November 17, 2023

Munger, Tolles & Olson Partner Rohit Singla Discusses the FTC’s Increased Scrutiny of Orange Book Patent Listings and the Potential for Related Litigation

Munger, Tolles & Olson partner Rohit Singla was quoted in a recent article titled “US FTC Delivers on Orange Book Threat,” published by BioWorld. 

The article focuses on the Federal Trade Commission’s recent pledge to crack down on “potentially anticompetitive” patent listings in the Food and Drug Administration’s Orange Book—the FDA’s catalog of approved drug products—and what it calls “improperly or inaccurately listed” patents. 

In addition to protecting legitimate patents, Orange Book listings give generic companies more clarity on the litigation risks associated with developing generic versions of a brand product. Mr. Singla noted that the risk can “be significant for generic companies, which typically sell their copies at a much reduced price compared with the innovator. If a company were found to have infringed a patent after it launched a generic, it would face damages based on the brand’s lost profits,” which could “far exceed any revenue the generic company made on its drug.”

A brand company that timely files a patent infringement action based on an Orange Book-listed patent may get a 30-month stay of FDA approval of a generic. This is to give companies time to litigate potential patent infringement matters before the generic launches, according to the article. However, Mr. Singla noted that patents that are not listed may still be litigated, and generic companies could face huge damages if litigation occurs after their product comes to market.

Read the BioWorld article. (Subscription may be required)