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Full-Text Articles in Law
Copyright Owners' Putative Interests In Privacy, Reputation, And Control: A Reply To Goold, Wendy J. Gordon
Copyright Owners' Putative Interests In Privacy, Reputation, And Control: A Reply To Goold, Wendy J. Gordon
Faculty Scholarship
My own view is that Goold overstates the explanatory role of tort law. But even were that not the case, the courts need to reach some kind of “settled” understanding on these various interests before a cause of action is created or definitively rejected, and that no such consensus on the three matters mentioned yet exists, whether they are viewed as forms of tort or otherwise. Goold’s work may nevertheless be an important step toward reaching closure on these and other open questions in copyright law.
The Myths Of Data Exclusivity, Erika Lietzan
The Myths Of Data Exclusivity, Erika Lietzan
Faculty Publications
This article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplicate version of the drug. This second application is a different type of application, and it may cost no more than a few million dollars to prepare. A similar sequence is true for biological medicines: …
Information Abundance And Knowledge Commons, Michael J. Madison
Information Abundance And Knowledge Commons, Michael J. Madison
Book Chapters
Standard accounts of IP law describe systems of legal exclusion intended to prompt the production and distribution of intellectual resources, or information and knowledge, by making those things artificially scarce. The argument presented here frames IP law instead as one of several possible institutional responses to the need to coordinate the use of intellectual resources given their natural abundance, and not necessarily useful or effective responses at that. The chapter aims to shift analytic and empirical frameworks from those grounded in law to those grounded in governance, and from IP law in isolation to IP law as part of resource …
Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin
Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin
All Faculty Scholarship
As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …
Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin
Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin
All Faculty Scholarship
Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v. U.S. …
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Book Chapters
This article reexamines the sources of exclusivity for drugs, considers their limitations, and evaluates exclusivity under the new biologics legislation in light of these limitations. The current overlapping legal protections for exclusivity in the pharmaceutical marketplace reflect a series of political compromises, repeatedly renegotiated to correct for unintended consequences in the previous version of the rules. Patents and patent challenges play a central role in this system of protection, and many of the patents at stake are ultimately held invalid in litigation. It is not easy to untangle a complex legal regime that allocates billions of dollars of profits. But …
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Other Publications
It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …
Notes On Trademark Monopolies, Wendy J. Gordon, Glynn S. Lunney Jr.
Notes On Trademark Monopolies, Wendy J. Gordon, Glynn S. Lunney Jr.
Scholarship Chronologically
Since 1742, when Lord Hardwicke seemingly equated trademark protection with monopoly in one of the first trademark cases, until the mid- 1950s, concerns that trademarks represented a form of illegitimate monopoly effectively constrained the growth of trademark protection. In the twentieth century, Edward Chamberlain became the leading proponent of the trademark as monopoly view with the publication of his work, The Theory of Monopolistic Competition, in 1933. In his work, Chamberlain argued that a trademark enabled its owner to differentiate her products and then to exclude others from using the differentiating feature. By doing so, trademark protection can effectively …
Limiting The Role Of Patents In Technology Transfer, Rebecca S. Eisenberg
Limiting The Role Of Patents In Technology Transfer, Rebecca S. Eisenberg
Other Publications
Federal policy since 1980 has reflected an increasingly confident presumption that patenting discoveries made in the course of government-sponsored research is the most effective way to promote technology transfer and commercial development of those discoveries in the private sector. Policymakers in the past may have thought that the best way to achieve widespread use of government-sponsored research was to make the results freely available to the public; the new pro-patent policy stresses the need for exclusive rights as an incentive for industry to invest in bringing new products to market.
Limiting The Role Of Patents In Technology Transfer, Rebecca S. Eisenberg
Limiting The Role Of Patents In Technology Transfer, Rebecca S. Eisenberg
Articles
Federal policy since 1980 has reflected an increasingly confident presumption that patenting discoveries made in the course of government-sponsored research is the most effective way to promote technology transfer and commercial development of those discoveries in the private sector. Whereas policymakers in the past may have thought that the best way to achieve widespread use of government-sponsored research was to make the results freely available to the public, the new propatent policy stresses the need for exclusive rights as an incentive for industry to undertake the further investment to bring new products to market. Although this propatent policy may make …
Limiting The Role Of Patents In Technology Transfer, Rebecca Sue Eisenberg
Limiting The Role Of Patents In Technology Transfer, Rebecca Sue Eisenberg
Articles
Federal policy since 1980 has reflected an increasingly confident presumption that patenting discoveries made in the course of government-sponsored research is the most effective way to promote technology transfer and commercial development of those discoveries in the private sector. Whereas policymakers in the past may have thought that the best way to achieve widespread use of government-sponsored research was to make the results freely available to the public, the new propatent policy stresses the need for exclusive rights as an incentive for industry to undertake the further investment to bring new products to market. Although this propatent policy may make …
Limitations Upon The Use, After Sale, Of Patented Articles, John B. Waite
Limitations Upon The Use, After Sale, Of Patented Articles, John B. Waite
Articles
In the case of Motion Picture Patents Co. v. Universal Film Co., 37 Sup. Ct. 416, the Supreme Court has just rendered a decision which reverses the much discussed case of Henry v. Dick Co., 224 U. S. 1. The opinion was by a divided court, however, as three of the justices dissented, and Justice McREYNOLDS "concurred in the result" only. It can, therefore, hardly be said to settle the ultimate rule as in contradiction to that followed in Henry v. Dick Co., and discussion of the case is of something more than mere academic value. The facts were that …