FTC’s Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA

The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug and biosimilar competition. In the case, Teva asserts that Amneal’s Abbreviated New Drug Application (“ANDA”) for an asthma inhaler infringes upon five patents it has listed in the FDA’s Orange Book–a challenge that under FDA regulations triggers a 30-month stay of FDA’s approval of the generic inhaler. Amneal’s counterclaims assert that the Teva patents, which relate to the inhaler device and dose counter, rather than the drug itself, were improperly listed and has asked the court for judgment on the pleadings and an order to delist the patents at issue.

The FTC has long expressed concerns about the impact of the Orange Book patent listing process on generic competition. The FTC has characterized improperly listed patents as an abuse of the regulatory system that creates an artificial barrier to entry and prevents lower cost drug alternatives from entering the market, hindering competitive drug pricing and harming the consumer and healthcare system as a whole. The FTC has cited such improper Orange Book listings as actionable conduct in challenging monopolization under Section 2 of the Sherman Act, asserting that the specter of infringement suits by brand drug manufacturers may chill investment in particular therapies.

The FDA’s Orange Book lists all approved drug products, and includes, among other things, information relating to a product’s patent and exclusivity protections. Under the Hatch-Waxman Amendments to the federal Food, Drug, and Cosmetic Act (FDCA), all New Drug Application (NDA) applicants must submit certain information concerning patents that claim either the drug itself—i.e., a drug substance (active ingredient) patent or drug product (formulation or composition) patent— or a method of using the drug. Upon approval, FDA includes such patent information in the Orange Book listing for the drug. The Orange Book puts generic companies on notice of patent protections for brand drugs. Generic companies seeking to file an ANDA must include within their application certifications relating to the patent protections of the brand drug. If a brand company timely sues a generic competitor for infringement of an Orange Book listed patent, this triggers an automatic statutory bar on the FDA’s approval the generic drug for up to 30 months.

In September 2023, the FTC issued a Policy Statement (supported and endorsed by the FDA) on Brand Pharmaceutical Manufacturers’ Improper Listing of Patents in Orange Book[1] warning pharmaceutical companies that they could face legal action if they improperly list patents in the Orange Book and outlined a number of potential enforcement methods for combatting these perceived harms. In November 2023, the FTC issued notice letters to a number of brand drug manufacturers challenging more than 100 patents held by manufacturers of brand-name drugs and drug products as improperly or inaccurately listed in the Orange Book.[2] Among these warning letters were notices to Teva covering, among others, the inhaler device-related patents at issue in the case against Amneal.

The FTC’s amicus brief argues for a narrow interpretation of the types of patents that may be listed in the Orange Book—excluding any patent that is not on its face specific to any FDA-approved drug. The FTC argues that device patents, such as the Teva patents at issue, that do not mention any drug in their claims do not meet the statutory criteria for Orange Book listing. In this case, the FTC notes that the same patents at issue are also listed in the Orange Book entries for 21 other drugs, only some of which contain the same active ingredient as the asthma inhaler that is the subject 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 Food & Com. Workers Loc. 1776 & Participating Emps. Health & Welfare Fund v. Takeda Pharm. Co., 11 F.4^th 118 (2021), in support of its position.

Both brand name and generic pharmaceutical and medical device manufacturers should be aware of these developments. We will continue to monitor the FTC’s high-priority campaign to utilize the FDA’s public comment processes, as well as its authority to enforce the federal antitrust laws to impact competition by generic drug development.

FOOTNOTES

[1] Fed. Trade Comm’n, Policy Statement, “Federal Trade Commission Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book” (Sept. 14, 2023), available here.

[2] See Fed. Trade Comm’n, Press Release, “FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book” (Nov. 7, 2023), available here.