AbbVie, AstraZeneca, and GSK are part of the 10 companies now on the Federal Trade Commission’s (FTC) radar as it begins challenging more than 100 patents in the “Orange Book.” The FTC alleges that these businesses erroneously or inaccurately listed items on the FDA-approved products list, intending to hold off competition from generic drugs.
The Orange Book, officially known as the Approved Drug Products with Therapeutic Equivalence Evaluations, is a publicly accessible list of FDA-approved drugs considered safe and effective. Referring to the colour of the cover of the printed document, the Orange Book is essentially a resource clinicians use to find generic equivalents of brand name drugs. However, the FTC notes that an Orange Book listing can serve as a tool to delay the entry of a generic competitor into the market.
The challenged patents span across products like inhalable asthma treatments from AstraZeneca and Boehringer Ingelheim, Mylan’s epinephrine autoinjectors, and AbbVie’s dry eye drug, Restasis. Other notable receivers of the FTC notice letters include Impax Laboratories, Kaleo, and subsidiaries of GSK and Teva Pharmaceutical. The FTC had previously warned the biopharma industry of its intent to scrutinize the Orange Book for improper patent listings back in September.
According to the FTC’s stern six-page policy statement, the onus regarding suitable patent listing in the Orange Book falls on brand drug manufacturers. The FTC cautions that this regulatory process, put in place by Congress to spur generic drug competition, can be misused by manufacturers, inadvertently increasing prescription drug costs and reducing their accessibility.
In conclusion, any interested person may challenge the accuracy or relevance of patent data in the Orange Book under FDA regulations. The FTC is undertaking this challenge within the FDA’s framework, which will promptly notify drug manufacturers. Consequently, companies will have a month to either withdraw or amend their listings or certify that the listings adhere to all applicable laws and regulations. However, the FTC reserves the right to take further action, including investigating their conduct as a potential violation of federal laws, to protect public interest.