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Ethical and Legal Considerations

Annette Flanagin

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Patent law protects invention and technology. A patent is a grant of property right by the government to protect a newly created idea on the basis of its technical and legal merit.60 In biomedicine, patents are commonly applied for and approved for new products, such as pharmaceuticals, reagents, assays, devices, and equipment and less commonly for procedures and methods. Patent law is intended to encourage discovery and investment in research of new technology by rewarding an inventor with a monopoly on the right to market the new product for a specified period. This law restricts other parties from manufacturing, selling, or using the new product without the patent holder’s permission for 20 years.60

In the United States, patents are awarded by the US Patent and Trademark Office (USPTO). For more details, instructions, and copies of patent forms, contact the USPTO:

  • US Patent and Trademark Office

  • Department of Commerce

  • Washington, DC 20231

  • Telephone: (703) 308-4357 or (800) 786-9199

  • Fax: (703) 305-7786

  • Email:


As with copyright, there is no international patent law or protection; patents are protected by individual countries. In some regions, a regional patent office (eg, the European Patent Office or the African Regional Intellectual Property Organization) accepts and grants patent applications in the member states of that region. Detailed information about international treaties on patents is available from WIPO (for contact information, see 5.6.14, Copyright Resources).

Controversy over claims for patents of naturally occurring substances, medical and surgical methods, and even genetically altered cells and gene fragments has appeared in the scientific literature.61-63 Desires for profit and primacy of discovery have been motives causing delay or suppression of the publication of important medical information.5,6,64 For this reason, editors should request that authors disclose information about patents, including ownership and upcoming and pending applications for patent grants, that are related to the work included in their submitted manuscripts in their financial disclosures to journals (see 5.5, Conflicts of Interest).

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