Patents Articles

When generic versions of Lilly's antidepressant Prozac (fluoxetine) were introduced in 2001, Prozac's volume fell precipitously—losing 73 percent of its share of new prescriptions within two weeks. Although that may be the most well -known example of the impact of generics, the Federal Trade Commission reports that between 1984 (when Congress passed the Hatch-Waxman Act) and 2002, generics' prescription share has risen from 19 to 47 percent. Today, the figure is widely reported to be more than 50 percent. Based o­n review of recent patent expiration data, such rapid losses of revenue for brand owners appear to be more common. Generic companies are stronger and more sophisticated, and payers are more effective in their efforts to influence the way prescriptions are written and filled.

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The number of pharmaceuticals derived from nature is staggering. Many medicine cabinet staples were first isolated from natural sources-penicillin from mold, quinine from the cinchona tree, digitalis (foxglove) for heart ailments, and the list goes o­n. But many modern miracle drugs also have their roots in nature. Cyclosporin, the immunosuppressant that revolutionized the prospects of organ transplant patients, was found in a fungus. And Taxol (paclitaxel), the potent anticancer agent, was discovered in the bark of the Pacific yew tree.

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ABARELIX;PLENAXIS,
PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 021320 001 ABARELIX;PLENAXIS 5968895 DEC 11, 2016 DP 6180608 DEC 11, 2016 DP U549 6423686 JUN 07, 2015 DS 6455499 JUN 07, 2015 U549 5843901 DEC 01, 2015 DS DP 6699833 DEC 11, 2016 DP 021539 001 ACETYLCYSTEINE;ACETADOTE ODE JAN 23, 2011 020899 001 ALBUMIN HUMAN;OPTISON 6273303 APR 20, 2021 DP 020949 001 ALBUTEROL SULFATE;ACCUNEB 6702997 DEC 28, 2021 U558 020949 002 ALBUTEROL SULFATE;ACCUNEB 6702997 DEC 28, 2021 U558 020560 005 ALENDRONATE SODIUM;FOSAMAX D-87 APR 16, 2007 021575 001 ALENDRONATE SODIUM;FOSAMAX D-87 APR 16, 2007 020886 001 ALITRETINOIN;PANRETIN 5932622 AUG 03, 2016 U562 021540 001 AMLODIPINE BESYLATE;CADUET


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Patents help ensure that companies can recoup their development costs-and make profits-by selling their products without competition for a set period of time. The pharma industry has followed that model for decades. So the industry has reacted with predictable horror to recent calls to ignore patents in sub-Saharan Africa to make AIDS medicines more affordable. Pharma companies believe that if patents are ignored, there will be little or no incentive for future research into new medicines, threatening the sustainability of the entire drug discovery process.

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A method for investigating the possibility of bias between sampling methods has been devised. It is effected by collecting paired samples from a number of different sampling targets. Paired samples are created by executing a standard sampling protocol and a sampling method under validation in a randomised fashion at each target. After chemical analysis of the two samples, the difference between a pair of results is an estimate of the bias for that target. Repeating the procedure for many distinct targets improves the precision of the estimate. If the analyte concentration range of the targets is small, the mean of the difference estimates is taken as the overall bias estimate. The mean bias can be tested for significance, if required, by a o­ne-sample test. If the concentration range is wide, potential biases can be considered as functions of analyte concentration.

Washington, DC-Pharma companies suffered a significant setback last month when developing countries at the World Trade Organization meeting pushed through a declaration allowing nations to override patent laws to cope with health crises. Although industry officials insisted that the agreement would have little impact o­n profits, the language sets the stage for more competition from cheap generic products in much of the world.

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David Filmore
MODERN DRUG DISCOVERY MAY 2004 A rarely used clause of the Bayh–Dole Act has been invoked to essentially override the patents o­n two drugs.


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Alan L. Jakimo and Karen Owen Dunlop
MODERN DRUG DISCOVERY APRIL 2004

Tom Brody, DNAX Research Institute, pp. 38-42.
BioPharm International, February 2002

For Full Article Click Here  (Complete Dember 2001 Issue)