[Federal Register Volume 65, Number 111 (Thursday, June 8, 2000)]
[Notices]
[Pages 36497-36498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14510]


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OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE

[Docket No. WTO/D-196]


WTO Consultations Regarding Argentina--Patent and Test Data 
Protection

AGENCY: Office of the United States Trade Representative.

ACTION: Notice; request for comments.

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SUMMARY: The Office of the United States Trade Representative (USTR) is 
providing notice that on May 30, 2000, the United States requested 
consultations with Argentina under the Marrakesh Agreement Establishing 
the World Trade Organization (WTO), regarding Argentina's failure to 
fully implement its obligations under the Agreement on Trade-Related 
Aspects of Intellectual Property Rights (TRIPS Agreement) with respect 
to its legal regimes governing patents and data protection. The United 
States considers Argentina's patent and data protection regimes to be 
inconsistent with its obligations under the TRIPS Agreement, including 
Articles 27, 28, 31, 34, 39, 50, 62, 65 and 70 of the Agreement. 
Pursuant to Article 4.3 of the WTO Dispute Settlement Understanding 
(DSU), such consultations are to take place within a period of 30 days 
from the date of the request, or within a period otherwise mutually 
agreed between the United States and Argentina. USTR invites written 
comments from the public concerning the issues raised in this dispute.

DATES: Although USTR will accept any comments received during the 
course of the dispute settlement proceedings, comments should be 
submitted on or before July 28, 2000, to be assured of timely 
consideration by USTR.

ADDRESSES: Submit comments to Sandy McKinzy, Monitoring and Enforcement 
Unit, Office of the General Counsel, Room 122, Office of the United 
States Trade Representative, 600 17th Street, N.W., Washington, D.C. 
20508, Attn: Argentina--Patent and Test Data Protection Dispute: 
Telephone: (202) 395-3582.

FOR FURTHER INFORMATION CONTACT: Stephen Kho, Assistant General 
Counsel, Office of the United States Trade Representative, 600 17th 
Street, N.W., Washington, D.C., (202) 395-3581.

SUPPLEMENTARY INFORMATION: Section 127(b) of the Uruguay Round 
Agreements Act (URAA) (19 U.S.C. 3537(b)(1)) requires that notice and 
opportunity for comment be provided after the United States submits or 
receives a request for the establishment of a WTO dispute settlement 
panel. Consistent with this obligation, but in an effort to provide 
additional opportunity for comment, USTR is providing notice that 
consultations have been requested pursuant to the WTO Dispute 
Settlement Understanding. If such consultations should fail to resolve 
the matter and a dispute settlement panel is established pursuant to 
the DSU, such panel, which would hold its meetings in Geneva, 
Switzerland, would be expected to issue a report on its findings and 
recommendations within six to nine months after it is established.

Major Issues Raised by the United States

    On May 6, 1999, the United States filed a consultation request (WT/
DS171/1) regarding Argentina's failure to provide a system of exclusive 
marketing rights for pharmaceutical products, and to ensure that 
changes in its laws and regulations do not result in a lesser degree of 
consistency with the provisions of the TRIPS Agreement. Consultations 
were held on June 15, 1999 and again on July 27, 1999. On May 30, 2000, 
the United States supplemented its claims in this dispute with 
additional concerns that have arisen as a result of Argentina's failure 
to fully implement its remaining TRIPS obligations that came due on 
January 1, 2000. These new concerns relate to Argentina's regimes 
governing patents in Law 24,481 (as amended by Law 24,572), Law 24,603, 
and Decree 260/96; and data protection in Law 24,766 and Regulation 
440/98, and in other related statutes and regulations. Specifically,

[[Page 36498]]

the United States believes that, in addition to the previous claims, 
Argentina:
     Fails to protect against unfair commercial use of 
undisclosed test or other data, submitted as a requirement for market 
approval of pharmaceutical or agricultural chemical products;
     Improperly excludes certain subject matter, including 
micro-organisms, from patentability;
     Fails to provide prompt and effective provisional 
measures, such as preliminary injunctions, for purposes of preventing 
infringements of patent rights from occurring;
     Denies certain exclusive rights for patents, such as the 
protection of products produced by patented processes and the right of 
importation;
     Fails to provide certain safeguards for the granting of 
compulsory licenses, including timing and justification safeguards for 
compulsory licenses granted on the basis of inadequate working;
     Improperly limits the authority of its judiciary to shift 
the burden of proof in civil proceedings involving the infringements of 
process patent rights; and
     Places impermissible limitations on certain transitional 
patents so as to limit the exclusive rights conferred by these patents, 
and to deny the opportunity for patentees to amend pending applications 
in order to claim certain enhanced protection provided by the TRIPS 
Agreement.
    As such, these new concerns appear to be inconsistent with 
Argentina's obligations under the TRIPS Agreement, including Articles 
27, 28, 31, 34, 39, 50, 62, 65, and 70 of the Agreement.

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.
    Information or advice contained in a comment submitted, other than 
business confidential information, may be determined by USTR to be 
confidential in accordance with section 135(g)(2) of the Trade Act of 
1974 (19 U.S.C. 2155(g)(2)). If the submitter believes that information 
or advice may qualify as such, the submitter--
    (1) Must so designate the 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(3) of the URAA (19 U.S.C. 3537(e)), 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, NW., Washington, DC 
20508. The public file will include a listing of any comments received 
by USTR from the public with respect to the dispute; if a dispute 
settlement panel is convened, the U.S. submissions to that panel, the 
submissions, or non-confidential summaries of submissions, to the panel 
received from other participants in the dispute, as well as the report 
of the panel; and, if applicable, the report of the Appellate Body. An 
appointment to review the public file (Docket WTO/D-196, Argentina--
Patent and Test Data Protection Dispute) 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 United States Trade Representative for Monitoring and 
Enforcement.
[FR Doc. 00-14510 Filed 6-7-00; 8:45 am]
BILLING CODE 3190-01-M