The Federal Trade Commission recently released a staff report on how the Noerr-Pennington
doctrine should be interpreted in three areas that have important implications for pharmaceutical

The Noerr-Pennington doctrine provides an exemption to the antitrust laws so as to protect the
rights of entities to engage in legitimate efforts to petition the government for redress under the
First Amendment. Noerr-Pennington immunity can be important to pharmaceutical companies
because it may shield certain conduct before the Food & Drug Administration (FDA) or the Patent
and Trademark Office (PTO) that might otherwise be subject to antitrust scrutiny. The FTC report
identifies three areas in which there has been recent dispute over whether Noerr-Pennington
immunity is warranted: 1) requests for ministerial government acts; 2) misrepresentations to
government decision makers in non-political contexts; and 3) repetitive unsuccessful requests for
government action where use of the government process is allegedly solely to suppress

In addressing these three areas, the report relied heavily on the FTC amicus brief in In re
Buspirone Patent Litig./In re Buspirone Antitrust Litig., and the subsequent related FTC
investigation. In In re Buspirone, the plaintiffs alleged that a branded manufacturer fraudulently filed
patents for a branded drug with the FDA in order to prevent generic entry. Under the Hatch-
Waxman Act, the FDA’s listing of those patents in its Orange Book gave the branded manufacturer
the right to trigger a 30-month stay of FDA approvals for rival generics. The FTC’s amicus brief
asserted that the branded manufacturer’s actions were anticompetitive, and were not protected
under Noerr-Pennington because the FDA Orange Book listing was a purely ministerial action.

The FTC report first focuses on the distinction between instances of urging the government to take
action and ministerial circumstances that involve no government discretion. The report takes the
position that Noerr-Pennington does not apply in the latter circumstance since it essentially does
not involve the type of petitioning that is protected by the First Amendment. According to the report,
filing a patent with the FDA is closer to a ministerial circumstance than petitioning conduct because
the applicant is not seeking government action and the FDA does not independently review patents
before listing them.

Second, the FTC report addresses misrepresentations to government decision makers in nonpolitical
contexts. While courts have found that misrepresentations in the political context are
protected under Noerr-Pennington because such statements are not taken as unverified truth and
therefore do not jeopardize the fairness of the government proceeding, the FTC takes the position
that deliberate misrepresentations that interfere with the legitimacy of a governmental proceeding
are not protected under Noerr-Pennington. [See Union Oil Co. of Cal.] Consistent with this view, the
report takes the position that misrepresentations to the PTO and FDA to obtain patents or Orange
Book listings that jeopardize fairness and legitimacy of government proceedings should not be
protected under Noerr-Pennington.

Third, the report discusses repeated filings of meritless lawsuits and invalid and unenforceable
filings with government agencies for the purpose of inhibiting competition. Case law applies a strict
standard for application of the “sham exception” to Noerr-Pennington in cases of a single meritless
lawsuit which is filed to delay or hinder competition. That standard, articulated in Professional Real
Estate Investors, Inc. v. Columbia Pictures Industries, Inc. (PRE), 508 U.S. 49 (1993), requires that
a lawsuit be “objectively baseless.” The FTC report attempts to distinguishes PRE from circumstances in which a party engages in a series of petitioning conduct. The Commission takes
the position that “a ‘pattern’ exception to Noerr should apply when a party invokes a series of
administrative processes, judicial processes, or a combination thereof, to hinder marketplace
rivals,” and that pattern exception does not require that every filing meet the objectively baseless

The staff’s report and recommendations make clear that the Commission will continue to scrutinize
the use of the Noerr-Pennington doctrine outside the political arena in circumstances in which
competition may be harmed through misrepresentations or the abuse of government process. The
Commission will urge courts to begin their analysis of Noerr protections by determining whether the
conduct in question is petitioning for government action or a mere filing warranting only ministerial
review, with the latter situation not protected by Noerr. Finally, staff will continue to advocate
against Noerr protection for a pattern of meritless petitioning that occurs outside the political arena,
even where the conduct does not meet the “objectively baseless” test. Interpretation of the Noerr-
Pennington doctrine will remain an area of continuing importance to pharmaceutical companies as
their filings before the FDA and PTO continue to be subject to increased scrutiny from the FTC and
other parties.