Orange Is The New Black: FTC Targets Improper Patent Listings As Anticompetitive

• Published date: 19 September 2023
• Subject Matter: Antitrust/Competition Law, Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Antitrust, EU Competition , Patent, Food and Drugs Law
• Law Firm: Mintz
• Author: Mr Joseph M. Miller and Sherwet H. Witherington

Nearly a year after announcing the expansion of its Section 5 "standalone authority" (https://www.mintz.com/insights-center/viewpoints/2022-11-14-dose-steroids-chair-khans-ftc-releases-expansive-policy), which encompasses conduct outside the scope of the foundational federal antitrust laws, the FTC voted unanimously to issue a policy statement explaining how its authority applies to the listing of brand-name drug patents in the Food and Drug Administration's (FDA) Orange Book.

On September 14, with support from the FDA, the FTC issued a policy statement warning brand-name drug manufacturers that improper listing of patents in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly known as the Orange Book, could result in legal action by the agency.¹

2023 Policy Statement

After reciting the history and purpose of the Hatch-Waxman Act,² a 1984 law intended to encourage generic drug competition, the policy statement goes on to describe how improper listing of patents may harm competitive conditions in the pharmaceutical industry.³ Specifically, as part of a new drug application (NDA), brand drug companies must provide the FDA with statutorily defined information for any patent that:

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 or has been granted in the application.⁴

In an open meeting discussing the policy statement, Chair Lina Khan asserted "a pharmaceutical company can weaponize the Orange Book to protect monopoly rights to a medical product even if those monopoly rights are invalid," thereby delaying or blocking innovative or generic drugs from entering the market and keeping prices "sky-high".⁶

The policy statement suggests that improper Orange Book listing may have distorted the pharmaceutical market for decades, relying on Supreme Court dicta in Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S⁷ suggesting that brand drug companies were purposefully exploiting the listing process to prevent generic competition. The FTC also relied on its own 2002 study, where the Commission identified instances where the 30-month stay was used to block competition.⁸

Finally, the statement reiterates the FTC's power, under Section 5, to take action against improper listings in the Orange Book that do not meet the statutory requirements. The FTC...