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Full-Text Articles in Law
Excluding Patentability Of Therapeutic Methods, Including Methods Using Pharmaceuticals, For The Treatment Of Humans Under Trade Related Aspects Of Intellectual Property Rights Article 27(3)(A), Michael Henry Davis
Law Faculty Articles and Essays
The Agreement on Trade Related Aspects of Intellectual Property Rights ("TRIPS"), the General Agreement on Tariffs and Trade ("GATT"), and the World Trade Organization ("WTO") debacle has radically altered the traditional ability of nations to adopt whatever patent regime seems appropriate to them. Instead, TRIPS requires all member nations, even those which never thought it appropriate to grant such state monopolies, to afford patent protection to areas which had never been granted before-most dramatically in the area of health related innovations and, most expensively, pharmaceuticals. Until TRIPS, most -- or at least a number approaching half -- countries simply did …
Where Are Your Drugs Really Made And Who Is Regulating It?, Floyd Trillis Iii
Where Are Your Drugs Really Made And Who Is Regulating It?, Floyd Trillis Iii
In the Balance
No abstract provided.
Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann
Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann
Law Faculty Articles and Essays
Reprocessing single-use medical devices is a growing but controversial industry subject to an increasingly complex and fast-developing set of regulations and a wide range of unresolved legal issues.
Why Don't We Enforce Existing Drug Price Controls? The Unrecognized And Unenforced Reasonable Pricing Requirements Imposed Upon Patents Deriving In Whole Or In Part From Federally-Funded Research, Michael Henry Davis, Peter S. Arno
Why Don't We Enforce Existing Drug Price Controls? The Unrecognized And Unenforced Reasonable Pricing Requirements Imposed Upon Patents Deriving In Whole Or In Part From Federally-Funded Research, Michael Henry Davis, Peter S. Arno
Law Faculty Articles and Essays
This Article discusses drug pricing in the context of federally funded inventions. It examines the “march-in” provision of the Bayh-Dole Act, a federal statute that governs inventions supported in whole or in part by federal funding. It discusses technology-transfer activity as a whole and the often-conflicting roles of the government, academia, and industry. The Article discusses the mechanisms of the Bayh-Dole Act and examines its legislative history. It notes that the Act has had a powerful price-control clause since its enactment in 1980 that mandates that inventions resulting from federally funded research must be sold at reasonable prices. The Article …
Rare Diseases, Drug Development And Aids: The Impact Of The Orphan Drug Act, Michael Henry Davis, Peter S. Arno, Karen Bonuck
Rare Diseases, Drug Development And Aids: The Impact Of The Orphan Drug Act, Michael Henry Davis, Peter S. Arno, Karen Bonuck
Law Faculty Articles and Essays
In this article, we examine the Orphan Drug Act with an eye toward its contribution to the public interest, using AIDS drugs to illustrate many of the central points. The major policy question is, How, if at all, can the act be used to meet the legislative goal of stimulating drug development for small patient populations without resulting in prices that make drugs inaccessible?
Mental Hospital Drugging - Atomistic And Structural Remedies, Sheldon Gelman
Mental Hospital Drugging - Atomistic And Structural Remedies, Sheldon Gelman
Law Faculty Articles and Essays
Thirty years have passed since the discovery of Thorazine, a neuroleptic drug, and the drugging of American state mental patients has become commonplace. Part I distinguishes between two approaches to remedy--"structural" and "atomistic"--and, as a basis for testing the two, describes a state hospital's handling of the most serious drug side effect. This account also provides a sense of the dimensions of the drugging problems in state hospitals. Part II explores a family of atomistic remedies. These would address drugging problems by seeking to ensure that state doctors are knowledgeable about drugs and/or reasonably careful in administering them. I reject …