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Are Developing Countries Going Too Far on TRIPS? A Closer Look at the New Laws in India

Published online by Cambridge University Press:  06 January 2021

Radhika Bhattacharya
Radhika Bhattacharya*
Affiliation:
Boston University School of Law, Biology and PPE (Politics, Philosophy & Economics), University of Pennsylvania
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Extract

The goal of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement is to harmonize the intellectual property rights of World Trade Organization (WTO) member countries to a certain minimum standard. As a WTO member, the organization required India to enact legislation that enforces TRIPS by 2005. Part of India's motivation to pass its 2005 Patents Act stemmed from its obligations as a WTO member nation, as well as the government's desire to stimulate greater foreign investment, innovative research and economic growth.

India's implementation of the TRIPS Agreement has generated a great deal of controversy. Disagreement exists about whether the Indian Patents Act overzealously protects intellectual property rights and whether the Patents Act goes beyond the spirit of the TRIPS Agreement. Many health officials and non-governmental organizations (NGOs) are seriously concerned about what the Patents Act implies for people suffering from diseases in less developed countries. Nonprofit and some World Health Organization officials argue that the new law prevents India from producing and supplying generic drugs within its borders and to other developing countries.

Type
Article
Information
American Journal of Law & Medicine , Volume 34 , Issue 2-3 , June 2008 , pp. 395 - 421
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2008

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References

1 World Trade Organization, Intellectual Property: Protection and Enforcement, http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm (last visited Apr. 11, 2007) [hereinafter WTO, Intellectual Property].

2 See World Trade Organization, Transition Arrangements, http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm#special (last visited Apr. 11, 2007). “If a developing country did not provide product patent protection in a particular area of technology when the TRIPS Agreement came into force (1 January 1995), it had up to 10 years to introduce the protection.” Id.

3 Kamal Nath's Statement on the Ordinance Relating to Patents (Third) Amendment, Press Info. Bureau (India) Dec. 29, 2004, http://pib.nic.in/release/release.asp?relid=6074 & http://lists.essential.org/pipermail/ip-health/2004-December/007318.html [hereinafter Kamal Nath's Statement].

4 See e.g., AIDS Patients in Demo Over Drugs Patent Bill, The East Afr. Standard, Mar. 19, 2005, http://www.eastandard.net/archives/cl/print/news.php?articleid=15790; Randeep Ramesh, Cheap AIDS Drugs Under Threat, Guardian (U.K.), Mar. 23, 2005, http://www.guardian.co.uk/world/2005/mar/23/india.aids1.

5 See, e.g., WTO, Intellectual Property, supra note 1; Ramesh, supra note 4.

6 See, e.g., Letter from U.N. Special Envoys for HIV/AIDS to the Prime Minister and President of India on the Amendments to the Patents Act Under Debate (Mar. 11, 2005), http://www.cptech.org/ip/health/c/india/unaids03112005.html. [hereinafter Letter from U.N. Special Envoys for HIV/AIDS]; see WTO, Intellectual Property, supra note 1; Ramesh, supra note 4. The phrase “neglected diseases” refers to the diseases of the developing world. Besides HIV/AIDS, many of these diseases have been virtually eliminated from industrialized nations yet still rampant in developing countries.

7 See, e.g., Letter from U.N. Special Envoys for HIV/AIDS, supra note 6; Ramesh, supra note 4.

8 See e.g., Letter from U.N. Special Envoys for HIV/AIDS, supra note 6; WTO, Intellectual Property, supra note 1; Ramesh, supra note 4.

9 Editorial, AIDS Drugs Threatened, N.Y. Times, Mar. 5, 2005, at A1.

10 Id.; Letter from Achmat Dangor, Director of Advocacy, Communication and Leadership for UNAIDS, to Kamal Nath, Minister of Commerce and Industry of India (Feb. 23, 2005), http://www.cptech.org/ip/health/c/india/unaids02232005.html. [hereinafter Letter from Achmat Dangor].

11 See Aaron Smith, India's Elephant in the Room: Weak Patent Laws, CNNMoney.com, May 4, 2007, http://money.cnn.com/2007/05/04/news/companies/india_biotech/index.htm.

12 See Ramesh, supra note 4 (Indian generics are $200/year compared to $4,800/year for patented product); Mike Palmedo, Action Alert on Indian Patent Amendments, IPHealth, Mar. 7, 2005, http://lists.essential.org/pipermail/ip-health/2005-March/007561.html.

13 See Kamal Nath's Statement, supra note 3 (“97% of all drugs manufactured in India are off-patent.”). Therefore, the major barriers to access in Sub-Saharan Africa pre-TRIPS were cost and infrastructure, though that topic would be for a separate paper.

14 See Ramesh, supra note 4 (quoting Ellen't Hoen: “Many people are building up resistance to the first generation of drugs and will need the newer treatments.”).

15 Ramesh, supra note 4 (quoting Ellen't Hoen: “But without the Indian drugs industry, where will they get cheap drugs from?”).

16 The Patents (Amendment) Act, 2005, No. 15 of 2005, Acts of Parliament, 2005, available at http://www.patentoffice.nic.in/ipr/patent/patent_2005.pdf.

17 AIDS Drugs Threatened, supra note 9; Letter from Achmat Dangor, supra note 10; Letter from Jim Yong Kim, HIV/AIDS Director of the World Health Organization, to Dr. A. Ramadoss, Minister of Health and Family Welfare of India (Dec. 17, 2004), available at http://www.cptech.org/ip/health/c/india/who12172004.html. [hereinafter Letter from Jim Yong Kim].

18 Letter from Jim Yong Kim, supra note 17.

19 Id.; Letter from U.N. Special Envoys for HIV/AIDS, supra note 6.; Letter from Achmat Dangor, supra note 10.

20 For text of the Doha Declaration on the TRIPS Agreement and Public Health see World Trade Organization, Ministerial Declaration of 14 November 2001, WT/MIN (01)/DEC/2, 41 I.L.M. 746 (2002), available at http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm [hereinafter the Doha Declaration].

21 Id.

22 Id.

23 Id.

24 AIDS Drugs Threatened, supra note 9; Ramesh, supra note 4.

25 Kamal Nath's Statement, supra note 3, comment 5.

26 Press Release, Press Info. Bureau, Gov't of India, Legislation on Patent Amendment by this Month End: Kamal Nath (Dec. 7, 2004), available at http://pib.nic.in/release/release.asp?relid=5439.

27 Kamal Nath's Statement, supra note 3, comment 12.

28 Id.

29 Global Drug Industry Welcomes Indian Patent Move, Reuters.com, Mar. 22, 2005, available at http://www.patentmatics.org/news2005.htm.

30 AIDS Patients in Demo Over Drugs Patent Bill, supra note 4.

31 Donald G. McNeil Jr., India Alters Law on Drug Patents, N.Y. Times, Mar. 24, 2005, at A3.

32 Id.

33 Id.

34 Id.

35 See AIDS Patients in Demo Over Drugs Patent Bill, supra note 4; Ramesh, supra note 4.

36 McNeil Jr., supra note 31; Ramesh, supra note 4.

37 AIDS Drugs Threatened, supra note 9.

38 AIDS Patients in Demo Over Drugs Patent Bill, supra note 4.

39 See Palmedo, supra note 12; Ramesh, supra note 4.

40 Palmedo, supra note 12; Press Release, Medecins Sans Frontieres, The Beginning of the End of Affordable Generics (Mar. 22, 2005), available at http://www.cptech.org/ip/health/c/india/ngos03222005.html. Ramesh, supra note 4.

41 Letter from Achmat Dangor, supra note 10.

42 The Doha Declaration extended the TRIPS 2006 deadline to 2016. World Trade Organization, The Doha Declaration Explained: Trade-Related Aspects of Intellectual Property Rights, http://www.wto.org/English/tratop_e/dda_e/dohaexplained_e.htm#trips (last visited Apr. 18, 2007).

43 Aids Patients in Demo Over Drugs Patent Bill, supra note 4; AIDS Drugs Threatened, supra note 9; Letter from Achmat Dangor, supra note 10; Letter from Jim Yong Kim, supra note 17; Letter from U.N. Special Envoys for HIV/AIDS, supra note 6.

44 Patents Seen Raising Drug Prices, Bus. Standard (India), Mar. 21, 2005; Palmedo, supra note 12.

45 See Press Release, Press Info. Bureau, Gov't of India, Important Changes Incorporated in the Patents (Amendment) Bill, 2005 as Compared to the Patents (Amendment) Bill, 2003 (Mar. 23, 2005), available at http://pib.nic.in/release/release.asp?relid=8096.

46 Letter from Achmat Dangor, supra note 10.

47 Government Plugs Gaps in Patents Bill, Bus. Standard (India), Mar. 22, 2005.

48 Id.

49 Id.

50 Kondro, Wayne, Supreme Court Rules Against Drug Patent “Evergreening”, 175 Canadian Medical Association J. 1508, 1508 (2006)Google Scholar.

51 See Government Plugs Gaps in Patents Bill, supra note 47 (explaining that in response to pressure, the new Patent Ordinance, excludes embedded software from the ambit of the product patent regime).

52 A.B. Rajasekaran, Indian Patent Office, Patents for Computer-Related Inventions in India (2005), http://www.intelproplaw.com/Articles/cgi/download.cgi?v=1114386244.

53 Id.

54 Palmedo, supra note 12.

55 Government Plugs Gaps in Patents Bill, supra note 47; see Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45.

56 Patents Seen Raising Drug Prices, supra note 44.

57 Id.

58 Id.

59 See e.g., Letter from Achmat Dangor, supra note 10.

60 See discussion infra Part I.B.

61 Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45; McNeil Jr., supra note 31.

62 Government Plugs Gaps in Patents Bill, supra note 47.

63 Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45.

64 Id.

65 Id.; Government Plugs Gaps in Patents Bill, supra note 47.

66 Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45.

67 Id.; Government Plugs Gaps in Patents Bill, supra note 47.

68 Id.

69 Id.; Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45. Judicial or administrative processes determine what practices are anticompetitive. Government Plugs Gaps in Patents Bill, supra note 47.

70 McNeil Jr., supra note 31.

71 Id.

72 Government Plugs Gaps in Patents Bill, supra note 47; Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45.

73 Government Plugs Gaps in Patents Bill, supra note 47; Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45.

74 Government Plugs Gaps in Patents Bill, supra note 47; Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45.

75 Government Plugs Gaps in Patents Bill, supra note 47.

76 Government Plugs Gaps in Patents Bill, supra note 47; Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45.

77 Government Plugs Gaps in Patents Bill, supra note 47; Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45.

78 Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45.

79 See Government Plugs Gaps in Patents Bill, supra note 47; Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45.

80 Important Changes Incorporated in the Patents (Amendment) Bill, 2005, supra note 45.

81 Government Plugs Gaps in Patents Bill, supra note 47.

82 Id.

83 Id.

84 Id.

85 Id.

86 Ramesh, supra note 4; AIDS Drugs Threatened, supra note 9.

87 James Love, Observations India Patent Bill, IP-Health, Mar. 22, 2005, http://lists.essential.org/pipermail/ip-health/2005-March/007652.html

88 Rajesh Unnikrishnan, Global Generic Drug Companies Descend on India, Fin. Express (India), Mar. 14, 2005, available at http://www.financialexpress.com/fe_full_story.php?content_id=85194.

89 McNeil Jr., supra note 31.

90 Id. See generally Hason, Averi K. & Shimotake, Jean A., Global Interdependence and International Commercial Law: Recent Developments in Patent Rights for Pharmaceuticals in China and India, 18 Pace Int’l L. Rev. 303, 313 (2006)Google Scholar (noting “mailbox applications” are patent applications that the Government of India started collecting prior to 2005, once it had announced that it would adopt the TRIPS Agreement. After the adoption of the Patents Act of 2005, the government will start reviewing applications in the order they were received. Among other things, these mailbox provisions allow the production of existing generic drugs to continue.).

91 The Beginning of the End of Affordable Generics, supra note 4061.

92 Ramesh, supra note 4.

93 Id.

94 Id.

95 Id.

96 See McNeil Jr., supra note 31.

97 See Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C art. 8(1), Apr. 15, 1994, 33 I.L.M. 81, available at http://www.wto.org/english/docs_e/legal_e/27-trips.pdf. (Marrakesh Agreement Establishing the World Trade Organization) [hereinafter the TRIPS Agreement].

98 Id.

99 Id.

100 Id.

101 Id. art. 27.

102 Id. art. 31.

103 Id.

104 Id.

105 Id.

106 Id.

107 Id.

108 Id.

109 Id.

110 Id.

111 Id. See discussion of DOHA Declaration below for modifications of domestic market exception.

112 Id.

113 Id.

114 Id.

115 Id. art. 16.

116 Id., arts. 15, 16.

117 Id.

118 See, e.g. Ramesh, supra note 4.

119 The Doha Declaration Explained: Trade-Related Aspects of Intellectual Property Rights, supra note 42.

120 The Doha Declaration, supra note 20.

121 Id.

122 Id.

123 The Doha Declaration Explained: Trade-Related Aspects of Intellectual Property Rights, supra note 42.

124 Id.

125 Id.

126 Id.

127 WTO, Intellectual Property, supra note 1.

128 Id.; The Doha Declaration Explained: Trade-Related Aspects of Intellectual Property Rights, supra note 42.

129 The Patents (Amendment) Act, 2005, No. 15 of 2005, Acts of Parliament, 2005, available at http://www.patentoffice.nic.in/ipr/patent/patent_2005.pdf.

130 Id.

131 The Patents Act, 1970, No. 39, Acts of Parliament, 1970, as amended by the Patents (Amendment) Act, 1999, available at http://www.patentoffice.nic.in/ipr/patent/patAct1970-3-99.html.num;chap16. Section 93, which will not be discussed in depth here, discusses the incidental powers of the Controller once he/she has decided to grant a compulsory license. Id. § 93.

132 Id.

133 Id. § 92(1).

134 Id. § 84(1):

84. Compulsory Licenses

(1) At any time after the expiration of three years from the date of the sealing of a patent, any person interested may make an application to the Controller alleging that the reasonable requirements of the public with respect to the patented invention have not been satisfied or that the patented invention is not available to the public at a reasonable price and praying for the grant of a compulsory licence to work the patented invention.

135 Id. § 84(5).

136 Id. § 84(2):

(2) An application under this section may be made by any person notwithstanding that he is already the holder of a licence under the patent and no person shall be estopped from alleging that the reasonable requirements of the public with respect to the patented invention are not satisfied or that the patented invention is not available to the public at a reasonable price by reason of any admission made by him, whether in such a licence or otherwise or by reason of his having accepted such a licence.

137 Id. § 84(3).

138 Id. § 84(4).

139 Id. § 85.

140 Id. § 86.

141 Id. § 86(2).

142 Id.

143 Id. § 89.

144 Id.

145 Id. § 89(4).

146 Id. § 85:

85. Matter to taken into account in granting compulsory licences

In determining whether or not to make an order in pursuance of an application filed under section 84, the Controller shall take into account, -

  • (i) the nature of the invention, the time which has elapsed since the sealing of the patent and the measures already taken by the patentee or any licensee to make full use of the invention;

  • (ii) the ability of the applicant to work the invention to the public advantage;

  • (iii) the capacity of the applicant to undertake the risk in providing capital and working the invention, if the application were granted, but shall not be required to take into account matters subsequent to the making of the application.

147 See generally Ann Seidman, Robert B. Seidman & Nalin Abeysekere, Legislative Drafting for Democratic Social Change: A Manual for Drafters (2001) (discussing the law as a tool to modify behavior, and analyzing various methods of limiting the targeted actor's discretion).

148 The Patents (Amendment) Act, 2005, No. 15 of 2005, Acts of Parliament, 2005, available at http://www.patentoffice.nic.in/ipr/patent/patent_2005.pdf.

149 Id.

150 Id. § 92A(1):

(1) Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory licence has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India.

151 Id.

152 See, e.g., Letter from U.N. Special Envoys for HIV/AIDS, supra note 6; Aids Patients in Demo Over Drugs Patent Bill, supra note 4; Ramesh, supra note 4.

153 The Patents (Amendment) Act, 2005, § 92A(2):

(2) The Controller shall, on receipt of an application in the prescribed manner, grant a compulsory licence solely for manufacture and export of the concerned pharmaceutical product to such country under such terms and conditions as may be specified and published by him.

154 For a discussion of factors involved in legislative measures and behavioral change, see Seidman, supra note 147.

155 2005 Patents (Amendment) Act, supra note 16, § 92A(3) (“The provisions of subsections (1) and (2) shall be without prejudice to the extent to which pharmaceutical products produced under a compulsory licence can be exported under any other provision of this Act.”).

156 Id. § 92A:

Explanation.—For the purposes of this section, “pharmaceutical products” means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use.

157 Id. § 84(iv); Hason & Shimotake, supra note 90, at 301-10.

158 2005 Patents (Amendment) Act, supra note 16, § 84 (iv); Hason & Shimotake, supra note 90 (citing Rochelle Chodock, TRIPS: Transformation of the Indian Patent System and Its Effect on the Indian Pharmaceutical Sector, SciTech Law 4, 4 (2005)).

159 Hason & Shimotake, supra note 90, at 314.

160 Keith Maskus, Intellectual Property Rights in the Global Economy 40-42 (2000).

161 WTO, Intellectual Property supra note 1, at Patents.

162 Id.

163 Matthew Allen, Novartis Challenges India's Patent Law, SwissInfo/Swiss Radio International, Jan. 29, 2007, http://www.swissinfo.org/eng/front/detail/Novartis_challenges_India_s_patent_law.html.siteSect=105&sid=7477353&cKey=1170144883000.

164 C.R. Sukumar, Novartis Loses Patent Claim on Gleevec in India, The Hindu Business Line, Jan. 25, 2006, http://www.thehindubusinessline.com/2006/01/26/stories/2006012601150500.htm; Jean-Francois Tremblay, Novartis Loses India Patent Case: Drug Maker Cipla Will File to Market Generic Form of Gleevec, Chemical & Engineering News, Feb. 2, 2006, http://pubs.acs.org/cen/news/84/i06/8406india.html.

165 Sukumar, supra note 164; Tremblay, supra note 164. See supra note 90 for an explanation of mailbox provisions.

166 Sukumar, supra note 164; see Tremblay, supra note 164.

167 Sukumar, supra note 164; see Tremblay, supra note 164.

168 See Novartis Perspective: Improving Indian Patent Law Helps Patients and Societies (2007), available at http://www.corporatecitizenship.novartis.com/downloads/aboutnovartis/Novartis_position-Glivec_Gleevec_patent_case_india.pdf.

169 Sukumar, supra note 164 ; see Tremblay, supra note 164.

170 Novartis Perspective, supra note 168.

171 Sukumar, supra note 164; Tremblay, supra note 164.

172 Sukumar, supra note 164; Tremblay, supra note 164.

173 Mueller, Janice M., Taking TRIPS to India -- Novartis, Patent Law and Access to Medicines, 356 New Eng. J. Med. 541, 541 (2007)Google Scholar.

174 Allen, supra note 163.

175 See Allen, supra note 163; Sukumar, supra note 164.

176 Sukumar, supra note 164.

177 Id.

178 Id.

179 Mueller, supra note 173, at 542-43.

180 Pat. Off., Manual of Patent Practice and Procedure 89 (India, Draft June 20, 2005).

181 Id.

182 Id.

If, upon consideration of the evidence, the Controller is satisfied that a prima facie case has not been made out for the making of an order he shall notify the Central Govt. or any person interested accordingly, and unless the Central Government or any person interested requests to be heard in the matter, within one month of the date of such notification, the Controller shall refuse the application.

Id.

184 Failure to make patented inventions available to public at a reasonable price has to be considered keeping in mind that the reasonable price for a patented article will depend upon the circumstances of each case.

Id. at 90.

185 Id.

186 Id.

187 Id.

188 The Manual further explains the considerations relating to these three circumstances:

A) Some Guidelines

  • 1) Failure to make patented inventions available to public at a reasonable price has to be considered keeping in mind that the reasonable price for a patented article will depend upon the circumstances of each case.

  • 2) Failure to work the patented invention within the territory of India will be Considered with respect to the facility available in India for the working of the invention. Provision of Importation of patented article is allowed. But the mere importation of patented articles when there is a possibility of manufacturing within India will be a factor that will receive consideration.

  • 3) Reasonable requirements of the public will be deemed as not satisfied if by reason of the refusal of the patentee to grant a license on reasonable terms, an existing trade or industry or the development thereof or the establishment of any new trade or industry in India or the trade or industry of any person or class of persons trading or manufacturing in India is prejudiced. Other conditions also are mentioned in S. 84(7).

Id.

189 Id.

190 Id. at 93-95. These rules include methods for deciding the terms of the license (i.e. royalty payments and whether license is exclusive or not) as well as appeal by the patentee. The ultimate arbiter of disputes between the Government and the Patentee is the High Court. Id.

191 Id. at 93.

192 Id. at 91.

193 Id.

194 Id.

195 Id.

196 Id. at 89-90.

197 Id. at 91-92.

198 Id. at 92.

199 Id. at 96.

200 Id.

201 Id. In March 2008, the U.S. Federal Reserve indicated that the Rupee-Dollar rate for February 2008 was 39.67. Federal Reserve Statistical Release: Foreign Exchange Rates (Mar. 3, 2008), http://www.federalreserve.gov/releases/g5/current/. That means that at this writing, these fees are approximately $37.81 and $151.25 respectively.

202 Pat. Off., Manual of Patent Practice and Procedure 89 (India, Draft June 20, 2005).

203 Id. at 96-97; see also Appendix 1.

204 Id. at 96.

205 Id. at 96-97.

206 Id. at 96-97.

207 Id.

208 Id. at 92-93.

209 Id.

210 Id. at 93.

211 Id.

212 Id.

213 Id.

214 As this section is intended to address the public health problems faced by a country having insufficient or no manufacturing capacity in the pharmaceutical sector and to facilitate access to affordable medicines for the people in these countries, it should be used in good faith and not with the primary purpose of addressing other objectives in particular objectives of a purely commercial nature.

Id.

215 Id.

216 Id. at 96.

217 Id. at 93.

218 Id. at 96-97.

219 Id.

220 Id. at 93.

221 Id. at 97.

222 Maskus, supra note 160, at 40-41, 235-38.

223 Id. at 40-42; WTO, Intellectual Property, supra note 1.

224 Maskus, supra note 160, at 40-42; WTO, Intellectual Property, supra note 1.

225 Legislation of Patent Amendment by this Month End, supra note 26; Kamal Nath's Statement, supra note 3.

226 McNeil Jr., supra note 31.

227 The Patents (Amendment) Act, 2005, No. 15 of 2005, Acts of Parliament, 2005, available at http://www.patentoffice.nic.in/ipr/patent/patent_2005.pdf.

228 Pat. Off., Manual of Patent Practice and Procedure 89 (India, Draft June 20, 2005).

229 Mueller, supra note 173; Sukumar, supra note 164; Tremblay, supra note 164.

230 The Patents (Amendment) Act, 2005, No. 15 of 2005, Acts of Parliament, 2005, available at http://www.patentoffice.nic.in/ipr/patent/patent_2005.pdf.

231 Id.

232 Manual of Patent Practice and Procedure at 92-97.

233 Id.

234 Id.

235 Id.

236 Id.

237 See generally Allen, supra note 163; Mueller, supra note 173; Sukumar, supra note 164; Tremblay, supra note 164.

238 See generally Allen, supra note 163; Mueller, supra note 173; Sukumar, supra note 164; Tremblay, supra note 164.

239 Mueller, supra note 173, at 542-43.

240 The Patents (Amendment) Act, 2005, No. 15 of 2005, Acts of Parliament, 2005, available at http://www.patentoffice.nic.in/ipr/patent/patent_2005.pdf.; Pat. Off., Manual of Patent Practice and Procedure 89 (India, Draft June 20, 2005).

241 See e.g., Aids Patients in Demo Over Drugs Patent Bill, supra note 4; Ramesh, supra note 4.

242 Smith, supra note 11; Patrick Mirandah Co., India: Are We TRIPS Compliant Yet?, Managing Intell.Prop., Mar. 2007, http://www.managingip.com/Article.aspx?ArticleID=1254082.