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Mere Possibility of Delay by First ANDA Filer Does Not Support Declaratory Judgment Jurisdiction

Client Alert | 2 min read | 09.12.08

In Janssen Pharmaceutica, N.V. et al. v. Apotex, Inc. (No. 2008-1062; September 4, 2008), the Federal Circuit affirms a district court's dismissal of a generic drug manufacturer's (Apotex's) declaratory judgment counterclaims of non-infringement based on the filing of Apotex's Abbreviated New Drug Application ("ANDA"). At issue are patents for the anti-psychotic drug risperidone (Janssen's U.S. Patent Nos. 4,804,663; 5,453,425; and 5,616,587).

Under the Hatch-Waxman Act, a Paragraph IV certification (filed in conjunction with an ANDA) is an act of patent infringement. A second generic drug manufacturer, Teva Pharmaceuticals USA, Inc. ("Teva"), was the first to file a Paragraph IV certification challenging the '425 and '587 patents, which thus entitled it to a 180-day period of market exclusivity for its generic risperidone product, but Teva did not challenge the validity or infringement of the '663 patent. Apotex was the second to file a Paragraph IV certification on the '425 and '587 patents, but, unlike Teva, Apotex later amended its ANDA to challenge the '663 patent. Janssen sued Apotex for infringement of the '663 patent but not for infringement of the '425 and '587 patents. Apotex responded by bringing declaratory judgment counterclaims of noninfringement for the two non-asserted patents. However, because Janssen then provided Apotex with a covenant-not-to-sue with respect to the '425 and '587 patents, the district court found "no case or controversy" with respect to these patents, and granted Janssen's motion to dismiss for lack of subject matter jurisdiction.

Apotex argued that there was a case or controversy based on "three actual and continuing injuries": (i) its asserted inability "to promptly launch its generic risperidone product and compete in the market immediately upon the expiration of the '663 patent;" (ii) that the approval of Apotex's generic risperidone product was "being indefinitely delayed;" and (iii) "its affiliates, suppliers, and downstream customers face patent uncertainty because Janssen's covenant-not-to-sue does not cover them." The Federal Circuit rejects all three arguments. First, the Court concludes that "Apotex's inability to promptly launch its generic risperidone product because of Teva's 180-day exclusivity period is not a cognizable Article III controversy." In reaching this conclusion, the Court distinguished case law cited by Apotex on the basis that Apotex had stipulated to the validity, infringement, and enforceability of the '663 patent. With respect to the indefinite delay argument, the Court rejects it as too speculative to create an actual controversy. Finally, the Federal Circuit determines that the covenant-not-to-sue does in fact protect Apotex's affiliates, suppliers and downstream customers.

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Client Alert | 5 min read | 12.12.25

Eleventh Circuit Hears Argument on False Claims Act Qui Tam Constitutionality

On the morning of December 12, 2025, the Eleventh Circuit heard argument in United States ex rel. Zafirov v. Florida Medical Associates, LLC, et al., No. 24-13581 (11th Cir. 2025). This case concerns the constitutionality of the False Claims Act (FCA) qui tam provisions and a groundbreaking September 2024 opinion in which the United States District Court for the Middle District of Florida held that the FCA’s qui tam provisions were unconstitutional under Article II. See United States ex rel. Zafirov v. Fla. Med. Assocs., LLC, 751 F. Supp. 3d 1293 (M.D. Fla. 2024). That decision, penned by District Judge Kathryn Kimball Mizelle, was the first success story for a legal theory that has been gaining steam ever since Justices Thomas, Barrett, and Kavanaugh indicated they would be willing to consider arguments about the constitutionality of the qui tam provisions in U.S. ex rel. Polansky v. Exec. Health Res., 599 U.S. 419 (2023). In her opinion, Judge Mizelle held (1) qui tam relators are officers of the U.S. who must be appointed under the Appointments Clause; and (2) historical practice treating qui tam and similar relators as less than “officers” for constitutional purposes was not enough to save the qui tam provisions from the fundamental Article II infirmity the court identified. That ruling was appealed and, after full briefing, including by the government and a bevy of amici, the litigants stepped up to the plate this morning for oral argument....

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