Law Commons^™

International Intellectual Property Shelters, Sam F. Halabi

Faculty Publications

The battle over the reach and strength of international protections for intellectual property rights is one of the critical flashpoints between wealthy and low-income countries: those protections are perceived to obstruct access to essential medicines, thwart regulatory efforts to promote individual and population health, and undermine traditional forms of agriculture and food production. While scholars have thoroughly tracked the bilateral and multilateral trade and investment treaties responsible for the expansion of international intellectual property rights worldwide, they have paid significantly less attention to the strength and form that opposition to international intellectual property expansion has taken. This Article examines the …

The Interaction Of Exhaustion And The General Law, Aaron K. Perzanowski, Ariel Katz, Guy A. Rub

Faculty Publications

In Statutory Domain and the Commercial Law of Intellectual Property, John Duffy and Richard Hynes argue that IP exhaustion — the doctrine that limits a patentee’s or copyright holder’s control over goods in the stream of commerce — was created and functions exclusively to confine IP law within its own domain and prevent it from displacing other laws.

In this essay, we explain why we are not persuaded. A central theme in Duffy and Haynes work is the argument that the common law did not play a role in the emergence and development of exhaustion. However, we show that the …

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: …