11 F.4th 118
2d Cir.2021Background
- Takeda developed ACTOS (pioglitazone) and listed its original pioglitazone patent in its NDA; that patent expired January 17, 2011.
- Takeda later acquired two combination patents (the ’584 and ’404 patents) covering compositions combining pioglitazone with other agents; those patents expired in 2016.
- In NDA supplements, Takeda represented the combination patents as “claiming” ACTOS; the FDA’s Orange Book initially listed them only as method-of-use patents due to listing limitations.
- Multiple generic firms filed ANDAs; some filed Paragraph IV certifications (seeking to invalidate or avoid the patents) and were sued by Takeda; others filed section viii certifications or relied on the Orange Book listing.
- After a Sandoz citizen petition and Takeda’s response, the FDA required Paragraph IV certifications for ACTOS generics, which plaintiffs say delayed generic entry and kept prices high from 2011–2013.
- The district court denied Takeda’s motion to dismiss; on appeal the Second Circuit held that combination patents do not “claim” a component drug under 21 U.S.C. § 355(b)(1) once the component’s own patent has expired, and plaintiffs need not plead that Takeda’s statutory interpretation was unreasonable to state a monopolization claim.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether a combination patent “claims the drug” under 21 U.S.C. § 355(b)(1) when the combination includes a separately patented active ingredient whose patent expired | Takeda’s combination patents were improperly treated as claiming ACTOS; listing them as drug claims was unlawful and delayed generics | Takeda: any patent that could reasonably be infringed by unauthorized sale of the NDA drug may be listed as “claiming the drug”; industry practice supports that reading | Held: “claims the drug” requires a claim that literally reads on the NDA drug; combination patents do not claim constituent drug after component patent expiration, so Takeda’s listing was improper |
| Whether plaintiffs must plead that Takeda’s statutory interpretation was unreasonable to sustain a monopolization claim under § 2 of the Sherman Act | Plaintiffs: need only plausibly allege market power and that Takeda mislisted patents causing antitrust injury | Takeda: absent an allegation that its interpretation was unreasonable, its conduct cannot be willfully improper and claims must be dismissed | Held: Plaintiffs were not required to allege unreasonableness; willful intent to act suffices and good-faith or arguably reasonable statutory interpretation does not bar a monopolization claim |
Key Cases Cited
- Mercoid Corp. v. Mid-Continent Inv. Co., 320 U.S. 661 (1944) (combination patent does not give monopoly over separate unclaimed components)
- Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336 (1961) (reaffirming that components of a combination patent are not separately protected)
- Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (2012) (FDA’s role in patent listing is ministerial; brands’ descriptions control)
- Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) (claim construction and that claims define patent scope)
- Apotex, Inc. v. Thompson, 347 F.3d 1335 (Fed. Cir. 2003) (patent must contain a product claim that reads on the NDA drug to be listed as claiming the drug)
- Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756 (Fed. Cir. 1997) (patent claiming a metabolite did not claim the parent drug for listing purposes)
- United States v. Grinnell Corp., 384 U.S. 563 (1966) (elements of monopoly under § 2: market power and willful acquisition/maintenance)
- Aspen Skiing Co. v. Aspen Highlands Skiing Corp., 472 U.S. 585 (1985) (benign or good-faith motives do not immunize anticompetitive exclusionary conduct)