LAS DOS COSAS ENCIMA DE LA LISTA DE LAS COSAS QUE NUNCA HARÍA

The first amendment to the Patents Act 1970 (India) was a direct outcome of WTO dispute settlement proceedings between India and the United States.

As a signatory to the Uruguay Round Agreements, India had decided to avail itself of

the benefit of a maximum transition period which was allowed under the TRIPS

Agreement 1994. With the status of a developing country, India had flexible timelines to implement its obligations under the TRIPS Agreement 1994. The first timeline in this regard was the creation of a mechanism for receiving mailbox applications by January

1, 1995.124

To meet this obligation, Shankar Dayal Sharma, then President of India, promulgated

Patents (Amendment) Ordinance, 1994 (India). This Ordinance sought amendments in the Patents Act 1970 (India) and provided that patent applications for pharmaceutical and agricultural chemical products would be accepted. However, these applications would be handled only after 1st January, 2005.12:1 The Ordinance also established an Exclusive Marketing Regime (EMR) for applications filed under the amended provisions of the Patents Act 1970 (India).126

124 Article 70 (9) of the TRIPS Agreement 1994.

Patents (Amendment) Ordinance, 1994 (India) at

http://ww\v.vvipo.int/clea/en/text pdf.isp?lanu-FN&id-2390 126 Section 24 A of Patents (Amendment) Ordinance, 1994 (India) at http://www.wipo.int/clea/en/text pdf.isp?lang=EN&^ 2 3 9 0

The Patents (Amendment) Ordinance, 1994 (India) lapsed on March 26, 1995 when the Indian Parliament failed to pass follow-on legislation which was mandated under Article 123(1) of the Indian Constitution. In March 1995, the Lok Sabha passed a

Patents (Amendment) Bill 1995 (India) to give permanent status to the Patents (Amendment) Ordinance, 1994 (India). This Bill, however, could not be passed in the Upper House of the Indian Parliament, the Rajya Sabha. In the Rajya Sabha, the Bill was referred to the Select Committee of the House which could not report before the dissolution of Lok Sabha in May 1995. The Bill ultimately lapsed.12

In May, 1996, the Office of the United States Trade Representative added India to its Priority Watch List and stated that:

India fails to provide patent protection for pharmaceutical or agricultural chemical products. It also has not legislatively established mailbox and marketing exclusivity systems in accordance with Article 70(8) and 70(9) of the TRIPS Agreement. Therefore, the United States will initiate formal consultations under WTO dispute settlement procedures in Geneva in the near future.12*

In July, 1996, the United States formally initiated World Trade Organization dispute settlement proceedings against India and a WTO Dispute Panel was formed on November 20, 1996.12'' The United States alleged violations of Article 70 (8) and Article

1 Panel Report, India - Patent Protection for Pharmaceutical anti Agricultural Chemical Products, World Trade Organization WT/DS50/R (5 September 1997) at

http: v vvAYAv.Yvto.org/english/trat op e/dispu e/cases e/ds50 e.htm

l2s Executive Office o f the President, Office o f the United States Trade Representative, USTR Announces Two Decisions: Title VII and Special 301 (April 30, 1996) 3 at

http:/7keionlinc.org/sites/default/files/ustr special301 1996.pdf

2 Panel Report, India - Patent Protection for Pharmaceutical and Agricultural Chemical Products,

70 (9) of the TRIPS Agreement 1994. The Panel reported its findings to the WTO Dispute Settlement Body on September 5, 1997 and found that India had failed to comply with its obligations under Article 70(8)(a) and in the alternative, paragraph 1 and 2 of the Article 63 of the TRIPS Agreement 1994.m On India’s request, the Appellate Body released its report on December, 19, 1997 and it upheld the findings of

the Panel Report regarding Articles 70(8) and 70(9) of the TRIPS Agreement 1994.

However, the Appellate Body reversed the findings of the Panel Report regarding paragraph 1 and 2 of the Article 63 of the TRIPS Agreement 1994.1,1 It was concluded that:

The Appellate Body upheld the Panel’s finding that India’s filing system based on “administrative practice” for patent applications for pharmaceutical and agricultural chemical products was inconsistent with Art. 70.8. The Appellate Body found that the system did not provide the “means” by which applications for patents for such inventions could be securely filed within the meaning of Art. 70.8(a), because, in theory, a patent application filed under the administrative instructions could be rejected by the court under the contradictory mandatory provisions of the existing Indian laws: the Patents Act of 1970 ... The Appellate Body agreed with the Panel that there was no mechanism in place in India for the grant of exclusive marketing rights for the products covered by Art. 70.8(a) and thus Art. 70.9 was violated.132

http://vvwvv.wio.org/english/tratop c/'dispii e/eascs c/ds50 c.htm 130 Ibid.

131 Appellate Body Report, India - Patent Protection fo r Pharmaceutical and Agricultural Chemical Products - A B -1997-5, WT/DS50/AB/R (19 December 1997) at

http://\vw;vv.vvto.org/english/tratop e/dispu e/cases e/ds50 e.htm. 132 Ibid.

Although some commentators such as Jerome Reichman133 have praised the balanced outcome of this dispute, the Indian political reaction to the adjudication was fierce. Mr Kushabhau Thakre, president of the Bharatiya Janata Party, demanded that India should leave the WTO.134 Given the political and economic policies of Bharatiya Janata Party, this demand was unusual as the party was committed to economic reforms and trade liberalisation.135

Finally, India enacted the Patents (Amendment) Act J999 (India) with a retroactive effect starting from January 1, 1995. It provided for the creation of the mailbox provision to receive patent applications which would not be examined before January 1,

2005.136 The Patents (Amendment) Act 1999 (India) also established an exclusive

marketing regime."7 One of the innovative features of the law was related to compulsory licensing provision. Pursuant to Section 24C, any time after the expiry of

Jerome Reichman, ‘Securing Compliance with the TRIPS Agreement after US v India’ (1998) 1 (4)

Journal o f International Economic Law 585-601. He observes that: ‘The decision of the WTO Appellate Body in India-Mailbox ease was a critical step in affirming the WTO-consistcncy of pursuing national and regional policies which take advantage of the absence of strict harmonization of IPRs standards at the worldwide level. The India-Mailbox decision suggests that the WTO will accord substantial deference to national and regional rules which manifest good faith compliance with the basic standards of the TRIPS Agreement.’

14 David K. Tomar, ‘A Look into WTO Pharmaceutical Patent Dispute between United Sates and India’

(1999) 17 (3) Wisconsin International Law Journal 579-603, 589.

135 Julia Brummer, India ’s Negotiation Position at the WTO, Dialogue on Globalization: Briefing Papers

(Geneva: Friedrich Ebert Stiftung, November 2005) 4 at http://1 ibrarv.fcs.dc/pdf- fi Ies/bueros/genl750205 ,pd f

L'6 Prabuddha Ganguli, ‘Towards TRIPs compliance in India: The Patents Amendment Act 1999 and

implications’ (December 1999) 21 (4) World Patent Information 279-287, 279.

137 Section 24 A of the Patents (Amendment) Act 1999 at

two years from the date of approval by the Controller for exclusive marketing rights to sell or distribute under Section 24B, any person interested may make an application to the Controller alleging that the reasonable requirements of the public with respect to the exclusive marketing rights have not been satisfied or that the product enjoying exclusive marketing right is not available to the public at a reasonable price and pray for the grant of a Compulsory Licence.

The enforcement of exclusive marketing rights granted under the Patents (Amendment)

Act 1999 (India) was always a point of concern for applicants. Eli Lilly’s exclusive marketing right of Cialis was stayed by the Calcutta High Court and it could not be enforced.I?s According to the sources of the Indian Patent Office, a total of 8,926 mailbox applications were filed for examination.139