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FTC Warns Against an “Over-broad Application” of the Noerr-Pennington Doctrine and Offers Insights on Pharmaceutical Cases

Nov.07.2006

On November 2, 2006, the FTC issued a staff report entitled “Enforcement Perspectives on the Noerr-Pennington Doctrine.” The report notes a lack of clearly delineated boundaries for Noerr’s application and worries about overly broad interpretations of the doctrine. It first summarizes the history and development of the doctrine and then offers perspectives on Noerr’s proper scope. Focusing on the potential abuse of government processes to seek anticompetitive rewards, the report analyzes three types of conduct: (1) requests for ministerial government acts, (2) misrepresentations to a government decision maker in a non-political context; and (3) meritless and repetitive requests for government action filed solely to abuse the government process to suppress competition. The FTC recommends that Noerr should not be applied to protect: (1) filings, outside of the political arena, that seek no more than a ministerial government act; (2) misrepresentations, outside of the political arena, that meet the standards set forth in the Unocal decision; and (3) patterns of meritless and repetitive petitioning outside of the political arena, that employ government processes, rather than the outcome of those processes, to harm competitors in an attempt to suppress competition.

The report does not purport to apply specifically to pharmaceutical cases, but its analysis and observations are particularly relevant to that context. First, the section on ministerial filings focuses in part on the decision in In re Buspirone Litig./In re Buspirone Antitrust Litig., 185 F. Supp. 2d 363 (S.D.N.Y. 2002), where the court held that Noerr does not shield the act of merely listing patents in the FDA’s Orange Book. The report sends a clear signal of preference for a limited scope of Noerr protection in such cases by emphasizing that Noerr does not protect filings outside the political arena and noting that even where “misrepresentations in the FDA drug approval context are deemed actual petitioning potentially protected by Noerr (rather than ministerial and not protected by Noerr), courts should consider whether Unocal and other relevant case law would disqualify such misrepresentations from Noerr protection.” Finally, in many pharmaceutical antitrust cases, plaintiffs allege that branded firms engage in anticompetitive litigation in an effort to delay the entry of generic drugs, and the FTC report asserts that “a ‘pattern’ exception to Noerr should apply when a party invokes administrative processes, judicial processes, or a combination thereof, to hinder marketplace rivals.”

Click here for the entire text of the FTC Staff Report,
Enforcement Perspectives on the Noerr-Pennington Doctrine.”

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