FTC puts 10 drugmakers on notice for Orange Book patent violations

The US Federal Trade Commission (FTC) is putting teeth into its September warning to pharmaceutical companies that gaming the Orange Book’s patent listing system will no longer be tolerated as a way to protect patents.

The commission notified 10 drugmakers that it is disputing 100 patents they have listed on brand-name inhalers, epinephrine autoinjectors, and other drug products as being improperly or inaccurately listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

FTC is pursuing the issue through the US Food and Drug Administration’s (FDA) patent listing dispute process. Under that process, when a drug product patent is disputed, FDA sends a statement to the New Drug Application (NDA) holder, who then has 30 days to withdraw or amend the listing, or certify under penalty of perjury that the the listings are accurate and comply with regulatory requirements.

“The FDA reminds all NDA holders they are obligated to ensure that patent listings comply with statutory and regulatory requirements and to substantively respond to statements of dispute provided under the FDA’s patent listing dispute process,” FDA Commissioner Robert M. Califf said in the FTC press release. “The FDA will continue its longstanding engagement with FTC to help protect American consumers.”

FTC reserved the option to take further action against the companies, including investigating their conduct as an unfair method of competition under the Federal Trade Commission Act.

The companies on notice include AbbVie, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Impax Laboratories, Kaleo, Mylan Specialty, and subsidiaries of Glaxo-Smith Kline and Teva, according to a statement issued by the FTC.

Some of the targeted products include Boehringer Ingelheim’s Spiriva inhaler, Astra Zeneca’s Symbicort inhaler, AbbVie’s Restasis, Glaxo’s Advair and Flovent, Teva’s ProAir inhalers, Mylan’s EpiPen and EpiPen Jr., Kaleo’s AUVI-Q epinephrine injector, Impax’s Adrenaclick epinephrine injector, and Glaxo Smith Kline’s Arnuity Ellipta and Ventolin HFA inhalers.

The commission detailed its reasoning in letters sent to each manufacturer.

“[P]atents improperly listed in the Orange Book may delay lower-cost generic drug competition. By listing their patents in the Orange Book, brand drug companies may benefit from an automatic, 30-month stay of FDA approval of competing generic drug applications. In addition to delays resulting from such a stay of approval, the costs associated with litigating improperly listed patents may disincentivize investments in developing generic drugs, which risks delaying or thwarting competitive entry,” FTC wrote. “The Supreme Court recognizes that improper Orange Book listings have prevented or delayed generic drug entry since at least the 1990s. Even brief delays in generic competition can reduce patient access to more affordable alternatives and increase costs across the entire health care system.”

The move follows FTC’s October policy statement, which warned of the impending action. The Orange Book requires drug manufacturers to claim the reference drug or the method of use. This protects them from FDA approval of any generic application for 30 months, regardless of any court findings over patent validity or infringement by a competing product.

But according to the FTC, some drugmakers are skirting that requirement, filing patents for products that are not truly unique and may only vary in ways that are materially inconsequential. This is a practice that FTC says protects the product, but also prevents lower-cost generics from freely entering the market.

Last year, the FTC filed an amicus brief in the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals. Jazz alleged that Avadel infringed on its patent for the distribution system of the narcolepsy drug Xyrem under a risk evaluation and mitigation strategy (REMS). Avadel then sought FDA approval of its own narcolepsy drug, Lumryz, and countersued Jazz in an effort to delist the Xyrem distribution patent (known as the ’963 patent) from the Orange Book on the basis that it does not claim Xyrem or a method for using it. In the meantime, the patent infringement suit triggered a 30-month stay on FDA’s approval of Lumryz (RELATED: FTC files amicus brief challenging REMS patent listings in FDA’s Orange Book, Regulatory Focus 14 November 2022).

“The Federal Circuit court eventually held that the patent was improperly listed in the Orange Book and ordered it to be delisted,” FTC Chair Lina M. Khan said in a statement in September. “Following this order, the FDA granted final approval of Avadel’s new drug—nearly 10 months after the original tentative approval. In that intervening period, Jazz continued to rake in monopoly profits and patients were deprived of a potentially superior formulation of a critical narcolepsy drug.”

The FTC action and its supporting policy statement are rooted in the 1984 Hatch-Waxman Act, which encourages generic drug competition and established a approval pathway for timely generic approvals through the abbreviated new drug application (ANDA) process.

As part of the law, brand-name drugmakers must file patent information in the Orange Book. That’s critical because the publication is the basis for identifying and resolving any patent disputes that may arise during the FDA’s generic review and approval process.

Patents cover either the drug itself or its method of use. Any attempt to market a generic before patents expire “triggers an immediate right for the brand company to sue for infringement, which if done timely, generally results in an automatic, 30-month stay of any approval of the generic company’s ANDA or 505(b)(2) application by the FDA,” the FTC policy notes.

But improperly listing a patent limits the ability of generic drugmakers to launch lower-cost competing products, FTC said.

“Brand drug manufacturers are responsible for ensuring their patents are properly listed,” FTC wrote in the policy statement. “Yet certain manufacturers have submitted patents for listing in the Orange Book that claim neither the reference listed drug nor a method of using it. When brand drug manufacturers abuse the regulatory processes set up by Congress to promote generic drug competition, the result may be to increase the cost of and reduce access to prescription drugs.”

FTC Statement

FTC puts 10 drugmakers on notice for Orange Book patent violations

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