Presentation

to
Commission on Intellectual Property Rights
Innovation & Public Health

by
D G Shah
Secretary General
Indian Pharmaceutical Alliance

New Delhi
November 4, 2004
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Outline of Presentation

Public Health
Innovation
IPRs
Remedy

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Public Health
Providing Access to Medicines
Stock Taking: Post-August 30 Decision
Overcoming Hurdles

Clinton Foundations decision to source ARVs from

generic companies
WHOs determined effort to defend scientific and
technical principles for the use of combination therapy
The World Bank initiative on the use of generics
Compulsory Licenses by Malaysia & Mozambique

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Public Health
Providing Access to Medicines
Stock Taking: Post-August 30 Decision
Creating Barriers

Bilateral and Regional Free Trade Agreements

Emergence of TRIPS-Plus world of The World
Intellectual Property Organisation (WIPO)-PCT Reforms,
PLT & SPLT
Aggressive Pursuit for Market Exclusivity through Data
Protection
Erection of Technical
Combinations (FDCs)

Barriers

for

Fixed

Dose

Inadequate legislative changes for implementing the

paragraph 6 decision
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Innovation
NCEs & Patents

No. of NCEs Approved by the US FDA and No. of

Patents Granted in the Main Patent Class for New
Drug Compositions:
Year

2000

NCEs

27

Patents

6,730

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Innovation
Patenting Minor or Trivial Developments

Dosage Forms
New Indications (therapeutic methods)
Combinations
Salts
Polymorphs
Isomers
Metabolites
Blood Level
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Innovation
Productivity of R & D Spend

60

1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
Source: US FDA

12
13
13
15
17
19
21
23
26
30
32

53

No of Drugs
Approved

26
25
22
28
53
39
30
35
27
24
17

50
39
40

N o. & B n$

Year

R&D
Spend (Bn$)

30
30

26

22

24 17

27

12

13

13

32

26

20
10

30

28

25

15

19

17

21

23
Productivity

0
1992 1993

1994

1995

1996

1997

Year
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R & D Spend

35

1998

1999

2000

2001 2002
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Innovation
Effects of Legal Systems
Litigate v/s Innovate

The legal systems that have evolved in the recent past

have led to reduction in pressure for innovation. In
order for the science to progress and keep the flow of
innovations alive, it is necessary to reform the legal
systems.

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IPRs
Inventions vs Commercialization
10
9.6
9

Total Filings

(In Millions)

8
7.1

7
5.9
6
5

4.5

4
2.8

3
1.6

1.8

2.0

0.59

0.62

0.64

2
1

3.4

2.3
0.63

0.69

0.68

0.70

0.72

0.75

0.83

First Filings

0
1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

Ref: Intellectual Property Rights.. Unleashing the Knowledge Economy

P. Ganguli ( Tata McGraw Hill, New Delhi 2001)
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IPRs
Patent Globalization Index (PGI)
12

Globalization Index

10
8
6
4
2
0
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000
PGI 1.69 1.86 2.07 2.66 3.34 4.01

5.5

7.4

8.85 10.6

Ref: Intellectual Property Rights.. Unleashing the Knowledge Economy

P. Ganguli ( Tata McGraw Hill, New Delhi 2001)
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IPRs
What Does PGI Indicate?

Patent Protection is Now Sought in

More Markets Than Before

Patenting Strategies that

Manipulate to Extend Market Exclusivity

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IPRs
Patenting Strategies that Delay Access
Example-1: Imatinib Mesylate (Novartis)

The first patent application for imatinib and its salts including the
mesylate salt, CH 1083/92 was filed in Switzerland in 1992.

The patent application came in to public domain in 1993 on the

publication of European equivalent EP-A-O 564409.

Subsequently, a specific patent application CH 1764/97 for the beta

crystalline form (polymorph) was filed in 1997 in Switzerland,
extending the patent life of the drug by five years.

Then, Australian equivalent AU 740713 on the beta crystalline form

was filed in 1998.

The Indian EMR is based on post-1995 application for a polymorph

of imitanib mesylate.

If not revoked, patent in India will expire in 2021, whereas patent

in Europe would have expired in 2017.
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IPRs
Patenting Strategies that Delay Access
Example-2: Rosiglitazone (GSK)

The first patent for the product was filed in 1987 in the USA.

The patent came in to public domain in 1994 on the publication of

the international application.

An equivalent patent was filed in Brazil in 1997.

Subsequently, a specific patent for rosiglitazone maleate was

filed in 1992, also in the USA, extending the patent life of the drug
by five years.

GSK claim for EMR in India is based on its post-1995 application.

If granted, patent in India will expire in 2017, whereas patent in
the USA would have expired in 2012.
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IPRs
Patenting Strategies that Delay Access
Erecting Barriers to Generics

Patenting of Impurities in a Medicinal Substance

as Chemical Compounds

Patenting of trivial part of a process to allege process

infringement

Impurity/Trivial Process Patents expire many years

after Original Patents

Delaying entry of Generics

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Remedy
Proposals for Improvement
New Drivers of Growth

The research-based companies must look for new

inventions to drive growth or be part of the generic
sector and drive growth through volume as generic
companies do.

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Remedy
Proposals for Improvement
Modification in Legal System

Modification of legal systems is a necessity to create

more pressure for innovations, progress the science
and promote access to medicines.

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Remedy
Proposals for Improvement
Role of UN & WHO

Bridge
the
Divide
Between
Innovative & Generic Sectors
Obtain Obligatory Licenses
New Mandate for WIPO

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Remedy
Proposals for Improvement
Help Desk at WHO

To assist legislative changes that would permit grant of

compulsory license or provide for government use in
case of public health problem
To help the least developed countries in incorporating
the extension of transition period in their property law
To ascertain the current IPR status of a product to
decide whether compulsory license is required
To encourage regional partnership for local production
of products required in large quantity for sustained
period
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Thank You
dgshah@vision-india.com

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