[Federal Register Volume 61, Number 87 (Friday, May 3, 1996)]
[Notices]
[Pages 19971-19972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11068]
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OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE
[Docket No. 301-104]
Initiation of Section 302 Investigation and Request for Public
Comment: Practices of the Government of Pakistan Regarding Patent
Protection for Pharmaceuticals and Agricultural Chemicals
AGENCY: Office of the United States Trade Representative.
ACTION: Notice of initiation of investigation; request for written
comments.
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SUMMARY: The United States Trade Representative (USTR) has initiated an
investigation under section 302(b)(1) of the Trade Act of 1974, as
amended (the Trade Act) (19 U.S.C. 2412(b)(1)), with respect to certain
acts, policies and practices of the Government of Pakistan that may
result in the denial of patents and exclusive marketing rights to U.S.
individuals and firms involved in the development of innovative
pharmaceutical and agricultural chemicals products. The United States
alleges that these acts, policies and practices are inconsistent with
the Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPs Agreement), administered by the World Trade Organization (WTO).
USTR invites written comments from the public on the matters being
investigated.
DATES: This investigation was initiated on April 30, 1996. Written
comments from the public are due on or before noon on Monday, June 3,
1996.
ADDRESSES: Office of the United States Trade Representative, 600 17th
Street, N.W., Washington, DC 20508.
FOR FURTHER INFORMATION CONTACT:
Joseph Papovich, Deputy Assistant USTR for Intellectual Property, (202)
395-6864, or Thomas Robertson, Assistant General Counsel, (202) 395-
6800.
SUPPLEMENTARY INFORMATION: Section 302(b)(1) of the Trade Act
authorizes the USTR to initiate an investigation under chapter 1 of
Title III of the Trade Act (commonly referred to as ``section 301'')
with respect to any matter in order to determine whether the matter is
actionable under section 301. Matters actionable under section 301
include inter alia, the denial of rights of the United States under a
trade agreement, or acts, policies, and practices of a foreign country
that violate or are inconsistent with the provisions of, or otherwise
deny benefits to the United States under, any trade agreement.
On April 30, 1996, having consulted with the appropriate private
sector advisory committees, the USTR determined that an investigation
should
[[Page 19972]]
be initiated to determine whether certain laws and regulations of
Pakistan affecting the grant of patents and exclusive marketing rights
in innovative pharmaceutical and agricultural chemical products are
actionable under section 301(a). Article 70 of the TRIPs Agreement
requires all countries that do not provide product patent protection
for pharmaceuticals and agricultural chemicals on January 1, 1995, to
establish by that time a means by which applications for patents for
such inventions can be filed, which is commonly referred to as a
``mailbox.'' These applications are to be reviewed when such protection
is ultimately provided in accordance with the transitional provisions
of the TRIPs Agreement. This provision allows ``mailbox'' applicants to
preserve their original filing date for the purposes of novelty and
nonobviousness considerations in patentability determinations. Article
70 of the TRIPs Agreement also requires those WTO members delaying the
grant of pharmaceutical and agricultural chemical product patent
protection to grant ``mailbox'' applicants up to five years of
marketing exclusivity if such applicants are granted a patent and
marketing approval in another WTO member and marketing approval in the
member providing marketing exclusivity. Pakistan has not yet
established a ``mailbox'' for the filing of pharmaceutical and
agricultural chemical product patent applications, no has it
established a system for the grant of exclusive marketing rights. These
failures would appear to be inconsistent with the obligations set forth
in Article 70 of the TRIPs Agreement.
Investigation and Consultations
As required in section 303(a) of the Trade Act, the USTR has
requested consultations with the Government of Pakistan regarding the
issues under investigation. The request was made pursuant to Article 4
of the WTO Understanding on Rules and Procedures Governing the
Settlement of Disputes (DSU) and Article 64 of the TRIPs Agreement (to
the extent it incorporates by reference Article XXII of the General
Agreements on Tariff and Trade 1994). If the consultations do not
result in a satisfactory resolution of the matter, the USTR will
request the establishment of a panel pursuant to Article 6 of the DSU.
Under section 304 of the Trade Act, the USTR must determine within
18 months after the date on which this investigation was initiated, or
within 30 days after the conclusion of WTO dispute settlement
procedures, whichever is earlier, whether any act, policy, or practice
or denial of trade agreement rights described in section 301 of the
Trade Act exists and, if that determination is affirmative, the USTR
must determine what action, if any, to take under section 301 of the
Trade Act.
Public Comment: Requirements for Submissions
Interested persons are invited to submit written comments
concerning the acts, policies and practices of Pakistan which are the
subject of this investigation, the amount of burden or restriction on
U.S. commerce caused by these acts, policies and practices, and the
determinations required under section 304 of the Trade Act. Comments
must be filed in accordance with the requirements set forth in 15 CFR
2006.8(b) (55 FR 20593) and must be filed on or before noon on Monday,
June 3, 1996. Comments must be in English and provided in twenty copies
to: Sybia Harrison, Staff Assistant to the Section 301 Committee, Room
223, Office of the U.S. Trade Representative, 600 17th Street, NW,
Washington, D.C. 20508.
Comments will be placed in a file (Docket 301-104) open to public
inspection pursuant to 15 CFR 2006.13, except confidential business
information exempt from public inspection in accordance with 15 CFR
2006.15. Confidential business information submitted in accordance with
15 CFR 2006.15 must be clearly marked ``BUSINESS CONFIDENTIAL'' in a
contrasting color ink at the top of each page on each of 20 copies, and
must be accompanied by a nonconfidential summary of the confidential
information. The nonconfidential summary shall be placed in the file
that is open to public inspection. An appointment to review the docket
(Docket No. 301-104) may be made by calling Brenda Webb (202) 395-6186.
The USTR Reading Room is open to the public from 10 a.m. to 12 noon and
1 p.m. to 4 p.m., Monday through Friday, and is located in Room 101.
Irving A. Williamson,
Chairman, Section 301 Committee.
[FR Doc. 96-11068 Filed 5-2-96; 8:45 am]
BILLING CODE 3190-01-M
