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Full-Text Articles in Law
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Articles
As finding breakthrough small-molecule drugs becomes more difficult, 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. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues 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 Food and …
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Articles
Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …
Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg
Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg
Articles
In this Article, I consider the possibility of giving the USPTO input from currently active technological practitioners in evaluating the obviousness of claimed inventions. Such input could potentially serve three useful functions. First, it could improve the accuracy of USPTO decisionmaking by providing access to the perspective of actual practitioners as to the obviousness of inventions from the perspective of the hypothetical PHOSITA. Second, it could help the USPTO document the evidentiary basis for rejections that rest in part upon tacit knowledge within technological communities. Third, it could provide a quality control mechanism that would improve the credibility of USPTO …
Upstream Patents = Downstream Bottlenecks, Rebecca S. Eisenberg, Michael A. Heller
Upstream Patents = Downstream Bottlenecks, Rebecca S. Eisenberg, Michael A. Heller
Articles
Thirty years ago in Science, Garrett Hardin introduced the metaphor "tragedy of the commons" to help explain overpopulation, air pollution, and species extinction. People often overuse resources they own in common because they have no incentive to conserve. Today, Hardin's metaphor is central to debates in economics, law, and science and powerful justification for privatizing commons property. While the metaphor highlights the cost of overuse when governments allow too many people to use a scarce resource, it misses the possibility of underuse when governments give too many people rights to exclude others. Privatization can solve one tragedy, but cause another.
Patents And The Progress Of Science: Exclusive Rights And Experimental Use, Rebecca S. Eisenberg
Patents And The Progress Of Science: Exclusive Rights And Experimental Use, Rebecca S. Eisenberg
Articles
In this article I analyze the proper scope of an experimental use exemption from patent infringement liability by comparing the rationales behind promoting technological progress through granting exclusive patent rights in inventions with competing arguments for promoting scientific progress by allowing all investigators to enjoy free access to the discoveries of other scientists. I begin by reviewing key features of the patent laws and theoretical justifications for granting patent monopolies in order to clarify the implications of existing patent doctrine and theory for an experimental use exemption. I then look to the literature in the sociology, history, and philosophy of …
Proprietary Rights And The Norms Of Science In Biotechnology Research, Rebecca S. Eisenberg
Proprietary Rights And The Norms Of Science In Biotechnology Research, Rebecca S. Eisenberg
Articles
As basic research in biotechnology yields increasing commercial applications, scientists and their research sponsors have become more eager to protect the commercial value of research discoveries through intellectual property law. Some scientists fear that these commercial incentives will weaken or even undermine the norms that have traditionally governed scientific research. In this Article, Professor Eisenberg examines the interaction of proprietary rights in inventions with these traditional scientific norms. Trade secrecy, she argues, is an undesirable strategy for protection of basic research discoveries because it impedes dissemination of new knowledge to the scientific community. She finds that patent law is in …