(Sec. 2) Defines such standards as: (1) a regulatory review period from application submission to application approval exceeding 60 months; and (2) the absence of substantial evidence overcoming the rebuttable presumption that the applicant for patent term restoration for the drug product acted with due diligence. Requires subtraction from the total amount of the restoration term of any time during the regulatory review period during which the Commissioner finds that the applicant for patent term restoration did not act with due diligence.
Limits a restoration period, after specified adjustments, to five years.
Requires restoration term applications to be filed within 90 days after enactment of this Act.
Provides for: (1) claim determination procedure; (2) interim restoration of the patent term pending final disposition; and (3) appeal of the Commissioner's determinations to the U.S. Court of Appeals for the Federal Circuit only.
Entitles to compensation by the patent owner of any person who has submitted an new drug application under the Federal Food, Drug, and Cosmetic Act for a drug product covered by a patent for which a patent term was restored under this Act, if such application has been found by the Food and Drug Administration on or before enactment of this Act to be sufficiently complete to permit substantive review. Sets the amount of compensation at: (1)$1 million; or (2) $500,000 for any holder of a Type II Drug Master File that has permitted a reference to its File to be made in such application. Limits a patent owner's overall liability to: (1) $5 million to persons submitting new drug applications; or (2) $2.5 million to holders of Type II Drug Master Files.
Requires the Commissioner to report to Congress: (1) an evaluation of the patent term restoration review procedure established by this Act; and (2) a recommendation whether Congress should consider establishing such a patent term review procedure for patents not covered by this Act.
Introduced in House
Introduced in House
Sponsor introductory remarks on measure. (CR E789)
Referred to the House Committee on the Judiciary.
Referred to the Subcommittee on Courts and Intellectual Property.
Subcommittee Hearings Held.
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