[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