title: The Role of Regulatory Agencies and Intellectual Property: Part I.
abstract: The patent and regulatory regimes of different agencies of the federal government are not always in agreement, and although the concept of the "unified executive" holds that the executive branch speaks with one voice, that is not always the case.(1) Some agencies, like the Food and Drug Administration, tend toward cooperation with government patent policies, whereas others, notably the Federal Trade Commission, are often at odds with the Patent Office, the patent system, or both. These skirmishes, when they arise, eventually come before federal courts and ultimately the Supreme Court, where balancing the differing policy objectives, as well as the will of Congress as embodied in its statutes, is subject to the vagaries of the politics of how the issues are framed by the courts, and the judges' and justices' own predilections and prejudices. Examples of these situations were prevalent in 2013 and the circumstances surrounding them illustrative of the tensions inherent between the various federal agencies.
authors.affiliation: McDonnell Boehnen Hulbert & Berghoff, LLP, Chicago, Illinois 60606-6709.
authors.forename: Kevin E
authors.initials: KE
authors.lastname: Noonan
mesh_terms: D004345:Drug Industry; D005820:Genetic Testing / Q000331:legislation & jurisprudence*; D006801:Humans; D018973:Intellectual Property; D017410:Practice Guidelines as Topic; D035521:Supreme Court Decisions; D014481:United States; D014485:United States Federal Trade Commission; D014486:United States Food and Drug Administration