FTC Continues to Rage Against Device Patent Listings in the Orange Book

March 27, 2024By Sara W. Koblitz

The FTC appears to be on a mission to cleanse the Orange Book of patents it deems improperly listed.  For the second time in recent years, the FTC has filed an Amicus Brief explaining exactly which patents should not be in the Orange Book.  Last time, back in 2022, the FTC took on REMS patents, explaining in litigation between Jazz and Avadel that the listing of REMS patents in the Orange Book is anticompetitive; this time, the FTC is going after device patents.  Late last week, the FTC submitted an Amicus Brief in recent Hatch-Waxman patent litigation in the District Court of New Jersey between Reference Listed Drug holder Teva Branded Pharmaceutical Products R&D Inc. and ANDA applicant Amneal Pharmaceuticals explaining that patents that claim the device constituent of a combination product but do not expressly claim the relevant drug substance should not be listed in the Orange Book.

In a seemingly run of the mill patent suit, Teva sued Amneal for infringement of 5 patents arising from the submission of Amneal’s ANDA referencing Teva’s combination product ProAir HFA NDA in fall 2023.  Those 5 patents, however, all covered the combination product’s device constituent, a Metered Dose Inhaler, rather than the drug constituent, albuterol sulfate.  In accordance with the Hatch-Waxman Amendments, Teva received a routine 30-month stay precluding FDA from approving Amneal’s ANDA for 30 months so that the patent litigation can proceed.  But this litigation coincided with FTC’s recent intervention into antitrust issues in the Orange Book during which the FTC asked 10 sponsors in November 2023, including both Teva and Amneal, to delist device patents.  Seizing on some opportune timing, Amneal, filed a counterclaim against Teva seeking a declaratory judgment of non-infringement and invalidity of all 5 patents, removal of those patents from the Orange Book, and relief from allegedly anticompetitive conduct in violation of state and federal antitrust laws.

On the heels of its pursuit of the eradication of the “improperly listed” patents in the Orange Book—where notably Teva refused to delist its device patents while Amneal complied—the FTC filed an Amicus Brief in the Teva and Amneal litigation.  The Amicus Brief explains that only drug substance, drug product, and method of use patents are to be listed in the Orange Book yet “Teva has triggered a 30-month stay based on inhaler and dose counter device patents that, on their face, are not specific to any FDA-approved drug” (noting that one patent has been listed with 21 different drug products).  Very clearly, the brief states “In the FTC’s view, device patents that do not mention any drug in their claims do not meet the statutory criteria for Orange Book listing, and a device patent that is improperly listed in the Orange Book must be delisted” (emphasis added).  This is plain as day for FTC, which is interesting considering that FDA—the entity responsible for maintaining the Orange Book—has refused to say a word on the subject, which, presumably, is the entire reason FTC has felt the need to intervene in the first place.

In reading this Amicus Brief, it is clear that FTC is not happy with Teva following Teva’s refusal to delist its device patents in response to the FTC’s Fall 2023 “warning letter” (called that by FTC in the Amicus Brief).  Though Teva listed the asserted patents as “drug product” patents, FTC explains that “none of the [patents in suit] mention any drug in their claims, much less the active ingredient in ProAir HFA, albuterol sulfate.”  (FTC also notes that the last expiring patents covering albuterol sulfate expired in 1989.)  Because a “drug product” is defined by regulation as a “Finished dosage form . . . that contains a drug substance,” FTC explains that “only those [patents] that claim the finished dosage form containing the drug substance of the relevant NDA” can be listed.  Teva’s patents do not meet that criterion.  FTC compares Teva’s listed patents to those at issue in the 2020 First Circuit decision in In re Lantus Direct purchaser Antitrust Litigation, where the Court held that device component patents that do not explicitly claim the drug product cannot be listed in the Orange Book.

Unsurprisingly, the brief takes a trip through antitrust laws as well, explaining FTC’s position why such listings are anticompetitive, and, as part of that analysis addresses head-on FDA’s “ministerial role” with respect to the Orange Book.  Indeed, there has been a lot of criticism of FDA for not intervening in Orange Book device patent-listing disputes, but the FTC excuses that because it is not the FDA’s mission to “resolve economic disputes about the coverage of patent claims.”  While that’s not exactly what industry has asked of FDA, framing it that way provides FDA coverage behind its claims that it “’lack[s] the resources, authority, or expertise to police patent claims’ that delay the entry of generic drugs.”  This lets FDA off the hook pretty easily considering that industry has been asking FDA explicitly whether device patents can be listed in the Orange Book for more than 20 years.  Hearing nothing, industry proceeded to list.

Nevertheless, if FDA is not going to get involved—and it appears that it will continue not to—at least FTC is providing industry with the clear guidelines it has been asking for.  And it doesn’t look like FTC is planning to stop policing the Orange Book any time soon.  It would not be surprising if we see more Amicus Briefs from the FTC in Hatch-Waxman patent suits or if FTC starts to take its own enforcement action beyond the request to delist.  FTC’s resolve here—and its clear assertion of its antitrust authority in this space—should serve as a warning to sponsors of combination products to review their Orange Book patent listings.