Teva ordered to delist Inhaler Patents from FDA Orange Book

In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist five patents from the Food and Drug Administration (FDA)’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the Orange Book). The court held that those patents did not satisfy the requirements for listing in the Orange Book, finding that the patents did not claim the drug or drug product for which the associated New Drug Application (NDA) was submitted, but rather components of a metered inhaler drug delivery device.

Amneal challenges the propriety of listing Teva’s inhaler patents in the Orange Book

The Teva plaintiffs listed five patents (Inhaler Patents) in the Orange Book for its ProAir® HFA Inhalation Aerosol product: US Patent Nos. 8,132,712; 9,463,289; 9,808,587; 10,561,808; and 11,395,889. Under the Hatch-Waxman Act, a patent listed in the Orange Book must (1) “claim[ ] the drug for which the applicant submitted the application,” and (2) be directed to a drug substance (active ingredient) or a drug product (formulation or composition). See 21 U.S.C. § 355(b)(1)(A)(viii)(I). The act authorizes the listing of only three kinds of patents in the Orange Book: drug substance patents, drug product patents, and method of use patents. Id. at § 355(b)(1)(A)(viii).

Teva’s Inhaler Patents relate generally to an inhaler device for delivering the drug. More specifically, the patents claim metered dose inhaler dose counters, including those with an anti-reverse rotation actuator, and methods of assembly thereof. It is undisputed that the Inhaler Patents do not claim the active ingredient, albuterol sulfate, in the reference ProAir® HFA Inhalation Aerosol product.

Amneal filed an Abbreviated New Drug Application (ANDA) with the FDA certifying that its generic version of the ProAir® HFA does not infringe any valid claim of the Inhaler Patents. Teva subsequently filed suit against Amneal for patent infringement, and Amneal counterclaimed, seeking the delisting of the Inhaler Patents from the Orange Book, and alleging federal and state antitrust violations. Teva subsequently filed a motion to dismiss the antitrust and delisting counterclaims. Amneal cross-moved for judgment on the pleadings on the delisting counterclaims. The Federal Trade Commission (FTC) submitted an amicus brief urging the court to order removal of the Inhaler Patents from the Orange Book, and arguing that these improper listings would trigger a 30-month stay, delaying the introduction of competing drug products, such as Amneal’s proposed generic version of the ProAir® HFA.

Court decides that the Inhaler Patents are improperly listed in the Orange Book

The court jointly addressed Teva’s motion to dismiss and Amneal’s cross-motion for judgment on the pleadings.

With respect to delisting, Teva argued that the Inhaler Patents were properly listed in the Orange Book for two reasons. First, § 355(b)(1)(A)(viii)(I) requires that a properly listed patent must claim the drug for which the applicant submitted the application, and Teva argued that the statutory definition of “drug” in 21 U.S.C. § 321(g)(1) was broad enough to cover the Inhaler Patents. Second, Teva argued that under the correct interpretation of 21 U.S.C. § 355, the Inhaler Patents qualify as drug product patents.

The court rejected both of these arguments:

“The Inhaler Patents are directed to components of a metered inhaler device, but do not claim or even mention albuterol sulfate or the ProAir® HFA. The applicant filed an NDA for an albuterol sulfate HFA Inhalation Aerosol. The statutory requirement that each patent ‘claim[] the drug for which the applicant submitted the application’ is not met.”

The court analogized the facts to the First Circuit case, In re Lantus Direct Purchaser Antitrust Litig., in which the First Circuit held that a patent directed to a disposable injector pen device for administering insulin glargine did not claim the drug for which the NDA was submitted. The court further reasoned that a patent claims only the subject matter that it has particularly pointed out as the invention. Therefore, because the patents did not claim albuterol sulfate specifically, they did not “claim the drug” as required for listing in the Orange Book. The court further rejected Teva’s argument that the Inhaler Patents were properly listed as drug product patents, because the patents did not claim the finished dosage form of the approved drug product.

Court allows Amneal’s antitrust counterclaims to proceed

With respect to Amneal’s antitrust counterclaims, Teva first argued that its Inhaler Patents were properly listed in the Orange Book and therefore any antitrust claim based on a purported improper listing should be dismissed.

Teva next argued that even if its Inhaler Patents were improperly listed, there was no cognizable claim for an antitrust violation. In support of its latter argument, Teva cited a 2004 US Supreme Court case, which held that under the Telecommunications Act of 1996, an incumbent local exchange carrier has an obligation to share its telephone network with competitors. Teva argued that the Listing Statute imposes an analogous statutory obligation on a brand drug company to list patents in the Orange Book so that generic drug companies may receive FDA approval, and ultimately compete with brand companies.

Allowing Amneal’s antitrust counterclaims to proceed, the court rejected the application of the 2004 US Supreme Court case cited by Teva, noting that the Telecommunications Act imposed the obligation for local exchange carriers to share their telephone network with competitors, in order to address anticompetitive harm. While Teva argued that the Orange Book Listing Statute was also a regulatory structure designed to address anticompetitive harm, the court noted that Teva offered nothing more than ipse dixit in arguing that the duties imposed by the two doctrines are analogous. The Listing Statute does not address cooperation with competitors; it only specifies information required for submission to the FDA. The court also cited with approval the FTC’s amicus brief, which argued that the 2004 US Supreme Court case cited by Teva is not applicable. This is because Amneal’s counterclaims are not an expansion of antitrust law, the FDA does not directly police the Orange Book, and the statutory amendment to add a delisting counterclaim does not transform a patent enforcement framework into an antitrust regulatory scheme.

The court concluded that the Listing Statute was not a regulatory structure designed to address anticompetitive behavior, and that the judicial delisting remedy alone is not “an effective steward of the antitrust function.” As a result, Amneal’s antitrust counterclaims are not foreclosed.

Pending appeal

Teva appealed the court’s decision to (1) order the delisting of the Inhaler Patents, and (2) find that Amneal’s antitrust counterclaims are viable. The Federal Circuit is set to hear oral arguments in November 2024. A number of parties have filed amicus briefs, including law professors, the FTC, and pharmaceutical companies.

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