FTC challenges more than 100 pharma patents
Commission targets big pharma companies over ‘improper listings’ | Agency argues that alleged inaccuracies may delay lower-cost generic drug competition, stall drug development, and stifle innovation.
The US Federal Trade Commission (FTC) has challenged more than 100 patents owned by companies including AbbVie, AstraZeneca, Boehringer Ingelheim, Impax Laboratories, Kaleo, Mylan, as well as subsidiaries of Glaxo-Smith Kline and Teva.
The commission confirmed the move in a statement released on Tuesday, November 7.
According to the FTC, brand-name asthma inhalers, epinephrine autoinjectors, and other drug products owned by these companies are improperly or inaccurately listed in the US Food and Drug Administration’s (FDA) Orange Book—a listing of drug products approved by the FDA as safe and effective.
When a brand lists a patent in the Orange Book, it may lead to a statutory stay that generally blocks the introduction of competing drug products for 30 months, including lower-cost generic alternatives.
The FTC sent notice letters to the companies, identifying the specific patents that the agency contends are improperly listed.
FTC Chair Lina Khan said: “Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition.
“The FTC’s action…identifies over 100 patents that we believe are improperly listed, affecting products ranging from inhalers to EpiPens. We will continue to use all our tools to protect Americans from illegal business tactics that are hiking the cost of drugs and drug products.”
The commission also disputes the relevance of the listed information for these patents, which may require that the manufacturers remove the listing or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.
FTC: improper listings ‘artificially inflates’ prices
Last month, the FTC issued a policy statement warning that the agency would be scrutinising the improper submission of patents for listing in the Orange Book. The commission contends that improper listings may harm competition from cheaper generic alternatives and keep brand prices artificially high.
According to the FTC, costs associated with challenging improperly listed patents can deter investment in developing generic drugs, which risks delaying or thwarting competitive generic alternatives.
“Delays in generic competition, even if brief, can reduce patient access to more affordable alternatives and increase costs across the entire health care system,” it said.
When the listing of a drug substance or drug product patent is disputed, the FDA will send the statement of dispute to the New Drug Application (NDA) holder who will then have 30 days to withdraw or amend these listings, or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.
Also commenting, FDA Commissioner Robert Califf said: “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.”
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