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Table 4 Characteristics of the drugs sorted by patent challenges

From: Patenting and patent challenges in South Korea after introducing a patent linkage system

 

Non-challenged

Challenged

% of challenged

P-value

Number of drugs (N)

481

94

(16%)

 

Drug type

   

 < 0.0001

 Chemical

396

93

(19%)

 

 Biologic

85

1

(1%)

 

Statutory exclusivity

   

 < 0.0001

 No

223

21

(9%)

 

 Yes

258

73

(22%)

 

Manufacturer type

   

0.0010

 Domestic

185

19

(9%)

 

 Foreign

296

75

(20%)

 

Administration

   

 < 0.0001

 Oral

305

82

(21%)

 

 Injection

124

4

(3%)

 

 Others

52

8

(13%)

 

ATC classification

   

0.0025

 J/L

154

13

(8%)

 

 A/B/C

184

51

(22%)

 

 M/N

65

12

(16%)

 

 Others

78

18

(19%)

 

Year

   

 < 0.0001

 2012

44

24

(35%)

 

 2013

82

18

(18%)

 

 2014

82

25

(23%)

 

 2015

98

14

(13%)

 

 2016

92

7

(7%)

 

 2017

83

6

(7%)

 

Patents

1.79

2.34

 

0.0042

Market size

413,749

466,502

 

0.1136

Number of manufacturers

379

395

 

0.5841

  1. Drugs approved from 2018 to 2019 were excluded in order to guarantee an observation period of at least three years