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Louisiana Wholesale Drug Co., Inc. v. Sanofi-Aventis

August 28, 2009


The opinion of the court was delivered by: Hon. Harold Baer, Jr., District Judge


In this action Plaintiff, Louisiana Wholesale Drug Co., Inc. ("LWD" or "Plaintiff"), alleged that Defendants Sanofi-Aventis, Sanofi-Aventi U.S., LLC and Aventis Pharmaceuticals, Inc. (collectively "Defendants" or "Aventis") violated the antitrust laws, specifically, Section 2 of the Sherman Act, 15 U.S.C. § 2, by filing with the Food and Drug Administration ("FDA") a sham Citizen Petition designed to delay approval of a generic version of Defendants' rheumatoid-arthritis drug leflunomide, sold under the name Arava. The case culminated in a jury trial which resulted in a defense verdict after the jury concluded that the Citizen Petition was not "objectively baseless," the first question of the two-pronged test for determining whether the Citizen Petition was protected bythe Noerr-Pennington doctrine or actionable under the so-called "sham exception" thereto. See Professional Real Estate Investors, Inc. v. Columbia Pictures Indus., 508 U.S. 49 (1993) ("PRE"). Following the verdict, LWD moved for a judgment as a matter of law pursuant to Fed. R. Civ. P. 50(b) or, alternatively, for a new trial pursuant to Fed R. Civ. P. 59. For the reasons that follow, LWD's motion is DENIED.


Familiarity with the facts of this litigation, as set forth in prior opinions,*fn1 is presumed and those facts will not be restated at length here. Leflunomide, a drug that combats rheumatoid arthritis, was developed and patented by Aventis under the market name Arava. Aventis produced 10 mg and 20 mg "maintenance doses" of Arava as well as a 100 mg "loading dose."

The Arava label recommends that treatment commence with a "loading dose of one 100 mg tablet per day for 3 days," and the clinical trials that preceded the original FDA approval of Arava included use of the loading dose in the form of a 100 mg tablet. Eventually, Aventis stopped selling the 100 mg loading dose in pharmacies, but made it available to prescribing doctors free of charge.

On the day that Aventis' period of patent exclusivity expired, March 10, 2004, several generic drug makers filed Abbreviated New Drug Applications ("ANDA") to obtain FDA approval to produce generic leflunomide.*fn2 At trial, Mark Gardella, an Aventis employee and member of the company's "Life Cycle Maintenance Group," testified that Aventis learned that generic manufacturers in Canada were producing generic leflunomide in 10 mg and 20 mg maintenance doses, but not the 100 mg loading dose referred to in the Arava label. Trial Transcript ("Tr.") 154. The FDA is required to keep the existence and contents of ANDAs confidential unless and until approved, and thus Aventis could only speculate that in the United States the generic manufacturers would similarly attempt to gain approval to produce the maintenance dose strengths, but not the loading dose.

On March 31, 2005, Aventis filed a Citizen Petition with the FDA that requested that the FDA not approve any ANDA for generic leflunomide unless the ANDA (1) contained "data from in vivo bioequivalence studies confirming that five of [the generic applicant's] proposed 20 mg leflunomide tablets are bioequivalent to one Arava 100 mg tablet"; or (2) sought "approval of 100 mg leflunomide tablets that are bioequivalent to 100 mg Arava tablets." P-Tex 625. The Citizen Petition referenced provisions of the FDCA and its regulations that provide that an ANDA must show that the label of the generic drug matches that of the branded or "reference listed" drug in all material respects. See id. (citing FDCA Section 505(j)(2)(A)(v), 21 U.S.C. § 355(j)(2)(A)(v); 21 C.F.R. §314.94(a)(8)(iv)). The Citizen Petition stated that "omission of the loading dose information [in the generic label] may render the generics less effective than Arava, thereby making the ANDAs unapprovable." Id. The Citizen Petition also noted that while the new drug application ("NDA") for Arava was pending, the FDA rejected a request by Aventis' predecessor to permit five 20 mg tablets to serve as an alternative to the 100 mg tablet loading dose without a showing of bioequivalence. Id. After one of the generic manufacturers, Kali Laboratories, Inc., submitted comments to the Citizen Petition, Aventis responded to the FDA in a letter dated June 10, 2005, that requested that the FDA not permit generic manufacturers to reference in their label a 100 mg tablet that they did not produce. P-TEx. 128.

The FDA denied the Citizen Petition on September 13, 2005, the same day that it approved the ANDAs for six generic manufactures to produce and sell generic leflunomide, including one manufacturer who did so pursuant to an agreement with Aventis to sell an "authorized generic" version of the drug. In denying the Citizen Petition, the FDA noted that Aventis' request for relief "seem[ed] to be based on a false premise," namely that if a generic manufacturer recommended a 100 mg loading dose it must either (1) produce its own 100 mg tablet; or (2) recommend using five 20 mg tablets. P-TEx. 285. Rather, the FDA commented, Aventis "seem[ed] to ignore a third possibility": that a label for generic leflunomide could recommend a loading dose with reference a 100 mg tablet that the generic manufacturer did not itself make. Id. The FDA noted that it is "not uncommon" for makers of brand name drugs, including Aventis, to reference in their labels drugs made by other manufacturers, a procedure that is known as "co-administration." Id.; Tr. 132. The FDA also noted that "there is nothing in the [FDCA] or the regulations that requires an ANDA applicant to seek approval for all available strengths of the [reference listed drug]." Id. Finally, the FDA noted that it would require the "labeling for generic leflunomide products to include the labeling approved for [the reference listed drug], Arava, concerning the use of a 100 mg loading dose." Id.

On August 17, 2007, LWD filed suit on behalf of a class of wholesale drug distributors who alleged they were injured by the delayed entry of generic leflunomide to market that they claimed was the direct result of Aventis' Citizen Petition, an alleged act of monopolization in violation of Section 2 of the Sherman Antitrust Act. The gravamen of LWD's complaint was that the Citizen Petition was merely a "sham" designed to exploit the FDA's citizen petition process to delay approval of generic leflunomide and thereby extend the period of Arava's exclusivity. Aventis countered that the Citizen Petition was protected by the First Amendment and, more specifically, the Noerr-Pennington doctrine, which confers antitrust immunity to acts of petitioning government so long as they are not a "sham." At trial, LWD offered evidence and argument that the relief requested in the Citizen Petition was not only contrary to FDA statutes, regulations, and practices, but also lacked medical or scientific basis. In response Aventis offered evidence to show that the loading dose issue raised by the Citizen Petition had not previously been addressed by the FDA and that the generic manufacturers themselves were unsure about how to address the issue in their ANDAs. After seven days of trial, the jury returned a verdict for Defendants; the jury concluded that LWD had failed to prove that the Citizen Petition was "objectively baseless," the first of two sequential inquiries that must be made to determine whether an act of petitioning is a "sham."


A. Judgment as a Matter of Law

"Judgment as a matter of law is appropriate when 'a party has been fully heard on an issue and there is no legally sufficient evidentiary basis for a reasonable jury to find for that party on that issue.' " Jarvis v. Ford Motor Co., 283 F.3d 33, 43 (2d Cir. 2002) (quoting Fed. R. Civ. P. 50(a)). Thus, in ruling on a motion for judgment as a matter of law, the Court must "consider the evidence in the light most favorable to the party against whom the motion [is] made" and "give that party the benefit of all reasonable inferences that the jury might have drawn in his favor from the evidence." Id. (quoting Tolbert v. Queens College, 242 F.3d 58, 70 (2d Cir.2001)) (internal quotation marks omitted). The Court "cannot assess the weight of conflicting evidence, pass on the credibility of witnesses, or substitute its judgment for that of the jury." Tolbert v. Queens College, 242 F.3d 58, 70 (2d Cir. 2001) (quotation marks and citation omitted).

The Second Circuit has instructed that judgment as a matter of law should not be granted unless:

(1) there is such a complete absence of evidence supporting the verdict that the jury's findings could only have been the result ...

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