1. PADMIN BUCH IPR Innovation & Global Market
ASSOCHAM & Dept of Pharmaceuticals, GoI Conference on IPR in Pharmaceuticals Balancing Innovation & Access
IPR
Innovation & Global Market
PADMIN BUCH
B.Pharm., MBA; CMC; PG Diploma in Patents Law
OCTOBER 07, 2015
Ahmedabad
For preliminary discussions only.
Details, data & assumptions are indicative

2. Competitive Advantage
Innovation is the key… 2

3. Innovation….??? Enterprising Gujarat & Gujarati …!!3

4. Patent applications filed with Indian Patent Office (Indicative)
Year
Total Patent applications filed
Patent applications
from India
(Indicative)
Patent applications from Gujarat (Indicative)
43000
9800
(22.00%)
590
(6.00%)
42500
9500
(20.00%)
570
39400
8670
435
(5.00%)
Source : Indian patent office 4

5. Global Patent filings ( Indicative, for the Year 2013)
Country
Patents filed
% Share
(indicative)
Total patents filed : 26,00,000
China
825,136
33%
USA
571,612
22%
Japan
328,436
12%
India
43,031
1.6%
Source : WIPO ( Dec 2014)

6. Pharma Patents in India
In Indian pharmaceutical sector, the number of patents filed have increased from little over 3500 in to over 5500 in , %

7. Patent Cooperation Treaty (PCT) filings
Though it is not a patent filing system, it is, however, indicative of patent-filing trends around the world.
Together, China and US accounted for 87% of the total growth in filings under WIPO's PCT, which saw some 2,15,000 applications in 2014
After China, India (1,394) is the largest user of the PCT system among BRICS countries

8. PCT filing by Indian Pharma sector
With about 290 PCT applications, Pharma sector is second in the list of top Indian filers under the Patent Cooperation Treaty (PCT) in 2014, seeking protection internationally for their inventions.

9. Innovations & IPR in Pharmaceuticals The Game Changer
We have moved in to the era of Ideas, Creativity, Inventions and Intellectual Properties- intensively and aggressively
Intellectual property (IP) has emerged as a key tool in Value Creation and Growth 9

10. Pharma Innovations !!!

11. World Economy : The Paradigm Shift
Agri. Economy
Industrial Economy
Knowledge Economy
Innovation
Applied research
Science & Technology
IPR
Land
Labour
Capital
Machinery
Management 11

12. The Indian Pharma Industry

13. Indian Pharma Zones India has three distinct Pharma Clusters (Zones) of manufacturing bases.
Primarily Bulk Drugs, Some Formulations
Southern India (Chennai-Hyderabad Axis)
III
-do-
Northern India II
Bulk Drugs, Formulation & Merchant Exports
Western India (Mumbai - Gujarat Axis) I
Product Focus
Region
Zone/ Cluster
Gujarat State is primarily a formulation zone

14. Indian Pharmaceutical Market Growth projections by year 2020
Assumed CAGR(%)
Status
Projected Size
(Billion US $)
Most Likely 10
Pessimistic case
35.00
14.50
Base case
55.00 17
Aggressive case
70.00
Source :India Pharma 2020 Report, McKinsey & Co. 14

15. Indian Pharmaceutical Market Growth projections
By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size 15

16. Indian Pharmaceutical Industry
Indian pharmaceutical manufacturing facilities registered with US Food and Drug Administration (USFDA) as on March was the highest at 550 plus for any country outside the US.
Every 3rd DMF filed in US is from India 16

17. Generic Opportunity
US $ 40 billion worth of drugs in the USA and US $ 25 billion worth of drugs in Europe are going off patent .
This translates to an opportunity of additional export of US $19.5bn
A rise in geriatric population making the nations to move to cheaper APIs and formulations which are India’s forte.

18. Generics
In order to overcome low margins, some generic drug manufacturers are venturing into the super generics opportunity.
Sold for a significantly higher price than their pure generic counterparts, super generics account for 18% of all spending on drugs.
Bio-similar drugs will account for more than $20 Billion in revenue by the end of 2020.

19. Generics- India Supplier of High Quality, Low Cost generic drugs
Recognized by UNICEF as global leader in supply of generics
Accounts for 40% of Generic drugs in USA
India is the manufacturing hub for most of the countries

20. Making Indian Pharma Industry Globally Competitive
IPR framework
Research & Development initiatives

21. Indian IPR Laws framework
WTO compliant
Legally Sound
Fair & transparent
WTO plus provisions
Section 3(d)
Compulsory licensing

22. Indian IPR Framework Proposed National IPR Policy
May consider
Facilitating Utility patents
Encourage IPR / Patent base at the SMEs and Academic institutions
Fresh & global look at patenting of Herbal patents
Direct & indirect Financial incentives for filing Domestic & International patents (Gujarat model with modifications)

23. Research & Development Initiatives . . .!!!

24. R & D Initiatives Government & Industry
Special focus on Small and Medium scale Pharma sector
Financial & Technical assistance for Upgrading & Up scaling
Sound NDDS research work
Incentives for linking with Patent filing
Facilitating setting up common Research & Development Centers in Pharma zones / Clusters

25. R & D Push Government & Industry
Increased & more result oriented incentives for basic research
FDI policy
Generic drugs
Herbal drugs –jointly with Drug control anfd IPR authorities

26. To Conclude . . .

27. Pharma : Innovation & IPR
Industry,IPR authorities, DoP and Drug Control Administration to collaborate
Formulating a road map
Identify, cultivate and create 1000 Smart Pharma units from the Small & Medium Sector

28. Smart
Life Style Disease Drugs

29. THANK YOU Padmin Buch . . . phbuch3@gmail.com