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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.
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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
Introduction Main Challenges:
•Patent cliff; •Increasing cost of pharmaceutical development; •National movement to reduce spending; •Increasing regulatory demands; •Social pressures.
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
Objetive
4
Analyze the patenting matrix of antiretroviral drugs in Brazil, identifying relevant patterns of competition in the pharmaceutical industry.
5
Methodology
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
IPC
8
Import to VantagePoint
9
“Teaching” VantagePoint (Thesaurus)
10
• VP Data Cleaning
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
•“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
After removal of redundancies
3199 documents
After manual selection
427 documents
•Results Plotting
•Incrementality Classification
•Search for triviality evidence
Results
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ARV Patent profile (Applicant Country)
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
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
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
Company A
19
Total incrementalities and % in ARV
20
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
(Patent status analysis)
Total applications Abandoned requests % abandoned
427 100 23,4
Search for triviality evidence
23
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.
Limitations
25
1. Non Incremental patents – Hard to visualize;
2. Two Years delay
3. PCT and national delay legal uncertainty.
Obrigado! Thank You!
Vielen Dank !
Roberto Reis, PhD roberto.reis@ini.fiocruz.br
26
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