FTC continues to scrutinize Orange Book patent listings

On April 30, 2024, the Federal Trade Commission (FTC) sent its second set of warning letters to 10 companies disputing the accuracy or relevance of more than 300 patents listed in the Food and Drug Administration (FDA)’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication, commonly known as the Orange Book. The patents span 20 different brand name products, including injectable drugs for weight loss and diabetes, asthma and COPD inhalers, and a nasal spray for treating diabetes.

The Federal Food, Drug, and Cosmetic Act requires a company seeking FDA approval of a new drug to include in their new drug application (NDA) any patent that either (1) “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 (2) “claims a method of using such drug for which approval is sought.” (See 21 U.S.C. § 355(b)(1)(A)(viii); see also 21 CFR 314.53). If the drug is approved, the patent information in the NDA is listed in the Orange Book with the drug. By listing patents in the Orange Book, a brand drug company may benefit from an automatic, 30-month stay of FDA approval of competing generic drug applications.

Background

Whether certain patents should be listed in the Orange Book has long been disputed by brand and generic drug manufacturers in court and has been a point of issue for varied stakeholders.

In September 2023, the FTC released a policy statement acknowledging that brand drug manufacturers may be harming generic competition through improper listing of patents in the Orange Book, and putting the market on notice that the FTC intends to scrutinize improper Orange Book listings to determine whether they constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act.

In November 2023, the FTC, using the FDA’s regulatory dispute process, challenged the listing of more than 100 patents that it asserted were improperly listed, including patents related to brand-name asthma inhalers and epinephrine autoinjectors.

The FTC’s April 2024 action, again using the FDA’s regulatory dispute process, expands its campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents in the Orange Book. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need,” said FTC Chair Lina M. Khan.

What types of patents should be listed?

The FTC’s April 30 press release included statements by FDA Commissioner Robert M. Califf, M.D. indicating that there may be more to come on the issue: “It is the responsibility of branded drug manufacturers to ensure that Orange Book submissions contain information only on the types of patents for which information should be submitted to FDA. The FDA will continue to engage with the FTC to identify and address potential efforts to impede competition so that consumers can get access to the medicines they need.” The letters and patents identified by the FTC solidify its position that drug-device patents should not be included in the Orange Book.

The “types of patents for which information should be submitted” by the FDA and FTC is seemingly unclear. In 2003, the FDA advised that a “drug product” for purposes of an Orange Book listing should include drug-device combinations where the finished dosage form includes a drug substance in a device for administration. However, in 2020, FDA solicited comments regarding the type of patent information that should be listed in the Orange Book. The response resulted in comments regarding drug-device patent listings. To date, the FDA has offered no further guidance.

FTC’s position on drug-device patents

The FTC takes the position that certain drug-device patents are non-listable. This is consistent with the FTC’s position in its amicus brief filed in March 2024 in the Teva v. Amneal matter. There, the FTC took the position that, because “drug product” as defined in the Hatch Waxman Act is limited to “a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily in association with one or more other ingredients,” patents claiming devices or device components that are “untethered” from any drug or formulation, are not listable.

What will happen next?

Under the FDA’s regulatory dispute process, and after receiving the FTC’s patent listing dispute communications, the FDA will send the dispute to the brand drug manufacturer who will then have 30 days to withdraw or amend the listings or certify under penalty of perjury that the listing complies with applicable statutory and regulatory requirements. The manner in which brand drug manufacturers proceed will depend on the claims of patents at issue.

Even if delisted, the patents may cover a proposed generic product, and some of the benefits of pursuing all claims during a wave of litigation before the generic drug product is approved and commercialized would be lost.

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