The Children's Vaccine Initiative Achieving the Vision (1993) / Chapter Skim
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Appendix A: Relevant Intellectual Property Rights Law
Appendix A: Relevant Intellectual Property Rights Law
Pages 147-159
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Appendixes
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by rewarding successful endeavors, patents provide inventors and their patrons with incentives to invest time and resources in research and development (Office of Technology Assessment, 1991~. Rights and Limitations The protection granted under patent laws is a 17-year "right to exclude others from making, using, or selling the invention throughout the United States" (35 USC § 154 (Supp.
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If patent protection is desired in a country other than the United States, one must apply for a patent in that country. There is an exception to the general term of 17 years that is relevant to vaccines: When a patent claims that a human drug product, medical device, or food additive has undergone regulatory review for the product, device, or additive to be commercialized or marketed, the patent may be eligible for an extension of up to 5 years, if certain conditions are satisfied (Office of Technology Assessment, 1991~.
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the exploration of commercialization opportunities prior to filing might be reduced because of the importance of early filing. However, the commission felt that the advantages in changing to a firstto-file system would outweigh any negative effects and that first-to-file is a necessary component of any global intellectual property rights harmonization package (many other nations will not consider an intellectual property rights treaty unless the United States agrees to a first-to-file system)
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Nevertheless, it is important to note that patents (even those relating to biotechnology) are granted faster in the United States than in any major examining office in world, and by a significant amount of time (Office of Technology Assessment, 1991~.
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Costs One of the most serious problems facing patent seekers is the financial clout necessary to obtain and retain patents. The financial strain includes the legal, user, and maintenance fees paid to receive and keep a patent; however, the main monetary threat comes from the costs of litigation in cases of patent infringement.
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patent holder with access to federal courts, in addition to the International Trade Commission, as a means of enforcement action (Office of Technology Assessment, 1991~.
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The law, which gave statutory preferences to small businesses and nonprofit organizations, was extended to larger companies in 1983 (Office of Technology Assessment, 19914. Expenn~ental Use Exception Added as an amendment to the Drug Price Competition and Patent Term 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 sell a patented invention solely for uses reasonably related so the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs" (Epstein, 1991, p.
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There are no subject matter limitations on what can constitute a trade secret; therefore, a broad array of information can be protected as such, including scientific processes such as the know-how to make vaccines, other biologics, and pharmaceuticals. Secrecy is the most important criterion that the information must meet to be a trade secret.
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In the event of an unauthorized disclosure and/or use, the trade secret owner can sue for breach of contract and seek an injunction to prevent future unauthorized disclosure and/or use, as well as monetary damages for past unauthorized disclosure and/or use. Implied Contract/Special Relationships In certain circumstances, a trade secret owner has the right to prevent the unauthorized disclosure and/or use of trade secrets because of an implied contract or special relationship with the person to whom the owner disclosed trade secrets.
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A trade secret owner may assert a misappropriation claim against a third party to prevent or remedy unauthorized disclosure and/or use by a third party when the third party knows that the information is considered to be a trade secret and the information was disclosed to the third party through a breach of duty (either by virtue of a contract or by a special relationship/implied contract owed to the trade secret owner)
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156-159. Office of Technology Assessment.
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Key Terms
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