Post on 14-Dec-2015
1987: first ARV AZT1996: TRIPLE HAART THERAPY
2000: Glaxo Blocks Access To Lamivudine/Zidovudine in Ghana
In letters to a drug distributor in Ghana and an Indian generic-drug maker, Glaxo said sales of generic versions of its drug, Combivir, in Ghana would be illegal because they would be violating company patents. As a result, the Indian company, Cipla Ltd. of Bombay, has stopped selling its low-cost version in Ghana, a small country in West Africa.
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).
In 2001 Novartis introduced Glivec (Imatanib Mesylate) in India
The Glivec story
1 month 1 year
Glivec US$ 2,500 US$ 30,000
Generic equivalent US$ 200 US$ 2,500
Comparative prices
INDIA SIGNED AN AGREEMENT WITH
WTO TO MOVE FROM
PROCESS PATENT
2005: PROCESS & PRODUCT
PATENTS FOR MEDICINES
In 1995…
The Glivec story
1998Novartis applied for patent in India on for a crystalline form or polymorphic form of its anticancer drug imatinib mesylate (Glivec)
Jan 2003
Based on this application Novartis applied for 5 yr EMR in India (no examination required or opposition allowed)
Nov 2003
Novartis granted EMR 6/9 pharmaceutical companies told by court to stop marketing affordable generic versions of imatinib
The Glivec story
2004: Result of Glivec’s EMR
CPAA could no longer supply the drug at subsidized rates.Meets with Lawyers Collective for Legal Aid
AND THE WORLD…PROTESTS AGAINST INDIA BECOMING TRIPS COMPLIANT WERE HELD IN…
SOUTH AFRICA
GERMANY
FRANCE
GENEVA
BURKINA FASO
MOROCCO
UNITED STATES OF AMERICA
KENYA
Innovation in decline?patent protection has increased over the last 20
years, but the mean innovation rate has fallen
Only 153 out of 1,035 new-drugs approved by th
e FDA
during a 12 year p
eriod fro
m 1989-2000
were for h
ighly innovative drugs – medicines that contained
new active ingredients and also provide
significant clinical im
provement. (NIHCM Foundatio
n, 2002)
68% of 3,096 new products approved in France
between 1981 and 2004 brought ‘nothing new’
over previously available preparations.
(Prescrire International, 2005)
Only 68 (5.9%) out of 1,147 newly patented drugs appraised by the Canadian Patented Medicine Prices Review Board between
1990 and 2003, met the regulatory criterion of being a breakthrough drug – the first drug to treat effectively a particular
illness or which provides a substantial improvement over existing drug products. (Morgan et al, BMJ 2005)
Prevention is better than cure3 steps
Law/guidelines setting the
patentability criteria Local
examination – law provides for examination of
every application
Pre - Grant Oppositions
Efforts to stop evergreening: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
Any other personGeneric CompaniesPatient Groups
Pre Grant OppositionPre Grant Opposition
Post Grant OppositionPost Grant Opposition
Challenging Decisions of Patent OfficeChallenging Decisions of Patent Office
Challenging decisions of Appellate BoardChallenging decisions of Appellate Board
Patent OfficePatent Office
Patent OfficePatent Office
Appellate BoardAppellate Board
CourtCourt
Patent InvalidationPatent Invalidation
Appellate BoardAppellate Board
High CourtHigh CourtPatent RevocationPatent Revocation
India Allows Pre-grant and Post-grant Opposition
Oppositions and Appeals Oppositions and Appeals
Novartis patent application on life saving cancer drug – CPAA files opposition in 2005
Glivec’s base compound, Imatinib mesylate, was patented in 1993 and was not eligible for an Indian Patent because India joined the WTO only in 1995.
Result of CPAA’s opposition
•Patent for Glivec rejected
•Generic versions of Glivec were once again available in the Indian market at affordable prices
Jan 2006
MSF worried
But since January 2005, India is obliged to grant
patents on medicines the source of HIV medicines
may dry
MSF pharmacist: Generic pipeline
Needed for(according to WHO)
TDF 1st and 2nd line
TDF based FDC 1st line
LPV/r tabs 2nd line
Ritonavir 2nd line
EC ddI 2nd line
ATV 2nd line
ABC 1st and 2nd line
All these needed ARVs will be at risk of production if patents are granted
Prognôsis
A granted patent in India for an essential drug (including
Antiretrovirals) will block generic production by Indian
companies and make drugs either unavailable or unaffordable
(or both) across the developing world
Partnerships: PLHIV networks, legal AID groups and MSF need
to work together on opposing HIV medicine patent applications
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
1970-71
1975-76
1980-81
1984-85
1985-86
1986-87
1987-88
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1989-90
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1998-99
Year
Nu
mb
er o
f A
pp
licat
ion
s
Domestic
Foreign
Patent Applications in India
US received 288K patent applications in 1999
Source: Annual Reports of the IPO
Source: Annual Reports of the IPO
• Major Increase in the number of patent applications filed at the Indian Patent Office (IPO)
• PCT is the favorite filing route
–~60% applications filed with the IPO were national phase filings under PCT
• Majority of filers are foreign residents (Bayer, Gilead)
• Major Increase in the number of patent applications filed at the Indian Patent Office (IPO)
• PCT is the favorite filing route
–~60% applications filed with the IPO were national phase filings under PCT
• Majority of filers are foreign residents (Bayer, Gilead)
Patent Filing Trends in India
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No. Patents Filed
Patent Filings at the IPO
Searching Indian Patents – A BIG Challenge- Opposition dependent on information available. But how
does patent office manage publication in India:- no searchable database to identify applications
(reduced to manual searching through thousands of patent applications)
- Publication of only abstract. requirement of publication of patent specification deleted making it difficult to oppose effectively.
- Information only available after visiting four patent offices in Mumbai, Delhi, Kolkata and Chennai (no centralised system)
- Refusal to provide examination report Access to examination report available under USPTO & EPO
- Refusal to provide copies of patent decisions/case law (trademark decisions are available in journals) under sec 153, rule 134 f).
How we did it : • Manual procurement of patent copies from the Indian
Patent Office• Need to submit request and fees at one of the four patent
office branches where the application was filed (involves travel time & cost)
• Regular follow-up required to obtain the copy of the patent application
• May take three to four weeks for one application
Ex. of AZT+3TC patent application
« a pharmaceutical composition and a method of inhibiting human immunodeficiency virus (HIV) is disclosed which comprises administering to an HIV infected patient a homogenous composition of lamivudine, zidovudine and a pharmaceutical glidant in an amount which achieves antiviral efficacy »
Patent WIPO India Status
Lopinavir Crystalline WO 01/74787
IN/PCT/2002/1243/
MUM Rejected
Divisional of (1243) WO 01/74787 894/MUMNP/
2007 Abandoned
Lopinavir Crystalline - process and intermediatesWO/
2002/018349259/MUMNP/
2003 Pending
Divisional of (259)WO/
2002/0183491732/MUMNP/
2009 Pending
Ritonavir Polymorphs WO00/04016
PCT/2001/00018/
MUM Abandoned
Divisional of (00018) WO00/04016676/MUMNP/
2007 Abandoned
Divisional of (00018) WO00/04016677/MUMNP/
2007 Abandoned
Divisional of (00018) WO00/040161638/MUMNP/
2007 Pending
Ritonavir - dosage formulationWO2006/09152
96733/DELNP/
2007 Pending
Lopinavir/Ritonavir - Heat stable tabletWO2005/03955
1339/MUMNP/
2006 Rejected
Divisional of 339WO2005/03955
1726/MUMNP/
2009 Abandoned
Divisional of 339WO2005/03955
12474/DELNP/
2009 Withdrawn
Lopinavir/Ritonavir - Soft Gel formulation WO 00/74677
IN/PCT/2001/01312/
MUM Abandoned
LPV/r Patent Status
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
Combivir patent opposition – Indian and Thai groups hold protests on the same day, issue joint press release…
…GSK announces withdrawal of Combivir patent application
7 August 2006: PLHIV protest outside GSK offices in Bangkok, Thailand.
7 August 2006: Indian groups demonstrate outside GSK offices in Bangalore, India.
Rejections due to local examination and application of strict patentability criteria
Source: Lawyers Collective HIV/AIDS Unit
Legal safeguards: Prohibition of Evergreening & right to file oppositions
• 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.
• It allows any person to file a technical opposition
STAGES OF EXAMINATION
PUBLICATION OF APPLICATION
REQUEST FOR EXAMINATION
REJECT/GRANT OF PATENT
3rd Party Representation
Revocation/Amendment
OPPOSITION
• PROMPTLY AFTER 18 MONTHS
• WITHIN 48 MONTHS FROM F.D.
• ALL OBJECTIONS TO BE COMPLIED WITHIN 12 MONTHS
• WITHIN 12 MONTHS
FILING OF APPLICATIONPROVNL. / COMPLETE
Decision of Controller
EXAMINATION-ISSUE OF FER
Appeal
Appellate Board
Shortlist drugs Shortlist drugs
• Use organisations like MSF, Pharmacists, other treatment providers like CPAA• Use organisations like MSF, Pharmacists, other treatment providers like CPAA
Strategy for India : Identifying Barriers
Study US/EP/PCT patent families of short-listed drugsStudy US/EP/PCT patent families of short-listed drugs
• As almost 80% patent filers are foreigners, there are good chances that the patent would have patent applications in US/EP/PCT
• Since full texts of all granted patents are not available online, and manual procurement of patents takes time, PCT, US, EP documents help in quick assessment
• As almost 80% patent filers are foreigners, there are good chances that the patent would have patent applications in US/EP/PCT
• Since full texts of all granted patents are not available online, and manual procurement of patents takes time, PCT, US, EP documents help in quick assessment
Order full text of patents from relevant branch of the IPOOrder full text of patents from relevant branch of the IPO
• Note the branch of the IPO in the application number, and order the full text from that branch only
• Presence of local vendor helps in regular follow up with the IPO and quicker delivery of patents
• Note the branch of the IPO in the application number, and order the full text from that branch only
• Presence of local vendor helps in regular follow up with the IPO and quicker delivery of patents
Order full text of patent applications/patents from patent officeOrder full text of patent applications/patents from patent office
• You can ask a patent agent to find
• You can directly ask patent office for equivalent patent application
• Protests, Right To Information laws, prominent leaders can help
• You can ask a patent agent to find
• You can directly ask patent office for equivalent patent application
• Protests, Right To Information laws, prominent leaders can help
Patents Not Absolute
• Patent applications can be opposed during examination process (pre-grant oppositions)
• Patents can be challenged after grant (post grant opposition)
• Patents considered valid until challenged (ex: Thai patent on ddI
Message: Why are pre-grant oppositions important?
• Pressure on patent offices to do thorough analysis of patent applications
• TRIPS does not define:– inventions– patentability criteria
• Great majority of patent applications are on new forms / improvements of known compounds
• Rejection means access to generic medicines which are affordable
Check legislation
• Does your country examine application locally and then
• Some countries have no pre-grant opposition procedure but have post grant
• Some countries have pre-grant but no post grant (Thailand)
• Some countries have both (India) • Some countries have neither (South Africa)• Some countries grant opponents right to be heard
(India) but others do not (Brazil)
Growing movement – SA, Thailand, Argentina, Philippines - Examination system weeds out patent applications that should not be granted. Direct benefit with earlier expiry of patents on ARVs.
Compulsory licensingChina - key announcement of proceduresIndia – applications by generic competitorsSouth Africa – reforms needed