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" It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under... "
Innovation and Patent Law Reform: Hearings Before the Subcommittee on Courts ... - Page 389
by United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice - 1985 - 2897 pages
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Drug Price Competition and Patent Term Restoration Act of 1984: Hearing ...

United States. Congress. Senate. Committee on Labor and Human Resources - 1984 - 474 pages
...years. To the extent, however, that such a reduction is the result of a compromise between the different interest groups involved, the Administration will...patented invention solely for uses reasonably related 163 -iito the development and submission of information needed for Federal regulatory review would...
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Drug Price Competition and Patent Term Restoration Act of 1984: Hearing ...

United States. Congress. Senate. Committee on Labor and Human Resources - 1984 - 390 pages
...years. To the extent, however, that such a reduction is the result of a compromise between the different interest groups involved, the Administration will...the bill would add a new paragraph (e) to section 27l of title 35, dealing with patent infringement. Specifically, this section would provide that the...
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Innovation and Patent Law Reform: Hearings Before the Subcommittee ..., Part 1

United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice - 1985 - 990 pages
...Finally Section 202 provides that it shall not be an act of patent infringement to make, use, or sell a patented invention solely for uses reasonably related to the development and submission of information under federal Law which regulates the manufacture, use or sale of drugs. The hearings brought...
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Agricultural Patent Term Restoration: Hearing Before the ..., Volume 4

United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice - 1986 - 172 pages
...Essentially those provisions stated that it would not be an act of infringement to make, use, or to sell a patented invention solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs. We recommend...
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Generic Pesticide Registration: Hearing Before the Subcommittee on ..., Volume 4

United States. Congress. House. Committee on Small Business. Subcommittee on Energy and Agriculture - 1987 - 156 pages
...Essentially, those provisions stated that it would not be an act of infringement to make, use or sell a patented invention solely for uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use or sale of drugs. a product is...
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Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1987 ...

United States. Congress. House. Committee on Agriculture. Subcommittee on Department Operations, Research, and Foreign Agriculture - 1988 - 1104 pages
...those provisions stated that it would not be an act of infringement to make, use or to sell a - 24 patented invention solely for uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use or sale of drugs. If a product...
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Handbook of Intellectual Property Claims and Remedies

Patrick J. Flinn - 2000 - 1388 pages
...patented inventions in the development of pharmaceuticals. It is not an act of patent infringement to use a patented invention solely for uses reasonably related to the development and submission of information under a federal law that regulates the use of drugs.46-3 The Federal Food, Drug, and Cosmetic...
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Performance and Accountability Report

United States. Patent and Trademark Office - 2005 - 156 pages
...that the safe harbor provisions of 35 USC § 271(e)(1), which exempt from patent infringement the use of a patented invention "solely for uses reasonably related to the development and submission of information" to the Food and Drug Administration (FDA), extend to experiments using patented drugs...
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Patent Fairness Act of 1999: Hearing Before the Subcommittee on Courts and ...

United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Intellectual Property - 2000 - 136 pages
...infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary...
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Pharmaceutical Patent Issues

Orrin G. Hatch - 2000 - 304 pages
...Hatch-Waxman Act provides generally that "[i]t shall not be an act of infringement to make, use, or sell a patented invention * * * solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs." 35 USCA §271(e)(1)....
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