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Thailand's Compulsory Licenses for Medicines
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SIGN-ON LETTER TO USTR SUPPORTS THAILAND'S COMPULSORY LICENSE FOR EFAVIRENZ

The following letter was sent to Honorable Condoleezza Rice, Secretary of State, and Ambassador Susan Schwab, United States Trade Representative, asking that the United State cease any opposition or interference with Thailand's efforts to use legal WTO flexibilities to buy generic AIDS medicines.   The letter was sent on Wed, December 20, 2006.

The letter was coordinated by Consumers Project for Technology, ben.krohmal@cptech.org. CPATH signed this letter.

Honorable Condoleezza Rice, Secretary of State
Ambassador Susan Schwab, United States Trade Representative

Dear Secretary Rice and Ambassador Schwab:

We are writing to express our concern that the United States Department of State and the United States Trade Representative and have intervened in the decision by the government of Thailand to issue a compulsory license on patents for the AIDS drug efavirenz, and to explain why the US government should refrain from such actions.

click here to read entire letter

In October, 2006, Thai Academics and Activists from the Thai Network of People Living with HIV/AIDS (TNP+) Spoke to Health Advocates in United States about the U.S.-Thai Free Trade Agreement

The Tour went to NY, DC, Austin, Philadelphia, Chicago, Indiana, Minneapolis, San Francisco

 

ENGAGE, in collaboration with Oxfam America’s CHANGE Initiative and the Thai Network for People living with HIV/AIDS (TNP+), and working with CPATH, coordinated the US-Thai FTA Speaker Tour.

Link to Engage

The touring representatives included AIDS Access Foundation leader and activist, Sangsiri Teemanka; Vice President of the Thai Network of People Living with HIV/AIDS (TNP+), Boripat Donmon; and associate professor at the Faculty of Pharmaceutical Sciences at Chulalongkorn University, Bangkok, Jiraporn Limpananont.  Their primary purpose in coming to the United States was to initiate dialogue between Thai and U.S. citizens concerning the pending Thai-U.S. Free Trade Agreement (FTA).  They will especially address predicted effects of the Thai-U.S. FTA on International Property Rights (IPRs) and therefore, access to medication in Thailand.

thaiftatour10-06016_edited.jpg
Sangsiri Teemanka

In addition to Sangsiri Teemanka’s current work with TNP+ and FTA Watch, she is part of the AIDS ACCESS Foundation (AAF), with whom she has designed and implemented training projects such as sex education for secondary school students, opportunistic infections and antiretroviral therapy, and counseling and behavior change.  She has also worked on successful campaigns to incorporate anti-retroviral medication (ARV) into the Thai public health system, the Bristol-Meyer-Squibb (BMS) court case to revoke the patent on ddl in Thailand, and recently, campaigns to oppose the application by Glaxo-Smith-Kline (GSK) for a patent on Combid in Thailand.  At the 14th International AIDS conference (IAC) in Bangkok, Teemanka played a large role in initiating the concept of the global village, now a permanent fixture of the IAC.

thaiftatour10-06020_edited.jpg
Jiraporn Limpananont

Jiraporn Limpananont has been an integral member and academic advisor to the ‘Drug Study Group,’ a network of university academics who fights to improve and protect access to medications and the Health and Development Foundation, who worked with others to successfully campaign against the GSK patent application on “Combid” in Thailand.  The Drug Study Group was also part of the ultimately successful, 3-year long lawsuit filed against BMS, which resulted in the revocation of the BMS ddl patent.  Limpananont expresses her concern for access to medication through her numerous publications about TRIPS, drug patents, the Thai health system, and implications of a Thai-U.S. FTA.  She is also a member of FTA Watch, a coalition formed under concern for the non-transparent manner in which FTA negotiations were being conducted by the Thai government.

copyofthaiftatour10-06014_edited.jpg
Boripat Donmon

Boripat Donmon has worked for PLHA since 1999.  He was a committee member of the community advisory board on vaccine trials in Thailand from 2004-2005 and participated in lobbying for the creation of a national Thai health security scheme by leading a campaign to gather 50,000 signatures.  He has been living with HIV for 13 years, but campaigns with other parties unduly affected by the Thai-U.S. FTA such as farmers.  He participated in protests during FTA negotiation rounds in Thailand, and his travels to Hong Kong with agricultural workers and representatives of slum networks to protest the 2005 WTO meeting inspired him to his present work, ensuring access to second line medication in Thailand.

Thailand: FTAs and Access to Medicines

 

Photos from Special Internal Medicine Noon Seminar: Friday 10/27, Moffitt Hospital, University of California, San Francisco, California: "International Trade and its Effect on Global HIV Treatment"

 

A Panel Discussion Featuring:

 

* Vivek Jain, M.D.Chief Resident, Internal Medicine, in conversation with

Ellen R. Shaffer, PhD MPH, CPATH (Center for Policy Analysis on Trade and Health)

*Kyra Busch and Brighid O'Keane, Engage

* International visitors from Thailand concerned with the predicted effects of the pending Thai-U.S. FTA on International Property Rights (IPRs) and access to medicines in Thailand:

  • Jiraporn Limpananont, associate professor at the Faculty of Pharmaceutical Sciences at Chulalongkorn University, Bangkok
  • Sangsiri Teemanka, AIDS Access Foundation leader and activist
  • Boripat Donmon, Vice President of the Thai Network of People Living with HIV/AIDS (TNP+)

We explored the history behind US-International trade agreements, how they impact the buying and selling of medications (especially generic drugs), and the current challenges that legislators and international health advocates are facing.

thaiftatour10-06015_edited.jpg
Boripat Donmon (l) addresses access to AIDS treatment, Kyra Busch (r)

UCSF Audience Engages with Thai Access Activists
thaiftatour10-06019.jpg

copyofthaiftatour10-06023_edited.jpg

(l-r) Vivek Jain, Brighid O'Keane, Boripat Donmon, Sangsiri Teemanka, Kyra Busch, Jiraporn Limpananont, Ellen Shaffer, Joe Brenner

Click Here for Tour Press Release

THAILAND ISSUES COMPULSORY LICENSE;
USTR PRESSURES THAILAND TO REVERSE COURSE
 
Responding to activists, Thailand announced in November that it will issue a 5 year compulsory licence for Merck's antiretroviral drug, Efavirenz.  The following 4 postings document the decision, a statement by Brook Baker for Health GAP on why the CL is important, and CP Tech's letter to the USTR opposing US pressure, and delineating the legal basis for the Thai action.   
 
1. Announcement of Compulsory License Use in Thailand

From: "tui" <tui@aidsaccess.com>
Date: Wed, 29 Nov 2006 15:40:39 +0700

Below, is the press release of Thai People Living With HIV/AIDS after we
marched to the Ministry of Public Health and urged them to use CL for ARV:

Bangkok 29 Nov. 2006 :   The Thai Ministry of Public Health has bowed to
pressure from HIV/AIDS lobbyists and NGOs and has agreed to issue a 5 year
compulsory licence (CL) for the anti retro viral drug, Efavirenz commonly
used in first line treatment for HIV. US Pharmaceutical company, Merck,
currently holds a patent on Efavirenz in Thailand making this medication
expensive and prohibiting the Government Pharmaceutical Organisation (GPO)
from producing a generic version. This decision from the new military regime
has been made despite years of unsuccessfully lobbying past governments.

This announcement comes after tireless work and lobbying from the Thai
Network of People Living with HIV/AIDS (TNP+) and other HIV/AIDS activists
to advocate for the government to utilise the flexibilities granted them in
the World Trade Organisation�s TRIPS agreement. The National Health Security
Office has also formed a committee dedicated to investigating the
possibility of issuing a CL. The CL will allow the Thai government to import
a generic version of Efavirenz from abroad until the GPO is able to produce
its own generic version saving the Public Health System millions of baht a
year.

This ground breaking decision sets an important precedent for the issuing of
CL for other desperately needed but costly medication for other chronic
diseases such as kidney disease and cancer.

================================
Sangsiri Teemanka
Advocacy Team, AIDS ACCESS Foundation
48/282 Center Place Ramkamheang Rd.
Sapansoong Bangkok 10240
Tel : 66 2 372 2113 -4
Fax : 66 2 3722116
___________________________________________________________
2. MSF Interview with Dr. Suwit Wibulpolprasert
Senior Advisor on Health Economics, Ministry of Public Health, Thailand
30 November, 2006

http://www.accessmed-msf.org/prod/publications.asp?scntid=30112006143362&contenttype=PARA&

____________________________________________________________________

3. Price-Cut Handcuffs:  Thailand must stand up to Merck and implement its compulsory license on efavirenz.
Brook K. Baker, Health GAP
From: B.Baker@neu.edu
December 3, 2006

On November 29, the Thailand Department of Disease Control, Ministry of
Health, announced that it had issued a compulsory license for Efavirenz
that would allow immediate importation at half the cost from India and
subsequent local production by GPO.  The compulsory license would be
effective through December 31, 2011 and would allow treatment of up to
200,000 Thais.  A modest royalty of .5% would be payable to the patent
holder, Merck.  This license is the result of years of advocacy by Thai
activists, including TNP+, and other NGOs trying to convince Thai officials
to secure more affordable and diverse sources of life-saving medicines.

Within two days, Merck leapt to the defense of its patent by offering to
discuss discount prices or voluntary licenses with the Government
Pharmaceuticals Organization.  In doing so, Merck complained that it had
received no prior warning's of the government's intention and further
claimed that there had "been no process in terms of Thai law or
international law, where the company has been consulted or where the
company has been asked what they [sic] could do to assist."

To the contrary, neither Thai law nor international law requires prior
negotiation for a voluntary license or for price discounts before issuing a
compulsory license for government, non-commercial use (commonly called
government or crown use) or for a health emergency such as that presented
by HIV/AIDS.  Article 31 of the TRIPS Agreement specifically authorizes
government use without negotiation, and the 2001 Doha Declaration on the
TRIPS Agreement and Public Health confirms this procedure.  There's no way
that Merck officials don't understand the legality of Thailand's stated
intentions, but that doesn't stop Merck's disinformation team from
suggesting that Merck has been treated unfairly and perhaps even illegally.

The U.S. and its drug companies have a long history of trying to prevent
issuance of compulsory licenses by developing countries.  The infamous
1998-2001 Big Pharma lawsuit in South Africa, the 2001 U.S. WTO complaint
against Brazil, and routine drug company and Congressional threats against
Brazil when it has threatened to issue compulsory licenses are only the tip
of the trade-threats iceberg.  The US Ambassador had written to the Thai
government in 1999 that "the Thai government certainly don't want to be the
cause of a trade dispute, which is what we have always told them would
happen if compulsary [sick] licensing clause should be invoked."  The
Ambassador continued that this would set "a worrisome precedent for the
rest of the drug industry."

Well, the U.S. government "always" resisted compulsory licenses, pre-Doha,
and it continues to do so now with backroom pressure and threats including
those routinely presented in its Section 301 Trade Reports where it has in
the past complained about Brazil's threatened issuance of compulsory
licenses.

Brazil actually represents a cautionary tale because it has cried wolf
three times by threatening to issue compulsory licenses for key,
second-line antiretrovirals.  However, each time, the government has
inexplicably backed down and accepted temporary price discounts that were
inferior to prices that could have been obtained through local production
or importation from India.  Rather than set a leading-developing-country
example that could catalyze more widespread compulsory licensing throughout
the Global South, Brazil set a negative example of caving into U.S.
pressure.
It is no secret to Merck that its supply chain in Thailand has been
erratic, threatening patient safety, nor that it has been charging prices
nearly double those available from WHO-prequalified generic competitors.
If Merck could figure out how to file a lawsuit, it would, like its
bedfellows Pfizer and Novartis have done in the Philippines and in India
(challenging government action allowing early registration and strict
definitions of pharmaceutical patentability respectively).  Since Merck
can't find even minimally plausible grounds for a lawsuit, it will instead
seek to mislead the public that it is the wronged party and then try to get
its USTR and Congressional bullyboys to apply pressure on the post-coup
Thai government.  Hopefully even a military government will see that the
future health of tens of thousands of PWAs in Thailand is dependent on
competitive sources of low-cost generic medicines of assured quality,
whether imported or produced locally.

___________________________________________________________________

4. Thailand compulsory license: Letter to Ambassador Susan C. Schwab (USTR)

From: James Love <james.love@cptech.org>
To: Ip-health <ip-health@lists.essential.org>
Subject: [Ip-health] Thailand compulsory license: Letter to Ambassador Susan C. Schwab (USTR)
Date: Wed, 13 Dec 2006 07:10:56 -0500


* Karan K. Bhatia, the Deputy U.S. Trade Representative, has recently
pressured the Thailand government over the compulsory license issued
on patents covering the AIDS drug efavirenz.

* This follows a long history of US pressure on Thailand concerning
patents and medicines.  See, for example:   Susannah Markandya,
"Timeline of Trade Disputes involving Thailand and access to
medicines," July 23, 2001. http://www.cptech.org/ip/health/c/thailand/
thailand.html, Tido von Schoen-Angerer, Jiraporn Limpananont, "US
pressure on Thailand," The Lancet, Vol 358, 20 July, 2001,  Dylan C.
Williams, "A Morality Tale on AIDS,"World Health: A Lethal Dose of
U.S. Politics , The Asia Times June 19, 2006 (Entered into the
Congressional Record by Congressman McDermott, http://www.house.gov/
mcdermott/sp060619.shtml).

This is a letter sent by CPTech yesterday to Ambassador Susan C.
Schwab of the USTR.  We discuss the nature of the dispute between the
USTR and the government of Thailand, clarify the trade rules
regarding prior negotiation when compulsory licenses are for
government uses, detail recent compulsory licenses in the United
States, and outline a more productive way to frame the global issue
of who pays for R&D on new medicines.  Jamie


http://www.cptech.org/ip/health/c/thailand/ustr12dec2006thailand.pdf
http://www.cptech.org/ip/health/c/thailand/ustr12dec2006thailand.html

Consumer Project on Technology
1621 Connecticut Avenue, NW, Suite 500, Washington, DC 20009

December 12, 2006

Ambassador Susan C. Schwab
United States Trade Representative
600 17th Street, N.W.
Washington, DC 20508
United States of America

Dear Ambassador Schwab:

We ask that the United States government not interfere with the Thai
government decision to issue a government-use license on patents
covering the AIDS drug efavirenz.

There is a concern that the USTR may have suggested to the Thai
government that the WTO TRIPS agreement requires prior negotiations
with patent owners before a compulsory license is issued. If so, the
assertion was wrong. Article 31 of the TRIPS does not require prior
negotiation before authorizing non-voluntary use of a patent, in any
of the following cases:

   1.  a national emergency or other circumstances of extreme urgency,
   2.  cases of public non-commercial use, or
   3.  where such use is permitted to remedy a practice determined
after judicial or administrative process to be anti-competitive

In this particular case, the non-voluntary use was for a government
owned entity that will provide medicines for a national program to
treat AIDS. Under the WTO rules, there is no obligation for prior
negotiation with patent owners in such cases.

There is also no requirement for prior negotiation with patent owners
under the various US bilateral (and regional) trade agreements the
United States has recently negotiated. The reason for this is
obvious. In the TRIPS and the bilateral or regional trade agreements,
these sections on prior negotiation were written to accommodate US
law and practice. Our own government is not required to negotiate
with patent owners or copyright owners before authorizing use by or
for the government.

The main United States statute regarding use of a patent in such
circumstances is 28 USC 1498. There is no obligation for prior
negotiation or prior notice with the patent owner under 28 USC 1498,
when a non-voluntary authorization is for the government./1 This
includes uses by third parties:

For the purposes of this section, the use or manufacture of an
invention described in and covered by a patent of the United States
by a contractor, a subcontractor, or any person, firm, or corporation
for the Government and with the authorization or consent of the
Government, shall be construed as use or manufacture for the United
States.

As trade officials charged with promoting US norms for intellectual
property protection, it is useful to review what those norms actually
are. The United State has a number of mechanisms to issue compulsory
licenses on patents. These include, in addition to 28 USC 1498, the
following:

    * Mandatory patent licenses under Section 308 of the Clean Air
Act (see: http://www.epa.gov/docs/fedrgstr/EPA-AIR/1994/December/
Day-30/pr-251.html). This statute is unfortunately not consistent
with the provisions of the US FTA agreements negotiated with Jordan
(2000), Singapore (2003), and Australia (2004).


    * Compulsory licenses for patents "affected with the public
interest" that are of primary importance in the production or
utilization of special nuclear material or atomic energy, for non-
military purposes (See 42 USC 2183). This statute is unfortunately
not consistent with the provisions of the US FTA agreements
negotiated with Jordan (2000), Singapore (2003), and Australia (2004).

    * The Bayh-Dole Act march-in rights for patents on inventions
conceived with federal funding,

    * Remedies to anticompetitive practices.

    * Compulsory licenses issued under the procedures set out by the
US Supreme Court in the recent eBay decision. This approach is
arguably not consistent with the provisions of the US FTA agreements
negotiated with Jordan (2000), Singapore (2003), and Australia (2004).

The following are a just few recent examples of the use of compulsory
licenses by the United States:


    * In 2001, DHHS Secretary Tommy Thompson used the threat to use
28 USC 1498 to authorize imports of generic ciprofloxacin, for
stockpiles against a possible anthrax attack.

    * In 2001, the Department of Health and Human Services used its
authority to exercise March-In rights for patents on stem cell lines
held by the Wisconsin Alumni Foundation as leverage to secure an open
license on those patents./2

    * In 2002, the US FTC ordered a compulsory cross-license of the
Immunex tumor necrosis factor ("TNF") patent, to Serono, including
the "freedom to practice in the research, development, manufacture,
use, import, export, distribution and sale of TNFbp-I Products and
certain glycosylated and nonglycosylated fragments, derivatives and
analogs thereof in the United States."

    * In 2002, the US Department of Justice required Microsoft to
license on reasonable and non-discriminatory terms intellectual
property rights in a number of different protocols needed to create
products that were interoperable with Microsoft Windows./3

    * In 2005, the FTC ordered a compulsory license of Guidant�s
intellectual property surrounding the RX delivery system for Drug-
Eluting Stents.

    * In 2005, the US Department of Justice cited its right to use
patents in 28 USC 1498 when it opposed injunctive relief for
infringement of the patents relating to the Blackberry email services
supplied to both the government and private firms that used the
Blackberry device to communicate with the government./4

    * In a November 2005 Congressional hearing, DHHS Secretary
Michael Levitt testified before the House of Representatives that he
had threatened to override the patents on treatments for Avian Flu if
companies had not expanded US production facilities./5 More recently,
the Centers for Disease Control threatened to use US Bayh-Dole "march-
in" rights to issue compulsory licenses on patents on reverse
genetics, which are needed to manufacture vaccines for avian flu.

    * In June 2006, a court granted Microsoft a compulsory license
to use two patents owned by z4 Technologies that relate to digital
rights management systems used by Microsoft for its Windows and MS
Office software programs./6

    * In July 2006, a court granted DirectTV a compulsory license to
use the Finisar patent on integrated receiver decoders (satellite set
top boxes), for a royalty of $1.60 per device./7

    * In August 2006, a court granted Toyota a compulsory license on
three Paice patents for hybrid transmissions, for a royalty of $25
per automobile./8

    * In September 2006, a court granted Johnson and Johnson a
compulsory license to use three of Jan Voda�s patents on guiding-
catheters for performing angioplasty./9

The point of this history lesson is to emphasize a point that some
USTR officials seem to overlook. The flexibilities in the TRIPS
agreement are there for good reasons. As evidenced by the many cases
described above, there are many situations where any country will
want to limit or create exceptions to the exclusive rights of a patent.

In the case of efavirenz patents, Thailand is clearly seeking to
create a policy that will strengthen competition among generic
suppliers, and enhance it's own capacity to manufacture AIDS
medicines. The benefits of this policy will be more pronounced over
time, as competition, economies of scale and learning by doing lead
to more efficient production by generic producers.

Looking more closely at Thailand, one can see why this is so
important. The United States has a much higher national income than
Thailand, but a much lower rate of HIV infection. When compared to
Thailand, the US has thirty-five times the income per HIV patient./10

                   United States      Thailand

Population (2005)      297 million    64 Million
GNI (2005 )           $13 trillion  $177 billion
GNI per capita (2005)
                      $ 43,740        $ 2,750
HIV+ population      1,200,000        580,000
Rate of HIV infection
(per 100,000)            404          906
GNI per HIV+ person  $10.8 million  $ .3 million

Because of US trade policies, including the 1993 agreement negotiated
by former USTR Mickey Kantor,/11 Thailand has been slow to provide
treatment to its very large population of AIDS patients. Until
November 2006, Thailand had not used the compulsory licensing
provisions that are permitted in the TRIPS. Thailand started its
treatment program by relying extensively on a handful of older AIDS
drugs that were off patent in Thailand. These products are not the
best that modern science offers. Many Thai AIDS patients suffer from
the predictable side effects associated with the older medicines. In
any case, over time, AIDS patients everywhere develop resistance, and
cannot be treated without access to new medicines.

Thailand will need sustainable access to second line AIDS drugs at
affordable prices. If Thailand does not issue compulsory licenses on
the patents for these medicines, it will have to limit access to
treatment. This will mean much suffering and death, an outcome that
is avoidable.

The United States should not pressure Thailand on the issue of
issuing compulsory licenses on patents for AIDS drugs. It should
accept the fact that Thailand, like all WTO members, has an
obligation to take measures to "promote access to medicines for all."/12

The United States and other high-income countries are increasingly
realizing that they too have to consider using compulsory licenses on
patents for medical inventions. For example, Canada and several
European countries have threatened to use compulsory licenses on the
Myriad patents for tests used to identify the risks of breast cancer
-- tests that are not widely available in the United States, because
of the high price./13 It is increasingly difficult for high-income
countries to afford the prices for new treatments for cancer or other
severe illnesses. With our own aging population, we cannot have a
sustainable program of access to the latest medical discoveries,
without having the ability to at least threaten to override the
exclusive rights of a patent.

The tough USTR positions on patents, pharmaceutical test data and
drug prices in trade negotiations are an attempt to deal with the
global problem of funding medical R&D. They focus entirely on
measures that raise drug prices. In our opinion, this is a mistake.
We believe the United States would be better off embracing a new
approach, one that focuses on sharing the costs of medical R&D -- not
just through high drug prices, but through any mechanism that
supports relevant R&D efforts. For example, we would benefit if our
trading partners would engage with the NIH to share the costs of
medical R&D for global health problems, provide sustainable funding
for the many new non-profit product development ventures, or if they
would fund new mechanisms to stimulate R&D, such as advanced
marketing commitments for new vaccines, or "prize funds" that reward
medical innovations that improve health outcomes./14

Last week the World Health Organization (WHO) convened the first
meeting of it's new Intergovernmental Working Group on Intellectual
Property Rights, Innovation and Public Health. At this first meeting,
thirty-three countries, including Thailand, supported work on a new
treaty or agreement to provide sustainable sources of R&D for global
health priority projects. It is in the interest of the United States
that other countries, rich and poor, do more to pay the costs of such
research. But for many of our trading partners, an agreement to
support medical R&D would be more appropriate and acceptable than a
trade framework that only seeks to raise drug prices.

As the new head of USTR, you have the opportunity to reframe our
trade policy so that it provides a rational, effective and ethical
solution to the global free rider problem. We need to ensure that
everyone contributes fairly to the costs of medical R&D, but in a
framework that ensures people can have access to new inventions.

I would like to meet with you and your staff to discuss these matters.

Sincerely,

James Love


Director
Consumer Project on Technology

Cc:

Karan K. Bhatia, Ambassador, Deputy U.S. Trade Representative

Victoria A. Espinel, Assistant U.S. Trade Representative for
Intellectual Property Rights

Barbara Weisel, Assistant U. S. Trade Representative for Southeast
Asia-Pacific and Pharmaceutical Policy

Senators Edward Kennedy, Hilary Clinton, Barack Obama, Sherrod Brown,
Bernie Sanders, Chuck Schumer, Diane Feinstein, Barbara Boxer, Trent
Lott, Chuck Grassley, Byron Dorgan, Richard Durbin, Ron Wyden,
Patrick Leahy

Speaker Nancy Pelosi, Representatives Charles Rangel, Henry Waxman,
John Dingell, Tom Allen, Janice Schakowsky, Rahm Emanuel, Dan Burton,
Rosa DeLauro, Jo Ann Emerson, Dennis Kucinich, Barbara Lee, Sander
Levin, Jim McDermott, Maxine Waters, Peter Stark, Charles Gonzalez,
John Lewis, Xavier Becerra, John Larson, Linda Sanchez, Lloyd Dogget,
Howard Berman, Lois Capps, Joe Crowley, Mark Udall, Betty McCollum,
Raul Grijalva, Hilda Solis

Dr. Margaret Chan, Director-General Elect, World Health Organization

Dr. Howard Zucker, Assistant Director-General, World Health Organization

Dr Suwit Wibulpolprasert, Senior Advisor on Health Economics,
Ministry of Public Health, Thailand

Cecilia Oh, UNDP

---------FOOTNOTES------------

1/ TRIPS Article 31.b states "In the case of public non-commercial
use, where the government or contractor, without making a patent
search, knows or has demonstrable grounds to know that a valid patent
is or will be used by or for the government, the right holder shall
be informed promptly." There is a similar provision in NAFTA. NAFTA
Article 1709(10)(b) also requires that patent owners be notified
"promptly," but not before a compulsory license is issued. See also:
Executive Order 12889, Implementation Of The North American Free
Trade Agreement, December 28, 1993:

Sec. 6. Government Use of Patented Technology. (a) Each agency shall,
within 30 days from the date this order is issued, modify or adopt
procedures to ensure compliance with Article 1709(10) of the NAFTA
regarding notice when patented technology is used by or for the
Federal Government without a license from the owner, except that the
requirement of Article 1709(10)(b) regarding reasonable efforts to
obtain advance authorization from the patent owner:

(1) is hereby waived for an invention used or manufactured by or for
the Federal Government, except that the patent owner must be notified
whenever the agency or its contractor, without making a patent
search, knows or has demonstrable reasonable grounds to know that an
invention described in and covered by a valid United States patent is
or will be used or manufactured without a license; and

(2) is waived whenever a national emergency or other circumstances of
extreme urgency exists, except that the patent owner must be notified
as soon as it is reasonably practicable to do so.

2/ September 5, 2001, "National Institutes of Health and WiCell
Research Institute, Inc.,

Sign Stem Cell Research Agreement," http://www.nih.gov/news/pr/
sep2001/od-05.htm.

3/ United States Of America, Plaintiff V. Microsoft Corporation,
Defendant. Civil Action No. 98-1232 (CKK), FINAL JUDGMENT, (November
12, 2002). For a detailed account of work to implement the order,
see: INTERIM JOINT STATUS REPORT ON MICROSOFT'S COMPLIANCE WITH THE
FINAL JUDGMENTS, http://www.usdoj.gov/atr/cases/f201300/201386.htm

4/ The United States� Statement Of Interest, November 2005., NTP,
INC., Plaintiffs, V. RESEARCH IN MOTION, LTD., Defendant., Civil
Action No. 3:01CV767.

5/ See video excerpts from November 8, 2005 Hearings of the
Subcommittee on Health of the House Committee on Energy and Commerce,
http://www.cptech.org/ip/health/tamiflu/hearingexcerpts11082005.html

6/ This case was decided under the new US Supreme Court standard for
granting injunctions on patents. See eBay Inc. v. MercExchange,
L.L.C., 126 S. Ct. 1837, 1839-1841 (U.S. 2006)).

7/ Ibid.

8/ Ibid.

9/ Ibid.

10/ Assuming that the ability to pay is linear in terms of income, a
second line AIDS drug that is sold for $1,000 in Thailand would be
equivalent to a product selling for $70,000 in the United States.
With health care budgets rising faster than incomes, the impact is
even worst for the lower income country.

11/ http://www.cptech.org/ip/health/c/agreements/thai-1994-ip.html.
See also: Susannah Markandya, Timeline of Trade Disputes involving
Thailand and access to medicines, July 23, 2001. http://
www.cptech.org/ip/health/c/thailand/thailand.html.

12/ Paragraph four of the 2001 Doha Declaration on TRIPS and Public
Health.

13/ The tests are more widely available in countries that have
shipped patient tests to offshore testing labs where patents are not
in effect.

14/ Aidan Hollis. An Optional Reward System for Neglected Disease
Drugs, 2005; Joseph Stiglitz, Give Prizes not Patents. New Scientist,
September 16, 2006; Thomas Pogge on Online Opinion. "A New Approach
to Pharmaceutical Innovations," June 21, 2005; James Love. "Measures
to Enhance Access to Medical Technologies, and New Methods of
Stimulating Medical R&D." Paper for the WIPO Open Forum on the draft
Substantive Patent Law Treaty (SPLT), March 2006.

---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton"

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