FTC to Issue Policy Warning Drugmakers Against Improper Patents

September 18, 2023

On Thursday, the FTC voted unanimously (3-0) to issue a policy statement warning pharmaceutical companies that they could face legal action for improperly listing patents in the FDA’s Orange Book in an attempt to stave off competition.

In recent years, drug companies have taken to improperly filing patents in the Orange Book — technically known as “Approved Drug Products With Therapeutic Equivalence Evaluations” — then simultaneously filing patent-infringement lawsuits against encroaching competitors.

Inclusion in the Orange Book automatically buys drugmakers a 30-month stay during which no competitors can enter the market while the companies litigate potential patent infringement.

Once investigated, though, it turns out most of these patents were filed improperly.

In this way, a pharmaceutical company can weaponize the Orange Book to protect monopoly rights to a medical product, even if those monopoly rights are invalid,” said FTC Commissioner Lina M. Kahn during the FTC’s open meeting Thursday.

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