[The ITSSD, an ad hoc observer to the WIPO Standing Committee on the Law of Patents (SCP), recently attended the 16th session meetings of the SCP that took place during May 16-20, 2011 in Geneva, Switzerland. As an ad hoc observer, the ITSSD heard, observed and contributed to the discussion during the SCP's Plenary sessions. The ITSSD has transcribed its notes of these Plenary sessions to the best of its ability in the interest of providing a reportage of the proceedings for the public interest. The ITSSD acknowledges that its 'Diary of the Proceedings' is incomplete and reflects in some cases a summary of the statements made by particular delegations; but it does provide an accurate assessment of those discussions the ITSSD was able to gather and report. To assist the reader in better understanding the context of those discussions the ITSSD has provided annotations containing SCP/WIPO document references and, in some instances, excerpts of those documents.
As noted above the ITSSD intervened in the discussions at various points. However, since those interventions were made in a contemporaneous and impromptu fashion, they are not fully reproduced in this Diary. The ITSSD has been assured that its interventions (or a summary thereof) have been recorded by the SCP and will be transcribed and incorporated within the Secretariat's Report for the SCP's 15th session.]
ITSSD Geneva Diary
Of
16th WIPO SCP Plenary Session
May 16-20, 2011
Geneva, Switzerland
Day 1 - Monday, May 16, 2011:
Introduction by Secretariat/Pooley - The purpose here is to secure the agreement that might otherwise not be.
There is growing interest in patent policies at the multilateral level
We must take advantage of opportunities to address issues which will contribute to a better patent environment internationally.
The Secretariat invites all to work in a politically positive way with goodwill and friendship.
Agenda Item #2 - Election of Chair and Two Vice Chairs:
The Secretariat seeks recommendations.
The Secretariat seeks recommendations.
Tramposh is new SCP Chair.
Agenda Item #3: Adoption of the Agenda of SCP 15:
France speaks for Group B – thanks for Item 12 – should adopt for this item a new label – contribution of committee to development agenda recommendations - “Contribution of this committee to implementation of respective development agenda recommendations”. The words in Agenda Item 12 currently are deleted.
Secretariat – translation work not finished but well under way.
Proposal from France adopted.
Agenda Item #4: Accreditation of Observers:
Medicines Patent Pool seeking ad hoc observer status. – contained in SCP 16/6. SCP invited to take position on request for ad hoc status.
Agenda Item #5 - Adoption of the Draft Report of the Fifteenth Session:
Proposed Adoption of Draft Report of 15th Session by SCP as Final.
Chair - Proposed changes will be adopted as a Final Report.
Agenda Item #6 - Report on the International Patent System:
Revised Annex II – SCP/16/2 – “Certain Aspects of National/Regional Patents Laws” available online at: http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_2-main1.pdf and http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_2-annex1.pdf - document continues to be open and can be updated.
South Africa, representing the African Group – wants to discuss patents & health, quality, tech transfer, exceptions, limitations. Balance of patent holders and users necessary. The Public Interest is extremely important. Public health is one of key priorities of the African continent. The proposed studies on patents and public health and the prior study on compulsory licenses (CL)’s - ; database on communicable & noncommunicable diseases; technical assistance; and other studies eac need to address development needs.
The UK and Canadian proposal for patent quality is appreciated. Flexibilities for patents are emphasized and supported. Brazil ’s proposal for a questionnaire on exceptions and limitations - SCP/16/3 - Draft Questionnaire on Exceptions and Limitations to Patent Rights - http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_3.pdf is appreciated and supported. Tech transfer is important to the African group – climate change, WHO, ITU, other groups. WIPO should actively participate in interaction between patents and technology transfer discussions. Capacity building, tech assistance, cooperation with academia for R&D discussions necessary to ensure tech transfer and that patent system contributes to innovation, tech dissemination and public interest.
Patent quality initiatives should take into account national patent systems.
SCP should focus on issues of common interest to membership. The Non-Exhaustive List ( http://www.wipo.int/edocs/mdocs/scp/en/scp_15/scp_15_inf_2.pdf )should be held open and any additions thereto should be approved by consensus. The same result should obtain for the Report on the Int’l System - http://www.wipo.int/meetings/en/doc_details.jsp?doc_id=160949 .
France, representing Group B. 16th session initiates new stage with adoption of new work program adopted last fall. There is a great opportunity for the SCP to implement its mandate. The SCP/16/3 - Draft Questionnaire on Exceptions and Limitations to Patent Rights - is very interesting. France has suggestions for its improvement. Regarding the UK and Canadian Proposal - SCP/16/5 -http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_5.pdf , a program on the quality of patents, Group B supports it. Tech infrastructure development, info exchange on quality of patents and process improvement are all important matters. This work program is complimentary to what is being done in the PCT system – processes. This program intends to improve quality at the national level. As concerns Item #9 – Patents & Health of the Agenda - SCP/16/1 -
http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_1.pdf , WIPO can contribute based on its technical expertise to work on this issue. But WIPO should NOT replicate the efforts of other fora. Agenda Item #10 - Client-Patent Advisor Privilege - SCP/16/4 Rev. - http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_4_rev.pdf (See also: SCP/14/ 2 - http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_ref_scp_14_2.pdf - is of interest to users. As concerns Agenda Item # 11 - on Transfer of Technology – SCP/14/4 Rev. - http://www.wipo.int/meetings/en/doc_details.jsp?doc_id=165339 – i.e., - the revised version of study 14/4Rev. – France and Group B appreciate the revision. There is a need to focus on which projects on the same subject are being undertaken in the CDIP to avoid duplication of efforts.
http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_1.pdf , WIPO can contribute based on its technical expertise to work on this issue. But WIPO should NOT replicate the efforts of other fora. Agenda Item #10 - Client-Patent Advisor Privilege - SCP/16/4 Rev. - http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_4_rev.pdf (See also: SCP/14/ 2 - http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_ref_scp_14_2.pdf - is of interest to users. As concerns Agenda Item # 11 - on Transfer of Technology – SCP/14/4 Rev. - http://www.wipo.int/meetings/en/doc_details.jsp?doc_id=165339 – i.e., - the revised version of study 14/4Rev. – France and Group B appreciate the revision. There is a need to focus on which projects on the same subject are being undertaken in the CDIP to avoid duplication of efforts.
India, representing the Development Agenda Group (DAG) makes the following statement. India joins other delegations in congratulating the new chairmanship. Since 2009, the SCP has provided a valuable forum for useful exchange of views on various issues. Patents have most direct impact on innovation, economic growth and national development – the SCP discussion has been very important. India has followed closely the discussions on exclusions, tech transfer, patents & standards and anticompetitive practices. India is interested in how patent systems can be calibrated to suit national needs and dismisses dogma that by not granting & enforcing patents strictly would cause problems. Countries face challenges in getting their patent system right – this has been exposed in the SCP.
It is important to have good provisions and to implement them wisely in sight of the broader goals of the patent system. India looks forward to safeguarding the fundamental balance in the patent system between the private rights of holders and the public interest. India also looks forward to continuing the consideration of the proposed work program on exclusions, limitations, tech transfer, client-attorney privileges and the opposition system, and patents/health and quality of patents. Discussions should lead to a work program that leads to balance and acceptance by all member states. There should be recognition of the linkages between patents and development. The SCP will report to the General Assembly to see how the WIPO Development Agenda will contribute to its work.
This SCP should remain abreast of new and emerging issues – the non-exhaustive list of issues should remain open. Background papers considered by the SCP and related discussions should be captured in a pragmatic manner on the WIPO website so they can be used by researchers, members, etc. Hyperlinks to relevant studies should be provided.
KEI – James Love – SCP/16/2 Revised annex II of 12/3/Rev. – wants the opportunity to comment on its contents. Agenda items should also include within the area of public health – an exploration of the conflicts between patents and standards and ways to address anticompetitive practices in this area.
AIPPI – seeks coffee break.
SAIFI - Curchod – exceptions & limitations; attorney-client privilege wants to focus on this week.
AIPPI – Statement - attorney-client – constructive comments should not be taken as detracting from AIPPI’s support of this report. The report discusses how civil law applies professional secrecy and common law applies privilege from forcible disclosure to protect attorney-client privilege. Privilege has nothing to do with the ability to seek access to the courts. Privilege derives from the need for trust & confidentiality to secure correct legal advice. Both systems of law recognize open dialogue between client and counsel necessary for securing correct legal advice. This principle has been accepted and applied in both civil and common law nations for centuries. Confidentiality actually protects the broader public interest in the administration of justice – lawyers need to help governments to address the burden on the courts to prevent disputes from arising that reach the courts. The protection for communications of non-lawyer patent advisors – is not an extension of confidentiality of protection for patent lawyer advisers. Both perform the same service. This is a new profession that deserves the same protection. AIPPI is concerned with the loss of privilege from the non-lawyer side to the lawyer side. Third World Network (TWN) questioned the privilege applied in the Nobel Pharma case – involved fraud not privilege. Privilege is not catalyst of such fraud, dishonesty is. Frank and open discussions are at risk. An uncertain privilege is better than no privilege at all. How does privilege relate to development? AIPPI observes most IP owners are companies. To develop trade, countries need to develop conditions through their laws in a way that does not create barriers there. The onus is not to create laws that impair trade, such as where confidentiality of legal advice is placed at risk. Failure to fix this problem is more pronounced in developing countries. Nearly every country protects confidentiality to some extent from forcible disclosure. Cross-border confidentiality must be solved by international agreement. National laws can resolve this problem. Two major forms are privilege for common law and professional secrecy for civil law. Protection from forcible disclosure does not conflict with patent law and implicate exceptions and limitations.
Chair – must provide statement in writing if make it verbally.
Substantive Discussion
Agenda Item #7 – Exceptions and Limitations to the Right
Secretariat – The documents submitted during last session - SCP/13/3 - Exclusions from Patentable Subject Matter and Exceptions and Limitations to the Rights - http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_ref_scp_13_3.pdf; SCP/14/7 – Proposal from Brazil - http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_ref_scp_14_7.pdf - Brazil proposal on exceptions/limitations - ; SCP/15/3 – Experts' Study on Exclusions from Patentable Subject Matter and Exceptions and Limitations to the Rights - http://www.wipo.int/meetings/en/doc_details.jsp?doc_id=154817. The main document is Draft Questionnaire on exceptions/limitations – prepared by secretariat for consideration by member states - SCP/16/3 - having 11 sections (supra). Member states should address in their response to the general questions: The source of law; rationale of law; scope or entitlement to limitation/exception; must explain particular legal framework for each that is adequate to secure the government objective sought; the practical problems of implementing exceptions/limitations. These are the most common exceptions/limitations, but others can be provided under Section XI.
Chair – What is the burden on developing patent offices? What should the length of the optimal questionnaire be?
South Africa, representing the African Group - Supports the 3-phase Brazil Proposal on exceptions/limitations: Phase 1 – questionnaire; Phase 2 - what exceptions are effective; Phase 3 – a manual on exceptions. Supports practical activities based on the results of the questionnaire.
SAIFI – Couchod – Recommends the book entitled IP Rights in Fair World Trade Systems – Proposals for Reforms for TRIPS – Max Planck Institute for Property Rights + Institute for IP Law – University of Stockholm . Amend TRIPS Article 30 to introduce mandatory limitations for patent rights. [Proposals to amend Articles 7 and 8, and add New Article 8a can be found online at: http://www.ip.mpg.de/shared/data/pdf/proposed_amendments_to_trips_20110504.pdf.
The paper describes but does not amend existing limitations and exceptions under TRIPS Article 31. The book is written by academics [authored by Annette Kur and Marianne Levin] and deals with what is desirable - http://ictsd.org/downloads/2011/04/agenda-may4.pdf;
[An abstract of this book can be found on Google and reflects academic efforts to reshape IP law so that it is more ‘in line’ with the enhance of ‘public goods’ and the ‘public interest’:
'This book is essential reading for anyone interested in intellectual property, global trade, international law, human rights, development, and competition. While many have lamented the impact of the TRIPS Agreement on the creative environment and social welfare, the heart of the volume is a deeply thoughtful, well-considered proposal for modifying the Agreement. The lead-up is equally compelling: essays by renowned experts describing the substantive, procedural, and institutional problems encountered post-TRIPS and an examination of socially responsible ways to promote innovation.' Rochelle Dreyfuss, New York University School of Law , US '. This book culminates Professor Annette Kur's longtime engagement in critique and reform of dominant IP patterns. Throughout several authoritative essays many by Professor Kur herself the book provides a comprehensive and in-depth overview of the ever growing academic efforts which, at an international level, struggle to reshape IP law paradigms in tune with the enhancement of public goods and interests even beyond the mere perspective of IP law's intersections with competition and consumer welfare in strict sense. This work constitutes a "must" for all those who, at any level of function and responsibility, engage in overcoming an historic unbalance that has so far basically precluded an adequate reconciliation of IP law with fundamental societal needs.' Gustavo Ghidini, University of Milano , and LUISS University , Rome , Italy . This important new book constitutes a serious examination of both the positive potential, as well as the deficiencies, of the TRIPS agreement. In the light of their analysis, the editors and their colleagues make a powerful case for wide ranging reforms. Intellectual Property (IP) law particularly in relation to international trade regimes is increasingly finding itself challenged by rapid developments in the technological and global economic landscapes. In its attempt to maintain a responsive legislative system that is interacting successfully with global trade rules, IP is having to respond to an increasing number of actors on an international level. This book examines the problems associated with this undertaking as well as suggesting possible revisions to the TRIPS agreement that would make it more relevant to the environment in which today's IP mechanisms are operating. The overall aim is to find an adequate response to the 'IP balance dilemma'. The theme is pursued throughout various topics, including a look at what this means in relation to the economy in a country like China, and also considering how IP is increasingly having to reconcile itself with human rights issues.This book will appeal to academics, policy makers and post-graduate students in IP and international trade law, as well as related fields, such as development and human rights.
Another abstract can be found online on the Max Planck Institute website, at: http://www.ip.mpg.de/ww/en/pub/news/amendment_of_trips.cfm . An excerpt reads as follows:
“The project took its cue from the growing discontent with the development of Intellectual Property (IP) in the post-TRIPS era. Indeed, what appeared to be the ultimate breakthrough of IP-oriented law and policy-making on a global level also marked a culmination point in the sense that the broad public esteem previously commanded by IP gradually lost ground. Fuelled by frustration of expectations raised with regard to the impact of IP on economic welfare, and resenting the restrictions imposed on communication and exchange of technology, deep skepticism towards the functioning of the system nowadays governs the perception of IP by large parts of the public, in particular when it comes to sensitive issues such as public health, nutrition, and dissemination of knowledge. IP is often seen as a mere tool for securing economic dominance of a few over a world of many, and as impeding rather than promoting a sound and sustainable socio-economic development...The proposals are structured as follows: Given the paramount importance of the general provisions in Part I for the interpretation of the TRIPS Agreement, the current wording of Articles 7 and 8 – Principles and Objectives – is fleshed out and amended so as to reflect the entire spectrum of policy goals to be aspired in a sound and thriving IP system, and to ensure its full application. In addition, a new provision – Article 8a – has been added, as an instrument modulating the balancing of interests between right holders, competitors, and the public at large.”
François Curchod was involved in the project as temporary or permanent group project member.
ITSSD - Intervention with respect to the Limitations and Exceptions Questionnaire concerning the lack of questions on adequate remuneration in Section II, IX. There is also a lack of questions on the protection of trade secret information and proprietary confidential data and clinical testing data. [ITSSD submits written comments to the SCP concerning these and other concerns about the questionnaire.]
ITSSD – As concerns the India proposal, we recommended that the term ‘legitimate’ modify the recommended language change – “public policy objective” - to reflect that this language is contained in WTO agreements.
Chair – Responded that an ad hoc NGO can only make non-binding ‘recommendations’ which members can take up if they so choose – they can’t make ‘proposals’.
TWN – Would like to make a statement on exceptions & limitations. Patents are statutory monopoly affecting lives of people living in developing countries to enjoy the right of health, information, etc. The TRIPS Agreement has been used to hamper the use of exceptions and limitations.
Chair Section III - Items 9-14; 15-20 – No comments.
Section IV –
Secretariat - Preparation of prescribed medicine – that appearing in a number of countries – Where “medicine is prescribed by medical practitioner” then a prescription for an individual patient preparation of medicine by a pharmacy would be considered a non-infringement of the patent right. See: Para . 115 within SCP/13/3.
Chair – interprets this as a formal proposal for amendment.
Section V –
Chair – is Russia referring to continuing use from before patent or only to use after patent grant?
Chair – There is a lack of full clarity on a complex issue. The Chair will seek clarification by the Secretariat for the next discussion of the text.
Section VI –
ITSSD – How to treat IP rights in the global commons – UNCLOS? For example, any IP developed by a member state national in the global commons will be considered ‘public goods’ under the ‘common heritage of mankind’ regime of the UNCLOS. How do WIPO member states address this issue in their national patent regimes? Is there a mechanism for such an eventuation? Is there agreement at the national level?
Chair – recommends clarification of issue with ITSSD. [ITSSD submits written research and comments to the SCP on these issues.]
Section VII
Section VIII – no comment.
Section IX – CLs
Chair – Would Russian propose dividing this section into two to reflect this difference?
ITSSD – Noncommercial use – Section II and Section IX – are they the same or different concepts?
Secretariat – they were referring to non-working and noncommercial use – different concepts. Section IX – refers to non-working, while Section II refers to noncommercial use.
Section X -
Secretariat – The Questionnaire is only intended to deal with patents.
Chair – Secretariat agrees in principle. Limitations on rights that were originally ‘extended’ look the same but are legally different than exceptions/limitations to ordinary patent rights.
Chair – cannot extend questionnaire to IP rights other than patents given scope of SCP mandate. It would NOT apply to UPOV protections.
Section XI
Chair – Arabic language will be included in translation as of 2012.
Chair – Secretariat would send out revised questionnaire by next SCP meeting. The U.S. should clarify its proposal.
Chair – The International Bureau should prepare questions in line with these comments with clarification from the U.S. Brazil wants the questionnaire revised before the next meeting. Is it important for delegations to see questionnaire revisions before having it distributed?
[Pursuant to Article 9 of the WIPO Convention, the International Bureau was established “as the Secretariat of the WIPO organisation under the direction of the Director General as the chief executive assisted by two or more Deputy Directors General. The International Bureau is very active. It plays a significant role in determining the vision of the organisation, shaping the nature and final outcome of treaty and other negotiations and discussions, drafting the recommendations by various bodies on various matters, admitting observers to various WIPO bodies and in preparing the draft agenda for the General Assembly.” See Sisule F Musungu and Graham Dutfield, Multilateral agreements and a TRIPS-plus world: The World Intellectual Property Organisation (WIPO), TRIPS Issues Papers No. 3, Quaker United Nations Office (QUNO), Geneva (© 2003), at pp. 7-8, available online at: http://www.geneva.quno.info/pdf/WIPO(A4)final0304.pdf].
Secretariat – Feasible to do whatever SCP requires.
Chair – Are all in favor of Brazil ’s proposal?
Chair – Secretariat will offer delegations a minimum of 6 months to answer the questionnaire given the need for interdepartmental coordination in many governments. A revised document will not likely be ready by the next SCP meeting. Would it be acceptable to revise questionnaire ‘as expeditiously as possible’?
Chair – Allow the Secretariat to consult amongst themselves. Secretariat will do what they can and get a fairly rough draft out within the next few days. Many delegations did not have time to review this document as reflected by the lack of questions being posed today.
Chair – does not see a consensus yet. Wishes to delay decision until tomorrow or Wednesday and consult with different groups to see if they are comfortable going forward.
Hungary Group B meeting tomorrow morning at 8pm.
DAG meeting tomorrow morning.
Agenda Item #8 –
Day 2 - Tuesday, May 17, 2011:
Agenda Item #8 – Quality of Patents, including Opposition Systems
Past efforts to achieve consensus to move the work program along has been stymied.
This problem has since been overcome.
All member states despite their level of development have patent systems granting patent rights.
The question is how IP regimes including patent offices can enhance patent-based innovation.
Nat’l patent systems must seek to achieve appropriate balance between holders, users and the public to promote social, economic development.
This proposal was created to focus SCP expertise on work to produce tangible benefits by creating a framework for patent quality including technical assistance and infrastructure development – items #10 and 11.
It sets forth a broad framework with three foundational components:
1. Technical infrastructure development – leveraging existing ICT mechanisms to maximize information resources; IT development is not the most efficient use of SCP resources.
2. Information Exchange – intended to help offices gain a better understanding of the processes that patent offices employ within the patent system at large for the purpose of leading to an improved quality of granted patents.
3. Process Improvement – identifying elements that national patent offices have been implementing to improve the patent grant process. National search and opposition processes and techniques used to enhance quality of documentation of submitted applications – quality in, quality out.
Encourage member states to contribute elements towards this process.
The issue of quality of patents including opposition systems was determined to be important enough for this committee to consider in-depth.
The proposal is deemed consistent with the mandate and core expertise of the SCP.
The first fundamental step should be focused on developing a commonly agreed upon definition of ‘patent quality’. We must look at the problem of ‘low quality patents’ first. Paragraph 3 of SCP/16/5 refers to the position that the SCP is in to make a meaningful contribution to the Development Agenda. India , however, cautions against the duplication of effort in the WIPO. A proposal is already underway within the DAG project, concerning the PCT process and capacity building and infrastructure development programs. How is the present proposal different from other activities already underway within WIPO, and how should this proposal links up to them? Paragraph of SCP/16/5 contains “appropriate balance of interest” language. India wishes to highlight that the goal of the patent system is to contribution to transfer and dissemination of technology. Paragraph 6 of SCP/16/5 places the patent quality issue solely on the shoulders of patent office. India believes that the judicial system also has an important role. Paragraph 7 of SCP/16/5 points to the link between patent quality and the DAG agenda. However, this issue goes beyond this narrow view to other issues – norm-setting, flexibilities, public policy/public domain/ technology transfer, ICT and access to knowledge.
The UK/Canada Proposal’s focus on technical infrastructure development to enhance existing sources of information can be considered similar to prior proposals. Developing countries without resources would need to rely on patent offices in developed countries which have networks with other offices and resources which would permit fast-track filing processes. Work-sharing could be problematic for developing countries could undermine the flexibilities existing in domestic patent law at the policy level. Providing access to the quantum of information available to patent offices to conduct high quality patent search and examination would be the better solution. A study should be conducted on the current state of affairs among patent offices of WIPO member states to access information and various databases. Also such a study should look at the cost of patent examination. To enhance the quality of search and examination, it is necessary to provide free access to databases to private and public domains in developed countries. Feedback from users should be part of prior art and examination processes. Users may be interested in securing faster and more secure grants of patent. This would lead to questions on reliability of other patent office processes rather than on patent quality. The function of the patent office is to scrutinize patent examination extensively before granting a patent right. Patent offices must institute rigorous examination processes with a view toward granting high quality patents and avoiding the grant of frivolous patents. Patent offices must seek the widest prior art search and examination possible. India supports improvement in patent office processes to improve patent quality, and to avoid mistaken grants of patents which are difficult to correct post-hoc.
The key problem with patent quality is how to prevent the ‘ever-greening’ of patents and the grant of ‘frivolous patents’ that do not make a significant contribution to society. The ‘test’ should be – what is the contribution of patented invention to society? The exchange of information between governments should deal with this issue. Patents are often used to prevent competition rather than contribute to innovation. In the pharma sector, in the EU, patents have been used to prevent introduction of competitive patents. The U.S. FTC has also called for improvement of the patent system given patent use based on competition rather than innovation objectives. Focus on patent quality should not result in national patent office use of policy space.
Chair – requests written versions of their interventions.
Brazil – Associates with statement of India on behalf of DAG, and welcomes discussion on the quality of patents. Brazil places priority on high quality patents. There is a need to agree on a clear definition of ‘quality of patents’. Brazil cannot otherwise accept what is being proposed on info exchange and process improvement. What is meant by ‘technical patent law’ in Paragraph 6 of SCP/16/5, or by ‘Quality of applications file’ in Paragraph 12? Brazil cannot understand the proposal of Korea that this should include some harmonization of law. Brazil wants to know ‘where’ we are going with the UK/Canada Proposal.
European Patent Office - supports the statement of Hungary . The EPO would be willing to share with the SCP information about the European Quality Management System experience - management of resources, quality assurance, two-way communications between examiners and users, etc. – i.e., the ‘end-to-end processing of patent applications. There is a continuous dialogue between the EPO and users of the patent system under the Partnership for Patent Quality.
CIPA-EPI – fully support UK/Canada proposal – external and internal quality management.
FICI- Fully supports the UK/Canada work program. Quality patents require good search and supplementary searches made by other offices before criteria are adjudged by the national patent offices. There is growing consensus of the basic criteria of ‘novelty’ and ‘inventive step’. Increased transparency should enable examiners in one office to see how a previous search was made in another office to avoid wasted efforts. Final determination should be made in view of local law. The PCT system is an ideal vehicle to improve prior art search practices. Details will be shared of data bases searched, classes searched in various national offices, key word combinations and key word class combinations used with national applications and PCT applications. We should seek to examine based on relevant prior art found by other national offices. Ongoing feedback mechanisms would be helpful as being discussed by PCT authorities.
KEI – More information on the cost of litigating patent disputes in different countries is necessary. The cost element of challenging poor quality patents has an impact on the quality of patents. There are better ways to share information on patents – in particular, information about those patents that have been challenged in litigation in different member countries. A database of proceedings in different countries where patents have been challenged would be very useful. The PCT propagates patents around the world with the presumption of validity. Countries should be permitted to reverse the presumption of validity if a patent is challenged in other countries. The ability to undo bad patents more efficiently is important. Historical references to patent quality show that today’s discussion on patent quality is the same. We can’t eliminate all bad patents, so must manage a system to address the management of bad patents.
KEI – side-bar – patent & health – Carlos Correa 1-3:30pm this afternoon.
ALIFAR – The patent quality issue is at the cornerstone of discussion. Tech transfer and infrastructure development will not solve the problem. National patentability criteria are the key issue dependent on the national policies of each country. The current system is being undermined – patents are being filed reflecting very little innovation in certain sectors. In the pharma sector, for example, many patents have little innovation – these minor patents are filed aggressively to prevent competition from other enterprises and trigger creation of trade barriers. Enormous multinational monopolies impair access to medicines. Industrial patents do not create such concerns in other industries. Examination criteria should reflect health and industrial policy. Each country should be able to decide on patentability based on their respective national examination criteria. They should also be able to identify the criteria for selection of material of shared information.
TWN – Poor quality patents lead to backlogs and unnecessary litigation, and increase levels of monopoly in markets and prevent competition. The highest criteria and thresholds are necessary. In developing countries, granting patents based on the highest level of criteria should not be based on incremental innovations. Only real inventions on which patents are based should be granted. Patent offices should be able to apply exclusions directly without accommodating through the ‘back door’. Patent quality cooperation should not result in the virtual harmonization of patent law around the globe. Rather, it should lead to substantive harmonization of patent law. TRIPS Article 27 reflects a trend to lower the threshold for patentability criteria. Some countries don’t use all prior art available. Traditional knowledge is not being considered adequately. The disclosure element is important in a patent application. Patent offices should have a mechanism to review decisions to grant patents throughout life of patent.
ICC – The ICC would like to refer delegates to a report issued by the ICC Commission on IP dealing with the coordination of patent office efforts to undertake prior art searches, dated 6/28/10. In particular, the ICC would like to draw delegates’ attention to Section IV. Searching – What ICC Would Like to See: An “Early Comprehensive, Coordinated Search”. [See: Cooperation Between Patent Offices: Prior Art Searching of Patent Applications, ICC Commission on Intellectual Property (6/28/10) at pp. 5-7, available online at: http://www.iccwbo.org/uploadedFiles/ICC/policy/intellectual_property/pages/ICC%20Statement_Patent%20Work%20Sharing_28%2006%2010.pdf .]
Opposition Systems -
India, representing the DAG, wishes to address the subject of ‘Opposition Systems’ within Secretariat study SCP/14/5 at: http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_ref_scp_14_5.pdf. The DAG attaches much importance to the role that opposition systems can play in addressing invalid patents. In addition to pre-grant opposition and post-grant opposition, there are also grounds that can be pursued in favor of development. Not only should opposition systems enhance patent quality, but they should also support the broader public policy objectives of developing countries. In the U.S. , reexamination procedures are rarely used and the common practice is litigation. Modeling national post-grant review processes after those of the European system would improve the review of prior art and would reduce the cost of litigation. Paragraph 21 of SCP/14/5 refers to the lack of resources at patent offices [“On the other hand, the opposition system also incurs costs, and is not always free from criticism. First, in order to set up an opposition procedure, the administration (the patent office) needs to have relevant resources, such as technically qualified examiners who are capable of reviewing the initial decision”]. And, in footnote #3 of SCP/14/5, patent offices which lack adequate resources can enter into cooperative mechanisms with other patent offices. [“As an alternative, a patent Office which does not have resources to conduct substantive review may conclude cooperation agreement with other offices.”] How could examiners in one office be sufficiently qualified to contribute to patent examination in other offices subject to other standards of patentability and other issues of national patent law? The lack of sufficient patent examiners makes a stronger case for a robust patent opposition system. How do opposition procedures can impose significant systemic delays in patent examination? Delays in granting patents b/c of opposition systems delay can impair innovation. We should evaluate the contributing factors of an enabling environment for a strong opposition system. Sufficient information in published patent applications, fees for proceedings and availability of qualified patent examiners contribute to good functioning of patent opposition system. India calls for dedicated page on the WIPO website where studies about patent opposition systems can be posted and questions posed.
Chair – will leave issue open for further discussion.
Chair – There is sufficient consensus to keep this item on the agenda and for the international bureau to revise the work it has done.
Secretariat/ Pooley – Appreciates member state interventions and comments on SCP/14/5, and promises that the Secretariat will revisit the study and provide an update to it during the next meeting. Member states are invited to provide information and experiences they have that would help the Secretariat to revise their document.
KEI – would be helpful to get costs of those using the opposition system.
ALIFAR – The opposition system study should go into more detail about pre-and post-grant opposition and review the obstacles to greater use of opposition systems.
Agenda Item # 10 - Client-Advisor Privilege -
Secretariat - SCP/16/4/REV [http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_4_rev.pdf ] must be read together with two prior documents [SCP/16/4 - http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_4.pdf; SCP/14/2 - http://www.wipo.int/edocs/mdocs/scp/en/scp_14/scp_14_2.pdf ]. It covers common law AND civil law countries, the preservation of confidentiality between clients and patent advisors, the feasibility of applying the same protections between lawyer and non-lawyer patent advisors, the mutual recognition of confidentiality cross-border, how confidentiality relates to the disclosure of proprietary information, the contribution of confidentiality to development and the ‘public interest’. There are five main issues. There is a diversity of national laws on this topic. Chap. 4 provides examples. [See SCP/16/4Rev. and SCP/16/4, at Chapter IV – “Sharing a Common Understanding”, at pp. 17-18; See also Chapter IV – “Rationale for Client-Patent Advisor Privilege”, in SCP/14/2 at pp. 52-56.]
India, representing the DAG, comments as follows. The purpose of the study is to further discuss issues noted first in SCP/4/2 dealing with attorney-client privilege not acknowledged in all countries and in countries with privilege but employing different practices. The current study is not presently consistent with international norms. The DAG does not share the understanding of the Secretariat regarding this document. In many countries the law of privilege falls within the province of the law of evidence and thus not a substantive patent law issue and should not be discussed in SCP. WTO GATS could be a better forum to discuss this matter, more so than the WIPO. SCP/14/2 goes beyond patent protection and patent system of each country. Concerning par. 261 of SCP/14/2, it is not practical to seek a uniform rule on confidentiality which would abrogate national differences. Patent advisors render technical as well as legal advice. There is a significant difference in judicial opinion within countries concerning the existence of such privilege. Studies assume a broad stroke of privilege even though attorney-client privilege is not based on the legal work of a lawyer per se, but rather on the fiduciary relationship between attorneys and the courts. Extending this privilege to non-lawyers that do not have fiduciary relationship with courts can lead to abuses. Q.163 – Attorney-Client Privilege – Report AIPPI Q-163.
Some members wanted to leave control over implementation of an international rule to individual countries. While they make recommendations to countries, they nevertheless respect the authority of the country to apply its own national law. The extent to which privilege is needed depends on the extent of discovery permitted in each legal system. If there is no broad power of discovery worldwide, there is no need to adopt a broad privilege worldwide. What is the implication of having a broad attorney-client privilege applicable to non-lawyer patent advisors?
South Africa – on behalf of the African Group, believes that attorney-client privilege once recognized should be extended to confidential communications and to foreign attorneys and patent advisors on the basis of reciprocity or even if not privileged in their own country. Privilege falls within the law of evidence and national jurisprudence. The Secretariat should invite member states to share their experience in extending privilege to non-lawyer patent advisors mindful of the differences in national laws on this matter.
India – Section 10.4 of the Indian Patents Act dealing with patent disclosure, requires that every complete specification disclose the ‘best method of performance’ of invention. The applicant cannot have a confidential matter. Harmonization of attorney-client privilege would lead to de facto grant of patent.
[“(4) Every complete specification shall... (b) disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection;” - See: THE PATENTS ACT, 1970, (39 of 1970, dt. 19-9-1970) (As amended by Patents (Amdt.) Act, 2005 (15 of 2005), dt. 4-4-2005) at p. 13, available online at: http://www.spicyip.com/docs/statute-combined%20patents%20act%202005.pdf].
AIPPI – By the introduction AIPPI made on Monday it wished to mark progress made by the SCP on the protection against forcible disclosure of IP legal advice. Common & civil law public interest is the foundation of protection - to limit disputes brought before the courts and to allow advice to resolve disputes before they get to court. This protection is centuries old. There is no SCP proposal that it be abrogated. WIPO has nailed to the wall the non-recognition by one country of protected legal advice protected under the laws of another country. AIPPI supports member states in mandating WIPO to do whatever information gathering they require to obtain information about how to maintain confidentiality of legal advice cross-border. AIPPI accepts w/re to SCP/16/4/REV – par. 64 non-exhaustive resources - #4 (iv) that there is no conflict between disclosure in patent law and maintenance of client confidentiality. Disclosure under patent law is statutory requirement and cannot be influenced by existence or nonexistence of attorney-client privilege. AIPPI will assist the WIPO and the SCP with respect to the questionnaire process if it goes ahead, as it had done with respect to AIPPI Resolution Q163. The Indian delegate referred to process in reaching resolution. Some members of AIPPI expressed reservations concerning matters reserved to national law. The Indian delegate’s comments leave the impression that within AIPPI there have been doubts. Actually, this was not so. The Indian delegate also raised the issue of GATS. We recommend that the Indian delegate review the AIPPI’s submission to WIPO concerning this issue – dated August 2009, which is available on the WIPO website. GATS Mode IV, concerning the provision of services of an employee of one country in another country requires national treatment. GATS does not affect the national ability of country to regulate legal services.
[See: Paragraphs 6.9 and 6.10 of the AIPPI Submission to WIPO on WIPO Report (Preliminary Study) SCP/13/4 – Client-Attorney Privilege (CAP): Protection against forcible disclosure of communications relating to intellectual property professional advice (August 2009), at p. 27, available online at: https://www.aippi.org/download/onlinePublications/AIPPI_Submission_SCP13-4_280809.pdf . (“GATS 6.9 GATS Mode 4 relates to the provision of the services of employees from one country to another. The agreement gives individual governments the ability to choose which services are included, and as to those services selected, to ‘set limitations specifying the level of market access and the degree of national treatment they are prepared to guarantee’.75 GATS does not affect the national ability of a country to regulate services. Legal services are normally governed by national laws requiring citizenship and/or residency in that country plus locally obtained qualifications. 6.10 Accordingly, GATS Mode 4 does not affect or in any way embargo the potential for making an agreement between countries to harmonise their laws relating to privilege, professional secrecy or any form of protection against forcible disclosure of IP professional advice... 75 See at 10 July 2009.)]
ICC – Client privilege is IP advice administered in the general interests of justice. Frank opinions should be able to be provided in writing without fear of disclosure. Client privilege in IP advice is truly a global issue going beyond national borders. The ICC proposal for an international instrument is referred to in secretariat’s report. The ICC looks forward to having the SCP go forward with this project. [See: Client Privilege in Intellectual Property Advice, ICC Commission on Intellectual Property (ICC Position Paper 450/1040 (Oct. 9, 2008)), available online at: http://www.wipo.int/scp/en/meetings/session_13/pdf/icc.pdf].
TWN - Extension of attorney-client privilege to non-lawyer patent advisors is problematic. Any information that is part of a patent application process is public information and falls within transparency for the benefit of the public interest. The extension of privilege would compromise governments’ ability to protect the public interest. The SCP is not the proper forum to discuss attorney-client privilege.
FICPI – Patent advisor-client privilege are no longer related to one country but are of an international character. IP advisors and their clients must be able to have frank, honest and open consultations so that the highest level advice can be provided. Attorney-client privilege is an award to the client, not to the attorney. Sufficiency of disclosure in patent applications and issue of privilege are distinct issues. There is a presumption here that the grant of privilege will adversely impact disclosure in patent application. A client cannot hide behind privilege with respect to his own knowledge, as the example in Paragraph 53 of SCP/16/4REV relates.
[This statement refers to the case of Nobelpharma Ab Usa v. Implant Innovations Inc (141 F.3d 1059 1998-1 Trade Cases P 72100, 46 U.S.P.Q.2d 1097), which was cited as an example of “where a patent agent, who had received from an inventor a draft patent specification containing a reference to a book that could become critical prior art for the determination of the patentability of an invention, had deleted the reference to that book from the patent application as filed, and the patent was granted.” The paragraph continues as follows: “As this example suggests, although the deletion of the reference to the prior art book from the patent application does not remove the existence of that book as prior art, the privilege or the professional secrecy obligation for patent advisors might be misused and could result in keeping critical information for the determination of the case away from public inspection. However, it
could be argued that the patent advisor’s advice to delete a relevant reference from the patent application was not in conformity with his professional ethics and code of conduct.”]
CIPA – EPI – IP Federation supports FICPI and AIPPI.
CIEPI – Let’s move forward not backward.
Chair – There is no clear consensus about whether to go forward on this issue. The Chair will prepare a summary of the discussion. A number of delegations agree that attorney-client privilege is a matter of national jurisprudence. No delegation advocated in favor of setting international norms concerning this issue. The SCP would need to recognize international differences in laws and rules regarding attorney-client privilege. There is no readiness to adopt common principles. There is a great deal of support for having the International Bureau collect more information about national practices and experiences regarding cross-border activities. There is also interest in hearing about countries’ bilateral agreements such as between Russia and the CIS. There is also interest in looking at particular country remedies for addressing cross-border reciprocity.
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Day 3 – Wednesday, May 18, 2011:
Agenda Item #9 – Patents and Health:
South Africa – Submits the African Group Proposal [See Proposal Submitted by the Delegation of South Africa on Behalf of the African Group and the Development Agenda Group, (SCP/16/7) (May 18, 2011), available online at: http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_7.pdf]. WTO TRIPS does not prevent member states from taking measures to protect public health. See also: WHO Global Strategy on Public Health, Innovation and Intellectual Property (GSPOA) [WHA61.21, Agenda item 11.6 (May 24, 2008) accessible online at: http://apps.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf]. IPRs should not prevent member states from taking measures to protect public health. Safeguards provided by TRIPS should be incorporated into national legislation. Bilateral and regional agreements should not undermine these safeguards.
Promotion of web program – Seeks to enhance capacities of developing countries and LDCs to adopt patent regimes to fully make use of flexibilities to promote public policy priorities related to public health. 3 elements: 1) elaboration of studies to be commissioned by SCP from renowned experts; 2) information exchange among member states experts; and 3) technical assistance to member states particularly LDCs.
1) The SCP was requested to commission a framework study to examine constraints and challenges faced by developing countries in pre-grant and post-grant stages. There is to be a component on the use of CLs (compulsory licenses) and government non-commercial uses of patented inventions/medicines and study of practices. The study was to identify the challenges faced and their impact on public health and the empirical data on royalty-rates imposed. The extent to which countries use exhaustion of patent remedies, a review of the use of generic names, and a cost-benefit analysis of the admissibility of Markush claims – criteria for patentability - would also be covered. [See: SCP/16/7 Para . # 8].
2) SCP should invite UN human rights liaison to present his study on human rights and medicines. Experience-sharing exercises of member state practices to promote public health. SCP should organize a technical workshop on the application of TRIPS articles dealing with flexibilities. SCP should create database on communicable and non-communicable diseases identified in consultation of member states and the patent status of medicines for these diseases to show how greater access to medicines can be had through use of TRIPS flexibilities. [See: SCP/16/7 Para . #s 9-12].
3) To enhance the outcomes of studies and information exchanges, the Proposal invites SCP and member states to develop targeted technical assistance examples – to create a new module relating to the grant of CLs pursuant to Parts 2 and 3 of TRIPS. TRIPS Article 44 [relating to Injunctions] is not subject to the restrictions limiting Articles 30 and Articles 31. The web program should have links to the DAG Agenda. [See: SCP/16/7 Para . #s 13-14].
Wants this proposal to be a working document of the SCP.
France – Group B needs more time to first review a copy in writing of South Africa ’s proposal. Under Agenda Item #9 we should concentrate on the added value that WIPO can bring to this issue based on its expertise and should not attempt to import discussions from other fora. SCP should present its current works and programs on patents and health including projects carried out with other international organizations.
Secretariat – The Secretariat would be pleased to create a WIPO document with respect to that proposal by today, but without all translations. With respect to Hungary and France ’s request, the SCP is willing to bring colleagues in to discuss international/global challenges addressed by this committee.
Chair – It is useful to have only an informal copy of the South Africa proposal available to all delegations during the coffee break.
Agenda Item #11 Technology Transfer –
The patent applicant’s disclosure of a patented invention is of key importance to technology transfer. There is presently an incentive to disclose as little as possible to freeze competition after the patent expiry. WIPO should help build capacity to examine patent applications with the objective of preventing the grant of applications where there is not full disclosure. Paragraph 59 – measuring the impact of patent protection on technology transfer – There is no conclusive evidence of any impact of patent protection on technology transfer. This should be looked at again. There is no evidence of a positive relationship between FD I and technology transfer. The study does not reflect studies indicating a negative impact of patent protection on technology transfer. EU biotechnology – strengthened the patentability standard b/c it found that broad patentability was impairing innovation. India wants further revision of this study, and wants the former proposals of DAG incorporated within it. India values the technology transfer created by patents. India wants the international commission or experts group nominated by member states to address issues relating to technology transfer particularly on use of patent flexibilities. SCP should organize a forum to exchange countries’ national experiences on technology transfer during the upcoming SCP meeting.
South Africa, on behalf of the African Group – SCP/14/4/REV provides useful insight into these complexities. It points to accessibility of information and the capacity of recipients to absorb technology. There is a need for access to information and skilled lawyers involved in technology licensing and public funds/universities. The studies are confined to these areas only, however. There remains concern that the patent system falls short regarding how patents can serve as a barrier to technology transfer. Patents allow holders not to exploit the technology. Patent trolls and patent thickets impair innovation. The study limits its analysis to improving the availability of patent information. It does not analyze how the patent system impedes technology transfer or how to preserve the public domain for the development goals of developing countries. Future work by SCP should consider studies to identify measures available in TRIPS on tech transfer and to alert experts about their availability. These include the R&D efforts of developing countries and mechanisms to facilitate tech transfer pursuant to TRIPS Art. 66.2. Developed countries must meet their requirements /obligations under this provision. What are they doing?
Chair – This agenda item is fairly advanced. Requests for further revisions of this document the SCP could undertake for availability during the next SCP meeting may be possible. At that point, the study would be fully cooked and member states should then decide whether there are other activities the SCP could undertake as reflected by consensus.
ITSSD – If we are speaking of changes, perhaps there should be more mention of the impact of national legislation/restrictions on the exercise of patents and contractual licensing rights on trade to restore some balance to the report. Obviously tech transfer is a complex multi-step process most of which deals with issues other than patents and related IP rights that goes beyond the expertise of the SCP.
ALIFAR – The SCP should examine how the quality of patents and patentability criteria could be obstacles to technology transfer. Businesses are not willing to share knowledge. TRIPS Article 66 has not had effects on technology transfer. TRIPS Articles 7 and 8 are also not effective. IP itself should not be allowed to create a barrier to knowledge transfer.
KEI – Tech transfer goes to the problem of development itself. It is useful to have the WIPO Economics Bureau – Carston Fink - to begin to identify what kind of statistics are needed to look empirically at the effectiveness of various technology transfer initiatives and the respective capacities in various developing countries. We need to look at the performance of various mechanisms where different countries have different legal regimes.
Secretariat Expert from WIPO on Patents & Health – Global Challenges Division – WIPO is a specialized UN agency focusing on IP and endeavors to lead the IP dialogue at the intersection of IP and global security issues. Problems are borne most by developing countries and LDCs. The global life science program includes coverage of public health issues. WIPO has established a strong relationship between the WHO and the WTO to look at the international program on global health. WIPO looks at UN agencies such as UNCTAD, UNDP and others as well as the private sector. WIPO has organized seminars, and has been engaged in public ‘IP landscaping’ and public IP management.
[‘IP Landscaping’ – is essentially an analysis of a particular technology area or set of companies in the context of patents or other IP. This includes identifying the areas that are public domain, proprietary, or unclaimed. IP Landscaping allows for educated decision-making about patent strategy, product development plans, R&D initiatives, licensing programs, or acquisition targets.]
With respect to biotechnology and the evolution of the regulatory framework on clinical test data, WIPO works to help with th\e Implementation of WHO global strategy and plan of action. With respect to access to medicines and medicines pricing the joint WIPO-WHO-WTO seminar 2010 brought forward good information. The Feb. 18, 2011 symposium looked into available patent information resources and looked at their use for public health purposes. This symposium was preceded by a workshop on patent searches and the ‘freedom to operate’ – basic patent searches and freedom to operate analysis.
[A ‘Freedom to Operate’ analysis entails a determination of whether a particular action, such as testing or commercializing a product can be done without infringing valid IPRs of others. Since IPRs are specific to different national jurisdictions, such an analysis should focus on particular countries or regions where operations may take place.]
A Dec. 2010 WIPO patent search report was prepared and submitted to a meeting of an open-ended working group. It was published on the WHO Avian Influenza website and on the WIPO website. There is a special program for research and training on tropical diseases. The African Union pharmaceutical manufacturing plant Unit 8 expert working group illuminated pertinent issues relating to licensing. Medicines patent pools were examined in connection with retroviral medicines. Trilateral cooperation between WIPO-WTO-WHO provides input into training activities and national and regional seminars on implementation of the TRIPS Agreement.
Secretariat Expert – We must be cautious to deal with expectations. We appreciate the feedback.
WHO Expert – The strategy points out how WHO shall place the strategic relationship between IP and public health and trade. Requests Directorate General of the WHO to coordinate with WIPO, WTO and UNCTAD to implement global strategy and plan action. There is an agreed effort to coordinate collaboration more effectively. Regular joint coordination meetings are organized where training programs, work programs etc. have been or are being scheduled with each entity’s respective expertise being contributed. There are a series of joint technical symposia to provide more facts of overlap between IP, public health and trade (procurement and access to medicines and freedom to operate). Work together on patent information, CDIP – WIPO to mandate patent landscaping to identify which diseases researchers are focusing on and where innovation is taking place. The WHO is doing research and is doing patenting. WIPO has provided patent search reports on endemic avian influenza preparedness. The WHO is considering the notion of ‘virus-sharing’ this week at the WHO Assembly.
WTO Expert – The WTO ensures that existing medical technologies get to patients needing them and that further progress is made by future innovation in the pharma sector. The WTO can offer effective tools to achieve this objective. IP and trade issues deserve full coverage as they intersect with public health. The WTO can consolidate available data and valuable experiences for the benefit of policymakers, and can provide access to technical capacity building initiatives. The basis of the WTO and the starting point for its engagement is the Doha Declaration on TRIPS and Public Health. There is increased focus in technical cooperation activities on IP. There is mutual participation from the WHO and the WIPO. Activities include: workshops to provide information and share experiences (on IP & Public Health last year); an advanced course for government officials taking place this week – on IP & Public Health; a colloquium for teachers with a module on IP & Public Health to spread knowledge within academic community; and national workshops. To provide factual and technical information, and to address flexibilities extensively, there is an annual review of the Doha Declaration on TRIPS and Public Health “Paragraph 6” system every year in October. During 2010, this moved beyond analysis of the operation of the system into broader aspects of public health, including IP rights. Look into the minutes of the report for this annual review.
WTO solves disputes also. There was the regulatory review exception case almost 10 years old (Canadian case). A recent WTO report contains a section on the activities relating to public health. Comprehensive oral reports by WTO secretariat are included as part of the review of the “Paragraph 6 system”. The October 2010 TRIPS Council meeting and March 2011 meeting addressed how to accept the protocol amending the TRIPS Agreement and national implementing legislation. In-training manual and handbook on TRIPS matters. There is a stand-alone module on TRIPS & public health.
[See: Little-used ‘Par.6’ system will have its day, WHO tells intellectual property and health review, (WTO: 2010 News Items (Oct. 26-27, 2010), available online at: http://www.wto.org/english/news_e/news10_e/trip_26oct10_e.htm; See also Members’ laws implementing the ‘Paragraph 6’ system, Intellectual Property: TRIPS and Health, WTO website at: http://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm ; TRIPS Council: Members Debate Biodiversity, Access to Medicine, International Center for Trade and Sustainable Development (ICTSD) - Bridges Weekly Trade News Digest, Vol.15, No. 8 (March 9, 2011), available online at: http://ictsd.org/i/news/bridgesweekly/102136/].
KEI - Element 5.3a WHO Strategy cited. What has WHO done to implement this recommendation? What data does WHO have on cancer drugs?
[See: Global strategy and plan of action on public health, innovation and intellectual property, WHA61.21 Agenda item 11.6 (May 24, 2008), at: http://apps.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf . See Element 5.3a – “The actions to be taken in relation to this element are as follows... (5.3) exploring and, where appropriate, promoting possible incentive schemes for research and development on Type II and Type III diseases and on developing countries’ specific research and development needs in relation to Type I diseases (a) explore and, where appropriate, promote a range of incentive schemes for research and development including addressing, where appropriate, the de-linkage of the costs of research and development and the price of health products, for example through the award of prizes, with the objective of addressing diseases which disproportionately affect developing countries.”]
WHO Expert – The WHO is exploring alternative mechanisms to finance innovation (e.g., including prize awards). The IP system is not sufficient to deal with ‘neglected’ diseases b/c the market is not there. It is also exploring why investment in innovation is lacking as well as other mechanisms to finance such innovation – this is the matter addressed by such paragraph. The WHO has installed a new expert working group to look into this and the results of their research will be submitted to the WHO General Assembly next year. There is no data in the WHO’s possession relating to cancer drugs.
[Lunch Recess]
Medicine Patent Pool side-bar
Secretariat – There is no budget for establishing a separate committee of experts as proposed. The WIPO Office of Chief Economist has established a series of discussions and presentations on economic related activities and issues.
ITSSD – Relating back to the discussion on technology transfer, there is a need for that study to highlight how patents can be positively used to realize the benefits from the triple helix relationship between the government, academic and private sectors to undertake joint R&D and technology commercialization efforts.
=Msu�ml�sPWTO Expert – The WTO ensures that existing medical technologies get to patients needing them and that further progress is made by future innovation in the pharma sector. The WTO can offer effective tools to achieve this objective. IP and trade issues deserve full coverage as they intersect with public health. The WTO can consolidate available data and valuable experiences for the benefit of policymakers, and can provide access to technical capacity building initiatives. The basis of the WTO and the starting point for its engagement is the Doha Declaration on TRIPS and Public Health. There is increased focus in technical cooperation activities on IP. There is mutual participation from the WHO and the WIPO. Activities include: workshops to provide information and share experiences (on IP & Public Health last year); an advanced course for government officials taking place this week – on IP & Public Health; a colloquium for teachers with a module on IP & Public Health to spread knowledge within academic community; and national workshops. To provide factual and technical information, and to address flexibilities extensively, there is an annual review of the Doha Declaration on TRIPS and Public Health “Paragraph 6” system every year in October. During 2010, this moved beyond analysis of the operation of the system into broader aspects of public health, including IP rights. Look into the minutes of the report for this annual review.
WTO solves disputes also. There was the regulatory review exception case almost 10 years old (Canadian case). A recent WTO report contains a section on the activities relating to public health. Comprehensive oral reports by WTO secretariat are included as part of the review of the “Paragraph 6 system”. The October 2010 TRIPS Council meeting and March 2011 meeting addressed how to accept the protocol amending the TRIPS Agreement and national implementing legislation. In-training manual and handbook on TRIPS matters. There is a stand-alone module on TRIPS & public health.
TWN –
KEI – As concerns the role of the WIPO economist – reporting data obtained regarding how patent system is working out with respect to technology transfer. Would the economist report to the SCP?
Secretariat – if members of the SCP agreed, we can invite a representative of the Office of the Chief Economist to attend an SCP meeting and to address issues concerning where the data is available and how to obtain it, subject to that office’s schedule.
[This statement inadvertently opened up a discussion which follows that led to South Africa , India and Brazil distorting the emphasis of the Bulgarian delegation’s comments. It led to a debate and to an improperly refocused inquiry. The ITSSD spoke with the Bulgarian representative and he admitted this was not his intent. The focus of the inquiry should be on what has been ‘successful’ with the technology transfer system, and NOT, as the DAG has sought, to focus on what is ‘wrong’ with the technology transfer system.]
India – Speaking in its national capacity, endorses Bulgaria, focusing on practical impediments/constraints to technology transfer and possible solutions to overcome them.
Chair – interesting area of IP/trade aspects of technology transfer. Problems of absorptive capacity and funding/capital, import and regulatory restrictions and other obstacles can stand in the way of effective technology transfer.
Chair – Draw on associations with particular expertise on technology transfer – LES and AUTM, to seek a symposium on this.
Secretariat – CDIP project referred to in this discussion CDIP/6/4REV was adopted at the penultimate session. [See Project on Intellectual Property and Technology Transfer: Common Challenges – Building Solutions (Recommendations 19, 25, 26 AND 28) [of the Development Agenda], CDIP/6/4 REV. (Nov. 26, 2010), at: http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_6/cdip_6_4_rev.pdf.] CDIP/6/4REV has 5 components: 5 regional consultation meetings; elaboration of several peer-reviewed studies; high-level int’l expert forum on tech transfer & IP; web form created on tech transfer; see how outcome of all phases can be streamlined into WIPO. The document speaks of a series of studies on IP and tech transfer focusing on areas receiving less attention in the literature and on possible obstacles to tech transfer and how obstacles can be overcome; studies on IP policies and initiatives that would promote tech transfers; favorable incentive policies; all well focusing on economic aspects of tech transfer.
Chair – There is no consensus yet to go forward. It is clear that there is information which needs to be obtained especially concerning the work of the CDIP. Were patents excluded from CDIP and relegated to SCP? If not, there would be duplication of effort were SCP to undertake to fulfill these proposals. The WIPO Chief economist should become involved. A tech transfer study may possibly be revised to take into account these proposals and consideration of the CDIP’s work.
Chair – The Secretariat will modify the summary to reflect if members are at a consensus. It will ask the International Bureau to look at possible impediments to technology transfer in the revised study. Member states should not prejudge that patents are impediments to tech transfer b/c the absence of patent can serve as an impediment to tech transfer. The revised study will include all types of impediments. The Secretariat must evaluate whether there is an overlap with work of CDIP.
Chair – No study will be conducted by the Office of Chief Economist. That office would only undertake work that would gather expertise for a forum or seminar. Such a forum would gather and discuss evidence of many possible impediments to tech transfer to ascertain whether a study should be commissioned.
France - Group B – can go along with a revision of the study proposed by the Chair. However, it is more logical to lead with in-depth consultations within CDIP to see if there is adequate coverage before proceeding forward.
Chair – The revised study will reflect the interventions of this meeting. The Secretariat will look into the overlap between CDIP and SCP. CDIP does mention IP which includes patents. Ambiguity will be clarified.
Chair – The understanding is that such project has not yet been done. Does it fall within terms of reference that CDIP has decided? Would it fall within the CDIP’s term / scope of work?
Chair seeks to clarify these relative scopes of activity on the same issue.
Chair – I have lost track of who has done what study on tech transfer and patents.
Chair – We have a tech transfer study here.
Chair – A study focusing on best practices and experiences is good. A study focusing on patents as impediments is not good. We cannot look at patents and tech transfer in isolation. Tech transfer is much more than a license to use a patent. Tech transfer entails the adaptation of technology to the local environment and to local regulations, to a level of funding, etc. We must look at the issue broadly and see what is necessary to undertake technology transfer. We can’t just separate out one aspect of patents on this issue.
Chair – We won’t find a consensus in the SCP that focuses on how patents serve as barriers to tech transfer.
Chair – It is intended that the revised study will include a section on impediments to tech transfer.
Chair – actually talking about study SCP/16/4.
Secretariat – The DDG – i.e., the International Bureau understands the request for additional elaboration, more citation, and more clarity whether the international patent system acts as a barrier to technology transfer.
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Day 4 - Thursday, 5/19/11:
ITSSD travels to Brussels for the day.
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Day 5 – Friday, 5/20/11:
Chair – As concerns the informal summary on 5 informal agenda items, we will gavel down and close out these items when we have full consensus.
Later there will be a formal presentation of the Summary by the Chair which reflects the sense of what has been agreed to at the meeting.
Agenda Item #7 – Questionnaire on Exceptions & Limitations to the Right –
Chair summary of Denmark proposal – Denmark proposes that the Chair provide as much time as possible for Member States to respond to the exceptions and limitations questionnaire. Only answers without analysis would be presented to the SCP. Only after the SCP has answers, they will determine if further analysis of the answers is necessary. September 30 would be a reasonable deadline.
Chair – Chair’s summary reflected this.
Agenda Item# 11 – Tech Transfer –
Chair – We will consult with the Office of WIPO Chief Economist on the margins of the next SCP. It remains uncertain whether following the conclusion of the proposed seminar the Chief Economist will be invited to sit alongside the SCP and to give a report to the SCP on the seminar.
Secretariat/Pooley – The word ‘mandate’ was never used by the SCP in discussing this possibility. The proper term that was used was to ‘invite’ - it was only an ‘invitation’.
Chair – A summary of the meeting should be available on the website for all member delegations of SCP.
“Suggestions by the Chair”
Chair – The UK/Canada proposal is of a different status than S. Africa patent/health proposal. It was submitted prior to this meeting.
Chair – We have presented consensus-based changes to Par. 2(a) and (b) of the Chair Suggestion Sheet – a/k/a – “Suggestions by the Chair”.
Chamber of Commerce of Russian Federation – What is deadline for revised Par. 2?
Chair – The Chair confirms the Philippines ’ understanding of Chair Suggestion Sheet Par. 4 [relating to Agenda Item 10 - Client-Patent Advisor Privilege – set forth as Paragraphs 16 and 17 in the Summary by the Chair].
Secretariat – will prepare in English only.
Secretariat – changes to Par. (c)
Phillippines - Supports Chair’s text on Par. 5.
Agenda Item #12 – Contribution of SCP to Implementation of Development Agenda Recommendations:
Secretariat – Member states will be given the opportunity to express their reviews on this topic through a special mechanism at the 16th SCP. The Secretariat has agreed to revised language on Agenda Item #12 [as noted earlier: “Contribution of this committee to implementation of respective development agenda recommendations”, supra at “Day 1”].
Patent/health issues have been addressed constructively in the WHO and the UN, but not in the WIPO. Hopefully constructive WIPO engagement in this issue will accelerate. More discussions in the SCP are necessary about how patents can affect societal welfare. There is an ongoing naïve presumption that ensuring stronger IP rights will ensure economic growth and development. This has been rejected in global experiences. Using exceptions and limitations and flexibilities has so far been an academic discussion in this committee. Formulation of the questionnaire is hopefully a first step to creating a working program to assist developing countries to adopt. Tech transfer is quite important as a manifestation of the impediments of the patent system. The SCP must show how tech transfer can be effectively accomplished. Identifying how patents can be impediments to tech transfer is at the heart of this committee’s work program. This is necessary for a ‘balanced’ SCP work program.
[See The 45 Adopted Recommendations under the WIPO Development Agenda, WIPO website, available online at: http://www.wipo.int/ip-development/en/agenda/recommendations.html].
The aspects reflect social reality. We must avoid duplication. The inclusion of development agenda items should not preclude discussion of other business in the SCP. The resulting lack of balance would convert this committee into a duplication of other committees.
Chair - Meeting suspended. The Chair seeks advice concerning how to reach consensus.
[The Chair subsequently published its summary of this week of meetings. See: Summary by the Chair, SCP/16/8 (May 20, 2011), available online at: http://www.wipo.int/edocs/mdocs/scp/en/scp_16/scp_16_8.pdf].