FTC Files Amicus Brief Outlining Anticompetitive Harm Caused by Improper Orange Book Listings

The Federal Trade Commission filed an amicus brief to address the anticompetitive harm that stems from improperly listed patents in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”

The Commission’s filing relates to an antitrust case brought by drug manufacturer Mylan Pharmaceuticals Inc. and several other affiliated entities alleging that Sanofi-Aventis U.S. LLC and other affiliated entities have engaged in anticompetitive conduct to monopolize the market for injectable insulin glargine, a drug used to treat diabetes. Mylan alleges Sanofi monopolized the injectable insulin glargine market in part by abusing the FDA’s Orange Book regulatory process. Specifically, Mylan alleges Sanofi delayed and blocked Mylan’s generic drug called Semglee from competing with Sanofi’s branded insulin glargine drug Lantus by improperly listing several drugs in the Orange Book.

In its amicus brief filed in Mylan Pharmaceuticals Inc., et al. v. Sanofi-Aventis U.S. LLC, et al., the FTC explains that improper Orange Book listings, such as those alleged in Mylan’s case, can cause significant harm to competition, including delaying consumer access to a lower-priced competing drug that would save patients money while also potentially offering better access and higher quality medications.

As detailed in the FTC’s amicus brief, when a brand pharmaceutical company lists a patent in the Orange Book it may lead to a statutory stay that blocks the introduction of competing drug products for up to 30 months, including lower-cost generic alternatives. When this stay is triggered by a patent that is improperly filed and does not meet the statutory listing criteria, the stay may improperly delay consumer access to a competing product that might reduce prices, improve quality and access, or both. Given the high cost of many drugs, even a short delay in competition can have enormous consequences for consumers in accessing cost-effective medications, the FTC stated in the brief.

In September, the FTC issued a policy statement which warned that the agency would be scrutinizing the improper submission of patents for listing in the Orange Book. The Commission’s statement warned that improper listings in the Orange Book may harm competition from cheaper generic alternatives and keep brand prices artificially high. In November, the FTC sent letters to 10 drug manufacturers notifying them of more than 100 improperly listed Orange Book patents.

READ MORE