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Media Alerts - In re ACTOS End-Payer Antitrust Litigation
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February 11, 2017
  In re ACTOS End-Payer Antitrust Litigation
Headline: Second Circuit Revives Pharmaceutical Antitrust Suit Over Takeda's Diabetes Drug ACTOS

Areas of Law: Patent; Antitrust

Issue Presented: Whether the plaintiffs adequately alleged that Takeda had harmed them by filing false patent descriptions about its diabetes drug ACTOS

Brief Summary: A group of drug purchaser plaintiffs sued Takeda Pharmaceuticals, alleging that it had falsely described two patents regarding its diabetes drug ACTOS, thereby delaying competitors from selling generic versions of the drug and causing them to pay monopoly prices. The United States District Court for the Southern District of New York dismissed their complaint, finding that the drug purchasers had not plausibly alleged that Takeda's allegedly false descriptions caused other generic competitors to delay their entry into the market. The Second Circuit affirmed in part and vacated in part, finding that the causation theory was plausible with respect to one out of the ten generic manufacturers. To read the whole opinion, please visit

Extended Summary: Takeda Pharmaceuticals received a patent for its diabetes drug ACTOS in the 1980s. The patent had an expiration date of January 17, 2011. Importantly, this expiration date marked the earliest point at which generic forms of ACTOS could enter the market. Takeda subsequently filed two more patents for the same drug, both of which had a later expiration date of June 19, 2016. According to the complaint, Takeda falsely represented the type of these patents to the FDA, thereby making it appear as though June 19, 2016 was the date until which generic competitors had to wait to enter the market.

Plaintiffs, purchasers of the drug ACTOS, brought a lawsuit alleging that Takeda's false descriptions of the two later patents to the FDA delayed competitors from offering generic versions of ACTOS on the market, thereby forcing plaintiffs to pay monopoly prices for longer than necessary. The district court dismissed the plaintiffs' claims, finding that plaintiff's complaint failed to adequately plead that the false descriptions had caused the generic competitors to delay entering the market.

The plaintiffs then appealed to the Second Circuit, alleging two theories of causation. The first theory was that Takeda's allegedly false descriptions of the two subsequent patents forced other pharmaceutical companies to file certifications, which triggered an exclusivity period. Plaintiffs claim that but for the false descriptions, other companies would not have filed certifications and no exclusivity period would have arisen. The Second Circuit concluded, however, that the complaint lacked the factual allegations necessary to allege that the other companies even knew Takeda had described the subsequent patents as drug product patents.

For the second theory of causation, Plaintiffs alleged that Takeda's allegedly false descriptions of the two subsequent patents caused FDA to make an announcement that they would not approve an ACTOS ANDA, and that this announcement specifically caused Teva (one of the generic manufacturers) to stall entering the market. The Second Circuit found that this theory of causation was plausible. Accrodingly, the Second Circuit affirmed the dismissal in part, and vacated it in part, explaining that the complaint could go forward specifically on "plaintiffs' theory as to Teva."

Panel: Circuit Judges Jacobs and Livingston; District Judge Rakoff

Argument Date: 09/16/2016

Date of Issued Opinion: 02/08/2017

Docket Number:

Decided: Affirmed in Part and Vacated in Part

Case Alert Author: Alexandra Dobles

Counsel: Steve D. Shadowen, Hilliard & Shadowen LLP for Plaintiffs-Appellants; Rohit K. Singla, Munger, Tolles & Olson LLP for Defendants-Appellees

Author of Opinion: Judge Rakoff

Case Alert Circuit Supervisor:
Emily Gold Waldman

    Posted By: Emily Waldman @ 02/11/2017 05:21 PM     2nd Circuit  

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