The innovative multinational pharmaceutical industry is highly dependent on the release and promotion of new drugs. However, recent economic evidence demonstrates a continuing decrease in new drugs’ market approval. Moreover, the industry is challenged by the “patent cliff”, where many blockbuster drugs are losing patent protection and facing ferocious competition. It seems that the shortage of new drugs points to an intensification of drug development based on molecules already known, leading to incremental patents. However, there is a suspicion that many incremental patents are actually trivial, because they add little or nothing to existing therapies, but still impose high drug costs. To analyze that hypothesis, the present study has drawn the profile of all patents filed in Brazil in the antiretroviral (ARV) field up to 2012. Using VantagePoint® and Questel Orbit® softwares, a patent matrix was constructed with quali-quantitative data. Next, the patent applications' claims were analysed in order to detect incremental patents and classified according to their incrementalities. Finally we looked for evidence of triviality. As a result, it was demonstrated that the ARV market is highly concentrated and patent applications basically belong to six countries. Evidence that many incrementalities are actually trivialities and act as entry barriers, was found. Patent landscape studies such as this one can be extrapolated to other areas or countries, and can be used as a tool for public policy’s analysis to really fuel technological advance.

1. Patent Landscape Analysis as a Tool for Public Policies Adjustment: The Case of Antiretroviral Drugs in Brazil
Roberto Reis, PhD
Evandro Chagas National Institute of Infectious Diseases
Ministry of Health, Brazil
1

2. 2
Introduction
Main Challenges:
•Patent cliff;
•Increasing cost of pharmaceutical development;
•National movement to reduce spending;
•Increasing regulatory demands;
•Social pressures.

3. 3
Introduction
Main types of incremental inventions :
•“Me-too” Patents
•Selection Patents
•New Formulation Patents
•Polimorphs Patents
•Combination Patents
•Intermediates Patents
•Solvates Patents
•Second Use Patents

4. Objetive
4
Analyze the patenting matrix of antiretroviral drugs in Brazil, identifying relevant patterns of competition in the pharmaceutical industry.

5. 5
Methodology

6. 6
NRTI
NNRTI
EI
FI
II
PI
ARV Classification
Manual reading of all selected documents
Relevant documents
Export to datamining software
Results
Patent Search
Parameters
A61P-31/18
BR
1995-2008
Merge all results
Removal of redundancies
Group by depositors
Plotting of results
Methodology – 1st Part

7. 7
IPC

8. 8
Import to VantagePoint

9. 9
“Teaching” VantagePoint (Thesaurus)

10. 10
•VP Data Cleaning

11. 11
2H-3,1-Benzoxazin-2-one, 6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)- (4S)
(S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one
(4S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one (4S)-6-chloro-4-(2-cyclopropylethynyl)-4-(trifluoromethyl)-1H-3,1-benzoxazin-2-one
Efavirenz Sustiva® Stocrin® C14H9ClF3NO2 DMP-266
How to manually separate documents and classify incrementalities?
•Title
•Abstract
•Claims
•Summary of Invention
•Full description

12. 12
•“Me-too”
•Selection
•New Formulation
•Polimorphs
•Combination
•Intermediates
•Solvates
•Second Use
Incrementality Classification
ARV patent analysis
Methodology – 2nd Part
Patents
Patent status
Sanitary authorization comparison

13. 13
After removal of redundancies 3199 documents
After manual selection 427 documents
•Results Plotting
•Incrementality Classification
•Search for triviality evidence
Results

14. 14
ARV Patent profile (Applicant Country)

15. 15
Number of patent applications and % by companies
58
53
40
27
27
24
22
15
13
11
11
10
116
13,6%
12,4%
9,4%
6,3%
6,3%
5,6%
5,2%
3,6%
3%
2,6%
2,6%
2,3%
27,2%
0%
5%
10%
15%
20%
25%
30%
0
20
40
60
80
100
120
140

16. 16
Patent applications NRTI
17
14
6
5
3
47
36%
30%
13%
11%
7%
0%
10%
20%
30%
40%
0
10
20
30
40
50
Gilead
GSK
Bristol
Johnson &
Johnson
Medivir
Total pedidos
N
%
NRTI
Patent applications NNRTI
32
23
12
10
9
100
32%
23%
12%
10%
9%
0%
5%
10%
15%
20%
25%
30%
35%
0
20
40
60
80
100
120
Johnson &
Johnson
Bristol
Roche
Pfizer
Boehringer
Total
N
%
NNRTI
Patent applications PI
28
20
15
10
8
104
27%
19%
14,50%
9,50%
7,70%
0%
5%
10%
15%
20%
25%
30%
0
20
40
60
80
100
120
Pfizer
Johnson &
Johnson
Abbott
Vertex
MSD
Total
N
%
IP
96%
86%
77%

17. 17
Patent applications FI
13
2
15
86,70%
13,30%
0%
20%
40%
60%
80%
100%
0
5
10
15
20
Roche-Trimeris
Rohm & Haas
Total pedidos
N
%
Patent applications II
11
6
4
3
3
28
40%
21%
14%
11%
11%
0%
10%
20%
30%
40%
50%
0
5
10
15
20
25
30
GSK-Shionongi
Pfizer
Bristol
Gilead
MSD
Total
N
Patent applications EI
11
11
9
8
6
60
18,5%
18,5%
15%
13%
10%
0%
5%
10%
15%
20%
0
20
40
60
80
MSD
Sanofi
Pfizer
Astrazeneca
Roche
Total
N
100%
96%
75%

18. 18
Company A

19. 19
Total incrementalities and % in ARV

20. 20

21. 21
Search for triviality evidence
(Comparison with sanitary authorization)
ARV
Incrementalities
Valid Records
Pharmaceutical presentation
Presentation / incrementality
ARV / incrementality
20
845
37
69
69/845 = 1:12
20/845 = 1:42

22. 22
(Patent status analysis)
Total applications
Abandoned requests
% abandoned
427
100
23,4
Search for triviality evidence

23. 23

24. Conclusions
24
1.Importancy of appropriation rights in the pharmaceutical field (Mansfield, Schwartz, e Wagner, 1981; Mansfield, 1986);
2.Patent pattern (427 patents for 20 ARVs, 1:21);
3.Patent protection "around”;
4.Necessity to distinguish between incremental and trivial patenting;
5. Use of patent landscape Improvement of PP (spaces to maneuver);
6.Possible methodology extrapolation to other fields.

25. Limitations
25
1.Non Incremental patents – Hard to visualize;
2.Two Years delay
3.PCT and national delay  legal uncertainty.

26. Obrigado! Thank You! Vielen Dank ! Roberto Reis, PhD roberto.reis@ini.fiocruz.br
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