DLA Piper
Teva Branded Pharma. Prods. R&D v. Amneal Pharms. The US District Court for the District of New Jersey, in N.Y., LLC, ordered Teva delist five patents. These patents did not meet the requirements for listing in the Orange Book, as they 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. 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(r) HFA Inhalation Aerosol product: US Patent Nos. The patents listed in the Orange Book are: US Patent Nos. 8,132,712 ; 9,463,289 ; 9,808,587 ; 10,561,808 ; and 11,395,889. According to the Hatch-Waxman Act a patent listed in Orange Book must: (1) “claim
a drug for which applicant submitted the application” and (2) be directed at a drug substance or drug product (formulation, composition or formulation). 21 U.S.C. SS 355(b)(1)(A)(viii)(I). The act allows only three types of patents to be listed in the Orange Book, namely drug substance patents (drug product patents), method of use patents and drug product patents. Id. at SS 355(b)(1)(A)(viii).[ ]Teva’s Inhaler Patents relate generally to an inhaler device for delivering the drug. The patents cover metered dose inhaler dosage counters, such as those with anti-reverse rotation actuators, and methods for assembly thereof. It is undisputed that the Inhaler Patents do not claim the active ingredient, albuterol sulfate, in the reference ProAir(r) HFA Inhalation Aerosol product.
Amneal filed an Abbreviated New Drug Application (ANDA) with the FDA certifying that its generic version of the ProAir(r) HFA does not infringe any valid claim of the Inhaler Patents. Teva sued Amneal a few months later for patent infringement. Amneal counterclaimed by requesting the removal of the Inhaler Patents listed in the Orange Book and alleging federal or state antitrust violations. Teva filed a motion for dismissal of the antitrust counterclaims and delisting claims. Amneal filed a cross-motion for judgment on the pleadings in 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(r) 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, SS 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. SS 321(g),(1) is broad enough to cover Inhaler Patents. Teva argued, secondly, that under the correct reading of 21 U.S.C. SS 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(r) HFA. The applicant filed a NDA for albuterol HFA Inhalation Aerosol. The statutory requirement for each patent to ‘claim
0 the drug for[] which the applicant filed the application’ has not been met.”
The Court compared the facts with the First Circuit case In re Lantus Direct Purchaser Antitrust Litig. in which the First Circuit ruled that a patent directed towards a disposable pen device for administering Insulin glargine didn’t claim the drug that the NDA was for. The court also reasoned that patents only claim the subject matter they have specifically pointed out as their invention. The court rejected Teva’s argument that the Inhaler Patents were properly listed as drug product patents, because they did not claim the finished dosage form of the approved drug product. 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. Teva cited the 2004 US Supreme Court decision that held that an incumbent local exchange carrier is required to share its telephone networks with competitors under the Telecommunications Act of 1996. 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. Teva argued the Orange Book Listing Statute is also a regulatory framework designed to address anticompetitive damage. However, the court noted Teva’s argument that the duties imposed under the two doctrines were analogous was merely ipse dixit. The Listing Statute doesn’t address cooperation with competitors, but only specifies the information required to be submitted to FDA. 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 transform a patent enforcement framework into an antitrust regulatory scheme. 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 will hear oral arguments on November 20, 2024. Amicus briefs have been filed by a number of parties, including law professors and pharmaceutical companies.
