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Learning From Past Mistakes — The Us Patent System And International Trade Agreements, Robin C. Feldman
Learning From Past Mistakes — The Us Patent System And International Trade Agreements, Robin C. Feldman
Robin C Feldman
To ensure that the TPP agreement works properly in practice with regard to patents and the governance of pharmaceuticals and semiconductors, strong mechanisms for enforcement and for rooting out system abuse are needed. To make this happen, regulators should learn from past mistakes of the U.S. patent system: the proliferation of non-practicing entities (NPEs), and strategic behavior that blocks or delays generic competition in the pharmaceutical industry. This Think Piece presents key findings of the author’s research on the complexity of the U.S. litigation and regulatory frameworks that have provided fertile ground for strategic behavior that can have negative effects …
Empirical Evidence Of Drug Pricing Games - A Citizen's Pathway Gone Astray, Robin C. Feldman, Evan Frondorf, Andrew Cordova
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 …
Patent Licensing, Technology Transfer, & Innovation, Robin C. Feldman, Mark A. Lemley
Patent Licensing, Technology Transfer, & Innovation, Robin C. Feldman, Mark A. Lemley
Robin C Feldman
Traditional justifications for patents are all based on direct or indirect contribution to the creation of new products. Patents serve the social interest if they provide not just invention, but innovation the world would not otherwise have. Non-practicing entities (NPEs) as well as product-producing companies can sometimes provide such innovation, either directly, through working the patent or transfer of technology to others who do, or indirectly, when others copy the patented innovation. The available evidence suggests, however, that patent licensing demands and lawsuits from NPEs are normally not cases that involve any of these activities.
Some scholars have argued that …
Open Letter On Ethical Norms In Intellectual Property Scholarship, Robin C. Feldman, Mark A. Lemley, Jonathan S. Masur, Arti K. Rai
Open Letter On Ethical Norms In Intellectual Property Scholarship, Robin C. Feldman, Mark A. Lemley, Jonathan S. Masur, Arti K. Rai
Robin C Feldman
As scholars who write in intellectual property (“IP”), we write this letter with aspirations of reaching the highest ethical norms possible for our field. In particular, we have noted an influx of large contributions from corporate and private actors who have an economic stake in ongoing policy debates in the field. Some dollars come with strings attached, such as the ability to see or approve academic work prior to publication or limitations on the release of data. IP scholars who are also engaged in practice or advocacy must struggle to keep their academic and advocacy roles separate.
Our goal is …
Regulatory Property: The New Ip, Robin C. Feldman
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 …