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 …

A Brief History Of Bioperl, Colin Crossman, Arti K. Rai

Faculty Scholarship

Large-scale open-source projects face a litany of pitfalls and difficulties. Problems of contribution quality, credit for contributions, project coordination, funding, and mission-creep are ever-present. Of these, long-term funding and project coordination can interact to form a particularly difficult problem for open-source projects in an academic environment.

BioPerl was chosen as an example of a successful academic open-source project. Several of the roadblocks and hurdles encountered and overcome in the development of BioPerl are examined through the telling of the history of the project. Along the way, key points of open-source law are explained, such as license choice and copyright.

The …

Patents And Cumulative Innovation, Clarisa Long

Faculty Scholarship

Proprietary rights to the products of biomedical research have repeatedly been a source of controversy for over twenty years. Patents on biomedical innovations have allowed scientists, academics, and research institutions to raise research funds and have contributed to the growth of the biotechnology industry. But “one firm’s research tool may be another firm’s end product.” Patents have been a source of great concern for academic and basic researchers, who fear that proprietary rights to basic research results will hamper the progress of science, stifle the free flow of new knowledge and the dissemination of research results, and chill the research …