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