FTC’s Marketing campaign Towards Improper Orange Guide Listings Continues with Amicus Temporary in Teva’s Problem of Amneal Bronchial asthma Inhaler ANDA

The Federal Commerce Fee (“FTC”) has filed an amicus transient in Teva Branded Prescribed drugs Merchandise R&D, Inc. v. Amneal Prescribed drugs of New York, LLC to additional the company’s efforts to advertise and defend generic drug and biosimilar competitors. Within the case, Teva asserts that Amneal’s Abbreviated New Drug Utility (“ANDA”) for an bronchial asthma inhaler infringes upon 5 patents it has listed within the FDA’s Orange Guide–a problem that underneath FDA rules triggers a 30-month keep of FDA’s approval of the generic inhaler. Amneal’s counterclaims assert that the Teva patents, which relate to the inhaler system and dose counter, relatively than the drug itself, have been improperly listed and has requested the court docket for judgment on the pleadings and an order to delist the patents at difficulty.

The FTC has lengthy expressed considerations concerning the affect of the Orange Guide patent itemizing course of on generic competitors. The FTC has characterised improperly listed patents as an abuse of the regulatory system that creates a man-made barrier to entry and prevents decrease price drug alternate options from coming into the market, hindering aggressive drug pricing and harming the buyer and healthcare system as an entire. The FTC has cited such improper Orange Guide listings as actionable conduct in difficult monopolization underneath Part 2 of the Sherman Act, asserting that the specter of infringement fits by model drug producers could chill funding particularly therapies.

The FDA’s Orange Guide lists all accredited drug merchandise, and contains, amongst different issues, data regarding a product’s patent and exclusivity protections. Beneath the Hatch-Waxman Amendments to the federal Meals, Drug, and Beauty Act (FDCA), all New Drug Utility (NDA) candidates should submit sure data regarding patents that declare both the drug itself—i.e., a drug substance (energetic ingredient) patent or drug product (formulation or composition) patent— or a way of utilizing the drug. Upon approval, FDA contains such patent data within the Orange Guide itemizing for the drug. The Orange Guide places generic firms on discover of patent protections for model medicine. Generic firms in search of to file an ANDA should embrace inside their utility certifications regarding the patent protections of the model drug. If a model firm well timed sues a generic competitor for infringement of an Orange Guide listed patent, this triggers an automated statutory bar on the FDA’s approval the generic drug for as much as 30 months.

In September 2023, the FTC issued a Coverage Assertion (supported and endorsed by the FDA) on Model Pharmaceutical Producers’ Improper Itemizing of Patents in Orange Guide[1] warning pharmaceutical firms that they might face authorized motion in the event that they improperly record patents within the Orange Guide and outlined various potential enforcement strategies for combatting these perceived harms. In November 2023, the FTC issued discover letters to various model drug producers difficult greater than 100 patents held by producers of brand-name medicine and drug merchandise as improperly or inaccurately listed within the Orange Guide.[2] Amongst these warning letters have been notices to Teva masking, amongst others, the inhaler device-related patents at difficulty within the case in opposition to Amneal.

The FTC’s amicus transient argues for a slender interpretation of the forms of patents which may be listed within the Orange Guide—excluding any patent that isn’t on its face particular to any FDA-approved drug. The FTC argues that system patents, such because the Teva patents at difficulty, that don’t point out any drug of their claims don’t meet the statutory standards for Orange Guide itemizing. On this case, the FTC notes that the identical patents at difficulty are additionally listed within the Orange Guide entries for 21 different medicine, solely a few of which comprise the identical energetic ingredient because the bronchial asthma inhaler that’s the topic of Amneal’s ANDA. The FTC cites favorably the First and Second Circuit opinions in In re Lantus Direct Purchaser Litigation, 950 F.3d 1 (2020) and United Meals & Com. Staff Loc. 1776 & Collaborating Emps. Well being & Welfare Fund v. Takeda Pharm. Co., 11 F.4th 118 (2021), in assist of its place.

Each model identify and generic pharmaceutical and medical system producers ought to concentrate on these developments. We are going to proceed to observe the FTC’s high-priority marketing campaign to make the most of the FDA’s public remark processes, in addition to its authority to implement the federal antitrust legal guidelines to affect competitors by generic drug improvement.


[1] Fed. Commerce Comm’n, Coverage Assertion, “Federal Commerce Fee Assertion Regarding Model Drug Producers’ Improper Itemizing of Patents within the Orange Guide” (Sept. 14, 2023), obtainable right here.

[2] See Fed. Commerce Comm’n, Press Launch, “FTC Challenges Extra Than 100 Patents as Improperly Listed within the FDA’s Orange Guide” (Nov. 7, 2023), obtainable right here.

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