[Federal Register Volume 62, Number 30 (Thursday, February 13, 1997)]
[Notices]
[Pages 6826-6827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3546]


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OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE

[Docket No. WTO/D-11]


WTO Dispute Settlement Proceeding Regarding Patent Protection in 
India for Pharmaceuticals and Agricultural Chemicals

AGENCY: Office of the United States Trade Representative.

ACTION: Notice; request for comments.

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SUMMARY: Pursuant to section 127(b)(1) of the Uruguay Round Agreements 
Act (URAA) (19 U.S.C. 3537(b)(1)), the Office of the United States 
Trade Representative (USTR) is providing notice that the United States 
has requested the establishment of a dispute settlement panel under the 
Agreement Establishing the World Trade Organization (WTO), to examine 
India's failure to make patent protection available for inventions as 
specified in Article 27 of the Agreement on Trade-Related Aspects of 
Intellectual Property Rights (TRIPS), or provide systems that conform 
to obligations of the TRIPS Agreement regarding the acceptance of 
applications and the grant of exclusive marketing rights. More 
specifically, the United States has requested the establishment of a 
panel to determine whether India's legal regime is inconsistent with 
the obligations of the TRIPS Agreement, including but not necessarily 
limited to Articles 27, 65 and 70. USTR also invites written comments 
from the public concerning the issues raised in the dispute.

DATES: Although USTR will accept any comments received during the 
course of the dispute settlement proceedings, comments should be 
submitted on or before March 3, 1997, to be assured of timely 
consideration by USTR in preparing its first written submission to the 
panel.

ADDRESSES: Comments may be submitted to Ileana Falticeni, Office of 
Monitoring and Enforcement, Room 501, Attn: India Mailbox Dispute, 
Office of the U.S. Trade Representative, 600 17th Street, N.W., 
Washington, DC 20508.

FOR FURTHER INFORMATION CONTACT:
Thomas Robertson, Associate General Counsel, Office of the General 
Counsel, Office of the U.S Trade Representative, 600 17th Street, N.W. 
Washington, DC 20508 (202) 395-6800.


[[Page 6827]]


SUPPLEMENTARY INFORMATION: On November 10, 1996, the United States 
requested establishment of a WTO dispute settlement panel to examine 
whether India's legal regime is inconsistent with the obligations of 
the TRIPS Agreement. The WTO dispute Settlement Body (DSB) considered 
the U.S. request at its meeting on November 20, 1996, at which time a 
panel was established. Very recently, three panelists were chosen to 
hear the dispute: Professor Thomas Cottier of the University of Berne 
in Switzerland, Mr. Yanyong Phuangrach of the Ministry of Commerce in 
Thailand, and Mr. Doug Chester of the Ministry of Foreign Affairs and 
Trade in Australia. The first meeting of panelists is scheduled to take 
place on February 19, 1997. Under normal circumstances, the panel would 
be expected to issue a report detailing its findings and 
recommendations within six to nine months after it is established.

Major Issues Raised by the United States and Legal Basis of 
Complaint

    The TRIPS Agreement requires all WTO Members 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 Members' nationals to file patent applications drawn 
to such inventions on or after that January 1, 1995. When the Member 
fully implements the product patent provisions of TRIPS Agreement 
Article 27, 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 persons who 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 this transitional 
protection and another Member, and a patent has been granted on 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.

Public Comment: Requirements for Submissions

    Interested persons are invited to submit written comments 
concerning the issues raised in the dispute. Comments must be in 
English and provided in fifteen copies. A person requesting that 
information contained in a comment submitted by that person be treated 
as confidential business information must certify that such information 
is business confidential and would not customarily be released to the 
public by the commenter. Confidential business information must be 
clearly marked ``BUSINESS CONFIDENTIAL'' in a contrasting color ink at 
the top of each page of each copy.
    A person requesting that information or advice contained in a 
comment submitted by that person, other than business confidential 
information, be treated as confidential in accordance with section 
135(g)(2) of the Trade Act of 1974 (19 U.S.C. 2155)--
    (1) Must so designate that information or advice;
    (2) Must clearly mark the material as ``SUBMITTED IN CONFIDENCE'' 
in a contrasting color ink at the top of each page of each copy; and
    (3) Is encouraged to provide a non-confidential summary of the 
information or advice.
    Pursuant to section 127(e) of the URAA, USTR will maintain a file 
on this dispute settlement proceeding, accessible to the public, in the 
USTR Reading Room: Room 101, Office of the United States Trade 
Representative, 600 17th Street, N.W., Washington, DC 20508. The public 
file will include a listing of any comments received by USTR from the 
public with respect to the proceeding; the U.S. submissions to the 
panel in the proceeding; the submissions, or non-confidential summaries 
of submissions, to the panel received from the other participants in 
the dispute, as well as the report of the dispute settlement panel and, 
if applicable, the report of the Appellate Body. An appointment to 
review the public file (Docket WTO/D-11, ``U.S.-India: Mailbox''), may 
be made by calling Brenda Webb, (202) 395-6186. The USTR Reading Room 
is open to the public from 9:30 a.m. to 12 noon and 1 p.m. to 4 p.m., 
Monday through Friday.
A. Jane Bradley,
Assistant U.S. Trade Representative for Monitoring and Enforcement.
[FR Doc. 97-3546 Filed 2-12-97; 8:45 am]
BILLING CODE 3190-01-M