The U.S. Federal Trade Commission (FTC) issued letters to various medical device companies and drugmakers, including AbbVie, AstraZeneca, and subsidiaries of Glaxo-Smith Kline and Teva, raising concerns about the accuracy and relevance of 110 patents, which could potentially lead to delays in generic competition.
The patents in question, many of which are listed in the Food and Drug Administration’s Orange Book, pertain to approved products such as asthma inhalers and epinephrine autoinjectors, as highlighted by the FTC.
FTC Chair Lina Khan expressed, “Wrongfully listed Orange Book patents by pharma companies can raise drug prices for Americans, harm fair competition, and delay better drugs.”
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She further noted, “Millions of Americans rely on inhalers to control their asthma. And even though some of the most popular inhalers have been on the market for decades, they can still cost patients hundreds of dollars a month.”
The Orange Book serves as a repository for drugs and products that the FDA has confirmed to be safe and effective. However, the FTC contends that some companies improperly list patents in the Orange Book, which can impede the introduction of more affordable generic alternatives.
The FTC said it sent notice letter to 10 companies, including the pharmaceutical companies mentioned above. The others include Boehringer Ingelheim Pharmaceuticals, Impax Laboratories, Kaleo, and Mylan Specialty.
Teva and GSK acknowledged the receipt of these letters, and a spokesperson from Boehringer Ingelheim stated that the company strictly adheres to all FDA regulations for patent listings in the Orange Book.
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Inhalers and EpiPens
In one of the letters addressed to Teva, the FTC challenged 35 patents associated with their inhalers, indicating that they have utilized the FDA’s regulatory process to communicate patent listing disputes with the FDA.
Similar letters were dispatched to Boehringer Ingelheim and GSK, pertaining to 22 and 14 inhaler-related patents, respectively. Mylan, now part of Viatris, received a similar letter concerning eight patents for EpiPens, which are used to treat life-threatening allergic reactions. It is worth noting that Mylan faced public backlash in 2016 when it raised the price of a pair of EpiPens to $600, resulting in legal action and costly settlements.
The FTC informed AstraZeneca that 10 patents related to its Symbicort inhaler, which generated $2.54 billion in revenue for the company in 2022, may have been inaccurately or improperly listed.
AbbVie was notified that the FTC would challenge four patents in the Orange Book related to Restasis Multidose, a product consisting of eye drops used for chronic dry eye.
In September, the FTC had previously warned pharmaceutical companies about potential legal action if they inappropriately listed patents with federal health regulators, emphasizing their commitment to scrutinize such improper listings.
The FTC has highlighted that FDA regulations permit the public to challenge patents in the Orange Book. While the FTC is currently following this process, they reserve the right to take further action against the companies involved.
In response to these challenges, the relevant drugmakers have a 30-day window to either amend or withdraw their patent listings or “certify under penalty of perjury” that the patents are legitimate, as per the FTC’s directives.
Information for this briefing was found via Reuters, Fierce Pharma, and the sources mentioned. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
