Law Commons^™

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii, Arti K. Rai

Faculty Scholarship

As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings.

In this Article, we provide a fresh diagnosis of, and prescription for, this major public policy problem. We argue that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of FDA …

Comment To The Sec In Support Of The Enhanced Disclosure Of Patent And Technology License Information, Colleen V. Chien, Jorge Contreras, Carol Corrado, Stuart Graham, Deepak Hedge, Arti K. Rai, Saurabh Vishnubhakat

Faculty Scholarship

Intangible assets like IP constitute a large share of the value of firms, and the US economy generally. Accurate information on the intellectual property (IP) holdings and transactions of publicly-traded firms facilitates price discovery in the market and reduces transaction costs. While public understanding of the innovation economy has been expanded by a large stream of empirical research using patent data, and more recently trademark information this research is only as good as the accuracy and completeness of the data it builds upon. In contrast with information about patents and trademarks, good information about IP licensing is much less publicly …

Innovation Heuristics: Experiments On Sequential Creativity In Intellectual Property, Stefan Bechtold, Christopher Buccafusco, Christopher Jon Sprigman

Faculty Scholarship

No abstract provided.

Sharing By Design: Data And Decentralized Commons, Jorge L. Contreras, Jerome H. Reichman

Faculty Scholarship

Ambitious international data-sharing initiatives have existed for years in fields such as genomics, earth science, and astronomy. But to realize the promise of large-scale sharing of scientific data, intellectual property (IP), data privacy, national security, and other legal and policy obstacles must be overcome. While these issues have attracted significant attention in the corporate world, they have been less appreciated in academic and governmental settings, where solving issues of legal interoperability among data pools in different jurisdictions has taken a back seat to addressing technical challenges. Yet failing to account for legal and policy issues at the outset of a …

Open Letter On Ethical Norms In Intellectual Property Scholarship, Robin Feldman, Mark A. Lemley, Jonathan Masur, Arti K. Rai

Faculty Scholarship

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 …