Sanofi Ruling Makes Getting Drugs on FDA Approved List Trickier

It just got tougher for drugmakers to protect patents listed in the FDA’s “Orange Book” of approved drug products when they don’t explicitly cover medication or methods of use, following a First Circuit ruling in a case against Sanofi.

The U.S. Court of Appeals for the First Circuit on Thursday revived an antitrust suit against Sanofi-Aventis U.S. LLC, requiring the company to face claims that it improperly used the Food and Drug Administration’s patent-listing process to hold off competition.

The opinion provides clarity on what patents are appropriately listed in the Orange Book—and which ones have been providing unfair cover ...