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Intellectual Property and Public Health in the Developing World

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Monirul Azam

Index

Texte intégral

access to medicines xxiii, xxiv, 3–4, 6, 7, 14, 16, 17, 18, 21, 26, 28, 29, 30, 37, 56, 81, 82, 85, 94, 106, 107, 108, 112, 114, 129, 135, 139, 148, 152, 178, 191, 193, 194, 195, 196, 197, 201, 204, 207, 213, 219, 221, 222, 225, 226, 228, 237, 240, 246, 257, 258, 259, 277, 279, 280

August 30 Decision (Doha Declaration) 3, 4, 15, 18, 19, 20, 27, 40, 102–105, 114, 116, 117, 128, 130, 170, 175

Bangladesh

Bangladesh Association of Pharmaceutical Industries (BAPI) 48, 60, 66, 68, 201, 202, 268, 269

Department of Patents, Designs and Trademarks (DPDT) xi, 39–44, 50, 56, 57, 81, 87, 152, 153, 160, 178, 189, 202, 230, 251, 260–263, 276, 312

Directorate General of Drug Administration (DGDA) xxiii, 44, 45, 46–48, 54, 56, 60, 61, 62, 67, 86, 147, 153, 187, 195, 198, 234, 236, 255, 264–268

Directorate of Drug Administration (DDA) xi, 5, 6, 34, 44, 45, 48, 49, 51, 53, 57, 58, 60, 64, 76, 87, 98, 172, 198, 230, 259, 264, 273, 276, 77

Drug Control Ordinance (DCO 1982) 49

National Health Strategy 270

Patents and Designs Act, 1911 (PDA) 14, 38, 38–39, 43, 96, 99, 146, 156–160, 162, 163, 167, 168, 172, 173, 176, 177, 178, 181, 183, 184, 187, 188, 190, 260

best mode 85, 153, 159, 160, 161, 162, 315

Bilateral Investment Treaties (BITs) 197

Bolar exceptions (Bolar exemptions) 111, 118, 124, 164, 165

Brazil

experience with TRIPS 106–114

Health Ministry 267

National Health Surveillance Agency (ANVISA) 112, 263

ceiling (floor vs. ceiling debate) 113, 127, 177, 203, 226–228. Seealso floor

China

experience with TRIPS 114–120

competition 14, 16, 59, 61, 62, 67, 86, 87, 99, 112, 113, 116, 126, 129, 130, 142–143, 145, 146–147, 155, 157, 158, 160, 163–167, 196, 197, 201, 204–210, 213, 220, 221, 237–238, 278, 280

compulsory license (CL) 17, 19, 22, 102–104, 108, 110–111, 114, 116–117, 125–126, 138, 139, 142, 159, 175–186, 210

counterfeiting 101, 171–172, 192–195

data protection 16, 57, 58, 120, 123, 128, 141, 145, 197, 217, 219–220

Directorate General of Drug Administration (DGDA). See Bangladesh

Directorate of Drug Administration (DDA). See Bangladesh

disclosure 115, 116, 124, 128, 145, 152, 153, 158–159, 160–163, 189, 218

diseases 78, 80, 81, 118, 155, 199, 211, 213, 235, 247, 253, 273

Doha Declaration. See August 30 Decision; Paragraph 6

Drug Regulatory Authority (DRA) 54

early working 111, 124, 126, 153, 164–166, 169

enforcement 7, 9, 39, 46, 51, 52, 92, 100–101, 113, 116, 153, 170, 179, 192, 193, 194, 210, 224, 227, 237, 243, 257, 265–267, 273, 277, 280, 313, 317

essential medicines 4, 14, 27, 53, 86, 198, 199, 202, 206, 210, 272

ever-greening 87, 124

exhaustion of rights 16, 19, 136, 171, 175

floor (floor vs. ceiling debate) 226–227. See also ceiling

Free Trade Agreements (FTAs) 166, 171, 191–192

General Agreement on Tariffs and Trades (GATT) 8, 10, 92, 100, 150, 229

generic medicine xxiii, 1, 5–6, 9, 12–16, 20, 22, 24–26, 29, 37, 50, 57, 63, 67, 68, 70, 77, 81–82, 86, 87, 92, 93, 98, 101, 104–105, 110–112, 114–121, 122, 123, 127–128, 130, 131, 134, 137–143, 147, 149, 151, 155, 158, 164–169, 174, 177–182, 187, 192–196, 200, 203–205, 209, 210, 211, 215, 217–218, 220–223, 225, 231, 237, 246, 248, 254, 261, 262, 271, 278

graduation 85, 229–230, 240, 241, 244, 245, 248–253, 257

high threshold 152–154, 158

HIV/AIDS 17, 19, 21, 24, 25, 38, 64, 81, 103, 104, 105, 109, 110, 113, 115, 117, 121, 128, 129, 130–135, 137, 142, 143, 151, 175, 193, 195, 203, 207, 209, 222–224, 240, 270

Human Development Index (HDI) 182, 256

human rights 7, 21, 109

incentive 10, 18, 72, 73, 86, 149, 211,

213, 214, 233, 273, 279

India

experience with TRIPS 120–129

innovation xxiii, 1, 4, 7, 10, 14, 18, 22, 27–29, 34, 35, 38, 55, 56, 71, 73, 82, 85, 93, 100, 106, 107, 114, 120, 121, 122, 126, 145, 146, 149, 151, 152, 153, 155, 158, 159, 160, 163, 164, 167, 179, 185, 189, 195, 197, 204, 213, 214, 216, 221, 226, 227, 228, 230–235, 236, 237, 241, 245, 247, 250, 254, 256, 258, 259, 264, 265, 270, 274, 275, 276, 277, 278, 280, 313

intellectual property xi, xii, xxiii, xxiv, 4, 7, 9, 10, 18, 28, 38, 39, 90, 126, 150, 157, 170, 175, 185, 192, 194, 206, 216, 225, 227, 242, 243, 275, 277, 313–314, 317

invention 14, 16, 38, 39, 40, 95–97, 108, 109, 111, 115, 116, 117, 124, 125, 136, 138, 139, 140, 141, 153–161, 163, 166, 167, 168, 173, 178, 180, 184, 185, 188, 190, 213, 232, 260, 261, 267, 314–315

inventive step 39, 108, 124, 153–154, 156, 314

investment 10, 11, 14, 22, 29, 30, 55, 59, 72, 73, 80, 83–86, 99, 113, 114, 147, 169, 178, 184, 186, 187, 189, 190, 191, 197, 201, 204, 210, 218, 220, 225, 228, 230, 232, 233, 234, 236, 237, 246, 248, 250, 254, 255, 264, 267, 271, 274, 278, 279

Least Developed Countries (LDCs) xiii, xxiii, 1–6, 12–14, 30, 35, 56, 82, 85, 103–105, 151, 195, 220, 224, 226, 229, 230, 234, 239–257, 317

licensing 19, 21, 23, 25, 46, 47, 51, 56, 58, 84, 90, 97, 102, 106, 108, 110, 111, 117, 125, 132, 133, 134, 136, 137, 138, 142, 145, 147, 151, 153, 175, 176, 178, 180, 181, 186, 208, 210, 221, 226, 234, 237, 275, 279

local production (local working) 10, 23, 49, 52–57, 58, 90, 97, 108, 110, 125, 129, 139, 151, 183, 195, 254

mailbox 15, 40–42, 84

Médecins Sans Frontières (MSF) 21, 22, 104, 109, 139, 222, 225, 226

Medicines Patent Pool (MPP) 214, 222–224

National Health Surveillance Agency (ANVISA). See Brazil

neglected diseases 213, 214, 233–235, 279

off-patent 16, 37, 57, 80–82, 86, 246, 247, 77

open source 197, 234–236

Paragraph 6 (Doha Declaration) 19, 20, 102

parallel imports 15, 17, 19, 25, 32, 118, 124, 132–136, 145, 151, 153, 164, 169–175, 208, 226

Paris Convention for the Protection of Industrial Property 9, 94–98, 100–102, 107, 126, 185, 253

patentability requirements 15, 115, 139, 145, 232

patent applications 40, 41, 43, 71, 84, 96, 98, 112, 124, 139, 159, 160, 189, 232, 254, 255, 259, 260, 263

patent claims 153, 163

Patent Cooperation Treaty, 1970 (PCT) 130, 161

patent examination 139, 145, 152, 191

patent law 6–7, 14, 17, 20–23, 28–34, 38–39, 50, 55–56, 58, 59–60, 74, 81, 84, 87, 89–91, 94–96, 98, 99, 106, 108, 109, 114, 116–118, 123, 126, 129–131, 136, 140, 142–146, 148, 151, 152, 153, 156, 157, 158, 163, 165, 167, 172, 183, 186, 190, 194–195, 210, 231, 232, 237–238, 259, 260, 271, 280

patent term 128, 159, 160, 191–192

pharmaceutical industry xxiii–xxiv, 4–7, 9, 13, 14, 24, 25, 29–32, 34, 37, 39, 48, 51, 53–55, 59, 60, 65, 66, 69, 72–74, 82, 84, 86, 87, 91, 94, 96, 106, 113, 117, 121, 123, 132, 133–134, 139, 147, 148, 153, 168, 170, 177, 186, 189, 196, 197, 208, 228, 229, 231–234, 237, 251, 254, 255, 257, 258, 259, 264, 266, 268, 274, 276, 278, 280

post-grant 123, 124, 140, 145, 152, 153, 187, 188, 189

pre-grant 123, 124, 140, 145, 152, 153, 188, 189

price control 70, 113, 127, 145, 146, 198–203, 205–206, 237, 271

pricing of drugs 34, 60, 120, 131, 204, 213, 271

prior art 116, 158, 232

prizes 211–214, 233, 237

process patents 50, 92, 95, 114, 122, 144, 230–232, 231–233, 255, 278, 316

product patent 12, 14, 70, 90, 93, 95–97, 127, 153, 217

rational use 195, 271, 280

regional exhaustion 170

regional trade agreements 103

Regulatory Enforcement Pyramid of Sanctions (REPS) 265–266

Reichman, J.H. 97, 227

research exceptions 140, 175

royalties 57, 123, 126, 146, 151, 177, 180, 182, 183, 221, 275

social business 197, 236–237

South Africa

experience with TRIPS 129–143

Medicines and Related Substances Control Act, 1997 (MRSCA) 16, 17, 131–135, 137, 141, 207, 208

National Drug Policy Committee 24, 25, 45, 49, 55, 131

Sustainable Development Goals (SDGs) 4

tax 53, 72, 73, 83, 204, 234

test data protection 57, 58, 120, 128, 141, 145, 220–221

traditional medicine 46, 71, 145, 277

transition period 2, 3, 38, 54, 82, 83, 111, 123, 144, 148, 157, 226, 229–230, 239–241, 269, 278

utility model 9, 100, 116–117, 190, 197, 230–232, 278

waiver xxiii, 3, 15, 37, 40, 50, 56, 82, 85, 148, 153, 182, 220, 228, 229, 230, 233, 234, 241, 245–248, 251, 253, 258, 270, 278

World Bank 10, 11, 52, 65, 93, 186, 206, 256

World Health Assembly (WHA) 27–29, 122, 175, 214, 215, 216, 222, 229, 279

World Health Organization (WHO) 11, 18, 19, 24–27, 29, 45, 48, 81, 104, 107, 112, 113, 122, 133, 135, 142, 152, 155, 167, 169, 170, 175, 193–194, 197, 213–216, 216, 219, 221, 222, 231, 235, 237, 254, 257, 262, 266, 268, 270–272, 277, 279–280

World Intellectual Property Organization (WIPO) xi–xii, 9, 15, 27, 43, 92, 100, 101, 104, 157, 161, 162, 193, 225, 254, 257, 260, 261, 263, 280

World Trade Organization (WTO) xii, xxiii, 1–4, 7–9, 11–13, 16–18, 19–21, 26, 27, 29, 32, 34, 38, 39, 49, 58, 66, 82, 85, 86, 90–92, 94, 96–99, 101–102, 104, 105, 107–109, 112, 114, 117, 119, 120, 122, 123, 124, 130, 132, 133, 134, 136, 137, 144, 146, 149, 150, 151, 155, 157, 161–162, 166, 170, 175, 180, 181, 182, 184, 192, 193, 206, 218, 225, 226–230, 239, 241–246, 251–252, 254, 257, 259, 261, 272, 278, 280, 314

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