[Ip-health] Open letter to those who collectively produced the May 23, 2012 statement to the WIPO SCP on the topics of patents and health

Jamie Love james.love at keionline.org
Fri May 25 05:06:07 PDT 2012


Open letter to those who collectively produced the May 23, 2012 statement
to the WIPO SCP on the topics of patents and health

Submitted by James Love [1] on 25. May 2012 - 5:58
Open letter to those who collectively produced the May 23, 2012 statement
to the WIPO SCP on the topics of patents and health

May 25, 2012

To each and everyone who worked on the SCP submission:

This letter outlines our concerns to the May 23, 2012 statement to the 18th
Session of the World Intellectual Property Organization (WIPO) Standing
Committee on the Law of Patents (SCP), on the agenda for patents and health.

In its opening, the USPTO said the following:

"Some of the public health issues facing developing and least developed
countries (DC/LDCs) include neglected diseases, the spread of TB, malaria
and HIV/AIDS, and availability of medicines to treat these and other
ailments. There is no easy solution to these problems. Reducing patent
protection is not likely to solve these thorny issues. Furthermore, the
notion that all developing countries face identical challenges and should
apply the options that exist under international agreements in a single way
– or that access to medicines would be enhanced by such an approach – has
been rejected by many WIPO member states, including developing nations."

Are you trying to say that reducing patent protection for AIDS drugs in
developing countries did not enhance access to medicines? If so, where have
you been the past 15 years? DHHS says the PEPFAR program pays on average 37
cents per day for ARV drugs to treat HIV/AIDS. Were you aware that by 2001,
some 24 countries in Saharan Africa had granted patents on nevirapine and
more than 30 had granted patents on 3TC, and that South Africa had patented
d4T, and the brand name price for an ARV regime of these products was
priced at more than $10k, in South Africa? Did you know that most patients
in the PEPFAR program were using fixed dose combinations of these drugs,
manufactured by generic drug manufacturers that benefited from compulsory
licenses in South Africa and in many Subsharan Africa countries, including
the LDC countries in Africa that used paragraph 7 of the Doha Declaration
on TRIPS and Public Health to ignore patents on these products? Do you know
how many people in Africa and other developing countries were receiving
AIDS drugs in 2001 and how many are receiving AIDS drugs today?

Did you know that Mitch Daniels said, when serving as director of the
Office of Budget and Management, that PEPFAR would not have been set up if
the US had to pay the brand name prices for patented AIDS drugs, and the
possibility of using cheap India generic drugs made the PEPFAR program

Is it your conclusion that Thailand did not expand access to patented
medicines for AIDS, heart disease and cancer when it granted compulsory
licenses on the patents for these products?

Is it true, in other words, that "reducing patent protection is not likely”
to enhance access? Or is this a blatant falsehood, which the USPTO has
expressed during the WIPO session on patents and health?

Is it true, as USPTO asserts, that:

"Weakening patent protection for innovative medicines is not a productive
approach to improving availability of health care, because many other
factors other than patents more directly affect the availability of

In the case of HIV/AIDS drugs, is this true? Is this true for cancer drugs
in the developing world? We mean, is it really “not a productive approach
to improving availability” of care? And even if other factors are also
important, as they surely are, is your point is that poor countries should
ignore high prices, and focus all of their attention on solving every
problem but high prices?

How much access to herceptin, the patented biologic drug for breast cancer,
exists in developing counties? How many patients in India received access
to Bayer's version of the patented cancer drug Nexavar? Is it really, as
USPTO claims, "not a productive approach" to override strong patent
protection when cancer drugs are priced at $50k to $70k per year in a
developing country? Do you have evidence that these drugs can be made
accessible in developing countries at these high prices? Or, does the USPTO
believe that people in developing countries do not need treatments for
cancer, either because they somehow never develop cancer during their
lifetimes, or their lives are not worth the cost of receiving the medicines?

We don't want to be repetitive, but its hard not to when addressing
repetitive assertions that strong patent rights do not present problems for
access that are contained throughout the 1200 word USPTO statement on
patents and health.

We were surprised that the USPTO continues to raise the paucity of patented
medicines on the World Health Organization’s List of Essential Medicines,
as evidence that patents do not harm access to medicines, because "their
availability in many markets is still limited." Yes, it is true. In
countries where incomes are low, there are all sorts of problems, and not
only a lack of access to essential drugs, but sometimes not enough food, or
decent shelter, or education opportunities. But as indebted as we are to
this brilliant insight, you of course leave out the more important insight,
which is that the lack of patented drugs on the WHO list of essential
medicines is not an accident, but rather a direct consequence of the impact
of the patents on the prices for these medicines. Thus, as you know from
our previous conversations and formal communications to WIPO on this topic,
the most recent cancer drug on the WHO model list is an off-patent drug
registered with the FDA in 1996. Does the USPTO appreciate or even care
what it means when the global health authorities tell poor people that none
of the cancer drugs developed since 1996 are "essential," because they are
too expensive to be cost effective when treating poor people? Is this what
the Obama Administration endorses, a system of extremely unequal access to
cancer drugs?

Does the USPTO believe that "Conducting a study on the positive impact of
patent systems in providing lifesaving medicines to developing countries"
is anything more that defending the indefensible, and using the power of
the Obama Administration against the developing countries who have tried to
fight the pharmaceutical company's most egregious abuses in terms of
pricing and anticompetitive practices?

As regards the USPTO objections to compulsory licenses, and your advice to
developing countries to avoid their use, can you explain why the Obama
Administration supported a mandatory compulsory licensing provision in the
US biologics pathway legislation passed as part of the health reform
legislation, and if the Obama Administration expressed any opposition to
these six compulsory licenses on medical technologies that were granted by
courts in the United States:

2006: Voda v. Cordis Corporation
2007: Innogenetics, N.V. v. Abbott Labs
2009: Bard Peripheral Vascular, Inc. v. W.L. Gore & Associates
2009: Medtronic Somafor Danek USA, Inc. v. Globus Med., Inc.
2010: Johnson & Johnson Vision Care, Inc., v. Ciba Vision Corp., 712 F.
Supp. 2d 1285 (M.D. Florida 2010)
2011: Edwards Lifesciences AG and Edwards Lifesciences LLC, Plaintiffs, v.
CoreValve, Inc. and, Medtronic CoreValve, LLC, Defendants. C.A. No.
08-91-GMS. United States District Court, D. Delaware., February 7, 2011.

Since the USPTO and apparently the rest of the Obama Administration is in
complete denial of the harsh consequences tough IPR protections on
medicines, allow me to point out that the George W. Bush Administration:

*  Embraced President Clinton's executive order protecting the right of
sub-Saharan Africa countries to grant compulsory licenses and use other
TRIPS flexibilities to protect access to medicines (Executive Order 13155),

*  Negotiated the 2001 WTO Doha Declaration on TRIPS and Public Health,

*  Endorsed a new amendment to the TRIPS agreement to expand the ability to
use compulsory licenses to export medicines,

*  Set a system for the FDA to approve the registration of generic
medicines to treat AIDS that were produced under compulsory licenses,

*  Set up the PEPAR program and allowed it to become the world's largest
consumer of products manufactured under compulsory licenses,

*  Agreed, on May 10, 2007, to introduce public heath safeguards in the
intellectual property chapters for developing country FTA agreements (a
policy recently abandoned in the TPPA negotiation), and

*  Negotiated and agreed to the 2008 World Health Organization Global
Strategy on Public Health, Innovation and Intellectual Property.

As pleased as we all are that Barrack Obama is now President, the
Administration seems to be leading a march backwards as regards policies
for the poorest and most vulnerable people on earth. At WIPO this week, the
USPTO is lending its considerable power and prestige to launch new attacks
on the welfare of poor people in developing countries.

All governments are huge institutions, and the US government is
particularly large. Often decisions are made by groups of officials, each
operating under somewhat different mandates and motivations. When there is
a moral vacuum at the top, as is the case for the White House on matters
concerning intellectual property and access to health care in developing
countries, there is a risk that your own efforts will contribute to an
outcome that you cannot in good conscience justify to your neighbors or
families. Given the raw nature of corruption in the way that political
campaigns are financed these days, it is not surprising that an agency like
the USPTO has become an enemy of moral values and basic decency ---
abandoning even the more compassionate values embraced by conservative
political figures like George W. Bush. But as individuals, you have to make
some choices. When you fail to object to offensive statements such as the
one delivered to the SCP on Wednesday, you become part of a large failure –
the failure of ordinary people to recognize and resist the worst and most
brutal acts by the powerful against the weak. You can do better.


James Love, Knowledge Ecology International
"Thiru Balasubramaniam, Knowledge Ecology International

James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.

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