You are viewing a free summary from Descrybe.ai. For citation checking, legal issue analysis, and other advanced tools, explore our Legal Research Toolkit — not free, but close.

In re Asacol Antitrust Litigation

Citations: 233 F. Supp. 3d 247; 2017 U.S. Dist. LEXIS 127457; 2017 WL 588288Docket: Civil Action No. 15-cv-12730-DJC

Court: District Court, D. Massachusetts; February 9, 2017; Federal District Court

Narrative Opinion Summary

In a complex antitrust class action, Direct Purchasers, comprising several pharmaceutical companies, allege that Warner Chilcott and Allergan engaged in monopolistic practices violating Section 2 of the Sherman Act. The case centers on claims of product hopping and reverse payment settlements designed to obstruct generic competition and maintain monopoly profits for mesalamine-based drugs used to treat ulcerative colitis. The Direct Purchasers argue that Warner Chilcott manipulated the market by transitioning from Asacol to Asacol HD and Delzicol, effectively excluding generic manufacturers. They further allege that Warner Chilcott's settlement with Zydus Pharmaceuticals constituted a reverse payment agreement incentivizing Zydus to delay generic entry, thereby sustaining Warner Chilcott’s monopoly. The court granted and denied parts of the defendants' motion to dismiss, maintaining that antitrust cases should rarely be dismissed before discovery. The court found the product hopping claim regarding Asacol HD insufficient but allowed allegations connected to the broader monopolization scheme to proceed. Additionally, the court examined the standing of Direct Purchasers in asserting reverse payment claims, emphasizing the need for plaintiffs to demonstrate a direct causal link between alleged antitrust violations and their injuries. The outcome of this procedural stage leaves room for further scrutiny into the alleged anticompetitive practices and their impact on market competition and consumer choice.

Legal Issues Addressed

Antitrust Law and Monopolization under Sherman Act Section 2

Application: The Direct Purchasers allege that the Defendants engaged in a monopolization scheme through anticompetitive practices like product hopping and reverse payment agreements.

Reasoning: The Direct Purchasers allege that Warner Chilcott designed Delzicol to obstruct potential generic competition, highlighting differences in inactive ingredients and tablet casing while relying on Asacol's clinical data for Delzicol's FDA approval based on bioequivalence.

Application of Rule 12(b)(6) in Antitrust Cases

Application: The Court applies a two-step inquiry to assess the plausibility of the Direct Purchasers’ claims, emphasizing the rarity of dismissals before discovery in antitrust cases.

Reasoning: The Court noted that in antitrust cases, dismissals before allowing discovery should be rare.

Product Hopping as Anticompetitive Conduct

Application: The Court examines whether the introduction of Asacol HD and Delzicol, combined with the removal of Asacol, constitutes anticompetitive product hopping.

Reasoning: Illegal product hopping occurs when a monopolist introduces a new product and engages in exclusionary conduct that limits market competition.

Reverse Payment Settlements in Antitrust Context

Application: The Direct Purchasers allege that Warner Chilcott and Zydus engaged in a reverse payment settlement delaying generic competition, forming part of an anticompetitive scheme.

Reasoning: The Direct Purchasers argued that Zydus was economically incentivized to choose the no-AG option, as it would yield higher profits due to the absence of competition from Warner Chilcott's authorized generic.

Standing in Antitrust Claims

Application: The Court evaluates whether the Direct Purchasers have standing to bring reverse payment claims by assessing injury, causation, and redressability.

Reasoning: Defendants argue that Direct Purchasers lack standing to claim overcharges for Asacol HD, as they have not shown that the Agreement between Zydus and Warner caused the delay in FDA approval and the subsequent failure to launch a generic Asacol HD before November 15, 2015.