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# Takeda Illegally Extended Actos Patents: Court
- URL: https://www.fdaweb.com/takeda-illegally-extended-actos-patents-court/
- Published: 2021-08-26T12:00:00.000Z
- Updated: 2026-09-14T17:12:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150024

The 2nd Circuit Court of Appeals says Takeda misdescribed Actos patents to FDA for *Orange Book* listings to improperly delay generic versions of its blockbuster diabetes drug Actos (pioglitazone). A three-judge panel affirmed that Takeda’s characterization of its patents was incorrect, and that distributors and health plans could pursue their claims that the company misled them to illegally extend Actos’ patent protection, monopolize the market, and charge higher prices.

*Reuters* [reports](https://www.reuters.com/legal/litigation/takeda-must-face-actos-antitrust-claims-2nd-circuit-says-2021-08-25/?ref=fdaweb.com) that Takeda listed a patent on pioglitazone that expired in 2011 and two patents on combinations with other ingredients that expired in 2016\. The company claimed that the combination patents covered the drug itself and not methods of using Actos that could be carved out. It sued potential generic manufacturers and reached settlements that allowed them to launch their generics in 2012.

Drug distributors and health plans that paid for the branded drug sued Takeda in 2013, saying it illegally delayed generics by misrepresenting that the combination patents were drug patents in the *Orange Book*, preventing the generic companies from launching their products when the active ingredient patent expired in 2011.

A federal district court denied Takeda’s motion to dismiss the case in 2019\. On appeal, the company said it correctly described the combination patents as drug patents because their claims, which outlined the scope of the invention, included the active ingredient and could be infringed by an Actos generic.

The judges said the combination patents don’t claim the drug itself because their claims are “broader than and different from” the scope of Actos, and thus the antitrust claims could continue.