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Abstract

Over 175 Federal District Court cases filed from September 2008 through July 2010 were analyzed to determine common features noted by applicants seeking longer patent term adjustments (“PTAs”) in view of a Federal District Court ruling, later affirmed by the U.S. Court of Appeals for the Federal Circuit in Wyeth v. Kappos, which held that the United States Patent and Trademark Office (“PTO”) misinterpreted a statute relating to the calculation of PTAs involving overlapping periods of delay attributable to the PTO or to the applicant. Applicant and PTO errors in calculating PTAs were common, often relating to counting errors due to the mischaracterization of events that occur at the beginning or end of specific delay periods. Asymmetries were also noted in the treatment of delay periods encountered in the prosecution of national phase applications based on earlier-filed international applications, compared to applications which take priority only to earlier-filed U.S. applications. Common patterns of delay were noted, and practices that minimize Applicant Delay, maximizing effective PTA, are highlighted. Despite the intent of Congress to compensate applicants for delays in prosecution in an industry-independent manner, applicants seeking reconsideration of a patent term adjustment in Federal District Court are highly-biased toward institutions seeking patents on pharmaceutical and related biotechnology inventions. Unlike patent term extensions, which are sought in a six-month period prior to regulatory approval and sale of a pharmaceutical product, and often long after a patent has issued claiming the product, court cases identifying patents needing longer PTAs provide early notice to the public, including investors and competitors, of technologies considered to have particular value to the applicant. Understanding the complex calculations behind PTAs, patent term extensions, and expiration dates, is key to the development of successful scientific, legal, and business strategies involving licensing and ownership of patented technologies.

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