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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 …
Reaching Through The Genome, Rebecca S. Eisenberg
Reaching Through The Genome, Rebecca S. Eisenberg
Book Chapters
The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.
Patent Rights In The Human Genome Project, Rebecca S. Eisenberg
Patent Rights In The Human Genome Project, Rebecca S. Eisenberg
Book Chapters
The various research efforts that comprise the Human Genome Project will inevitably both draw on and yield a multitude of patentable inventions. The broad subject matter of the patent laws potentially reaches every phase of the Genome Project, from the discovery of new research technologies, such as techniques and equipment for DNA sequencing, through the ultimate development of new products, such as screening tests for genetically transmitted diseases. Even bits and pieces of the human genome itself may be, and sometimes have been, patented.' Nor does the fact that the public is paying for the Genome Project through federal funding …