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Pharmaceuticals

Intellectual Property Law

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Much Ado About The Tpp's Effect On Pharmaceuticals, Emily M. Morris Jan 2017

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 Jan 2016

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: …