Corporate & Securities Law

"Citizen Petition" To FDA Raised Genuine Issues On Sham Exception To Noerr-Pennington Doctrine

By Sheppard Mullin Richter Hampton, LLP

On October 14, 2008, a federal district court in New York denied defendant pharmaceutical companies' motion for summary judgment after finding genuine issues of fact existed as to whether 1) the sham exception to antitrust immunity under the Noerr-Penington doctrine applied to defendants' filing of a Citizen-Petition to the FDA to block the approval of generic drug manufacturers' applications; and 2) defendants' Petition in fact delayed the generic manufacturers' applications.  Louisiana Wholesale Drug Co., Inc. v. Sanofi-Aventis, 2008 WL 4580016 (S.D.N.Y. Oct 14, 2008).

Background

Defendant Aventis Pharmaceuticals, Inc. enjoyed the exclusive right to market Arava, the brand-name version of the rheumatoid-arthritis drug leflunomide, for five years and six months beginning on September 10, 1998.  Aventis marketed 10mg, 20mg, and 100mg versions of Arava.  On March 10, 2004, six generic manufacturers submitted Abbreviated New Drug Applications ("ANDA") to market generic versions of Arava in 10mg and 20mg tablets, but not in 100mg.  On March 31, 2005, one year into the FDA review of the generic manufacturers' ANDA submissions, Defendants Aventis Pharmaceuticals, Inc., Sanofi-Aventis, and Sanofi-Aventi U.S., LLC (collectively "Aventis") filed a Citizen Petition pursuant to Section 505(j) of the Federal Food, Drug, and Cosmetic Act.

Aventis's Petition requested that the FDA withhold final approval of any applicant's ANDA that did not seek approval of a 100mg leflunomide tablet that was bioequivalent to Arava 100 mg or that failed to perform bioequivalence testing to confirm that five of its 20mg tablets were bioequivalent to one 100 mg tablet.  The Petition also requested that an applicant failing to establish either of the above not be permitted to either label its product so as to permit the use of five 20 mg tablets as an alternative to the 100mg, or reference a 100mg tablet that the generic did not manufacture.

Three months after the Citizen Petition was filed, the FDA informed the generic manufacturers that they would not receive final approval before the FDA resolved the issues raised in Avantis's Petition.  Three months later, just under the 180-day limit for the FDA to resolve Citizen Petitions, the FDA denied Aventis's Petition in its entirety.  The ANDAs were all formerly approved on the same day.

Louisiana-Wholesale Drug Company filed a complaint on August 17, 2007 alleging that Avantis violated antitrust law under Section 2 of the Sherman Act, 15 U.S.C. § 2, by filing an objectively baseless ("i.e. sham") Citizen Petition to delay final approval of the ANDAs.  A direct purchaser class ("plaintiffs") was certified by stipulation on April 10, 2008.

Noerr-Pennington Immunity and the Sham Exception

The Noerr-Pennington doctrine provides immunity for conduct aimed at persuading the government of a position even if the conduct interferes with competition; "such conduct is classic petitioning activity protected by the First Amendment and such actions may not be limited by the Sherman Act."  Louisiana Wholesale, at *3 (citing Eastern Railroad Presidents Conference v. Noerr Motor Freight Inc., 365 U.S. 127, 137-38 (1961) and United Mine Workers v. Pennington, 381 U.S. 657 (1965)).  The court explained, however, that such immunity is not absolute and does not protect the filing of "sham litigation."

In Cal. Motor Transp. Co. v. Trucking Unlimited, 404 U.S. 508, 516 (1972), the Supreme Court defined a two-step inquiry into a sham claim exception.  The first step requires that the lawsuit be objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits.  The second step is a subjective component where the court should focus on "whether the baseless suit conceals an attempt to interfere directly with a competitor's business relationships through the use of the governmental process - as opposed to the outcome of that process – as an anticompetitive weapon."  Louisiana Wholesale at *3 (citing Professional Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49, 60-61 (1993).

Aventis moved for summary judgment on the first step, arguing that the petition was objectively reasonable.  The court disagreed, stating "[n]o reasonable pharmaceutical manufacturer could have expected Aventis's Citizen Petition to succeed on the merits because Aventis ignored the law by requesting relief that was contrary to existing law and precedent."

First, the court found with respect to Aventis's demand that generic manufacturers of leflunomide be forced to produce their own 100 mg tablet in order to succeed with their ANDAs, that Aventis knew the FDA had long permitted ANDAs to be approved to market certain, but not all, dosage strengths of a branded drug.  Further, the court found that Aventis knew that the generic maintenance doses would be just as safe and effective as Arava's maintenance doses regardless of whether the generic manufacturers provided their own loading doses.  Second, with respect to Aventis's demand that the generic manufacturers establish bioequivalence between one 100 mg pill and a substitute of five 20 mg pills, the court stated that Aventis knew that establishing bioequivalence between different dosage strengths of the same drug is not required.  Finally, with respect to Aventis's demand that the generic manufacturers should not be permitted to reference Aventis's 100 mg pill in their label, the court noted that Aventis knew that drug manufacturers were permitted under FDA regulations to cross-reference other drugs and dosages because Avantis itself had done so in two instances.

The court concluded that from the record, it was clear Aventis was fully aware that the relief they requested in their Petition was contrary to FDA law and practice.  Thus the court held that Aventis was not entitled to summary judgment on plaintiffs' sham litigation claim because there were genuine issues of fact with respect to Avantis's objective basis for filing the Petition.

Aventis's Argument for Summary Judgment on Causation

The court next turned to Avantis's second ground for summary judgment – that plaintiffs were unable to show that the Citizen Petition in fact delayed the ANDAs.  To show causation, the court stated that plaintiffs were required to demonstrate that the injuries they alleged would not have occurred but for Avantis's antitrust violation.  Avantis argued that there were alternative bases for the delay of ANDA approvals.  First, Avantis argued that the any delay was due to the FDA's "cluster review" of the ANDAs, as evidenced by the approval of all six generic applications a day after the last generic manufacturer agreed to certain toxicity specifications.  Second, Avantis argued that the common deficiencies addressed and amended by the FDA were responsible for any delay, and not the Petition.

The court stated that whether or not the FDA reviewed the six ANDAs in a cluster, it doubted that the FDA would delay approval of one ANDA that was ready in order to await the approval of all ANDAs in a cluster because this would violate FDA regulations and undermine the purpose of cluster review, which is to expedite the introduction of cheaper generic drugs in the marketplace.  Second, the court found that the deficiencies raised after the Petition was filed were only minor issues and could arguably have been approved quickly via "Minor" or "Telephone" amendments either before or after approval pursuant to FDA regulations.  From the record, the court determined that there was nothing else in effect to block the applications and that at a minimum it was a jury question.

Authored by:

John S. Whittaker

(415) 774-2938

jwhittaker@sheppardmullin.com

Full post as published by Antitrust Blog Review on January 08, 2009 (boomark / email).