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Intellectual Property and Public Health in the Developing World

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Monirul Azam

Appendices

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Appendix 1: Status of Patents in Bangladesh (1972–2012)

Patent Applied

Patent Granted

Year

Local

Foreign

Total

Local

Foreign

Total

1972

51

158

209

9

3

12

1973

76

277

353

6

30

36

1974

74

171

245

10

265

275

1975

35

110

145

25

312

337

1976

35

119

154

10

119

129

1977

33

86

119

11

93

104

1978

36

113

149

13

108

121

1979

31

100

131

20

83

103

1980

34

102

136

19

92

111

1981

39

133

172

17

85

102

1982

40

104

144

13

105

118

1983

40

123

163

11

115

126

1984

62

108

170

17

94

111

1985

40

96

136

13

105

118

1986

16

77

93

26

81

107

1987

23

98

121

10

79

89

1988

24

109

133

8

67

75

1989

32

76

108

3

88

91

1990

32

76

108

8

86

94

1991

36

77

113

10

68

78

1992

72

89

161

6

55

61

1993

36

71

107

10

66

76

1994

39

99

138

29

69

98

1995

70

156

226

6

74

80

1996

22

131

153

18

52

70

1997

46

119

165

15

61

76

1998

32

184

216

14

126

140

1999

49

200

249

26

122

148

2000

70

248

318

4

138

142

2001

59

236

295

21

185

206

2002

43

246

289

24

233

257

2003

58

260

318

14

208

222

2004

48

268

316

28

202

230

2005

50

294

344

21

161

182

2006

22

288

310

16

146

162

2007

29

270

299

27

269

296

2008

60

278

338

01

36

37

2009

55

275

330

28

103

131

2010

55

287

342

20

71

91

2011

32

274

306

06

79

85

2012

65

289

354

14

139

153

Source: Department of Patents, Designs and Trademarks, Dhaka, Bangladesh, 2013.

Appendix 2: Relevant Provisions of the TRIPS Agreement

Article 1 Nature and Scope of Obligations

  1. Members shall give effect to the provisions of this Agreement. Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement. Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.

Article 6 Exhaustion

1For the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.

Article 7 Objectives

2The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

Article 8 Principles

  1. Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socioeconomicand technological development, provided that such measures are consistent with the provisions of this Agreement.

  2. Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.

SECTION 5 : PATENTS

Article 27 Patentable Subject Matter

  1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.5 Subject to paragraph 4 of Article 65, paragraph 8 of

3Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

  1. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

  2. Members may also exclude from patentability :

  1. diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

  2. plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

Article 29 Conditions on Patent Applicants

  1. Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application.

  2. Members may require an applicant for a patent to provide information concerning the applicant’s corresponding foreign applications and grants.

Article 30 Exceptions to Rights Conferred

4Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

Article 31 Other Use Without Authorization of the Right Holder

5Where the law of a member allows for other use7 of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

a)

authorization of such use shall be considered on its individual merits;

b)

such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a member in the case of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable.

6In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;

c)

the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi- conductor technology shall only be for public non-commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive;

d)

such use shall be non-exclusive;

e)

such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use;

f)

any such use shall be authorized predominantly for the supply of the domestic market of the member authorizing such use

g)

authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;

h)

the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;

i)

the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that member;

j)

any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that member;

Article 33 Term of Protection

7The term of protection available shall not end before the expiration of a period of twenty years counted from the filing date.

Article 34 Process Patents: Burden of Proof

  1. For the purposes of civil proceedings in respect of the infringement of the rights of the owner referred to in paragraph 1(b) of Article 28, if the subject matter of a patent is a process for obtaining a product, the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process. Therefore, members shall provide, in at least one of the following circumstances, that any identical product when produced without the consent of the patent owner shall, in the absence of proof to the contrary, be deemed to have been obtained by the patented process:

Article 66 LDC Members

  1. In view of the special needs and requirements of LDC members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, such Members shall not be required to apply the provisions of this Agreement, other than Articles 3, 4 and 5, for a period of 10 years from the date of application as defined under paragraph 1 of Article 65. The Council for TRIPS shall, upon duly motivated request by an LDC member, accord extensions of this period.

8Developed country members shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to LDC members in order to enable them to create a sound and viable technological base.

Article 67 Technical Cooperation

9In order to facilitate the implementation of this Agreement, developed country Members shall provide, on request and on mutually agreed terms and conditions, technical and financial cooperation in favour of developing and least-developed country Members. Such cooperation shall include assistance in the preparation of laws and regulations on the protection and enforcement of intellectual property rights as well as on the prevention of their abuse, and shall include support regarding the establishment or reinforcement of domestic offices and agencies relevant to these matters, including the training of personnel.

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