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Pharmaceuticals

Selected Works

2016

Articles 1 - 3 of 3

Full-Text Articles in Law

Correlative Obligation In Patent Law: The Role Of Public Good In Defining The Limits Of Patent Exclusivity, Srividhya Ragavan Dec 2016

Correlative Obligation In Patent Law: The Role Of Public Good In Defining The Limits Of Patent Exclusivity, Srividhya Ragavan

Srividhya Ragavan

In light of the recent outrageous price-spiking of pharmaceuticals, this Article questions the underlying justifications for exclusive rights conferred by the grant of a patent. Traditionally, patents are defined as property rights granted to encourage desirable innovation. This definition is a misfit as treating patents as property rights does a poor job of defining the limits of the patent rights as well as the public benefit goals of the system. This misfit gradually caused an imbalance in the rights versus duties construct within patent law. After a thorough analysis of the historical and philosophical perspectives of patent exclusivity, this Article …


Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova Dec 2015

Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova

Robin C Feldman

The FDA’s citizen petition process was created in the 1970s as part of an effort to fashion more participatory regimes, in which ordinary citizens could access the administrative process. The theoretical underpinnings hypothesize that a participatory structure will prevent regulatory agencies from being captured by the very industries they were intended to police. Anecdotal evidence suggests, however, that the FDA’s citizen petition process may have taken a different turn. This empirical study explores whether pharmaceutical companies are systematically using citizen petitions to try to delay the approval of generic competitors. Delaying generic entry of a drug — even by a …


Regulatory Property: The New Ip, Robin C. Feldman Dec 2015

Regulatory Property: The New Ip, Robin C. Feldman

Robin C Feldman

For thirty years, a new form of intellectual property has grown up quietly beneath the surface of societal observation. It is a set of government-granted rights that have the quintessential characteristic of intellectual property and other forms of property — that is, the right to exclude others from the territory. 

The impact of this form of IP on the US health care system, in particular, is enormous. In 2014, more than 40% of all new drugs approved by the FDA came through just one of these portals, with the companies collecting regulatory property rights along the way. 

Some forms of …