Oral Arguments Preview: Teva v. Amneal Tests Scope of Orange Book Device Patent Listings

Patent

by Dennis Crouch

Today at 2pm Eastern, the Federal Circuit will hear arguments in a case that could significantly shape pharmaceutical patent listing practices under the Hatch-Waxman Act. In Teva v. Amneal (No. 24-1936), the court will consider whether device patents that don’t explicitly recite active drug ingredients can be properly listed in FDA’s Orange Book. William Jay of Goodwin Procter will argue for Teva; Steven Maddox of Procopio will represent Amneal.  The judges are not yet listed for the case, but I expect it will be three judges picked from these six: Chief Judge Moore, Judge Dyk, Judge Prost, Judge Chen, Judge Hughes, or Judge Stark.  (Update: It is judges: Prost, Taranto, and Hughes).

The case centers on several Teva patents related to its ProAir HFA inhaler device and dose counter. After Amneal filed an ANDA for a generic version, it counterclaimed–seeking delisting of these patents from the Orange Book. The N.J. district court granted Amneal’s motion, ordering Teva to delist the patents. The key question on appeal is whether device patents must explicitly claim the active drug ingredient to qualify for Orange Book listing under 21 U.S.C. § 355(b)(1)(A)(viii).  The key benefit to patentees is an automatic 30-month stay of FDA approval that kicks in if the patentee sues a generic ANDA filer. This effectively blocks generic entry during litigation without requiring the patentee to show likelihood of success or irreparable harm as would be needed for a preliminary injunction.

Three key issues are likely to dominate today’s arguments:

  • First, the meaning of “claims the drug” after the 2020 Orange Book Transparency Act amendments. Teva argues this phrase should be interpreted consistent with patent law principles – if the patent “reads on” the drug product, it’s properly listed. Amneal counters that the 2020 amendments clarified that only patents explicitly reciting the active ingredient qualify.
  • Second, the role of the recent claim construction order. Just this week, the district court construed the inhaler patent claims narrowly as not requiring presence of an active drug. I had already assumed that this was the correct construction, but the formal district court opinion nails down that issue. While Amneal suggests this resolves the case, Teva argues in a supplemental filing that the flawed construction doesn’t address the core statutory interpretation question. Expect questions about whether and how this late claim construction impacts the analysis.
  • Third, the policy implications of device patent listings. The FTC and academic amici warn that improper listings delay generic competition, citing studies showing device patents extend market protection by over 5 years. Industry amici argue excluding device patents would frustrate Hatch-Waxman’s goal of early and clear patent dispute resolution.

The panel will likely grapple with several key precedents:

  • In Apotex, Inc. v. Thompson, 347 F.3d 1335 (Fed. Cir. 2003), the Federal Circuit court held (over a Judge Newman dissent) that the Orange Book “listing decision thus requires what amounts to a finding of patent infringement.” The court explained that a patent should be listed if a claim of the patent would be infringed by the commercial sale or use of the drug product. Notably, the court also held that the FDA’s role in listing decisions is purely ministerial – the agency has no duty to screen Orange Book submissions or determine whether listed patents actually claim the drug or method of use. The court deferred to FDA’s interpretation that Congress did not require the agency to police listing decisions. Judge Plager, while concurring, wrote separately to criticize this “poorly conceived administration of the laws” that effectively delegates government power to the self-interested original new drug application filers. However, as noted below, this decision predated the 2020 OBTA amendments which added express language about “drug substance” and “drug product” patents.
  • Another key case is In re Lantus Direct Purchaser Antitrust Litigation, 950 F.3d 1 (1st Cir. 2020) where the First Circuit found that Sanofi’s device patents for an insulin injection pen drive mechanism were improperly listed in the Orange Book, holding that the statute requires the patent to claim the drug for which the NDA was submitted, not merely a component used to administer it. The court rejected Sanofi’s argument that patents on “integral components” of a drug delivery device qualified for listing, explaining that “because the claims of the patent do not mention the drug for which the sNDA was submitted, the patent does not ‘claim the drug,’ and it was improper for Sanofi to have submitted it for listing in the Orange Book.”
  • Finally, the Orange Book Transparency Act of 2020 amended 21 U.S.C. § 355(b)(1)(A)(viii) to specify that listable patents must claim either “a drug substance (active ingredient) patent or a drug product (formulation or composition) patent” or “a method of using such drug.” A key question in the case will be whether this amendment, which essentially codified FDA regulations, was meant to preclude device patent listings that had previously been accepted by the FDA. Teva argues the amendment merely clarified existing law, while Amneal contends it demonstrates Congressional intent to limit Orange Book listings to patents explicitly claiming the drug substance or product.

The Federal Circuit’s decision to stay the district court’s delisting order pending appeal suggests serious questions about the proper interpretation of the statute. Today’s arguments should illuminate whether the court sees this primarily as a straightforward question of statutory construction or a more complex balancing of competing policy goals under Hatch-Waxman.