FTC Staff Report on Noerr-Pennington Doctrine Has Implications for Pharmaceutical Antitrust Cases

          by David A. Balto

Last week the FTC issued a staff report on the Noerr-Pennington doctrine, entitled "Enforcement Perspectives on the Noerr-Pennington Doctrine."  The FTC's press release and a link to the full report can be found by clicking here.

I thought there were a few interesting observations related to pharmaceutical antitrust issues:

1.  Ministerial filings:  Not surprisingly, the section on ministerial filings spends a great deal of time discussing the Buspar case, in which the FTC (in a critical amicus brief in the private antitrust case) argues that ministerial filings are not protected by Noerr.  The report gives a fairly complete analysis of the FTC's thinking on the subject.

2.  Pattern of filings:  Many pharmaceutical antitrust cases allege that branded firms engage in a pattern of anticompetitive litigation to delay the entry of generic drugs.  One of the interesting issues is whether there is a separate pattern exception, as suggested by the Second and Ninth Circuits in Primetime 24 and USS-Posco, or whether it is subsumed in the general PRE test.  One drug case that addressed this was the district court opinion in the Hytrin litigation (S.D. Fla. 2004), which did not follow the USS-Posco test.  The FTC suggested it may be wrong to follow the PRE standard when looking at a series of petitions.

3.  Orange Book filings:  Finally, the report recommends that the courts clarify that conduct protected by Noerr does not extend to misrepresentations outside the political arena that meet the standards set forward in the Commission's Unocal opinion.  And what does the FTC give as an example?  "For example to the extent that 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."  In recent Senate hearings there has been testimony that 20 of the past 21 citizen petitions have been rejected by the FDA.

David A. Balto is an antitrust lawyer practicing in Washington D.C.  He advises pharmaceutical manufacturers, retailers and distributors on antitrust issues including distribution, pricing, strategic alliances, mergers and joint ventures.  He is the former Policy Director of the Federal Trade Commission and a frequent author and speaker on pharmaceutical competition issues.