Teva v. Amneal: Orange Book Listing Requirements Under Scrutiny

Patent

by Dennis Crouch

The Federal Circuit is set to hear oral arguments in November 2024 in Teva v. Amneal, No. 24-1936, a case that could significantly impact Orange Book patent listing (and delisting) practices under the Hatch-Waxman Act (formally known as the Drug Price Competition and Patent Term Restoration Act of 1984).  Hatch-Waxman established a framework for generic drug approvals in the United States. It aims to balance incentives for pharmaceutical innovation with mechanisms to facilitate faster generic drug entry, including provisions for challenging patents listed in the FDA’s Orange Book and offering a 180-day exclusivity incentive for first generic entrants.  The Orange Book listing also comes with a powerful 30-month stay — pausing generic entry – if the patentee sues a generic seeking FDA approval.

At issue are five patents related to Teva’s ProAir HFA (albuterol sulfate) Inhalation Aerosol, a metered dose inhaler (MDI) product. The patents claim various aspects of the inhaler device and dose counter, but do not expressly recite the active ingredient albuterol sulfate. Teva listed these patents in the FDA’s Orange Book for ProAir HFA.  The big-money question in the case is whether these device patents are properly listed — recognizing that the Orange Book is particularly for patents that claim either the drug or a method of using the drug.

Amneal filed an Abbreviated New Drug Application (ANDA) for a generic version of ProAir HFA. In the ensuing Hatch-Waxman litigation, Amneal counterclaimed seeking an order requiring Teva to delist the patents from the Orange Book. The U.S. District Court for the District of New Jersey granted Amneal’s motion for judgment on the pleadings and ordered Teva to request removal of the patents from the Orange Book listing for ProAir HFA.

The statute at issue authorizes the innovator company add an Orange Book listing for patents that fit in one of two categories:

(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or

(II) claims a method of using such drug for which approval is sought or has been granted in the application.

21 U.S.C. § 355(b)(1)(A)(viii). A straightforward reading of these two prongs seems to suggest that patents covering an inhaler but not the particular drug would not fit.  But, FDA law is rarely straightforward.

Prior to 2020, the statute was less wordy. The underlined portion of the statute above was added by the Orange Book Transparency Act of 2020 (OBTA).  Prior to that point, it seemed true that the language “claims the drug” would include devices as well. But the 2020 amendment (which added language from FDA regs) further narrows the scope, but it remains unclear whether a delivery mechanism that is part of the approved drug qualifies as a “drug product.”

In Teva, the district court focused on prong I because these were not method of use claims and interpreted the provision as suggested – it requires that the patent explicitly claim an active ingredient, formulation or composition to be listable.  Ergo, since Teva’s patents covering the inhaler do not explicitly claim the ingredient, they are not properly listed in the Orange Book. At least according to the district court.

Teva appealed, and the Federal Circuit stayed the district court’s delisting order pending appeal. The case presents a significant question of statutory interpretation regarding the Hatch-Waxman listing requirements.

Party Briefs:

Briefs Amici:

Teva argues that “claims the drug” should be interpreted consistent with patent law principles, where a patent “claims” a product if it “reads on” that product. Teva contends a patent need not expressly recite an active ingredient to be listable, so long as the generic ANDA product would infringe the patent claims. Teva relies heavily on the Federal Circuit’s decision in Apotex, Inc. v. Thompson, which stated that the “listing decision thus requires what amounts to a finding of patent infringement.” 347 F.3d 1335 (Fed. Cir. 2003).  Of course, that decision comes prior to the OBTA.  In the antitrust context, two circuits have ruled against Teva’s interpretation. In re Lantus Direct Purchaser Antitrust Litigation, 950 F.3d 1 (1st Cir. 2020); United Food & Com. Workers Loc. 1776 v. Takeda Pharm. Co. Ltd., 11 F.4th 118 (2d Cir. 2021).

Teva further argues that the statutory definition of “drug” includes components of a drug product. 21 U.S.C. § 321(g)(1)(D). Since the patents claim components of the ProAir HFA product, Teva contends they “claim the drug” under the statute. Teva also emphasizes that FDA regulates ProAir HFA in its entirety as a drug product, not as a separate drug and device.  Teva also argued that its patents actually do incorporate the active ingredient when properly construed, even if not explicitly recited. This was a key part of Teva’s argument for why the district court erred by skipping claim construction.

Amneal and the FTC as amicus curiae counter that “claims” should be given its ordinary meaning in patent law – to “particularly point[] out and distinctly claim[]” the invention. 35 U.S.C. § 112(b). They argue a patent must expressly recite or require the presence of the specific NDA drug substance to be listable as a drug product patent. Amneal also argues against Teva’s interpretation — arguing that the statute already has a separate infringement prong and that that device patents should not be listable for drug products.

The amicus briefs filed in this case present several key arguments against Teva’s position on Orange Book patent listings. A group of 14 professors of medicine and law (led by William Feldman, Aaron Kesselheim, and Sean Tu) argue that improper listing of device patents in the Orange Book is part of a broader strategy by inhaler manufacturers to delay generic competition. They cite their own research showing that for 39 brand-name inhalers with device patents, these patents extended market protection by a median of 5.5 years beyond the last non-device patent to expire. Patenting Strategies on Inhaler Delivery Devices. CHEST (Aug. 2023). The result is higher prices, lower access and cost-related non-adherence. They cite studies finding that 1 in 6 patients with asthma or COPD reported cost-related non-adherence — leading to >4 million people in the U.S. who limit inhaler use because of cost.

A separate brief filed by 52 professors of law, economics and medicine (led by Mark Lemley) argues that Teva has misstated basic principles of patent law in claiming its device patents “read on” the approved drug product. The brief asserts that under established patent doctrine, a patent “claims” something only if each and every element of the patent claim is present in that thing. It argues Teva’s patents fail this test because they do not mention albuterol sulfate or any drug at all.

Deva Holding, a generic manufacturer, filed an amicus brief in support of Amneal, arguing that non-Orange Book listed patents still have value and can be enforced, just with different timing. Deva contends that Congress intentionally differentiated between listable and non-listable patents, and that any perceived imbalance in the Hatch-Waxman Act should be addressed by Congress, not the courts. The brief provides examples of non-Orange Book patents being successfully asserted by drug companies and argues that listing device patents untethered from the underlying drug would introduce additional problems. Deva also characterizes Teva’s inability to list its device patents as a “self-inflicted injury” resulting from failing to include drug names in the patent claims. Finally, Deva notes that the market for Teva’s ProAir HFA is already genericized, undermining arguments about preserving Teva’s monopoly.

Two industry briefs from AstraZeneca and Sanofi amicus brief argue in favor of listing the device patent.  AstraZeneca argues that the term “claims” in the Hatch-Waxman Act should be given its ordinary patent law meaning of “reads on” — and that a device patent that “read on” the approved combination product, even if it does not explicitly recite the active ingredient.  I.e., “comprising.”  Finally, the Sanofi amicus brief argues that excluding device patents from Orange Book listings would frustrate the purposes of the Hatch-Waxman Act by preventing early resolution of patent disputes.

I mentioned above the FTC’s amicus brief that also argues strongly against Teva’s position on Orange Book patent listings.  If you recall, it was really the FTC that began the strong push toward weakening patent rights in the early 2000s.

The FTC argues that improper Orange Book listings can significantly harm competition and may violate antitrust laws. By listing a patent in the Orange Book, brand companies can block generic competition for 30 months simply by filing a lawsuit, without having to show likely infringement or respond to invalidity assertions. This ability to delay generic entry can be enormously lucrative for brand drugmakers and may deter potential competitors from developing generic products. The FTC also urges the court to enforce the policy choices Congress made in the 2020 OBTA to prevent improper Orange Book listings. The brief argues that in enacting the OBTA, Congress clarified that the protection of the 30-month stay does not extend to every patent that an ANDA product may infringe, but only to specific types of patents listed above in the two prongs.

Teva v. Amneal setup has been brewing for a while, and highlights how the FTC and FDA see the law differently.  At its core, the case asks whether device patents that do not explicitly recite an active ingredient can be properly listed, potentially extending  automatic market exclusivity for branded drugs.