Intellectual Property and Public Health in the Developing World
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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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