ICIC 2014 Patent Landscape Analysis as a Tool for Public Policies Adjustment: The Case of...
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![Page 1: ICIC 2014 Patent Landscape Analysis as a Tool for Public Policies Adjustment: The Case of Antiretroviral Drugs in Brazil](https://reader034.fdocuments.us/reader034/viewer/2022051514/5481fc04b47959050d8b468f/html5/thumbnails/1.jpg)
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
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Introduction Main Challenges:
•Patent cliff; •Increasing cost of pharmaceutical development; •National movement to reduce spending; •Increasing regulatory demands; •Social pressures.
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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
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Objetive
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Analyze the patenting matrix of antiretroviral drugs in Brazil, identifying relevant patterns of competition in the pharmaceutical industry.
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Methodology
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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
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IPC
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Import to VantagePoint
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“Teaching” VantagePoint (Thesaurus)
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• VP Data Cleaning
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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
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•“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
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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)
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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
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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%
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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%
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Company A
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Total incrementalities and % in ARV
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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
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(Patent status analysis)
Total applications Abandoned requests % abandoned
427 100 23,4
Search for triviality evidence
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Conclusions
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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.
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Limitations
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1. Non Incremental patents – Hard to visualize;
2. Two Years delay
3. PCT and national delay legal uncertainty.