The financial regulator in the United States has taken action against ten companies accused of improperly listing patents in the FDA’s ‘Orange Book’ with the intention of blocking generic competitors from entering the market. The Federal Trade Commission (FTC) has raised concerns about over 100 patents held by manufacturers of brand-name products such as asthma inhalers, epinephrine autoinjectors, and other pharmaceuticals, disputing their accuracy and relevance.
In a stern warning issued in September, the FTC indicated its readiness to consider legal action against companies engaging in the practice of listing new patents in the Orange Book to trigger mechanisms that delay the introduction of generic alternatives.
The FDA, as per established regulations, is prevented from approving a generic drug for a duration of 30 months if a brand-name drug company initiates a lawsuit against a generic competitor for allegedly infringing on a patent listed in the Orange Book, irrespective of the final outcome of the legal proceedings.
Several prominent pharmaceutical companies have found themselves in the crosshairs of this crackdown, including AbbVie, AstraZeneca, Boehringer Ingelheim, Impax Laboratories, Kaleo, Mylan Specialty (a Viatris unit), and subsidiaries of GSK and Teva. Each of these companies has received notification letters pertaining to the FTC’s actions.
For instance, AstraZeneca is facing challenges concerning patents associated with its asthma inhaler Symbicort, which generated $2.5 billion in sales in the previous year. Other letters have highlighted Boehringer’s $1.6 billion therapy for chronic obstructive pulmonary disease (COPD) named Spiriva and Mylan’s EpiPen products, which brought in $378 million in revenue in 2022 and have been scrutinized for significant price increases in recent years.
The FTC’s Chair, Lina Khan, emphasized the consequences of wrongfully listed patents, stating that they can substantially raise the prices Americans pay for medications and pharmaceutical products while undermining fair and honest competition in the market. She asserted the FTC’s commitment to employing all available tools to safeguard Americans from unlawful business practices that drive up the costs of drugs and pharmaceuticals.
The FTC noted that it is the FDA’s responsibility to issue a statement of dispute to the patent owner, who then has a 30-day window to either withdraw or amend these listings or certify, under penalty of perjury, the validity of the listings.
FDA Commissioner Robert Califf also chimed in, reminding all holders of drug approvals of their obligation to ensure that their patent listings comply with statutory and regulatory requirements and to respond substantively to statements of dispute issued as part of the FDA’s patent listing dispute process.
This move by the FTC signifies an escalating level of scrutiny being directed toward the activities of the pharmaceutical industry. The FTC has adopted a tougher stance on mergers and acquisitions within the sector and initiated investigations into the role of pharmacy benefit managers in the medicines supply chain, further underlining its commitment to regulating the pharmaceutical industry more rigorously.