[Federal Register Volume 61, Number 131 (Monday, July 8, 1996)]
[Notices]
[Pages 35857-35858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17242]
=======================================================================
-----------------------------------------------------------------------
OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE
[Docket No. 301-106]
Initiation of Section 302 Investigation and Request for Public
Comment: Practices of the Government of India 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.
-----------------------------------------------------------------------
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 India 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
[[Page 35858]]
invites written comments from the public on the matters being
investigated.
DATES: This investigation was initiated on July 2, 1996. Written
comments from the public are due on or before noon on Monday, August
12, 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 July 2, 1996, having consulted with the appropriate private
sector advisory committees, the USTR determined that an investigation
should be initiated to determined whether certain laws and regulations
of India 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 provisions 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'' applications 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. India has not yet established a
permanent formal ``mailbox'' system for the filing of pharmaceutical
and agricultural chemical product patent applications, nor has it
established a system for the grant of exclusive marketing rights. The
Indian Government did attempt to establish such systems in early 1995
(although the marketing exclusively system appeared flawed), but the
Indian legislature failed to act in the area and they expired. United
States Government officials have repeatedly raised this issue with
their Indian counterparts, but have received no satisfactory response.
Indian's failure to establish such systems permanently in a way that
gives legal assurances to the parties that file ``mailbox''
applications 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 India 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 in 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 India which are the
subject of this investigation, the amount of burden or restriction on
U.S. commerce cause 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,
August 12, 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 301-106) 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. 301-106) may be made by calling Brenda Webb (202) 395-6186.
The USTR Reading Room is open to the public from 10:00 a.m. to 12 noon
and 1:00 p.m. to 4:00 p.m., Monday through Friday, and is located in
Room 101.
Irving A. Williamson,
Chairman, Section 301 Committee.
[FR Doc. 96-17242 Filed 7-5-96; 8:45 am]
BILLING CODE 3190-01-M