Albuterol sulfate – USA

Albuterol sulfate – USA

On Jun 10, 2024, New Jersey court denied Teva’s motion and granted Amneal’s motion for delisting of patent from Orange Book.



This case arises out of a patent infringement dispute under the Hatch-Waxman Act between Teva and Amneal. Teva holds approved NDA No. 021457 for ProAir® HFA (albuterol sulfate) Inhalation Aerosol (“ProAir® HFA”), and owns certain patents listed in the Orange Book as covering this product: U.S. Patent Nos. 8,132,712 (the “’712 patent”), 9,463,289 (the “’289 patent”), 9,808,587 (the “’587 patent”), 10,561,808 (the “’808 patent”), and 11,395,889 (the “’889 patent”) (collectively, the “Patents at issue” or the “Inhaler Patents”). Amneal has filed ANDA, seeking to make and sell a generic version of ProAir® HFA. After Amneal sent Teva the required notice letter, Teva filed the instant suit. The Amended Complaint asserts claims for patent infringement of the Patents at issue. Amneal filed an Amended Answer to the Amended Complaint asserting twelve counterclaim counts. Counterclaim Counts 1-5 seek declarations ordering Teva to delist the Patents at issue from the Orange Book. Counterclaim Counts 6-9 allege violations of the Sherman Act, and Count 10 alleges a violation of the New Jersey Antitrust Act, N.J.S.A. § 56:9.  The Federal Trade Commission (“FTC”) requested and was granted leave to file a brief as amicus curiae.



Teva moves to dismiss Counterclaim Counts 6-10. The Court first considers the motion to dismiss the antitrust counterclaims. Teva contends that the antitrust counterclaims are premised on two forms of alleged anticompetitive conduct: (1) improper Orange Book listing; and (2) sham litigation.

Teva contends that antitrust law provides no cause of action for improper Orange Book listing. Teva argues that because its patents are properly listed as a matter of law, any claim based on purported improper listing necessarily fails. However, this Court later concludes that Teva’s patents are not properly listed in the Orange Book as a matter of law. This conclusion does not support a Rule 12(b)(6) dismissal of an antitrust claim for improper Orange Book listing.

Teva further argues that even if the Court were to find that the listings are improper, given the Trinko doctrine, “antitrust law does not create a cognizable claim for Amneal based on purported improper listing in any event.” The Supreme Court in Trinko held that traditional antitrust principles do not justify adding a duty to aid competitors. However, the FTC distinguishes Trinko from the instant case, asserting that the FDA’s ministerial role in Orange Book listings differs greatly from the extensive FCC regulation of telecommunications competition described in Trinko. The FTC contends that the judicial delisting remedy does not provide for damages and alone cannot be an effective steward of the antitrust function. The Court finds the FTC’s arguments persuasive and concludes that Teva has failed to demonstrate that Trinko is analogous and forecloses Amneal’s antitrust counterclaims.

Teva also argues that the plain language of the Listing Statute precludes an antitrust claim predicated on improper listing, citing 21 U.S.C. § 355(j)(5)(c)(ii)(II). This statute prevents independent claims for correcting the Orange Book but does not address antitrust claims based on the alleged anticompetitive conduct. Therefore, the Court concludes that the statute does not prohibit the assertion of the antitrust counterclaims.

Lastly, Teva argues that Counterclaim Count 7 for sham litigation in violation of the Sherman Act fails to state a valid claim. Teva’s arguments focus on the improbability of success at trial or summary judgment, which does not suffice to dismiss the claim at the pleading stage. Teva also argues that Counterclaim Count 6 for an anticompetitive scheme fails because the counterclaim components do not state valid claims. However, as the Court has concluded that Amneal has pled viable claims for anticompetitive conduct, Count 6 remains valid.

Therefore, Teva’s Rule 12(b)(6) motion to dismiss the antitrust counterclaims was denied.



Teva moves to dismiss Counterclaim Counts 1-5, while Amneal cross-moves for judgment on the pleadings. Both motions turn on the interpretation of the Listing Statute, specifically 21 U.S.C. § 355(b)(1)(A)(viii), which authorizes the listing of certain patents. The statute allows for the listing of drug substance patents, drug product patents, and method of use patents. Teva contends that the Inhaler Patents are drug product patents properly listed pursuant to § 355(b)(1)(A)(viii)(I).

The Court finds that the Inhaler Patents do not meet the requirement that they claim the relevant drug. The FDA approval letter for NDA No. 021457 identifies the drug as “albuterol sulfate HFA Inhalation Aerosol.” Teva’s Inhaler Patents do not claim this drug but rather claim aspects of the inhaler device. As such, they do not satisfy the statutory requirement for listing in the Orange Book.



Thus, Teva’s motion to dismiss Counterclaim Counts 6-10 is denied. Amneal’s motion for partial judgment on the pleadings as to Counterclaim Counts 1-5 is granted.

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