Animal Drug Amendments and Patent Term Restoration Act of 1986

Summary

Animal Drug Amendments and Patent Term Restoration Act of 1986 - Title I: Animal Drug Amendments - Amends the Federal Food, Drug, and Cosmetic Act to authorize abbreviated applications for the approval of a new animal drug. Requires such application to show that permitted uses and ingredients, labeling, and other factors are the same as or bioequivalent to a drug already approved. Requires such application to contain 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 each owner of the patent (or owner-representative) and 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 of Health and Human Services 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 an approved animal 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 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 covers 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. Sets forth a formula for determining when an approved application becomes effective based upon the nature of the certification relating to patents. Prohibits an abbreviated application for a new animal drug based upon a non-abbreviated application approved after this Act's enactment until five years after the non-abbreviated application is approved, except as specified. Requires a three year wait for abbreviated applications based upon non-abbreviated applications approved after this Act's enactment which contain essential new investigations of an ingredient already approved. Requires the Secretary to disapprove the application if it does not contain certain patent information, or to withdraw approval if the patent information was not filed within a specified time after notification. Requires disapproval if substantial evidence of scientific particulars is missing or inadequate. 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 specific reasons. Requires the publication of the reasons for such action. Provides for the promulgation of regulations to administer the amendments made by this title. Title II: Patent Extension - Amends the patent laws to include animal drugs under the patent extension provisions applicable to human drugs which compensate for regulatory delays.

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2 official files

• Reported to Senate with amendment(s)

  summary · EN · 17 September 1986

  Open at official source

• Introduced in Senate

  summary · EN · 6 May 1986

  Open at official source

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