Y 4.589/1:100/48 LOPID PATENT TERM RESTORATION AND FAIRNESS ACT OF 1987 CIS RECORD ONLY: HEARING BEFORE THE SUBCOMMITTEE ON COURTS, CIVIL LIBERTIES, AND THE ADMINISTRATION OF JUSTICE OF THE COMMITTEE ON THE JUDICIARY HOUSE OF REPRESENTATIVES ONE HUNDREDTH CONGRESS FIRST SESSION 82-542 Printed for the use of the Committee on the Judiciary U.S. GOVERNMENT PRINTING OFFICE WASHINGTON: 1988 For sale by the Superintendent of Documents, Congressional Sales Office COMMITTEE ON THE JUDICIARY PETER W. RODINO, JR., New Jersey, Chairman JACK BROOKS, Texas BARNEY FRANK, Massachusetts HARLEY O. STAGGERS, JR., West Virginia BENJAMIN L. CARDIN, Maryland HAMILTON FISH, JR., New York F. JAMES SENSENBRENNER, JR., BILL MCCOLLUM, Florida WILLIAM E. DANNEMEYER, California D. FRENCH SLAUGHTER, JR., Virginia LAMAR S. SMITH, Texas M. ELAINE MEILKE, General Counsel SUBCOMMITTEE ON COURTS, CIVIL LIBERTIES, AND THE ADMINISTRATION OF JUSTICE ROBERT W. KASTENMEIER, Wisconsin, Chairman MIKE SYNAR, Oklahoma BENJAMIN L. CARDIN, Maryland CARLOS J. MOORHEAD, California Michael J. Remington, Chief Counsel Thomas E. Mooney, Associate Counsel Hutt, Peter, Esq., Covington & Burling Levy, Robert I., M.D., Professor of Medicine, Columbia University ADDITIONAL MATERIALS APPENDIX 2.-FURTHER MATERIALS SUBMITTED BY THE WARNER-LAMBERT CO. 1. Letter from Joseph D. Williams to Hon. Robert W. Kastenmeier (dated Oct. Page 3. Letter from Hon. Robert W. Kastenmeier to Joseph D. Williams (dated Jan. 22, 1988)....... 234 4. Letter from Joseph D. Williams to Hon. Robert W. Kastenmeier (dated Feb. 4, 1988) (with attachment). 236 APPENDIX 3.-FURTHER MATERIALS SUBMITTED BY PUBLIC CITIZEN 1. Dear Colleague Letter from Eric Hard, Esq. (February 25, 1988). 246 3. Rushford, Greg, "Drug Lobby Trades Up", Legal Times (March 14, 1988)....... 248 249 1. Letter from E.A. Cohen, President, Barr Laboratories, Inc. to Hon. Robert W. Kastenmeier (dated July 1, 1987).. APPENDIX 4.-FURTHER MATERIALS SUBMITTED BY BARR LABORATORIES, INC. 251 2. Letter from E.A. Cohen, President, Barr Laboratories, Inc. to Hon. Robert W. Kastenmeier (dated Oct. 26, 1987) 253 APPENDIX 5.-PREVIOUSLY PRINTED MATERIALS 1. Wood, Clive (ed.), "Further Progress with Gemfibrozil", Royal Society of Medicine Services Limited (1986). 254 2. Levy, Robert I. (ed.), "Lipid Regulation: A New Era in the Prevention of Coronary Heart Disease", American Heart Journal (1984). 320 LOPID PATENT TERM RESTORATION AND FAIRNESS ACT OF 1987 THURSDAY, OCTOBER 8, 1987 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON COURTS, CIVIL LIBERTIES AND THE ADMINISTRATION OF JUSTICE, COMMITTEE ON THE JUDICIARY, The subcommittee met, pursuant to notice, at 10 a.m., in room 2226, Rayburn House Office Building, Hon. Robert W. Kastenmeier (chairman of the subcommittee) presiding. Present: Representatives Kastenmeier, Synar, Crockett, Morrison, Berman, Boucher, Moorhead, Hyde, Lungren, DeWine, and Coble. Staff present: Michael J. Remington, chief counsel; David W. Beier, counsel; Thomas E. Mooney, associate counsel; and Audrey A. Marcus, clerk. Mr. KASTENMEIER. The committee will come to order. At the outset, the issue is whether or not consent should be given to permit the meeting to be covered in whole or in part by television broadcast, radio broadcast and/or still photography pursuant to Rule 5 of the Committee Rules. The gentleman from Virginia. Mr. BOUCHER. I have no motion to make, Mr. Chairman. Mr. KASTENMEIER. Well, all right. I will make the pro forma unanimous consent request that the meeting be covered in part or in whole by television broadcast. Mr. BOUCHER. I object to that, Mr. Chairman. Mr. KASTENMEIER. The gentleman from Virginia objects. I will be clear about that. The gentleman from Virginia and I both have misgivings about the fact that we are not able to identify the source, the aegis under which the photography is taken. For that reason, there seems to be no reason to suspend the rules to accommodate what otherwise would have been a request. This morning, the Subcommittee is hearing a bill, H.R. 3074, referred to as the "Lopid Patent Term Extension and Fairness Act of 1987." During the 98th Congress, the Subcommittee developed a consistent, open and fair procedure to deal with private patent legislation. The Committee, in oversight findings for two reports, found that the enactment of private patent bills creating specific exceptions to the patent laws should be the exception rather than the rule. Patent term extension can occur when "regulatory errors"—and I (1) |