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FTC Set To Take Enforcement Action Against Drugmakers Over Orange Book Patent Listings

 
• By Brenda Sandburg

Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.

Orange Book
FTC targets improper patent listings in FDA's Orange Book • Source: Shutterstock

The US Federal Trade Commission may take legal action against brandname drug manufacturers who improperly list patents in the US Food and Drug Administration’s Orange Book and factor this behavior in merger reviews. 

At their 14 September meeting, the three FTC Commissioners voted unanimously to adopt a policy statement that the agency will enforce the law against companies and individuals who wrongly list patents in the Orange Book claiming they cover their products

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