FTC challenges improper patents in FDA’s Orange Book, targeting pharma giants

USA —The United States’ financial regulator, the Federal Trade Commission (FTC), has initiated a crackdown on 10 companies, alleging that they have engaged in improper patent listings in the FDA’s ‘Orange Book’ to obstruct generic competitors.

The FTC is disputing the validity of over 100 patents held by manufacturers of brand-name products, including asthma inhalers, epinephrine autoinjectors, and other pharmaceuticals.

The agency has informed the FDA of its concerns regarding the “accuracy or relevance” of these patents.

This move follows the agency’s September warning that it might take legal action against companies that list new patents in the Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations, to trigger processes that delay the market entry of generic versions.

Under the current regulations, if a brand-name drug firm files a lawsuit against a generic competitor for infringing on a patent listed in the Orange Book, the FDA is automatically prevented from approving a generic drug for 30 months, regardless of the lawsuit’s outcome.

The FTC’s notice letters have been sent to several prominent companies, including AbbVie, AstraZeneca, Boehringer Ingelheim, Impax Laboratories, Kaleo, Viatris unit Mylan Specialty, and subsidiaries of GSK and Teva.

The contested patents cover a range of products, such as inhalable asthma treatments by AstraZeneca and Boehringer Ingelheim, Mylan’s epinephrine autoinjectors, and AbbVie’s dry eye drug Restasis.

For instance, AstraZeneca is facing challenges related to patents for its asthma inhaler Symbicort, which achieved US$2.5 billion in sales last year.

Boehringer’s US$1.6 billion chronic obstructive pulmonary disease (COPD) therapy Spiriva and Mylan’s EpiPen, with US$378 million in 2022 revenues, are also under the FTC’s spotlight due to significant price increases in recent years.

The biopharma industry was warned by the FTC in September that it would intensify its scrutiny of the Orange Book for improper patent listings.

FTC Chair Lina Khan emphasized the impact of wrongly listed patents, stating that they can substantially raise the cost of medicines and undermine fair competition. She vowed to use all available tools to protect Americans from such practices.

The FTC clarified that it is the FDA’s responsibility to send a statement of dispute to the patent owner, who then has 30 days to rectify or remove the listings or provide a sworn statement certifying their validity.

FDA Commissioner Robert Califf also weighed in on the matter, reminding all drug approval holders of their obligation to ensure patent listings comply with statutory and regulatory requirements and respond substantively to dispute statements under the FDA’s patent listing dispute process.

This action by the FTC reflects the agency’s heightened scrutiny of the pharmaceutical industry, which also includes a tougher stance on mergers and acquisitions and investigations into the role of pharmacy benefit managers in the drug supply chain.

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