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- Title
RITALIN TO ROUNDUP: EXPANDING THE PHARMACEUTICAL INDUSTRY STATUTORY EXPERIMENTAL USE EXCEPTION TO AGRICULTURE.
- Authors
Carter-Johnson, Jennifer
- Abstract
The modern agricultural biotechnology industry developed from a small cottage industry based on selective crop breeding into a multi-billion dollar industry based on the isolation and insertion of genes that code for commercially valuable crop traits. As it grew, the industry relied on patent protection to recoup its investment into new research and development of genetically engineered (GE) crops. A recent billion dollar patent infringement damage award to Monsanto based only on research activities of its competitors testifies to the importance of that patent protection. Had the Monsanto patent infringement case been between two pharmaceutical companies creating genetics-based drugs, the outcome would have been different. Instead of a one billion dollar award, the patent verdict would have been one of noninfringement. The difference between the two patent infringement cases lies with the Hatch-Waxman Act's statutory experimental use exception. The Hatch-Waxman Act controls the regulation of generic drugs by the Food and Drug Administration (FDA). Along with an abbreviated generic drug approval process, the Hatch- Waxman Act includes a statutory experimental use exception to patent infringement allowing pharmaceutical companies to conduct research on patented drugs if the research might be used in a regulatory submission to the FDA. This Article explores the history of the statutory experimental use exception and argues that it should apply to the agricultural biotechnology industry's development of GE crops. The Supreme Court's interpretation of the statute has resulted in a very broad experimental use exception, limited only by whether an invention is regulated by the FDA. Since GE crops are regulated by the FDA, the statutory experimental use exception should apply to their development. Such a broadening of the experimental use exception would have potentially vast impacts on the patent valuations as well as the structure of the entire agricultural biotechnology industry.
- Subjects
UNITED States; AGRICULTURAL biotechnology laws; INDUSTRIES; PHARMACEUTICAL industry; PATENT suits
- Publication
University of Cincinnati Law Review, 2016, Vol 84, Issue 1, p153
- ISSN
0009-6881
- Publication type
Article