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PUBLIC CONSULTATION WITH
U.N. SPECIAL RAPPORTEUR
Impact of 301 on
Access to Medicines
October 28, 2010
Dr.Amit Sengupta
All India Peoples Science Network
2010 Special 301 Report: Complaints against India
•
“counterfeiting, including the counterfeiting of
medicines, remains widespread and India’s
enforcement regime remains ineffective at
addressing this problem”
•
“One concern … is a provision in India’s Patent
Law that prohibits patents on certain chemical
forms absent a showing of increased efficacy”
•
“The United States also encourages India to
provide protection against unfair commercial use,
as well as unauthorized disclosure, of
undisclosed test or other data generated to
obtain marketing approval for pharmaceutical
and agricultural chemical products”
The Bogey of ‘Counterfeit’ Again!
•
Deliberate attempt to confuse issues. Counterfeiting is a trade
mark violation and under Indian law it is clearly an offence.
•
Counterfeiting is different from quality issues (drugs of substandard quality) and from sale of spurious products (that do not
contain the ingredients claimed in the label)
•
Counterfeiting does not pertain to generic drug manufacture, as
this is clearly permitted under Indian Law and as per provisions
of International treaties (viz. TRIPS)
•
However, there are continuous attempts to confuse the above,
and by inference label Indian generics of good quality as
Counterfeits
•
This has been a major cause of disagreement in the last World
Health Assembly, where India, Brazil and others have refused to
accept a confusing definition of ‘counterfeit’ that conflates issues
related to: a) trade mark violation; b) quality control; and c)
generic drug production
Section 3(d) of Indian Act
•
Section 3(d) explicitly designed to prevent
‘evergreening’ –bars fresh patents on: a) small
alterations to existing drugs unless significant
change in efficacy can be shown;
b) combinations of existing drugs; c) new use;
d) new dosage forms
•
It discourages frivolous claims and thus actually
encourages real innovative activity
•
It addresses the crisis in pharma R&D with too
little activity in developing novel products – e.g.
Prescrire’s examination of 359 drugs
introduced between 1999-2004 showed only
3% were a “real advance” while 72% were a
“marginal” or no advance
Examples of Use of 3(d) in India
•
Patent application for Imatinib (used to treat
chronic myeloid leukemia) by Novartis rejected
as claim was for new form of an old chemical
patented before 1995 -- led to generic
production at 5% of the cost of Novartis’ product
•
Patent application for Nevirapine
hemihydrate (first line anti-HIV drug) in syrup
form by Boehringer rejected as it is a new
form of an existing chemical
•
Patent application for Lamivudine/
Zidovudine combination (first line anti-HIV
drug) by GSK withdrawn (after patent opposition
by patient groups) as it is a combination of two
existing drugs patented around 1995
Data Exclusivity
•
Government appointed committee had opined that India is not
required to provide data exclusivity as per obligations under
TRIPS (as opposed to ‘data protection’)
•
Clear evidence that Data Exclusivity introduces another
layer of obstacle to generic drug production by:

Delaying introduction of generics after patent expiry or
grant of a Compulsory License

Creating a patent like monopoly even when a drug is not
granted a patent (can bypass section 3(d) of IPA)

Forces unethical duplication of clinical trials
•
Caution against its adoption of data exclusivity has been issued
by the WHO and CIPH
•
Recently released study of medicine prices in Guatemala has
shown price differences in the same therapeutic class ranging up
to 845000% because of data exclusivity
Implication of ‘concerns’ in 301 Report
•
ALL the ‘concerns’ expressed are designed to undermine
production of generic drugs in India
•
Has to be seen in the context of:

While India is the 4th largest producer of medicines
(about 9% by global volume), huge unmet needs
exist in the domestic market with 65% lacking
access to all essential drugs – a WB study (2001)
suggests that 2.2% of the population are pushed
below the poverty line each year as a result of out of
pocket medical costs

India exports generics to 200 countries, including
resource poor countries of the South

A 2010 study estimates that 80% of ARVs in the
developing world were procured from Indian generic
companies
Huge Price Differentials
without Generic Manufacture
• A course of Pegylated interferon (to treat
hepatitis C), patented in India now, costs
between $11,000 and $15,000
• Raltegravir (a new ARV drug) also patented in
India, costs $2,500 per patient per year
• Contrast this with the generic price of the
3 antiretrovirals, used as first line treatment
in India, at $60 per patient per year
A Proactive US Embassy!
“My key role is to promote high standard Intellectual
Property protection and enforcement in India…We
have worked with Indian government on various
programmes to promote the knowledge of
Intellectual Property and to educate Indian officials
like police officers, customs officers, etc. on various
intellectual property related issues.”
Interview with Dominic Keating, Secretary, Intellectual Property, By
KPO Consultants, 2009
IPR toolkits of the US embassy in India
• Implies data exclusivity is required in TRIPS
• In explanation of what is not patentable
under Indian law, does not include the
provisions of Section 3(d)
US regulatory bodies ‘fronting’ for US Companies!
 USPTO and Pfizer
Mr. Dominic Keating, IPR attaché representing USPTO, conducted
two meetings jointly with Pfizer. Meetings featured attacks on
Section 3(d) and on data exclusivity.
 US Federal Judge in Pharma funded event
George Washington University’s India Project hosts “IP Summits”
in India. funded by PHRMA, Microsoft, Qualcomm and others.
Participants include Judge Randall R. Rader, for U.S. Court of
Appeals for the Federal Circuit
 USFDA’s “safe medicine” initiative
Meeting attended by the USFDA and the USPTO with a strong thrust
on ‘counterfeits’
In Preparation for President Obama’s visit
“The US is "lobbying" for an intellectual property
rights (IPR) regime in India that protects American
patents, a senior official of the Obama Administration
said on Tuesday.”
Economic Times (Oct. 26, 2010)
At the heart of………
At the heart of this discussion today lies a
question:
What provides legitimacy to a process
that secures the commercial interests of a
few corporations over decisions in
sovereign countries that determine
whether people shall live or die?