The Federal Trade Commission (FTC) filed an amicus brief on November 20, 2023, addressing the anticompetitive harm resulting from improperly listed patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the “Orange Book.”
The filing is linked to an antitrust lawsuit initiated by Mylan Pharmaceuticals Inc. and other affiliates, alleging that Sanofi-Aventis U.S. LLC and its affiliates have engaged in anticompetitive practices to monopolize the market for injectable insulin glargine, a drug used to treat diabetes. The complaint accuses Sanofi of using the FDA’s Orange Book regulatory process to block and delay Mylan’s generic drug, Semglee, from competing with Sanofi’s branded insulin glargine drug, Lantus.
In its amicus brief submitted in the case, the FTC highlighted that improper Orange Book listings can cause significant competition harm. This includes delaying consumer access to lower-priced competing drugs, potentially saving patients money and offering better access to higher quality medications.
According to the FTC’s brief, when a brand pharmaceutical company lists a patent in the Orange Book, it can lead to a statutory stay of up to 30 months, blocking the introduction of competing drug products, including lower-cost generic alternatives. If this stay is triggered by an improperly filed patent that does not meet the statutory listing criteria, it may unjustly delay consumer access to a competing product. This could reduce prices, improve quality and access, or both. The FTC stressed that even a short delay in competition can have significant consequences for consumers accessing cost-effective medications.
In September, the FTC issued a policy statement warning of increased scrutiny over the improper submission of patents for listing in the Orange Book. The Commission cautioned that improper listings could harm competition from cheaper generic alternatives and keep brand prices artificially high. In November, the FTC notified 10 drug manufacturers of over 100 improperly listed Orange Book patents.
The FTC’s amicus brief was filed in the U.S. District Court for the Western District of Pennsylvania. The Commission vote approving the filing was unanimous (3-0). The Commission does not take a position on Mylan’s allegations.
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