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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Page 4
... period 5 of 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 ...
... period 5 of 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 ...
Page 9
... period of post - patent exclusive marketing , and the drug does not fall within any of the provisions of the state which grant market exclusivity or patent extension . When Warner - Lambert first started work on Lopid , and even when it ...
... period of post - patent exclusive marketing , and the drug does not fall within any of the provisions of the state which grant market exclusivity or patent extension . When Warner - Lambert first started work on Lopid , and even when it ...
Page 13
... period of post - patent exclusive marketing , and the drug does not fall within any of the provisions of the statute which grant market exclusivity or patent extension . Mr. Chairman , there are several important points which need to be ...
... period of post - patent exclusive marketing , and the drug does not fall within any of the provisions of the statute which grant market exclusivity or patent extension . Mr. Chairman , there are several important points which need to be ...
Page 30
... period , while the provision in the other section seems to indicate that enforceability would be limited to a certain " composition of matter " to be identified by the Commissioner . Also , the requirement of section 155 ( B ) ( b ) ( 2 ) ...
... period , while the provision in the other section seems to indicate that enforceability would be limited to a certain " composition of matter " to be identified by the Commissioner . Also , the requirement of section 155 ( B ) ( b ) ( 2 ) ...
Page 34
... play in the market exclusivity period that would arise from the approval , the FDA ap- proval of a second application of this drug which is expected to follow from the Phase IV study ? Dr. YOUNG . In the case of this particular drug 34.
... play in the market exclusivity period that would arise from the approval , the FDA ap- proval of a second application of this drug which is expected to follow from the Phase IV study ? Dr. YOUNG . In the case of this particular drug 34.
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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...