Orange Book Archives

Transparency Is the Best Medicine: Device Parts Don’t Justify Orange Book Listing

by Amit Kumar Saha, PhD | Jan 9, 2025 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s delisting of patents from the Orange Book because the patent claims did not “claim the drug that was approved” or the active ingredient of the drug that was approved. Teva Branded Pharmaceutical Products R&D, Inc., et al. v. Amneal Pharmaceuticals of New York, LLC, et al., Case No. 24-1936 (Fed. Cir. Dec. 20, 2024) (Prost, Taranto, Hughes, JJ.)

Teva owns the product that Amneal sought to delist, ProAir® HFA Inhalation Aerosol. The ProAir® HFA combines albuterol sulfate (the active ingredient) with a propellant and an inhaler device to administer the drug. Although the US Food and Drug Administration (FDA) approved Teva’s ProAir® HFA as a drug, the ProAir® HFA contains both drug and device components (the device components being the physical machinery of the inhaler). Teva lists nine nonexpired patents in the Orange Book for its ProAir® HFA.

Amneal filed an abbreviated new drug application (ANDA) seeking approval to market a generic version of the ProAir® HFA that uses the same active ingredient. Amneal asserted that it did not infringe Teva’s nine patents listed for the ProAir® HFA. Teva sued for infringement of six of those patents. Amneal filed counterclaims for antitrust and for a declaratory judgment of noninfringement and invalidity and sought an order requiring Teva to delist the five patents that it asserted against Amneal. Amneal moved for judgment on the pleadings on the ground that Teva improperly listed the asserted patents. The district court granted Amneal’s motion, concluding that Teva’s patents “do not claim the drug for which the applicant submitted the application.” The district court ordered Teva to delist its patents from the Orange Book. Teva appealed.

On appeal, Teva argued that a patent can be listed in the Orange Book if the claimed invention is found in any part of its new drug application (NDA) product. Teva argued that a patent “claims the drug” if the claim reads on the approved drug (i.e., if the NDA product infringes that claim). Teva also argued that according to the Federal Food, Drug, and Cosmetic Act’s broad definition of the word “drug,” any component of an article that can treat disease meets the statutory definition of a “drug.” With this interpretation, Teva’s patents “claim the drug” as the claim dose counter and canister components of the ProAir® HFA.

The Federal Circuit rejected Teva’s interpretation as overbroad because it would allow the “listing of far more patents than Congress has indicated.” The Court rejected Teva’s argument that a patent claiming any component of a drug is listable, explaining that Teva cannot list its patents just because they claim the dose counter and canister parts of the ProAir® HFA.

The Federal Circuit also rejected Teva’s argument that even if Teva’s statutory arguments were rejected, the Federal Circuit must remand the case to the district court to construe the claims. In doing so, the Court rejected Teva’s interpretation of the word “claims” in the listing and counterclaim/delisting provisions, [...]

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Patent Law Principles Apply to Claim Scope: Orange Book Delisting and Listing and Regulations

by Benjamin Ediger, Ph.D. | Mar 9, 2023 | Patents

The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method of use. Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Case No. 23-1186 (Fed. Cir. Feb. 24, 2023) (Lourie, Reyna, Taranto, JJ.)

Jazz Pharmaceuticals holds a new drug application (NDA) for Xyrem, an oral sodium oxybate solution prescribed to help those with certain narcolepsies manage cataplexy. Sodium oxybate itself is no longer covered by patents because it has been used in relation to narcolepsy since the 1960s. For this reason, Jazz built its patent portfolio around Xyrem’s formulation, use and distribution.

Jazz uses a single-pharmacy distribution system for Xyrem, known as a risk evaluation mitigation strategy (REMS). Implementing REMS was a condition of Xyrem’s US Food & Drug Administration (FDA) approval because it mitigates safety risks of dangerous active pharmaceutical ingredients such as sodium oxybate. One of Jazz’s patents is directed to this REMS distribution system. Abbreviated New Drug Application (ANDA) 505(b)(2) NDA (Hybrid NDA) approval is similarly conditioned on implementing a REMS that is sufficiently comparable to any that the NDA holder must implement. The FDA eventually determined that single-pharmacy systems were unnecessary for Xyrem and potentially detrimental.

Avadel submitted a hybrid NDA for a drug that requires only a single nightly dose, unlike Xyrem, which requires a patient to wake up during the night to ingest a second dose. Avadel’s application also proposed a more lenient REMS that utilizes multiple pharmacies. In view of these differences, Avadel believed that it could avoid a lengthy FDA approval process because all of Jazz’s Xyrem Orange-Book-listed patents seemed addressable without making any Paragraph IV certifications. As for the REMS patent, Avadel filed a statement under 21 U.S.C. § 355(b)(2)(B) because the patent was listed as claiming a method of use and Avadel was not seeking approval for the REMS system to which that patent’s claims were directed.

Jazz sued Avadel asserting seven patents, of which the REMS patent was the only Orange-Book-listed patent. Avadel asserted a counterclaim requesting that the district court order Jazz to delist the REMS patent from the Orange Book. The district court subsequently held a Markman hearing finding that the REMS patent’s claims were directed to a system and not a method. The district court granted Avadel’s motion for judgment on the pleadings, finding that the REMS patent did not claim “the drug for which the application was approved” and thus had to be delisted from the Orange Book. Jazz appealed.

Jazz argued that because the FDA permitted the REMS patent to be Orange Book listed, Avadel was prohibited from availing itself of the statutory delisting provision. The Federal Circuit disagreed, concluding that the language of the delisting provision was only concerned with whether a listed patent met the provisions’ conditions at the time of the triggering litigation.

Jazz also argued that there was no evidence that Congress imported patent-law [...]

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An Early Holiday Present for Generics? Legislation Requiring Greater Disclosure by Brands Passes the Senate

by Christopher M. Bruno | Dec 21, 2020 | Patents

Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if enacted, will require brand pharmaceutical companies to submit more information about their innovator products.

Potential Changes to Orange Book Listing Requirements for Non-Biologics Drugs

As part of its current obligations, an innovator product manufacturer must submit to the FDA the patent number and expiration date of any patents that claim the drug or a method of using the drug. The FDA then performs the ministerial function of listing the information in the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book. The Hatch-Waxman Act permits generic manufacturers to file a counterclaim to delist a patent that they believe is improperly listed. Over the years, FDA has issued technical regulations expanding on the requirements, which under statute, are relatively sparse. However, there has been some uncertainty regarding what patents must be listed—especially in the case of drug products with innovative delivery systems.

The Orange Book Transparency Act of 2020, H.R. 1503, seeks to codify certain existing regulations and bring some certainty to the process. First, the Orange Book Act provides greater clarity on the types of patents a brand company must list. Currently, the relevant statutes require submission of patent information for “any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug” that could be asserted based on the manufacture, use, or sale of the drug. The Orange Book Act would alter that language to require submission of patent information for patents that claim the drug substance (active ingredient), the drug product (formulation or composition), or a method of use that is included in the application (i.e., a method of use that corresponds with an approved indication/use code). All other patents—e.g., patents that cover off-label use—must not be listed.

Second, the FDA would be responsible for “specify[ing] any exclusivity period that is applicable,” including the 180-day exclusivity period for first-to-file applicants.

Finally, the Orange Book Act codifies certain existing agency requirements. Under current FDA regulations, brand manufacturers are required to promptly request delisting if they determine that a patent no longer qualifies or its relevant claims are invalidated, and within 14 days if court-ordered. The Orange Book Act would codify the duty on brand manufacturers to remove listed patents within 14 days—rather than “promptly”—when any claim of a listed patent “has been cancelled or invalidated pursuant to a final decision” by the Patent Trial & Appeal Board or a court once it is unappealable. This quick turnaround time of communicating to the public which patents have been found invalid will be key to giving generics an advantage in developing generic products and patents covering branded drug products invalid. The Orange Book Act includes a 30-day period for a brand manufacturer to list a patent after issuance; this requirement mirrors already existing FDA regulations.

While [...]

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Antitrust Liability Risk When Listing Patents in Orange Book

by Noah Feldman Greene | Mar 5, 2020 | Antitrust, Patents

The US Court of Appeals for the First Circuit held that pharmaceutical companies that wrongly list patents in FDA’s Orange Book must prove they acted in good faith to avoid antitrust liability. In re Lantus Direct Purchaser Antitrust Litigation, Case No. 18-2086 (1st Cir. Feb. 13, 2020) (Kayatta, J).

In applying for FDA approval to market new drugs, drug manufacturers must list all patents that “claim” the drug or the method of using the drug in FDA’s “Orange Book.” Listing a patent in the “Orange Book” allows the drug manufacture to trigger an automatic 30-month stay of FDA approval of any application for a competing drug product.

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