www.un.org/en/ecosoc/newfunct/pdf13/sti_cdp.pdf).
background paper by the CDP titled “Science, Technology and
Innovation for Sustainable Development” also spells out the negative
impact of intellectual property protection on technology transfer.(http://www.un.org/en/development/desa/policy/
According to this background paper, “intellectual property rights are now ruled by the TRIPS agreement and also increasingly by regional and bilateral free trade agreements (FTAs), which may restrict the range of policy options available for developing countries. These patent-based regimes are not necessarily compatible with the technological development stage of many developing countries and may deter innovation in these countries.”
The approach of the Secretariat to transfer of technology clearly contradicts the agreement between the UN and WIPO, which recognises WIPO as a specialised agency of the UN. Article 1 of the agreement states: “The United Nations recognizes the World Intellectual Property Organization (hereinafter called the " Organization ") as a specialized agency and as being responsible for taking appropriate action in accordance with its basic instrument, treaties and agreements administered by it, inter alia, for promoting creative intellectual activity and for facilitating the transfer of technology related to industrial property to the developing countries in order to accelerate economic, social and cultural development, subject to the competence and responsibilities of the United Nations and its organs, particularly the United Nations Conference on Trade and Development, the United Nations Development Programme and the United Nations Industrial Development Organization, as well as of the United Nations Educational, Scientific and Cultural Organization and of other agencies within the United Nations system.”
As a result of external submissions, the new document on technology transfer for the current SCP session (SCP/21/10) includes references of studies which recognise the barrier created by patents to facilitate technology transfer (http://www.wipo.int/edocs/mdocs/scp/en/scp_21/scp_21_10.pdf).
Technology transfer and intellectual property especially patents will be discussed again at the Committee on Development and Intellectual Property (CDIP), in its 14th session next week.
The uphill task before developing country Member States is to reorient the WIPO Secretariat to recognise patent barriers on technology transfer and to assist developing countries to successfully negotiate such barriers.+