[Ip-health] Transparency of patent landscapes

Jamie Love james.love at keionline.org
Tue Apr 26 05:55:35 PDT 2016


This is a long note, probably best read from the web page link, that was
motivated by Reed Beall and Amir Attaran's comments in their WIPO paper and
during the seminar where they presented the paper.   Beall and Attaran
claimed that "Strangely, the public health community has not placed much
priority on patent transparency," a comment that was certainly inaccurate
and many found offensive.    Jamie

http://www.keionline.org/node/2478

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.

1. 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.

2. 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

1. 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

2. 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.
http://keionline.org/sites/default/files/UN-HLP-A2M-Transparency-28Feb2016-Final.pdf

3. 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

4. 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."

5. 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

1. 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.

2. 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

3. 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."

4. 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. . ."

5. 2015 July. Patent and licenses on antiretrovirals: A snapshot. UNITAID.

6. 2015 July. Patent Landscape: elbasvir. UNITAID.

7. 2015 July. Patent Landscape: grazoprevir. UNITAID.

8. 2015 July. Patent Landscape: velpatasvir. UNITAID.

9. 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."

10. 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

11. 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

12. 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.

13. 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

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 2014 April. Patents and licenses on antiretrovirals: A snapshot. UNITAID.

9. 2014 January. Patent Landscape, SQ-109. UNITAID.

10. 2014 January. Patent Landscape, AZD5847. UNITAID.

11. 2014 January. Patent Landscape, sutezolid (PNU-100480). UNITAID.

12. 2014 January.. Patent Landscape, bedaquiline (TM-C207). UNITAID.

13. 2014 January. Patent Landscape, PA-824. UNITAID.

14. 2014 January. Patent Landscape, delamanid (OPC-67683). UNITAID.

2013

1. 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.

2. 2013 February. I-MAK, Patent Landscape Report for Pegylated Interferon
Alfa 2A & 2B.

2012

1. 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

2. 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

3. 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

4. 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

5. 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.

6. 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

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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.

8. 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.

i. WHO-WIPO-WTO/IP/MED/GE/11/A0. Summary and Key Issues Summary and Key
Issues.

ii. WHO-WIPO-WTO/IP/MED/GE/11/REF/A/CHAN. Opening Remarks - Mrs. Margaret
Chan, Opening Remarks - Mrs. Margaret Chan.

iii. WHO-WIPO-WTO/IP/MED/GE/11/REF/A2/LAMY. Opening Remarks - Mr. Pascal
Lamy, Opening Remarks - Mr. Pascal Lamy.

iv. 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.

v. 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.

vi. WHO-WIPO-WTO/IP/MED/GE/11/REF/B3/KRATTIGER. Managing IP for Access -
Mr. Anatole Krattiger. Managing IP for Access - Mr. Anatole Krattiger.

vii. 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.

viii. 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.

ix. 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.

x. 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.

xi. 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.

xii. 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.

xiii. 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.

xiv. WHO-WIPO-WTO/IP/MED/GE/11/REF/B11/TAMIN. Searching for Transparency:
Patent Information in Practice - Mr. Tahir Amin.

xv. WHO-WIPO-WTO/IP/MED/GE/11/REF/A1/GURRY. Opening Remarks - Mr. Francis
Gurry, Opening Remarks - Mr. Francis Gurry.

2010

1. 2010 December. Searching for Transparency: Improving Patent Information
to Increase Access to Medicines. BRIDGES, VOLUME 14 - NUMBER 4 17,Tahir
Amin.

2. 2010 May. Tahir Amin, HIV Drug Patents in China. I-MAK

3. 2010. How to conduct patent searches for medicines, Tahir Amin. World
Health Organization.

4. 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/

5. 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

1. 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.

2. 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

3. 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 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.

4. 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.

2008

1. 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;

2007

1. 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

2. 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

1. 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

1. 2005 December 3. Four Practical Measures to Enhance Access to Medical
Technologies," James Love. InNegotiating Health, Pedro Roffe, Geoff Tansy,
David Vivas-Eugui, Eds. Routledge. ISBN-13: 978-1844072958

2. 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

1. 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.

2. 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

1. 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

1. 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.

2. 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

3. 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

1. 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

2. 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


-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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