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In re Lipitor Antitrust Litigation

Citations: 46 F. Supp. 3d 523; 2014 U.S. Dist. LEXIS 127877; 2014 WL 4543502Docket: Civil Action No. 3:12-cv-02389 (PGS)

Court: District Court, D. New Jersey; September 12, 2014; Federal District Court

Narrative Opinion Summary

The case involves antitrust claims by direct purchasers against Pfizer and Ranbaxy, focusing on a reverse payment settlement agreement concerning the drug Lipitor. Plaintiffs allege that the agreement included a non-monetary reverse payment, delaying Ranbaxy’s generic entry and resulting in overcharges. This litigation is part of the In Re: Lipitor Antitrust Litigation, transferred to the court in 2012. The case's procedural history includes rulings influenced by the Supreme Court's decision in FTC v. Actavis, which provided clarification on reverse payment settlements. Plaintiffs assert violations of Sections 1 and 2 of the Sherman Act, alleging an unlawful restraint of trade and conspiracy to monopolize. The court evaluates the sufficiency of the complaint under Twombly and Iqbal standards, requiring plausible allegations supported by facts. The analysis involves the determination of whether there was a large and unjustified reverse payment in the settlement. The court notes a failure to adequately plead the monetary value of non-monetary payments, leading to a dismissal of the complaint with prejudice. The decision underscores the complexity of evaluating non-cash payments within the antitrust framework and emphasizes the necessity of a holistic analysis of the settlement agreement.

Legal Issues Addressed

Application of the FTC v. Actavis Decision

Application: The case applies the Supreme Court's standards from FTC v. Actavis to evaluate the legality of the settlement agreement under antitrust principles, focusing on the size and justification of any reverse payments.

Reasoning: The Supreme Court rejected this test, expressing concerns that RPSAs can significantly harm competition... It critiqued the scope-of-the-patent test for prematurely limiting inquiries into patent validity and infringement.

Evaluating Non-Monetary Payments in Antitrust Analysis

Application: The Court considers whether non-monetary payments within the settlement can be valued reliably to determine their antitrust implications.

Reasoning: In antitrust cases involving non-monetary payments, a plaintiff must provide sufficient factual support to establish a reliable cash equivalent.

Pleading Standards under Twombly and Iqbal

Application: The Court assesses the sufficiency of the plaintiffs' complaint under the Twombly and Iqbal standards, requiring plausible claims supported by factual allegations.

Reasoning: Plaintiffs did not meet the requirement to substantiate their claims beyond mere labels and conclusions, as established in Twombly.

Reverse Payment Settlement Agreements and Antitrust Implications

Application: The Court examines whether the alleged reverse payment settlement agreement between Pfizer and Ranbaxy constitutes an antitrust violation by delaying the entry of generic Lipitor into the market.

Reasoning: Plaintiffs argue that the Agreement was a strategic move by Pfizer and Ranbaxy to extend the Lipitor patent until November 30, 2011, preventing the entry of a generic version that would not infringe on existing patents.