Lopid Patent Term Restoration and Fairness Act of 1987: 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, October 8, 1987, Volume 4U.S. Government Printing Office, 1988 - 350 pages |
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Results 1-5 of 77
Page 4
... five years , and such patent shall have the effect as if origi- 6 nally issued with such extended term , if— 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 " ( 1 ) such composition has been subjected to a reg- ulatory review ...
... five years , and such patent shall have the effect as if origi- 6 nally issued with such extended term , if— 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 " ( 1 ) such composition has been subjected to a reg- ulatory review ...
Page 9
... five years . Lopid was patented by the Warner - Lambert Company in 1972. Without enactment of this legislation , the patent will expire in July of 1989 . In 1981 , Warner - Lambert received FDA approval for the market- ing of Lopid ...
... five years . Lopid was patented by the Warner - Lambert Company in 1972. Without enactment of this legislation , the patent will expire in July of 1989 . In 1981 , Warner - Lambert received FDA approval for the market- ing of Lopid ...
Page 11
... five years . The very unique background of the development of this drug , which will be detailed in testimony today , is what gives rise to the need for this legislation . would also stress at the outset , Mr. Chairman , that the ...
... five years . The very unique background of the development of this drug , which will be detailed in testimony today , is what gives rise to the need for this legislation . would also stress at the outset , Mr. Chairman , that the ...
Page 13
... five to seven years of market exclusivity the legislation which was to become the 1984 Act had not been introduced . Second , the five - year Helsinki Heart Study has -- become the longest , most expensive privately funded Phase IV ...
... five to seven years of market exclusivity the legislation which was to become the 1984 Act had not been introduced . Second , the five - year Helsinki Heart Study has -- become the longest , most expensive privately funded Phase IV ...
Page 14
... five year extension on the patent for Lopid if , and only if , the FDA approves its use for lowering the risk of heart attacks . The bill was drafted using the unique set of facts which have given rise to the inequity so that it would ...
... five year extension on the patent for Lopid if , and only if , the FDA approves its use for lowering the risk of heart attacks . The bill was drafted using the unique set of facts which have given rise to the inequity so that it would ...
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Common terms and phrases
apolipoprotein Association atherosclerosis baseline bill blood Capsules cardiovascular cent Chairman changes cholesterol cholesterol levels cholestyramine clofibrate Committee concentrations coronary heart disease decrease diabetic diet dose Drug Administration dyslipidaemic effect of gemfibrozil elevated fatty acid composition FDA approval Finland follow-up Food and Drug Framingham gemfibrozil treatment glucose HDL-cholesterol Health heart attacks Helsinki Heart Study hypercholesterolaemia hypertension incidence increase ischaemic heart disease Journal KASTENMEIER Kaukola laboratory legislation lipid lowering Lipid Research Clinics lipid-lowering lipoprotein cholesterol lipoprotein lipase lipoprotein lipase activity Lithell long-term Lopid Lopid patent low density lipoprotein LRC-CPPT male Manninen market exclusivity metabolism mmol/l mortality myocardial infarction Parke-Davis patent extension patent term extension patients pharmaceutical Phase IV study placebo Primary Prevention Trial ratio reduction regulatory risk factors Royal Society safety serum cholesterol serum lipid significant Society of Medicine Subcommittee Table Term Restoration Act therapy treatment groups triglycerides Vessby VLDL Warner-Lambert Waxman-Hatch
Popular passages
Page 113 - A simplified method for the estimation of total cholesterol in serum and demonstration of its specificity, J.
Page 113 - Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial Results, II: the relationship of reduction in incidence of coronary heart disease to cholesterol lowering.
Page 291 - Kagan A.: Serum lipoproteins and coronary heart disease in a population study of Hawaii Japanese men.
Page 73 - I am a partner in the Washington, DC law firm of Covington & Burling. I have been asked to present testimony on patent term restoration.
Page 341 - Five-year findings of the Hypertension Detection and Followup Program. I. Reduction in mortality of persons with high blood pressure, including mild hypertension.
Page 244 - For the purposes of paragraph (2)(B), the term "due diligence" means that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period.
Page 67 - HL-07182 from the National Heart, Lung and Blood Institute of the National Institutes of Health, and by the American Heart Association, Indiana Affiliate, Inc.
Page 8 - Mr. BOUCHER. Thank you very much, Mr. Chairman. I want to commend you...