DS: India — Patent Protection for Pharmaceutical and Agricultural Chemical Products

This summary has been prepared by the Secretariat under its own responsibility. The summary is for general information only and is not intended to affect the rights and obligations of Members.


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Summary of the dispute to date

The summary below was up-to-date at


Complaint by the United States.

On 2 July 1996, the US requested consultations with India concerning the alleged absence of patent protection for pharmaceutical and agricultural chemical products in India. Violations of the TRIPS Agreement Articles 27, 65 and 70 are claimed.


Panel and Appellate Body proceedings

The DSB established a panel at its meeting on 20 November 1996. The EC reserved their third party rights. On 29 January 1997, the Panel was composed. The report of the Panel was circulated on 5 September 1997. The Panel found that India has not complied with its obligations under Article 70.8(a) or Article 63(1) and (2) of the TRIPS Agreement by failing to establish a mechanism that adequately preserves novelty and priority in respect of applications for product patents for pharmaceutical and agricultural chemical inventions, and was also not in compliance with Article 70.9 of the TRIPS Agreement by failing to establish a system for the grant of exclusive marketing rights.

On 15 October 1997, India notified its intention to appeal certain issues of law and legal interpretations developed by the Panel. The report of the Appellate Body was circulated to Members on 19 December 1997. The Appellate Body upheld, with modifications, the Panelís findings on Articles 70.8 and 70.9, but ruled that Article 63(1) was not within the Panelís terms of reference.

The Appellate Body report and the Panel report, as modified by the Appellate Body, were adopted by the DSB on 16 January 1998.


Implementation of adopted reports

At the DSB meeting of 22 April 1998, the parties announced that they had agreed on an implementation period of 15 months from the date of the adoption of the reports i.e. it expired on 16 April 1999. India undertook to comply with the recommendations of the DSB within the implementation period. On 14 January 1999, the US requested consultations with India in accordance with Article 21.5 of the DSU (without prejudice to the US position on whether Article 21.5 requires consultations before referring to the original panel) regarding the Patents (Amendment) Ordinance, 1999, promulgated by India to implement the rulings and recommendations of the DSB. On 29 January 1999, the European Communities requested to join the consultations.

At the DSB meeting on 28 April 1999, India presented its final status report on implementation of this matter which disclosed the enactment of the relevant legislation to implement the recommendations and rulings of the DSB.


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