There is one summary for this bill. Bill summaries are authored by CRS.

Shown Here:
Introduced in Senate (05/27/1999)

Drug Patent Term Restoration Review Procedure 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 already extended (subject to a two-year limitation), as well as 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.

(Sec. 1) Defines such standards as: (1) a regulatory review period from application submission to application approval exceeding 60 months; (2) clear and convincing evidence by the owner of record of the patent (or its agent) that the patent owner acted with due diligence; and (3) absence of any detriment by the granting of patent restoration to the public interest and the interest of fairness. 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, together with any extension period, and subject to other specified restrictions and adjustments, to five years.

Requires restoration term applications to be filed within 90 days after enactment of this Act.

Specifies factors of public interest and fairness the Commissioner shall consider when making a term restoration determination, including whether: (1) grant of the application would disserve society's interest in the availability of innovative drugs at competitive prices; or (2) denial of the application would disserve society's interest in encouraging and rewarding pharmaceutical research and innovation.

Provides for: (1) claim determination procedure; (2) a one-year extension 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) $2 million; or (2) $1 million 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) $10 million to persons submitting new drug applications; or (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.

(Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to limit a certain required certification in an application (including an abbreviated application) for an approved product claimed in a patent whose term has been restored, to any patent that claims an active ingredient, including any salt or ester of the active ingredient, of the approved product, alone or in combination with another active ingredient (thus limiting the use of patents to prevent new drug approval).