An act to amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug applications, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes.

(Measure passed House, amended, in lieu of H. R. 3605) Drug Price Competition and Patent Term Restoration Act of 1984 - Title I: Abbreviated New Drug Applications - Amends the Federal Food, Drug, and Cosmetic Act to authorize abbreviated applications for the approval of a new drug. Sets forth the contents of an abbreviated application, including: (1) information to show that the conditions of use prescribed in the labeling proposed for a new drug have been previously approved for a drug that appears on a list prepared by the Secretary of Health and Human Services (listed drug); and (2) a certification relating to patents covering such listed drug. Requires an applicant who makes such a certification to state in the application that a specified notice has been given to: (1) each owner of the patent (or owner-representative); and (2) the holder (or holder-representative) of the approved application for the drug or drug use claimed by the patent. Sets forth information to be included in such notice. Requires the permission of the Secretary before an abbreviated application may be submitted for a new drug which has a different active ingredient or whose route of administration, dosage form, or strength differ from that of a listed drug. Directs the Secretary to approve an application for a drug unless specified findings are made. Requires the Secretary to approve or disapprove an application within a specified time. Requires the approval of a drug to be withdrawn or suspended if the application for approval was abbreviated and it refers to a drug the approval of which was withdrawn or suspended for specified reasons. Requires the Secretary, within 60 days of enactment, to publish: (1) a list of each drug which has been approved for safety and effectiveness before enactment of this Act; (2) the date of approval (if after 1981) and the number of the application; and (3) whether in vitro or in vivo bioequivalence studies, or both, are required for applications filed under this Act which will refer to the drug published. Provides for periodic revision of the list. Prohibits listing of a drug whose approval has been withdrawn or suspended. Requires the applicant to file with the application (or amend it when the information becomes available) the patent number and the expiration date of any patent which claims the drug or a method of using it and with respect to which a claim of patent infringement could reasonably be asserted if a non-licensee engaged in the drug's manufacture, use, or sale. Requires the Secretary to disapprove the application if it does not contain such patent information, or to withdraw approval if the patent information was not filed within a specified time after notification. Provides for periods of exclusive market life (from two or three to five years) for specified categories of recently or newly approved drugs. Requires a similar certification relating to patents covering a drug for which the applicant files a non-abbreviated application for approval. Requires the applicant who makes such a certification to state that the applicant has given notice to specified patent-owners and application-holders or their representatives. Requires safety and effectiveness data submitted in a non-abbreviated application to be made available to the public, if not previously disclosed, upon request, under certain conditions. Provides for the promulgation of regulations to administer the amendments made by this title. Title II: Patent Extension - Extends the term of a patent which claims a product, a method of using a product, or a method of manufacturing a product if specified conditions are met. Requires among such conditions that: (1) the term of the patent has not expired before an application for extension is submitted; (2) the term of the patent has never been extended; and (3) an application for extension is submitted by the owner of record of the patent or its agent and in accordance with specified requirements. Sets special conditions for an application for a product primarily using recombinant DNA technology. Limits to one the number of patents which may be extended for the same regulatory review period for any product. Permits the patent-holder to select the patent to be extended. Limits the rights derived from a patent during an extension period to the rights available before the term of the patent expired. Limits, with specified exceptions, the term of the extension to the time equal to the regulatory review period for the approved product. Sets forth the requirements for an extension application. Requires the Patent Commissioner to notify the Secretary of Health and Human Services of the extension application if the patent involves any human drug product, a medical device, or a food or color additive, or a method of use or manufacture subject to the Federal Food, Drug and Cosmetic Act. Provides for review of the application by the Secretary. Declares that it is not a patent infringement to make, use, or sell a patented invention (other than a new animal drug or veterinary biological product) solely for uses reasonably related to the development and submission of information under a Federal law which regulated the manufacture, use, or sale of drugs. Declares that it shall be a patent infringement to submit an abbreviated application for a drug claimed, or whose use is claimed, in a patent if the purpose of the submission is to obtain approval to engage in the commercial manufacture, use, or sale of such a drug before the patent expires. Sets forth civil remedies for such an infringement. Prohibits injunctive or other relief in an action for patent infringement if the relief would prohibit the making, using, or selling of a patented invention for uses reasonably related to the development of information under a Federal drug regulatory law. Makes the invalidity of a patent extension a defense in a patent infringement action. Title III: Amendments to the Textile Fiber Products Identification Act and the Wool Products Labeling Act of 1939 - Amends the Textile Fiber Products Identification Act and the Wool Products Labeling Act of 1939 to require a textile fiber or wool product to be so labeled if it has been processed or manufactured in the United States. Requires the product, as well as the package in which it is contained, to be labeled as to country of origin. Requires catalog sales descriptions and other advertisements for textile and wool products to contain country of origin information. Requires that the identification label on imported textile fiber or wool products be affixed to the most conspicuous place on the inner side of the product.

(Measure passed Senate, amended) Title I: Patent Law - Patent Law Amendments of 1984 - Authorizes the Commissioner of Patents and Trademarks to publish a statutory invention containing the specifications and drawings of a regularly filed application for a patent without examination if the applicant waives the right to receive a patent on the invention within a prescribed period and pays established fees. Makes such recording effective upon publication. Endows such recording with all the attributes of a patent except the right to compensation for Government-ordered secrecy and for infringement. Directs the Secretary of Commerce to convene an interagency coordinating committee to coordinate policy on the use of the statutory invention recording procedure by Federal agencies and to establish standards for evaluating the commercial potential of inventions to which the Government may have right of ownership. Provides that such policy shall require the use of the statutory invention recording procedure for inventions without commercial potential to which the United States may have the right of ownership. Directs the Secretary to report to Congress annually on the Federal use of such recording system. Permits the basic fee portion of an international fee to be paid within one month of filing rather than upon filing. States that the designation of the United States as the country in which patent is sought in an international patent filed under the patent cooperation treaty shall continue to have effect until the international application is withdrawn, if a claim for the benefit of a prior filing date is made before such application is ultimately withdrawn. Renders permissible (rather than mandatory as under current law) the receipt from the International Bureau of all international applications and search reports for international applications designating the United States. Permits the Commissioner to fix a later time for the completion of certain requirements than the commencement of the national state of an international application. States that failure to submit a copy of the application by commencement and lack of compliance with other specified requirements shall be regarded as abandonment of the application. Permits the Commissioner to receive a verification of the translation of an international application. (Under current law such receipt is mandatory.) Permits a surcharge to be levied as a condition for accepting the national fee or the oath or declaration if these requirements are not met by the commencement of the national stage. Eliminates the special fee and restoration of patent provisions for claims not searched in the international stage and later found not to comply with the requirement for unity of invention under the treaty. Prohibits the collection of fees for maintaining a plant patent in force. Merges the Board of Appeals and the Board of Patent Interferences into the Board of Patent Appeals and Interferences. Extends until April 21, 1992, the term of any patent encompassing a new drug product subject to the labeling requirements for oral hypoglycemic drugs of the sulfonylurea class as promulgated by the Food and Drug Administration in its March 22, 1984, ruling. Title II: Textile Fiber and Wool Products Identification Improvement Act - Textile Fiber and Wool Products Identification Improvement Act - Amends the Textile Fiber Products Identification Act and the Wool Products Labeling Act of 1939 to require a textile fiber or wool product to be so labeled if it has been processed or manufactured in the United States. Requires the product, as well as the package in which it is contained, to be labeled as to country or origin. Requires catalog sales descriptions and other advertisements for textile and wool products to contain country of origin information. Requires that the identification label on imported textile fiber or wool products be affixed to the most conspicuous place on the inner side of the product.

Patent Law Amendments of 1983 - Authorizes the Commissioner of Patents and Trademarks to issue a patent on an invention without the required examination if the applicant waives all legal remedies and pays a stated fee. States that no maintenance fees shall be required for such patents. Permits the Commissioner to require that the total issue fee for all patents be payable within three months of issuance or sooner. Permits the basic fee portion of an international fee to be paid within one month of filing rather than upon filing. States that the designation of the United States as the country in which patent is sought in an international patent filed under the patent cooperation treaty shall continue to have effect until the international application is withdrawn, if a claim for the benefit of a prior filing date is made before such application is ultimately withdrawn. Renders permissible rather than mandatory the receipt from the International Bureau of all international applications and search reports for international applications designating the United States. Permits the Commissioner to fix a later time for the completion of certain requirements than the commencement of the national state of an international application. States that failure to submit a copy of the application by commencement and lack of compliance with other specified requirements shall be regarded as abandonment of the application. (Under current law such receipt is mandatory.) Commissioner to receive a verification of the translation of an international application. Permits a surcharge to be levied as a condition for accepting the national fee or the oath or declaration if these requirements are not met by the commencement of the national stage. Eliminates the special fee and restoration of patent provisions for claims not searched in the international stage and later found not to comply with the requirement for unity of invention under the treaty Prohibits the collection of fees for maintaining a plant patent in force.