Academic journal article Albany Law Review

A Safe Harbor for Drugs Made Offshore: The Federal Circuit Renders the Bolar Amendment Available in [Section] 337 Actions in Amgen V. U.S. International Trade Commission

Academic journal article Albany Law Review

A Safe Harbor for Drugs Made Offshore: The Federal Circuit Renders the Bolar Amendment Available in [Section] 337 Actions in Amgen V. U.S. International Trade Commission

Article excerpt


In April 2009 the U.S. Court of Appeals for the Federal Circuit rendered an important decision regarding U.S. patent holders' ability to block the importation of pharmaceuticals made overseas. (1) The case addressed a complex interaction of laws pertaining to the infringement of pharmaceutical-related patents and international trade regulation, and held that the International Trade Commission ("ITC" or "Commission") must determine whether the importation it is investigating, at the behest of a patent holder, is being done in pursuit of Food and Drug Administration ("FDA") approval of a pharmaceutical, before taking remedial action. (2)

This paper discusses the decision in light of the legislation, legislative history, administrative action, and case law that shaped it. Part II discusses the Bolar Amendment of the Hatch-Waxman Act, a provision of patent law that exempts from patent infringement liability conduct done in pursuit of FDA approval of a pharmaceutical. In Part III, the role of the ITC in enforcing patent protection, as an alternative or adjunct to litigation in federal courts, is presented. Part IV discusses the Process Patent Amendments Act of 1988, which established patent infringement liability for the importation of the products of U.S. patents, subject to several safe-harbor provisions. In Part V, Federal Circuit precedent pertaining to the applicability of the safe harbor provisions of the Process Patent Amendments Act of 1988 to ITC actions, which set the stage for the controversy in Amgen III, is presented. Finally, in Part VI, Amgen III, as well as additional pending federal litigation, is discussed. In conclusion, Part VII articulates the current state of patent law as it pertains to importation and the pharmaceutical industry, in light of Amgen III. A suggestion is made that the decision in Amgen III is in keeping with recent Supreme Court precedent that the extraterritorial reach of U.S. patent law is limited absent express congressional intent.


The Drug Price Competition and Patent Term Restoration Act of 1984, (3) also known as the Hatch-Waxman Act, was enacted to serve dual purposes in fostering patent protection for pharmaceuticals. (4) One purpose it served was to extend the term of patent protection afforded by the Patent Act for developers of new drugs. (5) Generally, the term of a patent's protection terminates twenty years from the date on which the application for it was filed. (6) Because a patent might not issue until several years after the application for it was filed, due to the time it takes the U.S. Patent and Trademark Office ("PTO") to examine a patent application, there is typically a period of market exclusivity from the time a patent issues to the time its term expires of between seventeen and twenty years. (7)

Prior to the Hatch-Waxman Act, however, the actual period of market exclusivity for pharmaceuticals corresponded to a period of less than seventeen years. (8) Before entering the market, pharmaceuticals must undergo regulatory review for efficacy and safety by the Food and Drug Administration, which typically is not completed by the time a patent on the drug issues. (9) As a result, newly-patented pharmaceuticals generally do not enter the market until substantially more than three years after the filing of a patent application, meaning they are afforded less than the approximately seventeen-year term enjoyed by other patentees. (10) The Hatch-Waxman Act was intended to remedy this disparity by extending the term of pharmaceutical patent protection in accordance with the delay in market entry attributable to FDA review. (11)

A second function of the Hatch-Waxman Act was to expedite the development and entry into the marketplace of generic pharmaceuticals. (12) As with original pharmaceuticals, the period of regulatory approval of generic drugs by the FDA delayed their entry into the market, typically until several years after the expiration of the terms of the original pharmaceuticals upon which they were based. …

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