Drug Price Competition and Patent Term Restoration Act of 1984

(Measure passed Senate, amended)

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 Requires the approval of a drug to be withdrawn or suspended if the application for approval was abbreviated and it refers to a drug the approval of which was withdrawn or suspended for specified reasons.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 vitro 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 Prohibits listing of a drug whose approval has been withdrawn or suspended.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.

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 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 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: Separability Clause - Provides that if any provision of this Act is declared unconstitutional, then the remainder of such Act shall not be affected.

Title IV: Miscellaneous Patent Extensions - 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.