1. Twenty Years of WTO What did India Gain from the TRIPS Agreement?
Sudip Chaudhuri
Indian Institute of Management Calcutta
International Conference on “BRICS in the turmoil”, organised by the University of Guadalajara and the BRICS Seminar of the Fondation Maison des Sciences de l'Homme and the Ecole des Hautes Etudes en Sciences Sociales, of Paris
University of Guadalajara, Guadalajara, Jalisco, Mexico
5-7 June 2017

2. Outline of Presentation
Present some evidence on what has happened after TRIPS in India in pharmaceuticals
Analyse whether these changes are due to TRIPS or would have happened in any case
Raise the question of Reviewing TRIPS and limiting product patent protection in pharmaceuticals in developing countries

4. Sample of Potentially Patentable Molecules
Total no of molecules
Total Sales
Rs million
Sample no of molecules
Sales sample
Sample
Sales
(%)
Post 1994 monopoly molecules
265
10065
Top 50
9445
93.8
Post 2004 molecules approved in USA,
135
35939
33165
92.3
Post 1994 MNC monopoly molecules 72
8115
8061
99.3
Monopoly molecules approved in USA, 49
4631
100
Common among the above groups
350
42905
123
40708
94.9
Molecules with Patent disputes 36
Total sample
159
8124

5. Market Structure No of brands Total sales (Rs million) Sales: Patented
(%)
Patent rejected (%)
Not Patented (%) 1
9639
59.8
0.5
3.2 2
2979
17.9
0.7
0.4 3
877
1.8
0.6
1.6 4
3255
19.3
0.9 5
4375
0.1 18
6 to 10
4855
1.2
13.9
> 10
55260
94.4 62
Total
81240
100

6. Prices Note: Rs 100000 = USD 1550 approximately Price range (Rs)
Sales (%)
Patented molecules
Patent rejected molecules
Non-Patented molecules
> 3,00,000
100.00
0.00
2,00,000 to 3,00,000
1, 50,000 to 2,00,000
1,00,000 to 1,50,000
70,000 to 1,00,000
0.70
99.30
50,000 to 70,000
25,000 to 50,000
15,000 to 25,000
2.92
97.08
10,000 to 15,000
2.97
97.03
5,000 to 10,000
48.43
21.62
29.95
2,500 to 5,000
18.73
19.42
61.85
1000 to 2500
30.76
37.28
31.96
500 to 1000
24.89
33.86
41.25
100 to 500
6.54
62.37
31.09
50 to 100
55.99
35.97
8.04
10 to 50
14.16
58.86
26.97
< 10
2.45
84.39
13.16
Note: Rs = USD 1550 approximately

7. Group Patent status Unit for price Max price
Molecule
Group
Patent status
Unit for price
Max price
CABAZITAXEL
ANTI-NEOPLASTICS
Patented
60 MG INJECTION 1 ML
3,30,000
TRABECTEDIN
1 MG INJECTION
1,21,486
CETUXIMAB
500 MG INFUSION 50 ML
1,01,110
PEMETREXED
Not Patented
500 MG INJECTION
73,660
IXABEPILONE
45 MG INJECTION
71,175
TEMSIROLIMUS
25 MG INJECTION 1 ML
70,971
BORTEZOMIB
3.5 MG INJECTION
60,360
NIMOTUZUMAB
50 MG INJECTION 10 ML
51,242
ALTEPLASE
BLOOD RELATED
50 MG INJECTION
49,899

8. Group Patent status Unit for price Max price
Molecule
Group
Patent status
Unit for price
Max price
PEGAPTANIB
OPHTHAL
Patented
0.3 MG INFUSION 90 ML
44,571
BEVACIZUMAB
ANTI-NEOPLASTICS
100 MG INJECTION
41,250
TOCILIZUNAB
400 MG INJECTION
40,600
ABATACEPT
PAIN / ANALGESICS
250 MG INJECTION
30,000
TERIPARATIDE
HORMONES
Patented rejected
750 MG INJECTION 3 ML
23,462
PACLITAXEL
300 MG 50 ML INJECTION
19,826
PORACTANT ALFA
RESPIRATORY
80 MG 3 ML INJECTION
19,326
POSACONAZOLE
ANTI-INFECTIVES
40 MG ORAL SUSPENSION 105 ML
17,440
CLADRIBINE
10 MG INJECTION
13,400
CASPOFUNGIN ACETATE
Not Patented
70 MG INJECTION 10 ML
12,857

9. Patents withdrawn/not granted
No of brands
Unit
Highest price
Lowest price
IMATINIB MESYLATE 22
400 MG TABLET
397.44
161.38
ERLOTINIB 10
150 MG TABLET
396.67
SITAGLIPTIN 4
100 MG TABLET
45.00
28.43
PACLITAXEL 40
300 MG INJECTION
VALGANCICLOVIR 8
450 MG TABLET
490.00
235.58
OXCARBAZEPINE 37
600 MG TABLET
27.35
7.25
ATAZANAVIR 3
300 MG CAPSULE
76.67
70.00
ABACAVIR
300 MG TABLET
120.25
47.00
RITONAVIR
00 MG CAPSULE
57.14
30.00
NEVIRAPINE 7
200 MG TABLET
17.00
13.68
TENOFOVIR 12
150.00
36.67

10. TRIPS Flexibilities Section 3(d):
Specially after the Supreme Court judgment on Novartis’ Gleevec patent, secondary patent applications without improved therapeutic efficacy expected to be denied
But Compulsory Licensing is potentially much more powerful
Only three applications of which two rejected
Unless CL is pursued as an Industrial Policy and a Health Policy matter, outcome unlikely to improve in future

11. Partnership with MNCs: Examples
Marketing tie ups
Sun Pharma/Merck
Zydus Cadila/Bayer
Lupin/Eli Lilly
Biocon/Bristol Myers Squibb
Manufacturing tie ups
Aurobindo Pharma/Pfizer
Dr Reddys Labs/GSK
Torrent/AstraZeneca
Shasun/Eli Lilly

12. FDI flows in India, 2000 to 2012
Source Chalapati Rao et al, 2014

13. Source: UNCOMTRADE

14. Major Indian Cos: Export/sales (%)
2000
2005
2010
2016
Dr. Reddy'S Laboratories
26.4
55.8
61.7
70.6
Aurobindo Pharma
49.3
47.7
62.9
75.9
Lupin
18.2
44.5
59.6
Cipla
43.9
51.1
54.8
Cadila Healthcare
8.5
12.0
48.9
66.3
Sun Pharmaceutical Inds.
11.6
26.3
44.9
50.3
Divi‘s Laboratories
87.6
81.9
88.5
85.8
Torrent Pharmaceuticals
25.9
15.0
30.7
53.2
Intas Pharmaceuticals
2.3
23.6
30.1
49.5
Ipca Laboratories
46.5
53.3
48.2
47.8
Source: CMIE Prowess database

15. EXPORTS OF PHARMACEUTICALS 1994-95 USD million
Percentage of India’s total exports
USD million
Percentage of India’s total exports
Regulated markets
351.45
43.9
47.5 US
85.78
10.7
4025.8
26.7
Other markets
448.91
56.1
52.5
Asia
206.3
25.8
18.0
Latin America
20.2
2.5
984.23
6.5
Africa
85.3
20.0
Source: Complied from DGCI&S

17. Major MNCs in India: Export/sales (%) Company Name 1995 2005 2010 2016
Sanofi India
13.5
24.3
21.4
23.7
Merck
4.7
3.0
10.5
8.2
Abbott India
0.4
0.6
0.5
Novartis India
8.3
1.8
0.7
Pfizer
0.1
Glaxosmithkline
2.8
1.9
3.6
0.0
Astrazeneca Pharma India
10.0
4.3
Source: CMIE Prowess database

18. Source: UNCOMTRADE

19. Source: CMIE Prowess (Top 7 MNCs)

20. Major Indian Cos: R&D/sales
Companies with more than Rs 100 million R&D expenditure in 2012
Source: CMIE Prowess database

21. Major Indian Cos: R&D/sales
1995
2005
2010
2016
Dr. Reddy'S Laboratories Ltd.
2.0
18.2
8.7
13.6
Aurobindo Pharma Ltd.
0.0
4.7
3.1
Lupin Ltd.
6.9
11.4
16.1
Cipla Ltd.
4.1
4.6
8.5
Cadila Healthcare Ltd. NA
9.0
11.1
10.6
Sun Pharmaceutical Inds. Ltd.
7.7
12.2
Glenmark Pharmaceuticals Ltd.
5.0
7.2
Biocon Ltd.
3.5
6.3
6.4
Wockhardt Ltd.
7.9
8.0
13.5
Suven Life Sciences Ltd.
2.4
28.2
14.2
Natco Pharma Ltd.
5.2
3.0
2.5
6.6
Source: CMIE Prowess database

22. New Drug R&D by Indian companies
Started by Dr Reddys and Ranbaxy in early 1990s followed by several others - Glenmark, Lupin, Zydus Cadila etc
Several molecules under development including in collaboration with foreign companies, for example Sanofi and Forest labs by Glenmark
Initial euphoria subsided; setbacks; limited success
Neglected diseases: Ranbaxy, anti malarial drug an exception
Main target: developed countries market which in any case had product patent protection

23. MNCs: R&D/sales
Source: CMIE Prowess database: Top 8 MNCs

24. US Pharma Patents from India: 1969-2015
Foreign
Companies
Indian
Total 77 7 84
124
1240
1364
201
1247
1448
Source: USPTO

25. Source: USPTO

26. Source: USPTO

27. India based patenting in USA by foreign cos
Before TRIPS
Ciba-Geigy: 42
Hoechst: 35
After TRIPS
Mylan (including Generics UK): 44
Teva: 20
Fresenius Kabi Oncology: 12
Hoechst: 11
Aventis: 5
Novartis 7
Astrazeneca: 8

28. The Situation After TRIPS
Negative Impact due to TRIPS
Prices of new medicines
Rising imports
Acquisition of Indian companies by MNCs
Positive Impact not because of TRIPS
Exports by Indian companies
R&D by Indian companies for generics
R&D by Indian companies for new drugs
Patenting

29. Conclusion If Public Policy is based on Evidence,
TRIPS Agreement needs to be reviewed

30. Thank You sudip@iimcal.ac.in