INDIA - PATENT PROTECTION FOR PHARMACEUTICAL AND AGRICULTURAL CHEMICAL PRODUCTS
Document: Original: English INDIA - PATENT PROTECTION FOR PHARMACEUTICAL AND AGRICULTURAL CHEMICAL PRODUCTS Request for the Establishment of a Panel
Date: 8 November 1996
Document codes: WT/DS50/4
Complainant: U.S.
Respondent: India
Third parties: EU
Dispute stage: Appellate Body
Agreements cited: Art. 27, 65, 70  Intellectual Property (TRIPS)

INDIA - PATENT PROTECTION FOR PHARMACEUTICAL
AND AGRICULTURAL CHEMICAL PRODUCTS
Request for the Establishment of a Panel
The following communication, dated 7 November 1996, from the Permanent Mission of the
UnitedStates tothe Chairman of the DisputeSettlement Body, iscirculated at the request of thismission.
The Agreement on Trade-Related Aspects of Intellectual Property Rights (“ TRIPS” ) requires
all Members of the (“ WTO” ) to grant patents for the subject matter specified
in Article 27 of the Agreement. Article 70.8 of the TRIPS Agreement provides that where a Member
takes advantage of the transitional provisions under the Agreement and does not make product patent
protection available for pharmaceutical and agricultural chemical inventions as of the date of entry
into force of the WTO Agreement (i.e., January 1, 1995), that Member must implement measures
to permit parties to file patent applications drawn to such inventions on or after that date. When product
patent protection is established, these applications must be examined according to the criteria for
patentability set forth in the Agreement, based on the earliest effective filing date claimed for the
application. Patents granted on these applications must enjoy the term and rights mandated by the
TRIPS Agreement.
The TRIPS Agreement further requires Members subject to the obligations of Article 70.8
to provide exclusive marketing rights to those parties that have filed an application under the interim
filing procedures, provided that the product covered by the invention has been granted marketing approval
in the Member providing protectionand another Member, and a patent has been grantedon the invention
in another Member.
The legal regime in India currently does not make patent protection available for inventions
as specified in Article 27 of the TRIPS Agreement, or provide systems that conform to obligations
of the TRIPS Agreement regarding the acceptance of applications and the grant of exclusive marketing
rights. As a result, India’ s legal regime appears to be inconsistent with the obligations of the TRIPS
Agreement, including but not necessarily limited to Articles 27, 65 and 70.
In a communication dated July 2, 1996 (WT/DS50/1), the United States requested consultations
withIndia pursuantto Article 4 of the Understanding onRules and Procedures Governing the Settlement
of Disputes (“ DSU” ) and Article 64 of the TRIPS Agreement to the extent that it incorporates by
reference Article XXII of the General Agreement on Tariffs and Trade 1994. Consultations were held
on July 29, 1996, but did not result in a resolution of the dispute.

Accordingly, the United States respectfully requests the establishment of a panel to examine
this matter in light of the TRIPS Agreement, and to find that India’ s legal regime fails to conform
to the obligations of Articles 27, 65 and 70 of the TRIPS Agreement, and nullifies or impairs benefits
accruing directly or indirectly to the United States under the TRIPS Agreement.
The United States asks that this request be placed on the agenda for the meeting of the Dispute
Settlement Body scheduled to be held on November 20, 1996, and that the panel be established with
standard terms of reference as set out in Article 7 of the DSU.