Transparency of patents on medicines and other technologies
2016:1 KEI Briefing Note
Transparency of Patent Landscapes
April 25, 2016
At an April 12, 2016 WIPO seminar, Reed F. Beall and Amir Attaran presented a paper, “Patent-based Analysis of the World Health Organization’s 2013 Model List of Essential Medicines,” which includes the following odd comment:
“Strangely, the public health community has not placed much priority on patent transparency, although it has often expressed concern about the effect of patents on medicine access.” [page 26]
According to a report in IP Watch, Reed Beall criticized the recent United Nations Secretary-General’s High Level Panel on Access to Medicines, saying “amazingly people were more interested in having the ideological debate than simply focusing and asking for the data that can tell us exactly where there might be medicines access problems so that action can be taken.” [Ideologies Fly In Discussion Of WIPO Pharma Report Calling For Less Ideology, Catherine Saez, IP-Watch, March 13, 2016]
In the Beall/Attaran paper [KEI's April 12, 2016 comment here: http://www.keionline.org/node/2467], and in the WIPO seminar discussions about the paper, the authors have held themselves out as more or less lonely voices calling for transparency of patent landscapes on essential medicines. This surprised and offended the many people who have not only been concerned about the lack of transparency on patent landscapes, but have been doing most of the work in digging out the facts, and/or proposing remedies.
The Beall/Attaran paper deals specifically with the WHO Essential Medicines List (EML), and the authors might make the argument that not much is known about the patent landscape of the entire EML, per se, but that really misses the point. There are many studies and commentaries on the patent landscape for medicines that are essential, including both those on and off the WHO EML. Much of the work in publishing patent landscapes in recent years has been done by MSF, I-Mak, and the Medicines Patent Pool, as well as several academics and health NGOs. NGOs, including but not limited to KEI, have also addressed policy issues related to the transparency of patent landscapes, not only for medicines, but also in other areas, including clean energy, climate change, and standards essential patents on mobile computing devices, for example.
Below are just a few of the many data points regarding transparency of patents, most of them on medicines. Few of these deal only with the WHO EML, for two well-known reasons.
- First, from a historical perspective, the EML has generally avoided patented medicines. This includes the outdated version (2013, 18th Edition) that Beall and Attaran studied in their recent report.
KEI published an analysis by Paul Miano in 2011 which found that the WHO EML excluded all cancer drugs new enough to be patented. [2011:1. KEI Research Note: Paul Miano. Cancer: Approval, ownership, market structure, and placement on WHO Model Essential Medicines List, for 100 new molecular entities (NMEs) on the NCI alpha list of cancer drugs and vaccines.]
Until the EML began to change its policies on patented medicines, continually looking to find patents on the EML was mostly about proving the obvious -- a list that avoided patented medicines had few patents.
- Second, for those drugs that were likely to be patented, such as the drugs on the EML for HIV/AIDS, or more recently drugs for TB, HCV, and other illnesses where treatment efforts were being ramped up for medical reasons, studies have generally offered a deeper analysis focused on specific products, and the specific challenges of overcoming those patents, including patent evergreening on new formulations and new uses. There were also proposals to remedy the lack of transparency of patent landscapes.
This note addresses an exaggeration that seemed intended to portray groups concerned about patents and health as driven by ideological concerns, rather than an empirical approach. There have been extensive efforts for several years to improve the transparency of patent landscapes, involving many players. The work that Beall and Attaran dismiss as scattershot includes projects that have been the most important in overcoming patent barriers in places where they are consequential.
The following Annex provides a number of data points to illustrate how much is being done on this topic, though it is certainly not complete (See WIPO's http://www.wipo.int/patentscope/en/programs/patent_landscapes/ for many others not mentioned here). Apologies for the inconsistent approach to citations.
Annex: Some data points on the efforts to expand transparency of patent landscape
- 2016 March. The role of intellectual property in local production in developing countries, WHO, http://www.who.int/phi/publications/int_prop_role_local_prod_opportunities-challenges.pdf
- 2016 February 28. Discussion on transparency of ”Patent landscape” in Contribution To The United Nations Secretary General’s High Level Panel On Access To Medicines Increasing The Transparency Of Markets For Drugs, Vaccines, Diagnostics And Other Medical Technologies. Signed by 17 NGOs, 2 academics and 3 members of the European Parliament.
- 2016 February. Ensuring That Essential Medicines Are Also Affordable Medicines: Challenges And Options,discussion Paper, UNITAID. This UNITAID published report looks at the 19th WHO Essential Medicines List and the challenges to making new patented essential medicines affordable and available. The report includes patent status information of selected new essential medicines for cancer, TB and HCV. http://unitaid.org/images/marketdynamics/publications/Ensuring_that_essential_medicines_are_also_affordable_medicines_challenges_and_options.pdf
- 2016 February 25. Richard Laing And Margaret Ewen, Contribution To The United Nations Secretary General’s High Level Panel On Access To Medicines. http://www.unsgaccessmeds.org/inbox/2016/2/24/richard-liang-and-margaret-ewen. “The authors present evidence that nearly all essential medicines are not patent protected.”
- 2016 February 24. KEI intervention: TTIP Round 12 - Stakeholder events , Brussels KEI proposes: “the TTIP should mandate better transparency of the patent landscape on new medicines, including biologics. http://keionline.org/node/2424
- 2015. Intellectual property rights and challenges for development of affordable human papillomavirus, rotavirus and pneumococcal vaccines: Patent landscaping and perspectives of developing country vaccine manufacturers. Subhashini Chandrasekharan,Tahir Amin, Joyce Kim, Eliane Furrer, Anna-Carin Matterson, Nina Schwalbe, Aurélia Nguyen. Vaccine 33 (2015) 6366–6370.
- 2015. Patent Landscape Report on Assistive Devices and Technologies for Visually and Hearing Impaired Persons 2015. WIPO Patent Landscape Reports Project. http://www.wipo.int/edocs/pubdocs/en/wipo_pub_949_1.pdf
- 2015, November 23. KEI’s Initial Comments on the MPP/BMS license to patents and know-how for daclatasvir (DCV) http://keionline.org/node/2373. “In several areas, BMS is setting an important precedent, including the extensive transparency of the patent landscape for daclatasvir.”
- 2015 July 30. Written Statement of Knowledge Ecology International on Patents and Health at WIPO Standing Committee on the Law of Patents, SCP 22. http://keionline.org/node/2301. “The TPP also threatens to ban the effective implementation of liability rules, by create norms for the payment of damages that exceed current national laws and WTO TRIPS norms. We have published an article about this today in IP-Watch, highlighting the practical negative impact on this on the U.S. law to induce transparency of patents on biologic drugs. . .”
- 2015 July. Patent and licenses on antiretrovirals: A snapshot. UNITAID.
- 2015 July. Patent Landscape: elbasvir. UNITAID.
- 2015 July. Patent Landscape: grazoprevir. UNITAID.
- 2015 July. Patent Landscape: velpatasvir. UNITAID.
- 2015 July 10. KEI letter to HHS, regarding 3 issues in the TPP. http://keionline.org/node/2277. “The rationale for limiting damages in 35 U.S.C. 271(e)(6)(B) is to create an incentive for the biologic drug manufacturer to be more transparent about patent landscapes, and thus reduce the risks to the biosimilar drug company. The TPP would make the U.S. at risk for litigation under ISDS and sizable damages if this provision in the ACA is not changed.”
- 2015 March. Patent Situation of Key Products for Treatment of Hepatitis C, Sofosbuvir Working Paper, Prepared for the World Health Organization (WHO) by Thomson Reuters, Updated version, http://www.who.int/phi/implementation/ip_trade/sofosbuvir_report_updated.pdf
- 2015 March. Patent Situation of Key Products for Treatment of Hepatitis C, Ledispavir Working Paper, Prepared for the World Health Organization (WHO) by Thomson Reuters, http://www.who.int/phi/implementation/ip_trade/ledipasvir_report_update.pdf
- 2015 February. Hepatitis C medicines technology and market landscape. Geneva: UNITAID. href="http://www.unitaid.eu/images/marketdynamics/publications/HCV_Meds_ Landscape_Feb2015.pdf">http://www.unitaid.eu/images/marketdynamics/publications/HCV_Meds_ Landscape_Feb2015.pdf.
- 2015 January. Legal and regulatory frameworks for antiretroviral medicines and treatment in selected countries of the Commonwealth of Independent States, A Sub-regional Analytical Report including Belarus, Kazakhstan, Russia, Tajikistan, and Uzbekistan, UNDP, http://www.eurasia.undp.org/content/dam/rbec/docs/UNDP%20Essential%20ARV_web_V3.pdf
- 2014. Do companies publicly disclose patent status? Access to Medicine Index 2014, Page 107. http://www.accesstomedicineindex.org/sites/2015.atmindex.org/files/2014_accesstomedicineindex_patents_0.pdf
- 2014 October. Patent Landscape Report on Animal Genetic Resources Prepared for the World Intellectual Property Organization By Paul Oldham, Stephen Hall, Colin Barnes, in cooperation with the Food and Agriculture Organization of the United Nations (FAO), http://www.wipo.int/edocs/pubdocs/en/wipo_pub_947_3.pdf
- 2014 August. Patent Situation of Key Products for Treatment of Hepatitis C, ABT-450, Working Paper, Prepared for the World Health Organization (WHO) by Thomson Reuters, http://www.who.int/phi/implementation/ip_trade/ABT-450_report_2014-09-02.pdf
- 2014 August. Patent Situation of Key Products for Treatment of Hepatitis C, Daclatasvir, Working Paper, Prepared for the World Health Organization (WHO) by Thomson Reuters, http://www.who.int/phi/implementation/ip_trade/daclatasvir_report_2014_10-27.pdf
- 2014 August. Patent Situation of Key Products for Treatment of Hepatitis C, Dasabuvir, Working Paper, Prepared for the World Health Organization (WHO) by Thomson Reuters, http://www.who.int/phi/implementation/ip_trade/dasabuvir_report_2014-09-02.pdf
- 2014 August, Patent Situation of Key Products for Treatment of Hepatitis C, Ombitasvir, Working Paper, Prepared for the World Health Organization (WHO) by Thomson Reuters, http://www.who.int/phi/implementation/ip_trade/ombitasvir_report_2014_09-02.pdf
- 2014 August. Patent Situation of Key Products for Treatment of Hepatitis C, Simepravir Working Paper, Prepared for the World Health Organization (WHO) by Thomson Reuters, http://www.who.int/phi/implementation/ip_trade/simeprevir_report_2014_09-02.pdf
- 2014 April. Patents and licenses on antiretrovirals: A snapshot. UNITAID.
- 2014 January. Patent Landscape, SQ-109. UNITAID.
- 2014 January. Patent Landscape, AZD5847. UNITAID.
- 2014 January. Patent Landscape, sutezolid (PNU-100480). UNITAID.
- 2014 January.. Patent Landscape, bedaquiline (TM-C207). UNITAID.
- 2014 January. Patent Landscape, PA-824. UNITAID.
- 2014 January. Patent Landscape, delamanid (OPC-67683). UNITAID.
- 2013 November. Patent Landscape Report on E-Waste Recycling Technologies prepared for the World Intellectual Property Organization by Thomson Reuters IP Analytics in Cooperation with the Basel Convention Secretariat, Ed White and Rohit Singh Gole.
- 2013 May, How Do Public Health Safeguards in Indian Patent Law Affect Pharmaceutical Patenting in Practice?, Bhaven N. Sampat, Tahir Amin, Journal of Health Politics, Policy and Law 2013 Volume 38, Number 4: 735-755, http://jhppl.dukejournals.org/content/38/4/735.abstracttoken=pU4mbnToKj4...
- 2013 February. I-MAK, Patent Landscape Report for Pegylated Interferon Alfa 2A & 2B.
- 2012 December. Amy Kapczynski , Chan Park , Bhaven Sampat, Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents, http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0049470
- 2012 July. Barbara Milani and Cecilia Oh. PATENT INFORMATION AND TRANSPARENCY: A Methodology for Patent Searches on Essential Medicines in Developing Countries. United Nations Development Programme. ISBN: 978-0-615-67214-4. http://apps.who.int/medicinedocs/documents/s19575en/s19575en.pdf
- 2012 March. Patent Landscape Report on Membrane Filtration and UV Water Treatment, Prepared for the World Intellectual Property Organization By CambridgeIP - Helena van der Vegt, Ilian Iliev, http://www.wipo.int/edocs/pubdocs/en/patents/947/wipo_pub_947.pdf
- 2012 February. Intellectual property, technology transfer and manufacture of low-cost HPV vaccines in India, Swathi Padmanabhan, Tahir Amin, Bhaven Sampat, Robert Cook-Deegan & Subhashini Chandrasekharan, Nature Biotechnology 28, 671–678 (2010) doi:10.1038/nbt0710-671
- 2012. Patent Landscape Report on Vaccines for Selected Infectious Diseases Prepared for: World Intellectual Property Organization By France Innovation Scientifique & Transfert FIST S.A., http://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946_3.pdf
- 2012. Secondary Patenting Of Branded Pharmaceuticals: A Case Study Of How Patents On Two HIV Drugs Could Be Extended For Decades. Health Affairs, 31, no.10 (2012):2286-2294. Tahir Amin and Aaron S. Kesselheim. doi: 10.1377/hlthaff.2012.0107.
- 2012. Patent Landscape Report on Solar Cooling Technologies prepared for the World Intellectual Property Organization By Swiss Federal Institute of Intellectual Property, Daniel Kunz, Heinz Müller and Christian Soltmann, http://www.wipo.int/edocs/pubdocs/en/patents/948/wipo_pub_948_3.pdf
- 2011 November. Patent Landscape Report on Atanazavir Prepared for the World Intellectual Property Organization By Thomson Reuters IP Solutions, IP Consulting Group In cooperation with the Medicines Patent Pool (MPP), http://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946_2.pdf
- 2011 November. Patent Landscape Report on Desalination Technologies and the Use of Alternative Energies for Desalination Prepared for the World Intellectual Property Organization by CambridgeIP - Helena van der Vegt, Ilian Iliev, Quentin Tannock, Sarah Helm, In cooperation with the International Renewable Energy Agency (IRENA) with participation of the Global Institute for Water, Environment and Health (GIWEH), http://www.wipo.int/edocs/pubdocs/en/patents/948/wipo_pub_948_2.pdf
- 2011 October 28. Patent Landscape Report on Ritonavir Prepared for the World Intellectual Property Organization By Landon IP http://www.wipo.int/patentscope/en/programs/patent_landscapes/reports/ritonavir.html
- 2011 August. Patent Landscape Report on Solar Cooking Prepared for the World Intellectual Property Organization By SCOPE e-KNOWLEDGE CENTER PRIVATE LIMITED, http://www.wipo.int/edocs/pubdocs/en/patents/948/wipo_pub_948_1.pdf
- 2011 April, Patent Status of ARVS, Medicines Patent Pool (launched in April 2011, updated frequently), http://www.medicinespatentpool.org/patent-data/patent-status-of-arvs
- 2011. Paul Miano. Cancer: Approval, ownership, market structure, and placement on WHO Model Essential Medicines List, for 100 new molecular entities (NMEs) on the NCI alpha list of cancer drugs and vaccines. 2011:1. KEI Research Note. http://keionline.org/rn2011-1
- 2011 April 13. Patent data mining: a tool for accelerating HIV vaccine innovation. Clark K1, Cavicchi J, Jensen K, Fitzgerald R, Bennett A, Kowalski SP. Vaccine. 2011 May 31;29(24):4086-93. doi: 10.1016/j.vaccine.2011.03.052. Epub 2011 Apr 13.
- 2011 February 18. Meeting Code: WHO-WIPO-WTO/IP/MED/GE/11. Geneva, Switzerland. Access to Medicines, Patent Information and Freedom to Operate; a Technical Symposium. http://www.wipo.int/meetings/en/details.jsp?meeting_id=22322. The Beall/Attaran paper may have been related to this technical workshop, which explored the same issues. As one can observe from the video and the presentations, there were two basic camps at the meeting, those who were trying to promote greater transparency in the areas where patents were perceived to be a problem (i.e. Amin, Hoen, etc), and those more interested in claiming the lack of patents on the WHO EML was evidence that patents did not hurt patient access to drugs - the school of thought associated with the notion that poor people would not need new drugs.
- WHO-WIPO-WTO/IP/MED/GE/11/A0. Summary and Key Issues Summary and Key Issues.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/A/CHAN. Opening Remarks - Mrs. Margaret Chan, Opening Remarks - Mrs. Margaret Chan.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/A2/LAMY. Opening Remarks - Mr. Pascal Lamy, Opening Remarks - Mr. Pascal Lamy.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/B1/MIRZA. Access and Information Needs from a Public Health Perspective - Mr. Zafar Mirza Access and Information Needs from a Public Health Perspective - Mr. Zafar Mirza.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/B2/TAUBMAN. Access to Medicines, Patent Information and Freedom to Operate - Mr. Anthony Taubman. Access to Medicines, Patent Information and Freedom to Operate - Mr. Anthony Taubman.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/B3/KRATTIGER. Managing IP for Access - Mr. Anatole Krattiger. Managing IP for Access - Mr. Anatole Krattiger.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/B4/KOWALSKI. Patent Literature and Methodology: WHO Model List of Essential Medicines - Mr. Stan Kowalski Patent Literature and Methodology: WHO Model List of Essential Medicines - Mr. Stan Kowalski.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/B5/LAING. The Patent Status of Medicines on the WHO Model List of Essential Medicines - Mr. Richard Laing The Patent Status of Medicines on the WHO Model List of Essential Medicines - Mr. Richard Laing.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/B6/THOEN. The Medicines Patent Pool - Understanding the Patent Status of Antiretroviral Drugs - Mrs. Ellen ‘t Hoen The Medicines Patent Pool - Understanding the Patent Status of Antiretroviral Drugs - Mrs. Ellen ‘t Hoen.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/B7/FRIEDE. Patent Landscaping for Vaccines: Patent Information, Tools and Methodologies - Mr. Martin Friede Patent Landscaping for Vaccines: Patent Information, Tools and Methodologies - Mr. Martin Friede.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/B8/MAHONEY. IP and Dengue Vaccines: A case study - Mr. Richard T. Mahoney. IP and Dengue Vaccines: A case study - Mr. Richard T. Mahoney.
- WHO-WIPO-WTO/IP/MED/GE/11/REFB9//LM. WIPO's Legal Status Data Project - Mr. Lutz Mailänder WIPO's Legal Status Data Project - Mr. Lutz Mailänder.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/B10/LOGEZ. Global Fund Experience: Access to Patent Information and Impact on Procurement of Medicines - Ms. Sophie Logez Global Fund Experience: Access to Patent Information and Impact on Procurement of Medicines - Ms. Sophie Logez.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/B11/TAMIN. Searching for Transparency: Patent Information in Practice - Mr. Tahir Amin.
- WHO-WIPO-WTO/IP/MED/GE/11/REF/A1/GURRY. Opening Remarks - Mr. Francis Gurry, Opening Remarks - Mr. Francis Gurry.
- 2010 December. Searching for Transparency: Improving Patent Information to Increase Access to Medicines. BRIDGES, VOLUME 14 - NUMBER 4 17,Tahir Amin.
- 2010 May. Tahir Amin, HIV Drug Patents in China. I-MAK
- 2010. How to conduct patent searches for medicines, Tahir Amin. World Health Organization.
- 2010 July 16. Establishment of the Medicines Patent Pool which created the most comprehensive and transparent data base on patents for HIV medicines building on previous work by MSF. Available here: http://www.medicinespatentpool.org/patent-data/patent-status-of-arvs/
- 2010 October 14. KEI proposed the WIPO SCP 15 create a cluster create a cluster of experts to examine: “Possible best practices or global norms for mandatory obligations to disclose patents relating to open standards for some essential information or energy technologies or other essential areas of technology.” http://keionline.org/node/978
- 2009. Development Agenda project DA_19_30_31_01 (“Developing Tools for Access to Patent Information”) described in document CDIP/4/6, adopted by the Committee on Development and Intellectual Property (CDIP) at its fourth session held from November 16 to November 20, 2009.
- 2009 Fall. Franklin Pierce Law Center Educational Report: Patent Landscape Of Adjuvant For Hiv Vaccines. http://www.wipo.int/export/sites/www/patentscope/en/programs/patent_landscapes/documents/itti_patent_ls_hiv_vaccine_adjuvants.pdf
- 2009 February 13. Comments by WIPO SCP Members and Observers on the WIPO Report on the International Patent System. Comments by WIPO SCP Members and Observers on the WIPO Report on the International Patent System. http://keionline.org/blogs/2009/02/13/patent-report-comments.
The SCP could explore the creation of a multilateral mechanism administered by WIPO to share information on disputes over patent quality. This could include the creation of a database, possibly associated with the Patent Cooperation Treaty or through a separate instrument. The database could include information about administrative actions, such as patent reexaminations, as well as private litigation between parties, including both cases decided by the courts and those privately settled.
* The SCP could consider minimum standards for transparency of such disputes.
* The burden of disclosing information on patent challenges could be placed on patent owners.
The sanction for non-disclosure could be the non-enforcement of patent rights – an approach used in the United States when patent owners fail to disclose U.S. Government rights in patents that are based upon government funded research.
Background paper: James Love, “Measures to Enhance Access to Medical Technologies, and New Methods of Stimulating Medical R & D, UC Davis Law Review, Volume 40, Issue No. 3 Symposium: Intellectual Property and Social Justice, 679. An earlier version of this paper is found in James Love, “Four Practical Measures to Enhance Access to Medical Technologies,” in Negotiating Health (Pedro Roffe et al. Eds., cited below).
- 2009 March 23. Knowledge Ecology International (KEI) organized a Briefing on Patents and Standards at WIPO’s 13th meeting of the Standing Committee on Patents (SCP), where the issue of disclosure of standards relevant pages was discussed. http://keionline.org/blogs/2009/03/23/scp-13-side-event, and provided this comment on SCP/12/3 Rev.2, Annex III, page 36:
Standard setting organizations have a legitimate interest in knowing before they adopt a standard if it will be free of patents, or if the patents relating to the standard will be licensed on reasonable terms. Increasingly this is a global problem. The Internet Engineering Task Force (IETF), the World Wide Web Consortium (w3c) and other bodies create global standards. They should know the entire global patent landscape before they act. At present there is no global framework that requires patent owners to disclose patents relevant to the standard.
In establishing standards for new technologies, protocols and platforms, it is generally the case that a standard setting organization (SSO) seeks disclosure of patent claims essential to the working of the relevant field of technology. If there exist relevant patent claims, the SSO will either (a) choose a different standard not encumbered by the patent, or (b) ask the patent owner to agree not to enforce existing or future patent claims against those implementing the standard, (c) request the patent holder to license the patent on a royalty-free basis, or (d) seek a commitment by the patent owner to license on reasonable and non-discriminatory (RAND) terms.
Patent owners are not currently required to disclose such patent claims, except in limited circumstances in some countries. For example, in the United States and some other countries, there is an expectation that patent owners must sometimes disclose patent claims when they are members of the body adopting the standard. This obligation is inadequate, however, because it does not exist in some countries, or to patent owners who are not active in the standard setting process.
The WIPO report highlights that tensions can arise between patents and standards with respect to the disclosure of patents “which become apparent when the implementation of a standard calls for the use of technology covered by one or more patents.” As the International Bureau has noted, current competition and legal remedies may not be enough to solve the inherent tensions that routinely arise in the realm of patents and standards. Reiterating our call at the 12th session of the WIPO SCP, WIPO should consider if the current systems of providing constructive notice regarding patent status to standards making bodies is working well in a global economy. WIPO should also consider whether or not it can facilitate global disclosures of patents on proposed standards, including a possible an instrument on patents and standards that would address both the issue of disclosure and remedies to non-disclosure, not only for members of standards-making organizations, but extending to third parties as well.
2009 February 13. Comments by WIPO SCP Members and Observers on the WIPO Report on the International Patent System. Comments by WIPO SCP Members and Observers on the WIPO Report on the International Patent System. http://keionline.org/blogs/2009/02/13/patent-report-comments.
KEI notes that issues concerning standards are increasingly global concerns, involving goods and services that move in international trade across borders.
One issue that is very important and highlighted in the WIPO report concerns the disclosure (and non-disclosure) of patents relevant to the implementation of a proposed standard. When goods move in international trade, the systems for such disclosure cannot be based upon the laws of a single country, and there is a strong rationale for global norm-setting in this area.
Companies and patent owners who operate in good faith do not rely upon patent ambushes.
We note that many businesses believe that the current systems for disclosure are inadequate, in part because they do not extend outside of the membership of standard-setting bodies, and the disclosures that are made are often deliberately not helpful. Issues of standards are increasingly important for vast areas of the modern economy, including of course information, computing and telecommunications technologies and services, as well many other many other areas, such as certain energy and environmental technologies, and important elements of transportation technologies, to mention a few.
In March 2005, a multi-stakeholder group proposed a treaty on access to knowledge. This included a mechanism for managing disclosures on patents relevant to proposed standards.
- 2008 May. World Health Assembly (WHA) Global strategy and plan of action on public health, innovation and intellectual property (GSPOA). Resolution 61.21(Sixty-first). NGOs and others asked for action on greater patent transparency. The GSPOA as a result includes the following paragraph:
5.1.c. facilitate widespread access to, and promote further development of, including, if necessary, compiling, maintaining and updating, user-friendly global databases that contain public information on the administrative status of health-related patents, including supporting the existing efforts for determining the patent status of health products, in order to strengthen national capacities for analysis of the information contained in those databases, and improve the quality of patents;
- 2008 April 7-8. Life Sciences Symposium: Public Policy Patent Landscaping in the license sciences, organized by the World Intellectual Property Organization (WIPO) in cooperation with the Food and Agricultural Organization (FAO), April 7 and 8, 2008 at WIPO, 34, chemin des Colombettes, Geneva. http://www.wipo.int/meetings/en/2008/lifesciences/patent_landscaping/
Day 2: Life Sciences Public Policy Landscaping
- Ms. Precious Matsoso, Director, Department of Technical Cooperation for Essential Medicines, Drugs and Traditional Medicines, WHO [PDF]
- Mr. Fred Abbott, Professor of International Law, Florida State University College of Law [PDF]
- Ms. Pascale Boulet, Legal Adviser, Campaign for Access to Essential Medicines, Médecins Sans Frontiers (MSF) [PDF]
- Patenting trends in relation to neglected diseases: Tuberculosis, African sleeping sickness, rabies, African river blindness, leprosy, AIDS, leishmaniasis Mr. Raj Hirwani, Unit for Research and Development of Information Products (URDIP), India
- Patent landscape on avian flu, Mr. Ben Prickril, PIIPA [PDF]
- Ms. Corrina Moucheraud Vickery, Program on Global Health and Technology Access Terry Sanford Institute of Public Policy Duke University
- Edward Hammond, Consultant, Third World Network
- Mr. Martin Friede, Initiative for Vaccine Research, Product Research, and Development, Immunization, Vaccines and Biologicals, WHO [PDF]
- Mr. Tahir Amin, Harvard Medical School
- Mr. Antony Taubman
- Mr. Paul Oldham, ESRC Centre for Economic and Social Aspects of Genomics [PDF]
Health-Related Patent Landscaping
The public health policy context: patent information needs, current policy concerns and patent landscaping initiatives
Review of landscaping initiatives
Commentary: review of methodology, limitations, lessons for policymakers
Commentary: review of methodology, limitations, lessons for policymakers
Patent information and the multilateral environment agreements
- 2007 April. From Transparency to Quality: Bridging the Gap Between Access to Knowledge and Medicines. Tahir Amin, I-MAK. http://static1.1.sqspcdn.com/static/f/129694/796876/1177967266993/From+Transparency+to+Quality+-+A2K2Tahir+Amin.pdf
- 2007 March, James Love, "Measures to Enhance Access to Medical Technologies, and New Methods of Stimulating Medical R & D, UC Davis Law Review, Volume 40, Issue No. 3 Symposium: Intellectual Property and Social Justice, 679. This paper proposed a mechanism to promote the “Transparency of Relevant Patents” for drugs and vaccines. http://lawreview.law.ucdavis.edu/issues/40/3/developing-drugs-for-developing-word/DavisVol40No3_Love.pdf
As flawed as the Orange Book system is, however, it could easily be modified to work better. In particular, a listing of patents could be required or encouraged in various ways. For example, drug registration authorities could require or encourage the disclosure, without linking the disclosure to drug registration, by providing that patent owners could not enforce undisclosed patents against generic competitors. Although this approach would likely still result in the listing of patents of dubious quality or relevance, the drug registration authorities would not use the listing to block generic competitors. The patent owners would have to seek enforcements in national court systems, as is the case now in most countries, and everywhere for nonpharmaceutical inventions.
Regional or multilateral bodies concerned with health care, such as the African Union, the Pan American Health Organization, the World Bank, the Joint United Nations Program on HIV/AIDS, the Global Fund, regional patent pools, or the World Health Organization (“WHO”) could also play an important role in requiring or encouraging patent listings. For example, donors for AIDS treatments could meet with the handful of companies that develop key AIDS drugs and insist that they disclose the relevant patent numbers and countries where the patents are approved. This information could then be published on the Internet.
The task of disclosure could also be managed by local, regional, or multilateral patent offices, including the Patent Cooperation Treaty (“PCT”), which is administered by the World Intellectual Property Organization (“WIPO”). While patent offices have not played a traditional role in such disclosures, it is increasingly difficult to ignore the enormous problems presented by the lack of transparency of patent status.
One advantage of a global system would be the availability of information about the differences in the patent landscape for the same drug sold in different countries. Countries that face a high number of patents may seek to understand why such patents are not listed for other jurisdictions. The global authority could also do a more efficient job of “delisting” patents that are not relevant.
- 2006 November. The Patenting of Human DNA: Global Trends in Public and Private Sector Activity (The PATGEN Project). http://www.wipo.int/export/sites/www/patentscope/en/programs/patent_landscapes/documents/patgen_finalreport.pdf
- 2005 December 3. Four Practical Measures to Enhance Access to Medical Technologies,” James Love. In Negotiating Health, Pedro Roffe, Geoff Tansy, David Vivas-Eugui, Eds. Routledge. ISBN-13: 978-1844072958
- 2005, May 10. A number of NGOs, including KEI, proposed a treaty on access to knowledge. The treaty proposal included and Article 6-2, on Disclosure obligations for patents relating to standards development organizations.
- 2004 July. Analysis of "Junk DNA" Patents: “Intron Sequence Analysis Method for Detection of Adjacent and Remote Locus Alleles as Haplotypes.” Carol Nottenburg and Jade Sharples. CAMBIA. http://www.wipo.int/export/sites/www/patentscope/en/programs/patent_landscapes/documents/patentlens_techlandscape_junkdna.pdf. This report notes that "Technology landscapes, by their very nature, become outdated" as soon as they are published.
- 2004 May. "How Do Patents And Economic Policies Affect Access To Essential Medicines In Developing Countries?" Health Aff May 2004 vol. 23 no. 3 155-166. Amir Attaran.
- 2003 May. Drug patents under the spotlight: Sharing practical knowledge about pharmaceutical patents. Médecins Sans Fronti`eres, Pascale Boulet, Christopher Garrison, Ellen ‘t Hoen. http://apps.who.int/medicinedocs/en/d/Js4913e/
- 2001 October 17. Do patents for antiretroviral drugs constrain access to AIDS treatment in Africa?" Amir Attaran and Lee Gillespie-White. JAMA. 2001 Oct 17;286(15):1886-92.
- 2001 October 16. "Comment on the Attaran/Gillespie-White and PhRMA surveys of patents on Antiretroviral drugs in Africa," by Consumer Project on Technology, Essential Action, Oxfam, Treatment Access Campaign, and HealthGap. http://www.cptech.org/ip/health/africa/dopatentsmatterinafrica.html
- 2001 September 30. Tom Bombelles (Merck), presents PhRMA data on patent landscape for HIV and WHO EML, at American Society of Law, Medicine & Ethics (ASLME) conference on Law and Human Rights.
- 2000 December. Patent Protection and Access to HIV/AIDS Pharmaceuticals in Sub-Saharan Africa. International Intellectual Property Institute (IIPI) for WIPO. http://www.wipo.int/export/sites/www/about-ip/en/studies/pdf/iipi_hiv.pdf
- 2000 January. UNAIDS/WHO, Pascale Boulet, Jos Perriens, Françoise Renaud-Théry, Patent situation of HIV/AIDS drugs-related drugs in 80 countries. http://www.who.int/3by5/en/patentshivdrugs.pdf