H.R.1598 - Patent Fairness Act of 1999106th Congress (1999-2000)
Summary: H.R.1598 — 106th Congress (1999-2000)
Patent Fairness Act of 1999 - Amends Federal law to require, if the Commissioner of Patents and Trademarks determines that certain standards are met, restoration of the term of any patent, in force on September 24, 1984, and on the filing date of a patent term restoration application under this Act, that claims: (1) a drug product; (2) a method of using a drug product; or (3) a method of manufacturing a drug product.
Introduced in House (04/28/1999)
(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.