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Articles 1 - 4 of 4
Full-Text Articles in Law
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 …
Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca Sue Eisenberg
Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca Sue Eisenberg
Law & Economics Working Papers
For a quarter century following the landmark 1980 decision of the Supreme Court in Diamond v. Chakrabarty, inventions and discoveries in biotechnology research appeared to be eligible for patent protection, assuming they meet the statutory standards for patent protection. The Supreme Court reopened the issue of patentable subject matter in 2005 when it granted certiorari in Laboratory Corporation v. Metabolite on the question of whether a method of diagnosing vitamin deficiency by observing a biomarker was unpatentable as a “basic scientific relationship.” Although the Court later dismissed the case without reaching a decision on the merits, since that time the …
Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg
Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg
Articles
In 1980, the Supreme Court gave a reassuring signal to the then-nascent biotechnology industry about the availability of patent protection for the fruits of its research when it upheld the patentability of a genetically modified living organism in Diamond v. Chakrabarty. Twenty-five years later, the Court seemed poised to reexamine the limits of patentable subject matter for advances in the life sciences when it granted certiorari in Laboratory Corporation v. Metabolite. But the Federal Circuit had not addressed the patentable subject matter issue in Laboratory Corporation, and the Court ultimately dismissed the certiorari p etition as improvidently granted. Five years …
Antibiotic Resistance, Jessica D. Litman
Antibiotic Resistance, Jessica D. Litman
Articles
Ten years ago, when I wrote War Stories,' copyright lawyers were fighting over the question whether unlicensed personal, noncommercial copying, performance or display would be deemed copyright infringement. I described three strategies that lawyers for book publishers, record labels, and movie studios had deployed to try to assure that the question was answered the way they wanted it to be. First, copyright owners were labeling all unlicensed uses as "piracy" on the ground that any unlicensed use might undermine copyright owners' control. That epithet helped to obscure the difference between unlicensed uses that invaded defined statutory exclusive rights and other …