[co-authors: Wan Chieh (Jenny) Lee, and Nicole Ng]

Summary

On June 10, 2024, the District Court for the District of New Jersey ordered Teva to delist five patents from the Orange Book for ProAir® HFA (albuterol sulfate) Inhalation Aerosol. The patents were directed to components of a metered inhaler device and did not claim the active ingredient, albuterol sulfate. The court held that these five patents do not claim the drug because they do not claim the “finished dosage form” of Teva’s product. On June 13, 2024, this ruling was stayed for 30 days pending appeal. All five patents in Teva v. Amneal were identified, among others, in November 2023 in a FTC Warning Letter to Teva relating to ProAir® HFA. Most recently, the FTC opened an investigation into Teva relating to its Orange Book listing of medical device patents. In view of the FTC’s increased focus on Orange Book listed patents, patentees may want to closely monitor this appeal and assess its own Orange Book listings against the continuously evolving standard for listing patents in the Orange Book.

The U.S. District Court for the District of New Jersey’s recent decision in Teva v. Amneal ¹ elaborates on the standard for listing patents in the Orange Book.

The question at issue in Teva was whether Teva properly listed five patents in the Orange Book as covering ProAir® HFA (albuterol sulfate) Inhalation Aerosol.² The provision requiring submission of patent information in the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(b)(1)(A)(viii)(I), provides the following requirements for listing a patent in the Orange Book: 1) the patent must “claim[ ] the drug for which the applicant submitted the application”; and 2) the patent must be directed to a drug substance (active ingredient) or a drug product (formulation or composition).³ The volume around decades-old questions about the standard for listing in the Orange Book has steadily increased over the several months, as evidenced by FTC’s policy statement and its series of warning letters to NDA holders.

Here, the District of New Jersey’s recent decision arises from Amneal’s submission of an ANDA for a product referencing ProAir® HFA, which contained a Paragraph IV certification to the five patents at issue.⁴ It was undisputed that no claim in any of the patents disclosed the active ingredient, albuterol sulfate.⁵ Five patents listed in the Orange Book were only directed to components of a metered inhaler device.⁶ Teva filed suit, alleging infringement of those five patents by Amneal under the Hatch-Waxman Act.⁷

Amneal filed twelve counterclaims: Counterclaim Counts 1-5 sought declarations ordering Teva to delist the five patents; Counterclaim Counts 6-9 alleged violations of the Sherman Act; and Count 10 alleged a violation of the New Jersey Antitrust Act, N.J.S.A. § 56:9.⁸ In response, Teva filed a motion to dismiss the delisting counterclaims, arguing they were premised on erroneous interpretations of Hatch-Waxman’s patent submission provision, and arguing the antitrust counterclaims failed to state a legally cognizable claim for relief.⁹ Amneal filed a motion for partial judgment on Counterclaim Counts 1-5, arguing the five patents do not meet the statutory requirements to be listed in the Orange Book, and asking the court to order Teva to delist the five patents.¹⁰

The FTC weighed in as well, submitting an amicus brief supporting Amneal’s position.¹¹ The FTC took the view that the five patents did not comply with the listing requirements of the Orange Book because they did not mention any drug in their claims.¹² The FTC maintained that the patents, on their face, are not specific to any FDA-approved drug, but nonetheless could trigger the 30-month stay simply because they are listed.¹³ The FTC stated that device patents that do not mention any drug in their claims are improperly listed in the Orange Book, and must be delisted.¹⁴ If a brand manufacturer does not voluntarily delist, it is within the powers of a district court to compel delisting.¹⁵

In an opinion authored by Judge Stanley Chesler, the District of New Jersey held the five patents at issue were improperly listed in the Orange Book for failure to meet the requirements of the patent submission provision of the Hatch-Waxman Amendments, and because they did not claim the finished dosage form.¹⁶

The parties agreed that 21 U.S.C. § 355(b)(1)(A)(viii) authorizes the listing of three kinds of patents: drug substance patents, drug product patents, and method of use patents.¹⁷ Amneal and the FTC contended the patents at issue do not “claim[ ] the drug for which the applicant submitted the application,” albuterol sulfate.¹⁸

In reaching this opinion, the Court found the facts of In re Lantus¹⁹ parallel to the case at hand.²⁰ In Lantus, the First Circuit held that only patents “that claim the drug for which the NDA is submitted should be listed in the Orange Book,” and found the patent at issue in that case improperly listed.²¹ Here, because Teva’s five patents were only directed to components of a metered inhaler device and not albuterol sulfate HFA Inhalation Aerosol, the Court found that the five patents did not claim the drug for which the NDA was submitted.²² Using the First Circuit’s analysis, the Court held the five patents did not meet the statutory requirement that each patent listed in the Orange Book “claim[ ] the drug for which the applicant submitted the application.”²³

There was significant disagreement surrounding the meaning of the statute’s language requiring the patent to “claim[ ] the drug.” Teva argued that “a patent ‘claims’ a product if the patent would be infringed by the product.”²⁴ The Court rejected this argument, finding that “a patent claims only the subject matter that it has particularly pointed out as the invention, and no more.”²⁵ Second, Teva argued the broad definition of “drug” under the Federal Food Drug & Cosmetic Act established the patents are properly listed.²⁶ The Court also rejected this argument, finding the patents still did not claim the approved drug, albuterol sulfate HFA Inhalation Aerosol, even under the FDCA’s expansive definition.²⁷ Finally, Teva argued the five patents were properly listed as “drug product” patents under § 355.²⁸ The Court rejected this argument, because the patents did not claim “the finished dosage form” of the approved drug product.²⁹

The opinion in Teva v. Amneal provides another important data point in the continuously evolving debate on the appropriate standard for listing patents in the Orange Book. Judge Chesler’s opinion stays true to the principles described by the First Circuit in Lantus and provides additional elaboration on the meaning of key terms in the statute. Doubtless, Teva v. Amneal will not be the last word in this important discussion.