Professional Documents
Culture Documents
Outline of Presentation
Opportunities
Challenges-Post 2005
VISION: 10/03
Demand will Grow Fastest in Emerging Markets Generic Options Available for Most Large Disease Segments Westernization of Disease Patterns in the Developing World Elderly Population will Fuel Demand In Developed Markets
VISION: 10/03
Increase to 2030
30% 25% 20% 15% 10% 5% 0% 4% 9% 9% 6% 7% 9% 10% 8% 8% 8% 11% 16% 18% 20% 21% 23% 24% 24% 24% 28%
New Zealand
Germany
India
China
United States
Australia
United Kingdom
France
Source: US Census Bureau: National Institutes on Aging Note: Represents 2002 data
VISION: 10/03
Canada
Japan
Price
9% Generics
New Elements
2.5%
91% Brands
2.7%
83% Brands
17% Generics
4.1%
4.3%
1.2% 1998
1.4% 2002
+15 +8 +7 +8 +2 +2 +10 +1
60%
Generics Prescriptions as % of Total Prescriptions
47%
49%
52%
New Zealand
Germany
Australia
United States
United Kingdom
France
Japan
Canada
East Asia West Europe North America Africa East Europe South Asia LAC West Asia OAC Total
Source: Chemexcil
VISION: 10/03
2.4 10.1 53.3 15.0 -0.9 9.1 -7.8 16.4 -3.2 12.1
Africa 13%
98,135 100.0
USA Germany Russia Nigeria China Brazil Hong Kong UK Vietnam Singapore Netherland Spain Switzerland Sri Lanka Japan Thailand Nepal Canada Mexico UAE Others Total
16,201 4,987 4,771 3,767 3,747 3,493 3,413 2,798 2,117 1,948 1,911 1,690 1,566 1,521 1,501 1,486 1,509 1,474 1,489 1,413 35,333 98,135
16.5 5.1 4.9 3.8 3.8 3.6 3.5 2.9 2.2 2.0 1.9 1.7 1.6 1.6 1.5 1.5 1.5 1.5 1.5 1.4 36.0 100
64.4 16.1 -4.0 8.9 40.3 -4.9 -22.9 14.8 13.2 -9.3 -0.1 2.7 27.9 -12.3 7.5 -0.8 13.3 -12.1 -8.6 10.1 8.9 12.1
Others 36%
Rus s ia 5%
Nigeria 4%
Mexico 2% Canada 2% Nepal 2% Thailand 2% Japan 2% Sri Lanka 2% Switzerlad 2% Spain 2% Netherland 2%
Vietnam 2%
Singapore 2%
Source: Chemexcil
VISION: 10/03
$57 $10
ROW
$28
Europe
US
13.6%
Source: Datamonitor
VISION: 10/03
10
Opportunities
VISION: 10/03
11
Opportunities
Leveraging Knowledge Base
VISION: 10/03
12
Opportunities
Moving up the Value Chain of R & D
2000E 2005
5%
NCE
30%
30%
35%
65%
Process Development
35%
VISION: 10/03
13
Opportunities
Partnering Global Players
Product Development
VISION: 10/03
14
Data Exclusivity
Patent Law Treaty (PLT) Substantive Patent Law Treaty (SPLT) Non Tariff Barriers
VISION: 10/03
15
VISION: 10/03
16
Patenting In Pharmaceuticals
The number of new chemical entities approved for use by US Food and Drug Administration (FDA) declined to 27 in 2000, compared to about 60 in 1985
but the number of patents granted in the main patent class for new drug compositions was 6,730 in 2000.
Year: 2000 NCEs: 27 Patents: 6,730
VISION: 10/03
17
Formulations/Dosage Forms Salts Processes Combinations Polymorphs Optional Isomers New Indications (therapeutic methods)
VISION: 10/03
18
Patenting Strategies
Blanketing: a jungle or a minefield of patents Flooding: multiple patents, major as well as minor Fencing: blocking certain lines or directions of R & D
Surrounding: an important central patent is fenced in or surrounded by other less important patents that block the use of the central patent, even after its expiration Networking: building of a patent portfolio to strengthen overall protection and bargaining power
VISION: 10/03
19
TRIPS Article 39.3 Period of Exclusivity ? Retrospective Effect ? Impact of Data Exclusivity
VISION: 10/03
20
13
15
20
25
27
PATENT FILING
PATENT EXPIRY
GENERIC SUBMISSION
GENERIC APPROVAL
0
VISION: 10/03
10 13
15
20
25
27
21
VISION: 10/03
22
1st Draft in November 2001 Revised in May 2002-Lays Down World Patent Law
VISION: 10/03
23
Spreading Doubts About Product Quality Working to Deny/Delay Product Registrations Raising Standards of Regulatory Approvals
VISION: 10/03
24
Under no circumstances do companies based in some countries that have poor regulatory quality standards match the standards of quality, service, and innovation on a sustainable basis that international companies provide.
IFPMA
VISION: 10/03
25