ramesh m (ushealth)indian drug industry- strengths • mature industry with strong manufacturing...
TRANSCRIPT
The move to globalise the protection of intellectual property is not politically
sustainable without at the same time, making the delivery of health technology more
equitable
Global health Forum
Feb 2000
“Governments to ensure the
accessibility of pharmaceuticalsas well as their
affordability to all”
UN Commission on Human Rights April 2001
Recent Landmark Events 2000-2003
• HIV/AIDS case in South Africa• Compulsory licensing of
HIV/AIDS drugs in Brazil• Anthrax Scare• International Commission on
Intellectual Property Rights Commission Report
• Doha and post Doha events
• IP System is one factor among several others that affects access to medicines by the poor
• Lack of resources, absence of suitable health infrastructure, other policies contribute adversely
• Increase public funding to stimulate research on health problems of the poor
• Ensure that IP protection regime not counter to public health policies
• Establish differential pricing mechanism but stop leakage of low priced drugs
• Use compulsory licensing with workable laws and procedures
C td
• Adopt strict standards of patentability
• Exclude diagnostic, therapeutic & surgical methods from patentability
• No ‘new use’ patents• Use “Bolar Exception” to facilitate
entry of generic competitors
To install transitional facility, i.e., ‘mail-box’ for product patent applications and grant of exclusive marketing rights (EMRs), from 1.1. 19951999-First Amendment-The Patents (Amendment) Act, 1999 - made effective from 1.1. 1995To comply with obligations relating to rights of patentee, term of patent, compulsory licensing, reversal of burden of proof, from 1.1. 20002002-Second amendment- The Patents (Amendment) Act, 2002 - made effective from 20.5. 2003
Public interest protectionAvailability of product at reasonable price through compulsory license of patents(Chapter 16)Emergent situations (Section 92)Parallel import (Section 107A(b)Use of invention for the purpose of Government and acquisition of invention by the Government in public interest (Chapter 17)
Import of medicines by Government (Section 47)Acquisition of patent right by Government (Section 102)Conditional grant of patent (Section 47)Bolar provision ( Section 107A(a)Research and Experimentation Exemptions (Section 47)Revocation of Patent in public interest (Section 66)
50000065000Total Number of Doctors
8.922.8Death Rate(Per Thousand)
69146Infant Mortality(Per Thousand)
62.9 Yrs41.2 YrsLife Expectancy
20001960
Indian Paradoxes
• Richest 20% enjoy 3 times the share of public subsidy compared to the poorest quintile
• Poorest 20% have double the mortality rates, fertility rates and under nutrition levels than the richest 20%
• Poorest spend 12% of their incomes on healthcare as opposed to 2% by rich
• One episode of hospitalization wipes out all the assets of a poor family
Indian Pharmaceutical Industry
2000plus
90s
80s
70s
60s
50s
Strong GenericsNew Molecule Research
Drugs & Pharma
Insignificant importsFormulationBulk Drugs
Marginal importsMostly indigenous manufacture based on domestic R&D
FormulationBulk Drugs
Little ImportIndigenous manufacture
FormulationBulk Drugs
Domestic endeavour on importedFormulation
Mostly imported MNC DominanceFormulation
565877
VaccinesTotal
134Large Volume Parentarels
4354Formulations
1333Bulk Drugs
No. of Mfrs.
TYPE
(not 20,000)
Indian Drug Industry- Strengths• Mature industry with strong manufacturing base
with capacity to produce quality drugs at relatively lower costs.
• A very rich base of traditional knowledge in therapeutics i.e. Ayurveda, Sidha & Unani
• Well developed engineering base to produce a wide range of pharmaceutical equipment and machinery
• Abundance of S&T talent and infrastructure.• Successful experience in innovative process
chemistry• Access to brain bank of internationally acclaimed
NRI S&T professionals.
Indian Drug Industry - Weaknesses• Sub-critical R&D investments• Lack of truly innovative R&D culture in
industry• Poor networking among constituents in the
innovation chain• Inadequate framework for clearance of
new drug investigation and registration• A policy framework for testing on animals
and their import that is not facilitative• Inadequate trained manpower in emerging
areas.» Contd.
Indian Drug Industry- Opportunities
• Due to rising costs of R&D overseas, greater opportunity of outsourcing and networking.
• Expertise to blend knowledge of traditional medicines with modern science.
• Increasing competence in molecular biology, immunology and biotechnology.
• Early R&D wins boosting confidence (Reddy’s, Ranbaxy’s, Dabur’s, Shanta Biotech’s)
• Large number of patients covering wide range of diseases.
• Potential for clinical trials.• Major high quality generics supplier.
• Filling of patent infringement suits• Paying the generic company for
delaying the introduction of the product
• Withdrawing the product from the market and reintroducing a new ‘version’
• Initially a new study of the patented product to enable FDA to approve extension of patent life of the original product by six months.
New Drug Discovery Programs• Ranbaxy• Dr Reddy’s Laboratories• Wockhardt• Torrant• Cadila Healthcare• Cadila Pharmaceuticals• Nicholas Piramal• Glenmarn• Orchid• Dabur• Lupin
5Sahajanand Biotech Private Limited125Lupin Limited115J.B. Chemicals & Pharmaceuticals Ltd.10
5Aurobindo Pharma Limited
9 6Khamar, Bakulesh, Mafatlal8
6Avestha Gengraine Technologies Pvt. Ltd.78Sun Pharmaceutical Industries Limited6
10Biocon India Limited5
16Orchid Chemicals & Pharmaceuticals Limited4
19Dr. Reddy’s Laboratories Limited3
56Ranbaxy Laboratories Limited
2
184Council of Scientific and Industrial Research (CSIR)
1
No. of
ApplicantsApplicantRank
Major PCT Applicants from Developing Countries(2002)
28SingaporeThe National University of Singapore924SingaporePhilips Electronics Singapore PTE Ltd.10
84ChinaHuawaei Technologies Co.5
31ChinaSAE Magnetics (H.K.) Ltd.847Rep of KoreaLG Chem Ltd.756IndiaRanbaxy Laboratories Ltd.6
125ChinaLG electronics Inc4136ChinaBiowindow Gene Development Inc3184Rep of KoreaSamsung Electronic Co.
184IndiaCouncil of Scientific & Industrial Research1
No( appl)
CountryApplicantRank
CSIR Patent Filing
71 91 112199
454
590
728
96/97 97/98 98-99 99/2000 2000/01 2001/02 2002/03
6 4 4 7 8 10 1123 32 37 38
69
145
020406080
100120140160
90 91 92 93 94 95 96 97 98 9920
0020
0120
02US Patents Granted to CSIR
Use of Traditional Medicine90%70%70%60%60%
EthiopiaIndiaRwandaTanzaniaUganda
Populations using traditional medicine for primary health care
70%48%49%42%31%
CanadaAustraliaFranceUSABelgium
Populations in developed countries who have used complementary and alternative medicine at least once
Gugulipid – An Inspiring Story
• Utility of guggulu in treating lipid disorders– Sushrutta Samhita (600BC)
• Guggul – hypolipidemic effect– BHU(1964)
• Guglip – hypolipidemic drug– CDRI, 1981
• Scientific basis for Guglip action– 1984-88 Scientific Journals
• New exciting science follows in major journals (2002)
Excitement !It is an intriguing possibility that characterization of the efforts of
natural products on such receptors will identify agents that
like guggulsterone have more desirable activities
Virazar et.al. , Science (2002)
Guggulsterone highly efficacious antagonists of Formesoid-x receptor, a
nuclear harmone receptor activated by bile acids
Virazar et.al. , Science (2002)
INDIA’S VAST BIODIVERSITY45,000 PLANT SPECIES, 15,000 MEDICINAL PLANT
RICH TRADITIONAL KNOWLEDGEBASEAYURVEDA, SIDHA, UNANI, TRIBAL
STRONG SCIENCE BASE150,000 R&D PERSONNEL
CSIR COMPETENCIESNEW DRUG DISCOVERY
BIOACTIVE MOLECULE DISCOVERY & DEVELOPMENT
DEGENERATIVES
METABOLICDISORDERS
CNS
TROPICAL INFECTIVES
OTHERS
IGIB CDRI CIMAP
IICBIICT IMT
ITRCRRL,J
ALZHEIMER
ATHEROSCLEROSIS
BACTERIAL
CANCER
DEPRESSION
DIABETICS
FILARIASIS
FUNGAL
GASTRIC ULCER
HEPATITIS
HYPERTENSION
IMMUNOMO-DEFICIENCIES
INFLAMMATION
LEISCHMANIA
MALARIA
MEMORY REDUCTION
NEURO DISORDERS (3)
PARKINSONIAN
INVITRO/INVIVO SCREENING
CCMBTRANSGENIC ANIMAL MODELS
EMPLOYED
SAMPLES RECEIVED
EXTRACTS PREPARED
EXTRACTS DISTRIBUTED
FIRST LEVEL POSITIVES
67 FORMULATIONS
197
3342 (6 LABS AND 18 DISEASES)
126
IMMUNO MODULATORS/ MEMORY ENHANCERS
ANTI MALARIAL
27
13 HEPTO PROTECTIVE
15
ANTI BACTERIAL/
FUNGAL
16
3
ANTI FILARIAL
3
ANTI CANCER
12
ANTI LEISHMANIA
15
ANTI ULCER
7
ANTI ARTHRITIC
ASMON
• Polyherbal medication provides relief in bronchial asthma
• Blocks both, leukotriene and lymphotriene causing asthma
• Available in convenient liquid and capsule form
Ethanol Induced Ulceration
TREATEDCONTROL
CONSTITUENTS AP-19 AP-20 AP-75K AP-76p OMEPRAZOLE
A a1 a2 a3 a4 -
B b1 b2 b3 - -
C - - c3 - -
D - - - d4 -
ULCER INDEX 50 80+ 87 100 50
CANDIDATES UTILITY PATENTS NEW PRODUCT PATENTS
India’s emergence as global R&D platform
• 100 global players set up R&D centres in India in last five years
• General Electric R&D Centre –expanding to 2400 employees!
• Advantage India –– S&T budget 2002 - $ 5 billion– Pfizer budget 2002 > $ 5 billion
• Strong networking with public R&D too
Public Private Partnership
Partners• For profit companies (Pharma)• Not for profit organisation
– s– Foundations– Philanthropic institutions
• International organisations• Development & Aid Agencies• Government• Academia
Some PPPs
• International Aids Vaccine Initiative
• Global alliance for TB Drug Development
• Roll Back Malaria• Medicines for Malaria Venture• Others
Global Funding – Which Sources?
• Private foundations• Bilateral donors• International organizations• Debt-for-technology swaps• Private foundations in developing countries• Industry• Shifting priorities in developing countries
Klaus M. Leisinger, October 7th 2003
The PPP valueproposition:
CollaborativeR&D
MMV Input•Stakeholder $$$•Background IPR•Link to RBM•Expertise
Pharma Input•Chemistry IPR•Know How•Assets in Kind•Opportunity Cost
MMV Gets•Rights in DEC•IPR in ‘Field’•Drug Supply•$ Return on non DEC Sales
Pharma Gets•Rights in non DEC•IPR outside ‘Field’•PR•$$$ Return in non DEC
$
$
Public
Private
Key Partners in current MMV projects
L a r g e P h a r m a B a y e r B r is t o l M y e r s S q u ib b G S K R o c h e N o v a r t is
S m a l l P h a r m a J a c o b u s S -P K o r e a R a n b a x y , In d ia
A c a d e m ia B r is t o l , H K U S T H o w a r d H u g h e s L S H T M , L e e d s M a h id o l M o n a s h N e b r a s k a S T I , T e x a s A & M W a s h in g t o n W R A IR Y a le U C B e r k e le y
U K H o n g K o n g U S A U K U K T h a i la n d A u s t r a l ia U S A S w it z e r la U S A U S A U S A U S A U S A U S A
MMV Funding March 2003Total $55 million
Bill & Milenda Gates Foundation
44%
U.K. DFID18%
Rockefeller Foundation10%
Netherlands Minister Devt. Co-operation
6%
WHO/RBM6%
Swiss Government S.D.C.
5%
World Bank5%
Wellcome Trust5%
Exxon Mobil Foundation1%
PPP Global Chain
• Scientists at the University of Nebraska discovered Synthetic Peroxide. Roche Pharma partner
• Funding from WHO/TDR • MMV funding including for Swiss Tropical
Institute and Monash University• Roche hands over to Ranbaxy as
Development Partner.
What can be done ?
• Global Knowledge pool for global good through global funding