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 …

Diagnostic Patents At The Supreme Court, Arti K. Rai

Faculty Scholarship

No abstract provided.

The Costs Of Changing Our Minds, Nita A. Farahany

Faculty Scholarship

This isn’t quite a draft yet – it’s a concept paper. You’ll see after the first 10 pages a good bit of text in brackets, which are primarily notes for me, but it’ll give you a sense of the content of those sections. I’d like to talk through the concept – the “duty” to mitigate emotional distress damages and how courts have struggled with it, as a foray into a broader dichotomy that I see in a number of areas of law that suggest an implicit value in “cognitive liberty.” This is a smaller version of a broader book project …

Biomedical Patents At The Supreme Court: A Path Forward, Arti K. Rai

Faculty Scholarship

Although most would argue that software patents pose a bigger challenge, the U.S. Supreme Court has recently focused on biomedical patents. Two of the Court's recent decisions scaling back such patents, Mayo v. Prometheus and AMP v. Myriad, have provoked justifiable anxiety for those concerned about biomedical innovation, particularly in the area of personalized medicine. While acknowledging significant limitations in the Court's reasoning in both cases, this Essay sketches a reading that is consistent with the results and innovation-friendly.

The Nagoya Protocol And Synthetic Biology Research: A Look At The Potential Impacts, Margo A. Bagley, Arti K. Rai

Faculty Scholarship

This report, prepared for the Synthetic Biology Project at the Woodrow Wilson International Center for Scholars, analyzes the 2010 Nagoya Protocol to the Convention on Biological Diversity and how it may affect U.S. researchers working in the field of synthetic biology. The objective of the Protocol is to provide a transparent framework for the acquisition and sharing of genetic resources on fair and equitable terms that facilitate the conservation of biological diversity and associated traditional knowledge. The report finds significant uncertainty surrounding the temporal scope of the Agreement as well as the types of genetic material that will be covered …

A Neurological Foundation For Freedom, Nita A. Farahany

Faculty Scholarship

No abstract provided.

Unstandard Standardization: The Case Of Biology, Arti K. Rai

Faculty Scholarship

How applicable are the approaches adopted by information and communication technology standards-setting organizations to biological standards? Most engineering-based industries construct products from standard, well understood components. By contrast, despite the early attachment of the moniker “genetic engineering” to biotechnology, standardization in the biological sciences has been relatively rare.

Synthetic Biology: Caught Between Property Rights, The Public Domain, And The Commons, Arti K. Rai, James Boyle

Faculty Scholarship

Synthetic biologists aim to make biology a true engineering discipline. In the same way that electrical engineers rely on standard capacitors and resistors, or computer programmers rely on modular blocks of code, synthetic biologists wish to create an array of modular biological parts that can be readily synthesized and mixed together in different combinations. Synthetic biology has already produced important results, including more accurate AIDS tests and the possibility of unlimited supplies of previously scarce drugs for malaria. Proponents hope to use synthetic organisms to produce not only medically relevant chemicals but also a large variety of industrial materials, including …

Synthetic Biology: The Intellectual Property Puzzle, Arti K. Rai, Sapna Kumar

Faculty Scholarship

Synthetic biology, which operates at the intersection of biotechnology and information technology, has the potential to raise, in a particularly acute manner, the intellectual property problems that exist in both fields. A preliminary patent landscape reveals problematic foundational patents that could, if licensed and enforced inappropriately, impede the potential of the technology. The landscape also reveals a proliferation of patents on basic synthetic biology "parts" that could create transaction cost heavy patent thickets. Both foundational patents and patent thickets are likely to be particularly problematic to the extent they read on standards that synthetic biologists would like to establish. Synthetic …