Sanofi Denies Abuse of FDA's Orange Book

Antitrust attorney Kenneth Racowski was cited in a Global Competition Review article about a case between two pharmaceutical companies over listing a patent in the U.S. Food and Drug Administration's (FDA) Orange Book. Drugmakers whose patents are admitted into the Orange Book can secure a 30-month stay of generic drug applications. In the case, Mylan Pharmaceuticals alleges that Sanofi-Aventis engaged in anticompetitive bundling and abused the FDA's Orange Book to maintain control over the market for injectable insulin.

The Federal Trade Commission (FTC) recently issued a new policy statement that calls for increased scrutiny of the Orange Book, saying that companies that abuse the process violate Section 5 of the FTC Act. Mr. Racowski explained that the policy statement could affect ongoing private litigation by favoring a generic company pursuing antitrust claims.

"FTC enforcement activity against a patent holder in this area, as it often does, will likely lead to private litigation," he said, adding that the policy statement raises the stakes "by suggesting the possibility of individual liability and criminal liability."

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