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Books Books 1 - 10 of 16 on RNA, hybridoma technology, or other processes involving site specific genetic manipulation....
" RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale... "
Patenting life. - Page 59
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Designing Value-added Soybeans for Markets of the Future

Richard F. Wilson - Technology & Engineering - 1991 - 135 pages
...shall not be an act of infringement to make, use, or sell a patented invention . . . solely for the uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use, or sale of drugs." (24). Outside the narrow domain of this legislation,...
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Intellectual Property Law: Commercial, Creative, and Industrial Property

Jay Dratler, Stephen M. McJohn - Law - 2014 - 2500 pages
...intellectual property involved. The patent statute contains an exception for pre-marketing activities "reasonably related to the development and submission of information under a Federal law" regulating drugs or veterinary biological products," the purpose of which is to allow generic drug...
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The Children's Vaccine Initiative:: Achieving the Vision

Committee on the Children's Vaccine Initiative: Planning Alternative Strategies, Institute of Medicine - Medical - 1993 - 240 pages
...Restoration Act of 1984, this clause provides an exception to infringement on patent rights, whereby it is not an act of infringement to "make, use or...submission of information under a Federal law which regulates the manufacture, use or sale of drugs" (Epstein, 1991, p. 452.14). For example, it would...
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Patenting the Recombinant Products of Biotechnology

Philippe Georges Ducor - Law - 1998 - 179 pages
...RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development...submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products. (2) It shall be...
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Handbook of Intellectual Property Claims and Remedies

Patrick J. Flinn - Law - 1999 - 1000 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...and submission of information under a federal law that regulates the use of drugs.46-3 The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) is such...
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Handbook of Intellectual Property Claims and Remedies

Patrick J. Flinn - Law - 1999 - 1000 pages
...RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development...submission of information under a Federal law which regulates the manufacture, use, or sale of drugs. (2) It shall be an act of infringement to submit...
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Legal Battles that Shaped the Computer Industry

Lawrence D. Graham - Law - 1999 - 251 pages
...RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development...submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products. (2) It shall be...
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Pharmaceutical Patent Issues

Orrin G. Hatch - 2000 - 291 pages
...certification. 21 USC 355(j)(2)(B). The Hatch-Waxman Act provides generally that "[i]t shall not be an act of infringement to make, use, or sell a patented...submission of information under a Federal law which regulates the manufacture, use, or sale of drugs." 35 USCA 271(e)(1). Inclusion of a paragraph IV...
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Dispute Settlement Reports 2000: Volume 5, Pages 2235-2620

World Trade Organization - Law - 2002 - 390 pages
...Agreement). As regards Section 55.2(1). its express language allowed "any person to make, construct, use or sell [a] patented invention solely for uses...related to the development and submission of information required under any law of Ciinada. a province or a country other than Canada that regulates the manufacture,...
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The International Political Economy of Intellectual Property Rights

Meir Perez Pugatch - Law - 2004 - 284 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...submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products'; See also Correa...
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