[Federal Register Volume 62, Number 119 (Friday, June 20, 1997)]
[Notices]
[Pages 33695-33696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16129]


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OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE


Pakistan: Conclusion of WTO Dispute Settlement Proceeding 
Regarding Patent Protection for Pharmaceuticals and Agricultural 
Chemicals

AGENCY: Office of the United States Trade Representative.

ACTION: Notice of termination and monitoring.

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SUMMARY: On April 30, 1996, the United States Trade Representative 
initiated an investigation under section 302(b)(1) of the Trade Act of 
1974 regarding the inadequate patent protection provided by the 
Government of Pakistan to United States individuals and firms involved 
in the development of innovative pharmaceutical and agricultural 
chemical products, in light of Pakistan's obligations under the World 
Trade Organization (WTO) Agreement on Trade-Related Aspects of 
Intellectual Property Rights (TRIPS). Following consultations between 
the United States and Pakistan, Pakistan issued Ordinance No. XXVI of 
1997, establishing the framework for a filing system for patent 
applications drawn to such products and for the grant of exclusive 
marketing rights under certain circumstances. On February 28, 1997, the 
United States and Pakistan jointly notified the WTO Dispute Settlement 
Body (DSB) of the settlement of this matter in light of Pakistan's 
planned implementation of Ordinance No. XXVI. Having reached a 
satisfactory resolution of the issues under investigation, the USTR has 
terminated this section 302 investigation and will monitor 
implementation of the agreement under section 306 of the Trade Act.

EFFECTIVE DATES: This investigation was terminated on June 9, 1997.

ADDRESSES: Office of the U.S. Trade Representative, 600 17th Street 
NW., Washington, DC 20508.

FOR FURTHER INFORMATION CONTACT:
Thomas Robertson, Associate General Counsel, Office of the United 
States Trade Representative (202) 395-6800.

SUPPLEMENTARY INFORMATION: On April 30, 1996, the United States Trade 
Representative (USTR) initiated an investigation under section 
302(b)(1) of the Trade Act of 1974 (Trade Act) regarding the inadequate 
patent protection provided by the Government of Pakistan to United 
States individuals and firms involved in the development of innovative 
pharmaceutical and agricultural chemical products. 61 FR 19971 (May 3, 
1996). The investigation specifically considered whether Pakistan 
failed to meet its TRIPS Agreement obligations by failing either to 
provide patent protection for pharmaceutical and agricultural chemical 
inventions as specified in Article 27, or to establish systems for the 
acceptance of applications for patents on such inventions and the grant 
of exclusive marketing rights in accordance with Article 70.8 and 70.9. 
See 61 FR 19771 for further details. Pursuant to section 303(a) of the 
Trade Act, the USTR requested consultations with the Government of 
Pakistan under the procedures of the WTO Understanding on Rules and 
Procedures Governing the Settlement of Disputes (DSU) and Article 64 of 
the TRIPS Agreement.

Resolution of Dispute

    After consultation between the Governments of the United States of 
America and Pakistan in accordance with DSU procedures, Pakistan 
formally agreed to the United States' interpretation that Pakistan is 
required to establish mailbox and exclusive marketing rights systems 
under the TRIPS Agreement. On February 4, 1997, Pakistan President 
Farooq Ahmad Khan Leghari issued Ordinance No. XXVI of 1997, to 
establish these systems. In a February 28, 1997, notification to the 
WTO DSB, the United States and Pakistan notified the WTO that Pakistan 
would implement the ordinance in accordance with the TRIPS Agreement.
    Under the Ordinance, Pakistan will implement regulations which 
establish a system by which WTO Members' nationals can file with 
Pakistan's patent authorities a product patent application for a 
pharmaceutical or agricultural chemical product invention until January 
1, 2000, preserving as the filing date the date the application was 
received by the authorities. After January 1, 2000, Pakistan will 
implement the priority filing benefits provisions in Article 4 of the 
Paris Convention on the Protection of Industrial Property, thus 
allowing Members nationals who file patent applications with Pakistan's 
patent authorities to claim up to one year priority. Those Members' 
nationals who would have submitted applications between January 1, 
1995, and the date the Ordinance issued, but were unable to do so 
because Pakistan had no ``mailbox'' filing system in place, will be 
able to file such applications for one year after the date the 
ordinance was issued, and will receive the filing date of the original 
application filed in another WTO Member.
    In addition, the Ordinance provides that exclusive marketing rights 
will be granted if the applicant has been granted a patent and 
marketing approval on the product that is subject of the application in 
another WTO Member and the applicant is granted marketing approval in 
Pakistan. The period of marketing approval shall be for a period of 
five years after these conditions are met or until a product patent is 
granted or rejected in Pakistan, whichever term is shorter. In 
accordance with the Article 70.9 requirement that such marketing right 
be ``exclusive,'' the Government of Pakistan will implement the 
Ordinance so that under no circumstances will exclusive marketing 
rights be subject to any limitation or exception, including the 
imposition of a compulsory license. No party may be granted marketing 
approval for a product that is the subject of exclusive marketing 
rights without the express consent of the holder for such exclusive 
marketing rights.
    Based on the developments of the formal consultations and the 
measures Pakistan has undertaken to implement its obligations under the 
TRIPS Agreement, the United States and Pakistan jointly notified the 
WTO DSB that they have reached a mutually satisfactory solution to the 
matter, and that the United States has formerly withdrawn this matter 
from further consideration by the DSB. On the basis of the measures 
Pakistan has undertaken to provide a satisfactory resolution to the 
matter under investigation, the USTR has decided to terminate this 
section 302 investigation. Pursuant to section 306 of the Trade Act, 
the USTR will monitor Pakistan's implementation of its TRIPS Agreement 
obligations in accordance with the Ordinance and the

[[Page 33696]]

terms of the U.S.-Pakistan joint notifications to the DSB.
Irving Williamson,
Chairman, Section 301 Committee.
[FR Doc. 97-16129 Filed 6-19-97; 8:45 am]
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