Open Access. Powered by Scholars. Published by Universities.®
- Discipline
- Institution
Articles 1 - 5 of 5
Full-Text Articles in Law
Distorted Drug Patents, Erika Lietzan
Distorted Drug Patents, Erika Lietzan
Faculty Publications
Drug patents are distorted. Unlike most other inventors, drug inventors must complete years of testing to the government’s specifications and seek government approval to commercialize their inventions. All the while, the patent term runs. When a drug inventor finally launches a medicine that embodies the invention, only a fraction of the patent life remains. And yet, conventional wisdom holds — and empirical studies show — that patent life is essential to innovation in the pharmaceutical industry, perhaps more so than any other inventive industry. Congress tried to do something about this in 1984, authorizing the Patent and Trademark Office to …
Preparing For The Apocalypse: A Multi-Prong Proposal To Develop Countermeasures For Biological, Chemical, Radiological, And Nuclear Threats, Constance E. Bagley, Anat Alon-Beck
Preparing For The Apocalypse: A Multi-Prong Proposal To Develop Countermeasures For Biological, Chemical, Radiological, And Nuclear Threats, Constance E. Bagley, Anat Alon-Beck
Faculty Publications
The false alarm of an Hawaiian nuclear attack in January 2018 is an example of the lack of U.S. preparedness for attacks using nuclear and other weapons of mass destruction. To address such threats, this Article proposes the establishment of a nation-wide integrated defense of health countermeasures initiative (“DHCI”), which is a multi-prong program to create a defensive triad comprising government, private industry, and academia to develop countermeasures for health threats posed by biological, chemical, radiological, and nuclear (“BCRN”) attacks. Key elements of our multi-faceted proposal include the use of the government’s Other Transaction Authority to simplify procurement arrangements, the …
Much Ado About The Tpp's Effect On Pharmaceuticals, Emily M. Morris
Much Ado About The Tpp's Effect On Pharmaceuticals, Emily M. Morris
Faculty Publications
The Trans-Pacific Partnership Agreement’s many provisions that were beneficial to the pharmaceutical industry have caused a good deal of controversy. Specifically, critics allege that the TPP’s provisions requiring that member states expand patentable subject matter, adjust pharmaceutical patent terms, and link regulatory marketing approval to a drug's patent status would have raised drug prices and hindered access to medicines, particularly in developing countries. Closer examination of these provisions as well as the various ways in which member states can modify or ameliorate the effects of these provisions suggests that their potential effect on drug prices and access to health care …
The Myths Of Data Exclusivity, Erika Lietzan
The Myths Of Data Exclusivity, Erika Lietzan
Faculty Publications
This article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplicate version of the drug. This second application is a different type of application, and it may cost no more than a few million dollars to prepare. A similar sequence is true for biological medicines: …
Dangers In Prescription Drugs: Filling A Private Law Gap In The Healthcare Debate, David G. Owen
Dangers In Prescription Drugs: Filling A Private Law Gap In The Healthcare Debate, David G. Owen
Faculty Publications
No abstract provided.