INDIA - PATENT PROTECTION FOR PHARMACEUTICAL AND AGRICULTURAL CHEMICAL PRODUCTS
Document: Original: English INDIA - PATENT PROTECTION FOR PHARMACEUTICAL AND AGRICULTURAL CHEMICAL PRODUCTS Notification of an Appeal by India under paragraph 4 of Article 16 of the Understanding on Rules and Procedures Governing the Settlement of Disputes (DSU)
Date: 16 October 1997
Document codes: WT/DS50/6
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
Notification of an Appeal by India under
paragraph 4 of Article 16 of the Understanding on Rules
and Procedures Governing the Settlement of Disputes (DSU)
The following notification, dated 15 October 1997, sent by India to the Dispute Settlement
Body (DSB), is circulated to Members. This notification also constitutes the Notice of Appeal, filed
on the same day with the Appellate Body, pursuant to the Working Procedures for Appellate Review.

2. India requests the Appellate Body to review the following issues of law covered in the Panel
report and legal interpretations developed by the Panel.
(A) Article 70.8 of the TRIPS Agreement.
(i) Whether Article 70.8(a) of the TRIPS Agreement creates the obligation "to eliminate any
reasonable doubts regarding whether mailbox applications and eventual patents based on them
could be rejected or invalidated".
Subparagraph (a) of Article 70.8 of the TRIPS Agreement obliges the developing country Member
concerned to:
"...provide as from the date of entry into force of the WTO Agreement a means by which
applications for patents for [pharmaceutical and agricultural chemical products] can be filed."
This provision establishes merely a procedural obligation to create a means of filing, commonly
referred to as a "mailbox". The rights to be accorded on the basis of mailbox applications are set out
in subparagraphs (b) and (c) of Article 70.8, which apply only after a transitional period of ten years.
The Panel concluded in its report that:
"...Article 70.8 requires the Members in question to establish a means that not only appropriately
allows for the entitlement to file mailbox applications and the allocation of filing and priority
dates to them, but also provides a sound legal basis to preserve novelty and priority as of those

dates, so as to eliminate any reasonable doubts regarding whether mailbox applications and
eventual patents based on them could be rejected or invalidated..." (paragraph 7.31, emphasis
added)
The ruling that subparagraph (a) of Article 70.8 requires the establishment of legal certainty
as to the future treatment of mailbox applications effectively incorporates into this provision obligations
arising only after a ten-year transitional period under subparagraphs (b) and (c) of that Article. India,
therefore, considers that the Panel erred in interpreting Article 70.8(a) of the TRIPS Agreement.
(ii) Whether developing country Members intended to give up their right to determine the validity,
under their domestic law, of any mailbox established pursuant to Article 70.8 of the TRIPS Agreement.
There is no dispute that India has established a mailbox under its current administrative practice
under which it continues to receive applications. Despite finding that India's reliance on this
administrative practice was "not unconstitutional", the Panel found that "there would remain doubt
during the transitional period regarding the eligibility of these products [covered by the mailbox
applications] for future patent protection". (paragraphs 7.37 and 7.38)
On a proper interpretation of the ordinary meaning, context and object and purpose of
Article 70.8and onthe basisof the negotiatinghistory thereof, India considersthata developing country
Member has fulfilled its obligations under Article 70.8 if it establishes a mailbox based on its own
determination of the validity of the mailbox under its domestic law.
Subsidiarily,among otherissues, India wishes the Appellate Bodytoexamine whether the Panel
did not reverse the burden of proof in violation of established principles by requiring India to demonstrate
that its mailbox could not be subjected to a possible legal challenge in the future.
(B) Whether Article 70.9 of the TRIPS Agreement requires the establishment of a system for the
grant of exclusive marketing rights.
Article 70.9 of the TRIPS Agreement obliges India to grant exclusive marketing rights to
pharmaceutical or agricultural chemical products that meet the following conditions:
(a) A mailbox application has been filed in India in respect of a pharmaceutical or
agricultural chemical product;
(b) A patent application has been filed in respect of that product in another Member after
1 January 1995;
(c) The other Member has granted the patent;
(d) The other Member has approved the marketing of the product; and
(e) India has approved the marketing of the product.
The Panel found that India had not denied the grant of exclusive marketing rights to any product
meeting the above conditions. The Panel nevertheless concluded that India did not comply with its
obligations under Article 70.9 of the TRIPS Agreement because it had failed to establish under its
domestic law "a system" for the grant of exclusive marketing rights as of the entry into force of the
WTO Agreement (paragraph 8.1). However, Article 70.9 of the TRIPS Agreement does not require
the establishment of a system for the grant of exclusive marketing rights. While there are many
provisions in the TRIPS Agreement that explicitly require Members to create the authority for the grant

of certain rights in their domestic law, Article 70.9 was drafted as a transitional provision merely
requiring the grant of exclusive marketing rights to specific products after the occurrence of specified
events. India therefore considers that the Panel erred in interpreting Article 70.9 of the TRIPS
Agreement.
(C) Whether a Panel is authorized to make findings and recommendations on a matter on which
the complaining party had not requested findings and recommendations.
The United States requested the Panel to find that India had failed to implement the obligation
in Article 70.8 of the TRIPS Agreement to establish a "mailbox system". The United States further
requested the Panel to find:
"In the alternative, if the Panel finds that India has had a valid mailbox system in place, India
has failed to comply with its transparency obligations under Article 63 of the TRIPS Agreement."
(paragraph 3.1(c), emphasis added).
The Panel concluded that India's current mailbox system did not conform to the requirements
of Article 70.8 but nevertheless ruled on the United States' Article 63 claim. Under Articles 3, 7 and 11
of the DSU, panels are to make findings and recommendations only on matters submitted to them by
the parties to the dispute. India therefore considers that the Panel exceeded its authority under the
DSU by ruling on the United States' subsidiary claim after accepting its principal claim.
In paragraph 6.44 of its interim report, the Panel had justified its initiative by declaring that
the United States' subsidiary request was "better understood as an additional request". India objected
to this characterization of the United States' request. In paragraph 6.11 of its final report, the Panel
justified its decision by "the need to avoid a legal vacuum in the event that, upon appeal, the Appellate
Body were to reverse the Panel's findings on Article 70.8." Given the possibility of an appeal, the
United States could have requested the Panel to present findings on Article 63 irrespective of the Panel's
conclusions on Article 70.8. However, the possibility of an appeal did not authorize the Panel to present
such findings on its own initiative.