Kaleo, Inc.

Pictured: Doorway sign at the FTC building/iStock, Gromit702 The Federal Trade Commission is challenging over 100 patents currently held by the makers of epinephrine autoinjectors, asthma inhalers and other drugs that are “improperly or inaccurately listed” on the FDA’s Orange Book, the regulator announced Tuesday. The FTC has issued letters to 10 drugmakers including AbbVie, AstraZeneca, GSK, Mylan, Boehringer Ingelheim, Impax Laboratories, and Kaleo, as well as subsidiaries of Teva and GSK. According to the FTC, the letters dispute the notifications provided to the FDA and show the specific patents that it has determined are “improperly listed” on the Orange Book—which identifies drug products approved on the basis of safety and effectiveness. The products that are in dispute include multiple asthma treatments and inhalers, including Symbicort, Spiriva, Combivent Respimat, Atrovent HFA, Advair HFA, Flovent HFA, as well as epinephrine injectors EpiPen and EpiPen JR. “Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” FTC Chair Lina Khan said in a statement. “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 FTC notified the FDA that it is disputing the “accuracy or relevance” of the listed information for the patents. This action may require the drugmakers to remove the listing entirely or certify listings comply with specific regulatory requirements. The FDA will also send a statement of dispute to the individual New Drug Application (NDA) holders, who have 30 days to withdraw or amend their listings under penalty of perjury. “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,” Commissioner Robert Califf said in a statement. The move from the FTC comes after issuing a policy statement in October 2023 that stated it would be going after “improper submission” of patents for listing in the Orange Book. The policy statement also notified pharma and manufacturers that the costs associated with challenging patents may be considered improper, which could lead to disinterest in making generic drug products and not allow for more generic alternatives to be available on the market. “Boehringer Ingelheim follows all FDA regulations regarding the listing of patents in the Orange Book, including combination drug-device products such as inhalers. Orange Book listings include not only the drug ingredient but also the drug delivery system such as inhalers, which is criteria set forth by FDA,” a Boehringer Ingelheim spokesperson said in an emailed statement to BioSpace. A Teva spokesperson told BioSpace in an email that the company had received a letter of notification from the FTC and is reviewing it “to determine what the letter entails and any next steps.” The other manufacturers did not immediately respond to the query, though GSK indicated in an email response that it is “aware of the notice.” Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

The US Federal Trade Commission (FTC) has challenged more than 100 patents held by drugmakers and medical device companies that it claims are “improperly listed” in the US Food and Drug Administration’s (FDA) ‘Orange Book’, noting that these could "delay lower-cost generic drug competition, stall drug development and stifle innovation”. The patents in the FDA’s listing of approved products that the agency is contesting the “accuracy or relevance” of are for brand-name asthma inhalers, epinephrine auto-injectors and other drug products. The FTC has so far sent letters to ten companies including, AbbVie, AstraZeneca, Boehringer Ingelheim, Impax Laboratories, Kaleo, Mylan Specialty, and subsidiaries of GSK and Teva. 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.” When the listing of a drug substance or drug product patent is disputed consistent with the applicable FDA regulations, the FDA will send a statement of dispute to the patent holder, who will have 30 days to withdraw or amend these listings or certify under penalty of perjury that they are valid. FDA commissioner Robert Califf, said “The FDA reminds all new drug application 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.” The challenge comes less than two months after the FTC said it would consider taking legal action against companies that improperly list patents in the Orange Book that do not meet the statutory listing criteria. According to the FTC’s policy statement issued in September, costs associated with challenging improperly listed patents can disincentivize investments in developing generic drugs, which could delay or prevent competitive generic alternatives. “Given the enormous profit margins of many branded drugs, even small delays in generic competition can generate substantial additional profits for brand companies at the expense of patients,” the agency noted.

AbbVie, AstraZeneca, and GSK are among the 10 companies now under scrutiny by the Federal Trade Commission, which is cracking down on businesses it says improperly or inaccurately placed items on a list of FDA-approved products as a way to hold off generic competition. The commission on Tuesday said it is challenging more than 100 patents in this “Orange Book,” disputing the accuracy or relevance of the listed patent information. The challenge means that product manufacturers might have to remove their listings. The Approved Drug Products with Therapeutic Equivalence Evaluations is the published list of FDA-approved drugs deemed both safe and effective. It is more commonly called the Orange Book, a reference to the color of the cover of the printed document. This publication may be viewed by anyone, and clinicians can use it to search for generic equivalents to brand name drugs. But an Orange Book listing can also serve as a way keep a generic competitor from reaching the market for a little while longer. When a generic drugmaker files an application seeking product approval before a branded product’s patents have expired, the manufacturer of the branded product can sue for patent infringement. Filing suit grants a 30-month stay of a regulatory approval of the generic product. This stay is intended to give both parties time to resolve the litigation, but the FTC notes that this provision can also be used to delay lower-cost generic alternatives from reaching the market. If a patent’s listings in the Orange Book is improper as defined by the law, that listing may negatively affect competitive conditions, the agency said. The patents challenged by the FTC cover products such as inhalable asthma treatments from AstraZeneca and Boehringer Ingelheim; epinephrine autoinjectors from Mylan; and the AbbVie dry eye drug Restasis. The other companies who received FTC notice letters are Impax Laboratories, Kaleo, and subsidiaries of GSK and Teva Pharmaceutical. The FTC warned the biopharma industry in September that it would be taking a closer look at the Orange Book for improper patent listings. “Brand drug manufacturers are responsible for ensuring their patents are properly listed,” the agency said in its six-page policy statement. “Yet certain manufacturers have submitted patents for listing in the Orange Book that claim neither the reference listed drug nor a method of using it. When brand drug manufacturers abuse the regulatory processes set up by Congress to promote generic drug competition, the result may be to increase the cost of and reduce access to prescription drugs.” Improper Orange Book listings may have distorted the pharma market for decades, the policy statement said. An FTC review of the potential effects of improper Orange Book listings was included in a 2002 study that “identified numerous instances in which the 30-month stay was used to block competition.” Under FDA regulations, any interested individual may dispute the accuracy or relevance of patent information in the Orange Book. The FTC is challenging patents within the FDA’s dispute framework, under which the FDA will notify the drugmakers. That notice gives companies 30 days to withdraw or amend their listings, or alternatively certify that the listings comply with all applicable laws and regulations. But the FTC added that its own letters of notice to the 10 companies indicate that the antitrust regulator retains the right to take further action in the public’s interest, including investigation of their conduct as a violation of federal laws.