On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. The Federal Circuit affirmed the district court’s decision that Teva’s patents were improperly listed and must be removed from the Orange Book.[1] The ruling clarifies that the statutory framework for Orange Book listings require listed patents to claim the active ingredient of the approved drug.[2] Patents claiming solely device components of a combination product are not listable in the Orange Book.[3]
Background of the Dispute
The case arose over Teva’s ProAir® HFA, a metered-dose inhaler containing albuterol sulfate, a medication used to treat bronchospasm.[4] Teva had listed nine non-expired patents in the FDA’s Orange Book relating to the ProAir® HFA.[5] The five asserted patents claim physical components of an inhaler, and not the active ingredient (albuterol sulfate).[6]
When Amneal filed an Abbreviated New Drug Application (ANDA) with a paragraph IV certification, Teva sued Amneal for patent infringement under the Hatch-Waxman Act.[7] In response, Amneal filed several counterclaims, including a claim seeking an order requiring Teva to delist the five asserted patents from the Orange Book.[8] The district court concluded that the asserted patents are not directed to the active ingredient—albuterol sulfate—but rather to the metered inhaler device and rejected Teva’s arguments that (1) under the Hatch-Waxman Act a patent claims a drug if the approved drug infringes the patent and (2) the asserted patents are Orange Book listable because the claimed articles are intended for use as a component of ProAir® HFA.[9] The district court ordered Teva to remove the challenged patents from the Orange Book, which the Federal Circuit has now affirmed.[10]
The Court’s Reasoning
- Statutory interpretation
The Federal Circuit explained that a patent that “claims the drug for which the applicant submitted the application” in 21 U.S.C. § 355(b)(1)(A)(viii)(I) does not mean that “the claim could somehow be interpreted to read on the drug.”[11] The Federal Circuit rejected Teva’s argument that a patent claims a drug if the approved drug would infringe the patent.[12] The Federal Circuit clarified that “[w]hether Teva’s [New Drug Application (NDA}] infringes Teva’s patents is separate from the issue of whether those patents actually claim the drug for which Teva submitted the application.”[13] Moreover, the Federal Circuit noted that, contrary to Teva’s assertions, this decision aligns with earlier rulings, such as Apotex and United Food.[14] The Federal Circuit concluded that “Teva’s argument does not acknowledge that claiming and infringement have separate statutory bases and that the listing provision identifies both as separate requirements.”[15] It held that determining whether a patent is properly listed involves considerations of both claiming the drug and reasonably asserting infringement.[16] The Federal Circuit further noted that interpreting the statute provision according to Teva’s interpretation would create statutory redundancy.[17] In this case, the Federal Circuit found that Teva’s patents, which were directed to the inhaler’s device components, did not meet these statutory requirements.[18]
- Orange Book Listable Patents
Turning to the issue of which patents are Orange Book listable, the Federal Circuit dismissed Teva’s argument that these patents were properly listed because they covered the ProAir® HFA device.[19] The Federal Circuit clarified that a patent must specifically claim the active ingredient or its formulation, or an approved method of using the drug, in order to be eligible for listing in the Orange Book.[20] This conclusion is based on the drug regulatory approval pathway, which focuses on the active ingredient.[21] In contrast, the Federal Circuit noted that devices have a distinct approval pathway.[22]
The Federal Circuit rejected Teva’s arguments that (1) this interpretation is inconsistent with the statutory definition of a drug as a component for use in an article to treat disease, and (2) its ProAir® HFA inhaler—a combination product containing both drug and device components—should allow the device-related patents to be listed in the Orange Book.[23] The Federal Circuit noted that “the fact that the FDA approved Teva’s ProAir® HFA combination product as a drug does not make the inhaler’s device parts a drug. They are still devices, just ones present in the product that was approved, in a single application, under the NDA pathway.”[24] Therefore, the Federal Circuit concluded that patent claims directed only to a product device feature, such as the inhaler’s dose counter mechanism, is insufficient.
Lastly, The Federal Circuit dismissed Teva’s request for a remand for the district court to construe the claims of its patents, arguing that they did claim an active ingredient. [25] The Federal Circuit found no need for a Markman hearing in this instance because, even under Teva’s proposed construction, the claims of the asserted patents do not satisfy the statutory requirement of claiming the active ingredient as Teva’s proposed construction merely would require reading the presence of “an active drug” into the claims.[26] The Court explained that a claim requiring “an active drug” is far too broad to particularly and distinctly claim the drug approved in Teva’s product.
Implications for the Pharmaceutical Industry
The decision is significant for both innovator and generic pharmaceutical companies. For innovator companies, the ruling serves as a reminder to carefully review which patents are included in the Orange Book to ensure compliance with the Hatch-Waxman Act’s requirements.
For generic drug manufacturers, this decision provides an opportunity to challenge improper listings that may delay their market entry. Generic drug manufacturers may seek delisting of patents that do not directly claim the active ingredient of a drug to expedite FDA approval as part of their overall strategy for bringing their products to market.
In 2023-2024, the Federal Trade Commission (“FTC”) sent warning letters to numerous pharmaceutical manufacturers for improper or inaccurate listings of patents in the Orange Book, and notified the FDA that it disputes more than 300 Orange Book patents listings across 20 different brand name products. Immediately upon release of the Federal Circuit’s decision, the FTC issued the following statement:
We are pleased the court agreed with the FTC that these improper inhaler patent listings must be wiped from the Orange Book. Removal of junk patent listings is critical to ensuring drugmakers can fairly compete to offer generic drugs at a lower price for consumers. This decision is important not only for lowering asthma inhaler costs, it also sets the stage for removal of junk listings on a range of other critical medications where junk device listings impede competition.
The Federal Circuit’s ruling in Teva v. Amneal clarifies the requirements for Orange Book patent listings under the Hatch-Waxman framework and marks a victory for generic drug developers. In view of the decision and the numerous patents that have been flagged by the FTC, it will be interesting to see if pharmaceutical manufacturers that are on notice will now remove patents from the Orange Book or continue to maintain their listings and await litigation or Federal enforcement actions.
Disclaimer: The information contained in this posting does not, and is not intended to, constitute legal advice or express any opinion to be relied upon legally, for investment purposes or otherwise. If you would like to obtain legal advice relating to the subject matter addressed in this posting, please consult with us or your attorney. The information in this post is also based upon publicly available information, presents opinions, and does not represent in any way whatsoever the opinions or official positions of the entities or individuals referenced herein.
[1] Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of New York, LLC, No. 2024-1936, 2024 WL 5176737 (Fed. Cir. Dec. 20, 2024).
[2] Id.
[3] Id.
[4] Id. at 5.
[5] Id. at 6.
[6] Id. at *7.
[7] Id.
[8] Id.
[9] Id.
[10] Id. As of December 23, 2024, all five of Teva’s patents that are the subject of this decision remain listed in the Orange Book.
[11] Id. at 12.
[12] Id. at 11.
[13] Id.
[14] See id. at 11-12; Apotex, Inc. v. Thompson, 347 F.3d 1335 (Fed. Cir. 2003); and United Food & Commercial Workers Local 1776 v. Takeda Pharmaceutical Co., 11 F.4th 118 (2d Cir. 2021).
[15] Id. at 12.
[16] Id.
[17] Id. at 9.
[18] Id.
[19] Id. at 13.
[20] Id.
[21] Id. at 14.
[22] Id. at 13-14.
[23] Id. at 15.
[24] Id. at 16.
[25] Id. 17.
[26] Id.