On September 30, 2024, U.S. District Judge Ronnie Abrams adopted the Report and Recommendation of U.S. Magistrate Judge Stewart D. Aaron, certifying two classes—Direct-Purchaser Plaintiffs and End-Payor Plaintiffs (collectively, “Plaintiffs”)—in consolidated antitrust actions against Takeda Pharmaceuticals Co. (“Takeda”). Plaintiffs accuse Takeda of unlawfully inflating the price of its diabetes treatment, Actos (pioglitazone), by delaying the entry of generic alternatives.
The U.S. Food and Drug Administration (“FDA”) regulates the development and introduction of both brand-name and generic drugs in the pharmaceutical industry. Under the Federal Food, Drug, and Cosmetic Act, brand-name drug manufacturers are required to submit a New Drug Application, including “a full list of the articles used as components of such drug” and “a full statement of the composition of such drug,” in order to go to market and to protect their patents. 21 U.S.C. § 355(b)(1). However, generic drug manufacturers follow a simplified process under the Hatch-Waxman Amendments and are only required to file an Abbreviate New Drug Application, which relies on the FDA’s prior safety and effectiveness findings for the appropriate brand-name drug. 21 U.S.C. §§ 355(j)(2)(A)(ii), (iv).
As part of their application, prospective generic drug manufacturers must certify that their product does not violate the brand-name manufacturer’s patents. One type of certification that generic drug manufacturers can make is that the brand-name patent is either invalid or will not be violated by the prospective generic alternative (a “Paragraph IV” certification). Paragraph IV certifications allow the brand-name manufacturer to sue, which triggers an automatic delay in generic approval—and, if the generic manufacturer wins (or is not sued), the generic manufacturer is awarded a 180-day period of market exclusivity as the first generic Paragraph IV applicant.
Plaintiffs allege that Takeda and its co-defendants engaged in anticompetitive and monopolistic conduct by delaying the introduction of generic pioglitazone into the market. Specifically, it is alleged that Takeda unlawfully triggered the 180-day exclusivity period granted to a first generic Paragraph IV applicant, which prevented other generic manufacturers from entering the market. Takeda is further accused of misrepresenting the scope of two newly listed patents to the FDA in an effort to extend its monopoly beyond the expiration of the original patent.
As a result of the delayed market entry for generic alternatives, both pharmaceutical wholesalers (Direct-Purchaser Plaintiffs) and individuals or entities paying for brand-name Actos (End-Payor Plaintiffs) were forced to purchase the higher-priced branded drug, incurring millions of dollars in overcharges.
In January 2024, Plaintiffs filed motions for class certification, which Takeda opposed. After a hearing on July 31, 2024, wherein the Court heard arguments from counsel and testimony from live witnesses, Magistrate Judge Aaron issued his Report and Recommendation advising that both End Payor Plaintiffs and Direct Purchaser Plaintiffs be granted class certification.
Miller Shah LLP is a part of both Direct-Purchaser Plaintiffs’ and End-Payor Plaintiffs’ litigation teams. Updates will be posted to this blog as the matter progresses. The case caption for this action is In re: Actos Antitrust Litigation, Case No. 1:13-cv-09244, in the United States District Court for the Southern District of New York.
The legal team at Miller Shah LLP has significant experience representing class action matters. If you have any questions regarding this subject or this post, please contact Madison Gregg (magregg@millershah.com) or Natalie Finkelman Bennett (nfinkelman@millershah.com). The firm can also be reached toll-free at (866) 540-5505.
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