Transcript Treatment + research activism in India Challenges and

Treatment + research activism in India
Challenges and opportunities
UAEM conference
John Hopkins University
30th October 2011
Brief history
Post independence high prices of medicines, because of
patent law carried over from British rule
Monopoly: Product patents to MNCs meant that Indian
domestic producers could not manufacture
Know How: No capacity to manufacture
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Unaffordable: Highest prices in the world
What is a patent?
Patent
No patent
One producer
Multiple producers
No competition
Competition
High prices of
imported medicines
Low prices of locally
produced medicine
“MY IDEA OF A BETTER ORDERED
WORLD IS ONE IN WHICH MEDICAL
DISCOVERIES WOULD BE FREE OF
PATENTS AND THERE WOULD BE NO
PROFITEERING FROM LIFE OR
DEATH.”
- Indira Gandhi, Prime Minister of India at
the World Health Assembly, Geneva, 1984
1970: Legal reform aimed at Local production
“no product patents” in 1970 Patents Act
Set up PSUs who developed know how to
produce API (raw material) and formulations
1970 – 2005: Indian generic companies become
the “pharmacy of the developing world”
AIDS Treatment costs come down with Indian supplies of low cost,
quality medicines
Source: ‘Untangling the Web of Antiretroviral Price Reductions’ Campaign for Access to Essential Medicines (MSF), 12th
edition, 2009, http://utw.msfaccess.org/
INDIA BECOMES PHARMACY OF
THE DEVELOPING WORLD
The absence of patent barriers allowed generic
Companies to innovate simpler treatment - fixed
dose combinations
Cancer Medicines
Imatinib Mesylate – used in Chronic
Myeloid Leukemia
Novartis price: US$ 2500 per patient per
month
Generic companies: US$ 200 per patient
per month
Cancer Patients Aid Association: US$ 20
per patient per month
Globalisation of Patent Rules
• 1995 WTO Trade related aspects of intellectual
property rights agreement (TRIPS)
• “minimum” standards of protection of intellectual
property rights
• 20 year patents on pharmaceutical products
• No differentiation between lifesaving medicines
and trivial goods
• 2005 Indian amended its patents act to be
compliant with TRIPS and starts to grant
product patents (transition period ends).
2005 – Product patent regime
CIVIL SOCIETY
OPPOSITION
AGAINST INDIA
CHANGING ITS
PATENT LAW
TOOK PLACE…
ACROSS INDIA…
AND THE WORLD…PROTESTS
AGAINST INDIA BECOMING TRIPS
COMPLIANT WERE HELD IN…
UNITED STATES OF AMERICA
MOROCCO
SOUTH AFRICA
GENEVA
BURKINA FASO
KENYA
GERMANY
FRANCE
2005 Indian Patents Act
• Public health safeguards:
– Automatic licensing for drugs already in production
– Pre-grant opposition
– Section 3d – Narrows the scope of patentability & limits
patenting to real innovations
– Compulsory licensing for drugs patented in India but not yet
produced by generic manufacturers
• Indian law sets international precedent for TRIPS
implementation for developing countries
Key Indian law safeguard: Evergreening
• The basic patents on Nevirapine (NVP)
were applied for by Boehringer Ingelheim
in November 1990, and are due to expire in
November 2010.
• BI also applied for a patent on the
hemihydrate form of NVP, used in the
suspension in 1998, which is due to expire
2018.
• Additionally, BI applied for a patent on the
extended release formulation of nevirapine
in 2008, which is due to expire in 2028.
• India has a specific provision in its patent
law that does not grant patents on minor
changes to existing medicines.
Efforts to stop evergreening:
Patentability criteria –new, must have
inventive step, industrial application.
India:
Section 3(d) stipulates that the following shall not be treated as an invention within the
meaning of the Act:
“ the mere discovery of a new form of a known substance which does not result in the
enhancement of the known efficacy of that substance or the mere discovery of any
new property or new use for a known substance or of the mere use of a known
process, machine or apparatus unless such known process results in a new product or
employs at least one new reactant.”
Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites,
pure form, particle size, isomers, mixtures of isomers, complexes, combinations and
other derivatives of known substance shall be considered to be the same substance,
unless they differ significantly in properties with regard to efficacy
Glivec patent history
• 1993 Novartis filed patent applications for the
cancer drug imatinib in most countries in 1993.
• At the time India did not grant product patents at
that time.
• 1998, Novartis applied for a patent on the betacrystalline polymorph of a mesylate salt of imatinib
i.e. imatinib mesylate, in India.
• 2005 India to examine the 1998 application
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Blockbuster Orphan Drug
• FDA approval in 2001
• Gleevec received orphan drug designation in US and EU
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US tax credits
grants for clinical research cost during development
waiver of FDA prescription drug user fees.
Additional incentives EC includes the possibility of EMEA fee
waivers. Some EU members states provide additional
incentives: free scientific advice, exemptions from fees and
taxes
• Gleevec’s sales have been 7.5 billion US$ in less than 5
years.
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Result – Prevent Evergreening
• CPAA files first pre-grant opposition
• In January 2006, the patent on imatinib
mesylate, (Gleevec) was rejected in India on
the grounds that it only represented a
new form of a known substance and
therefore was not an innovation and not
patentable under Indian law.
• the selection of a salt of the active
ingredient with the purpose to improve
bioavailability is known in pharmaceutical
art. It is common knowledge in the
pharmaceutical field that salts result in
different solubility and, therefore, in
different bioavailability.
• Novartis case!
Efforts to stop evergreening
Not all patent applications are valid. Many patent applications are for a new
use of an old drug, or simply for derivatives of old drugs or combinations of old
drugs. (TRIPS requires patent protection for ‘inventions’)
E.g. AIDS drug patent applications:
1.
a fixed dose combination of lamivudine/zidovudine used in the
treatment of HIV/AIDS: not a new invention but simply the
combination of two existing drugs. Status of application - Withdrawn
2.
tenofovir disoproxil fumarate (TDF), a key AIDS drug: forming a salt
(fumaric acid) out of an existing compound (tenofovir disoproxil), is
common practice within the pharmaceutical industry, and should not be
considered a new invention. Status of applications - Opposed
II. Any person can oppose the grant of a patent application
Efforts to stop evergreening
Not all patent applications are valid. Many patent applications are for a new
use of an old drug, or simply for derivatives of old drugs or combinations of old
drugs. (TRIPS requires patent protection for ‘inventions’)
E.g. AIDS drug patent applications:
1.
a fixed dose combination of lamivudine/zidovudine used in the
treatment of HIV/AIDS: not a new invention but simply the
combination of two existing drugs. Status of application - Withdrawn
2.
tenofovir disoproxil fumarate (TDF), a key AIDS drug: forming a salt
(fumaric acid) out of an existing compound (tenofovir disoproxil), is
common practice within the pharmaceutical industry, and should not be
considered a new invention. Status of application - Rejected
II. Any person can oppose the grant of a patent application
Oral Valganciclovir (four month therapy)
Treatment for:
cytomegalovirus retinitis (CMV)
in people with AIDS can lead to
Blindness
(CMV can be effectively treated with
oral doses of valganciclovir consisting
usually of 264 tablets given over four
months).
Alternative treatment:
using intravenous ganciclovir
requires infusions twice a day for
2 or 3 weeks, and then daily
Infusions for another 2 or 3
Months with intraocular injections
of ganciclovir - doctors have to
repeatedly jab patients in one or
both eyes
In most countries Roche price
US$ 10,000
A patent on valganciclovir was granted
in India in June 2007. This prevented
patients/govt from procuring the
generic valganciclovir, leaving Roche
as the sole source for the drug. Roche
Price in India – Rs. 1040/450mg
tablet or total cost approximately Rs.
2,74,560 per patient
2010 – In the post grant opposition
grant order on valganciclovir revoked
recognising that it is a old drug in a
new form)
Patented drugs expensive
Patented Hepatitis treatment in India
Pegylated interferon alfa 2a
Rs. 14,700 per injection (180 mcg)
Patented cancer drug sorafenib
• Rs. 2,80,000 per month/per patient
2010
Free Trade Agreements and access to
medicines
EU INCLUDES DATA EXCLUSIVITY in DRAFT TEXT
COLCHICINE
• Extracted from plants of the genus
Colchicum (autumn crocus, Colchicum
autumnale, also known as "meadow saffron")
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Use particularly as a therapeutic agent in the
treatment of gout has a history of 3000 years;
cannot be patented
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Tablet formulation was widely available as a
generic prescription drug in the United States
since the 19th century.
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It costs almost nothing to produce but was
granted marketing exclusivity after US FDA
accepted a 1 week trial of the drug done by a
company & was then bound to grant DE.
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The company enforced its exclusivity rights
forcing other manufacturers off the market &
the drug price rose 50 times from $0.09 to
$4.85.
Police Arrest during protest May-2010
Police beat People living with HIV with lathis during
2nd Udyog Bhavan protest Oct 2010
Comment posted "I have never seen so many police people with batons and guns.“
http://www.bbc.co.uk/news/health-11488711
Activists donate 5 ml blood to get
FTA message to Carla Bruni
• Global Fund ambassador
visits India (wife of
French President)
• How to get our concerns
on FTAs to her?
Thousands came to protest in March 2011
Public Announcement
India will not provide data exclusivity: Anand Sharma
Business Standard Reporter / New Delhi March 30, 2011, 0:10 IST
The government on Tuesday took a firm stand on protection of intellectual property rights (IPR)
and the aspect of data exclusivity for drug manufacturers saying that the country would not
extend data exclusivity that would hamper the domestic pharma industry.
This was asserted during a meeting of consultative committee of the Parliament on challenges in
Intellectual Property Rights-international and domestic, which was chaired by minister of
commerce and industry Anand Sharma.
"India does not provide data exclusivity for pharmaceuticals and agro-chemicals which is in the
paramount interest of our generic pharmaceutical industry as grant of data exclusivity would
have considerable impact in delaying the entry into the market of cheaper generic drugs,"
Sharma said in the meeting.
Data exclusivity provides protection to the technical data generated by innovator companies to
prove the merit of usefulness of their products. In the case of pharmaceuticals, it means the
data generated by drug companies through expensive global clinical trials to prove the efficacy.
R&D
TB
Old Drugs - Old diagnostics
leave half of all patients
undiagnosed!
Challenges and opportunities
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Complex issues
Ministry of Science & Technology
Resources and treatment activists
Research exemption clauses in patent
law
Mapping the policies and money
Technical work
Getting research institutions to adopt
pro-access licensing
International movement on R&D
treaty
Norms for clinical trials
Very different context from the US
and other developed countries
Hierarchy/bureaucracy
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Civil society
Research institutions open to talk
Media
Student movement waiting to
happen
MSF and DNDi
Rejection of the Indian Bayh
Dole Bill (UAEM + Indian civil
society)
India is where the research is starting to
happen
Generic industry
Any Questions?