Bill Summary & Status for the 106th Congress

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H.R.1598
Sponsor: Rep Bryant, Ed (introduced 4/28/1999)
Latest Major Action: 7/1/1999 House committee/subcommittee actions
Title: To provide a patent term restoration review procedure for certain drug products.
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TITLE(S):  (italics indicate a title for a portion of a bill)
STATUS: (color indicates Senate actions) (Floor Actions/Congressional Record Page References)
4/28/1999:
Referred to the House Committee on the Judiciary.
5/7/1999:
Referred to the Subcommittee on Courts and Intellectual Property.
7/1/1999:
Subcommittee Hearings Held.
COMMITTEE(S):
RELATED BILL DETAILS:

***NONE***

AMENDMENT(S):

***NONE***

COSPONSORS(77), ALPHABETICAL [followed by Cosponsors withdrawn]:     (Sort: by date)

Rep Aderholt, Robert B. - 7/29/1999 Rep Archer, Bill - 5/24/1999
Rep Baker, Richard H. - 7/20/1999 Rep Barr, Bob - 7/30/1999
Rep Bartlett, Roscoe G. - 9/23/1999 Rep Blagojevich, Rod R. - 7/20/1999
Rep Blunt, Roy - 4/28/1999 Rep Boehner, John A. - 6/30/1999
Rep Bono, Mary - 4/28/1999 Rep Callahan, Sonny - 5/26/1999
Rep Cannon, Chris - 5/19/1999 Rep Castle, Michael N. - 7/20/1999
Rep Chambliss, Saxby - 6/22/1999 Rep Clement, Bob - 5/6/1999
Rep Collins, Mac - 6/22/1999 Rep Conyers, John, Jr. - 4/28/1999
Rep Davis, Thomas M. - 6/9/1999 Rep Delahunt, William D. - 4/28/1999
Rep DeMint, Jim - 9/23/1999 Rep Diaz-Balart, Lincoln - 9/14/1999
Rep Duncan, John J., Jr. - 4/28/1999 Rep Ehrlich, Robert L., Jr. - 7/29/1999
Rep Eshoo, Anna G. - 4/28/1999 Rep Filner, Bob - 5/19/1999
Rep Ford, Harold, Jr. - 4/28/1999 Rep Franks, Bob - 4/28/1999
Rep Frelinghuysen, Rodney P. - 4/28/1999 Rep Frost, Martin - 6/9/1999
Rep Gibbons, Jim - 2/8/2000 Rep Gordon, Bart - 4/28/1999
Rep Green, Gene - 6/16/1999 Rep Hayes, Robin - 10/26/1999
Rep Hefley, Joel - 7/13/1999 Rep Hill, Rick - 10/6/1999
Rep Hilleary, Van - 4/28/1999 Rep Hobson, David L. - 10/19/1999
Rep Hoyer, Steny H. - 4/28/1999 Rep Hyde, Henry J. - 6/16/1999
Rep Isakson, Johnny - 9/14/1999 Rep Istook, Ernest J., Jr. - 10/6/1999
Rep Jackson-Lee, Sheila - 4/28/1999 Rep Jenkins, William L. - 4/28/1999
Rep Johnson, Nancy L. - 6/22/1999 Rep Linder, John - 5/19/1999
Rep Maloney, James H. - 10/26/1999 Rep Matsui, Robert T. - 9/23/1999
Rep McCrery, Jim - 7/1/1999 Rep McDermott, Jim - 4/28/1999
Rep Menendez, Robert - 4/28/1999 Rep Moran, James P. - 6/30/1999
Rep Ney, Robert W. - 6/22/1999 Rep Northup, Anne - 2/8/2000
Rep Norwood, Charlie - 7/20/1999 Rep Pastor, Ed - 4/28/1999
Rep Payne, Donald M. - 4/28/1999 Rep Pickering, Charles (Chip) - 6/22/1999
Rep Price, David E. - 6/30/1999 Rep Riley, Bob - 7/29/1999
Rep Rothman, Steve R. - 4/28/1999 Rep Roukema, Marge - 9/8/1999
Rep Sandlin, Max - 7/20/1999 Rep Saxton, Jim - 10/4/1999
Rep Sessions, Pete - 9/8/1999 Rep Shays, Christopher - 7/1/1999
Rep Simpson, Michael K. - 10/19/1999 Rep Smith, Adam - 9/8/1999
Rep Smith, Christopher H. - 10/6/1999 Rep Smith, Lamar - 4/28/1999
Rep Stump, Bob - 10/26/1999 Rep Sununu, John E. - 10/26/1999
Rep Tanner, John S. - 5/6/1999 Rep Tauscher, Ellen O. - 4/28/1999
Rep Thornberry, William (Mac) - 7/30/1999 Rep Wamp, Zach - 4/28/1999
Rep Watt, Melvin L. - 9/23/1999 Rep Weldon, Curt - 7/30/1999
Rep Wicker, Roger F. - 4/28/1999
Rep Emerson, Jo Ann - 4/28/1999(withdrawn - 5/4/1999) Rep Wexler, Robert - 5/13/1999(withdrawn - 2/2/2000)
Rep McCollum, Bill - 5/24/1999(withdrawn - 6/27/2000) Rep Cook, Merrill - 9/8/1999(withdrawn - 11/18/1999)
Rep Thompson, Mike - 10/19/1999(withdrawn - 10/21/1999)

SUMMARY AS OF:
4/28/1999--Introduced.

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.

(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.