GSK, Amneal and Kaleo pull patents from FDA database after FTC challenge

Following the U.S. Federal Trade Commission’s recent crackdown on “improper” patents in the FDA’s Orange Book, at least three drugmakers have made the requested changes.

GSK has removed four patents related to inhaler products Advair, Arnuity, Flovent and Ventolin from the Orange Book after the FTC questioned their legitimacy last month.

The U.S. antitrust watchdog challenged more than 100 patents in the FDA Orange Book, arguing that improper listings can delay generic challengers. The patents targeted by the agency are mainly for drug products that require special delivery devices, such as an inhaler or an injector.

Besides GSK, Amneal’s Impax Laboratories also withdrew two patents on its epinephrine autoinjection AdrenaClick. The eight patents that the FTC targeted for Kaleo’s epinephrine injection Auvi-Q have also been delisted in the FDA’s database.

To explain its decision, GSK cited changes in regulatory policy and case law regarding the proper criteria for listing patents covering drug-device combinations in the Orange Book. Despite the FTC’s challenge, the British pharma giant decided to keep one patent for Arnuity after concluding that the claim remains appropriate.

“None of the five GSK patents challenged by the FTC has delayed or affected in any way the development or entry of generic versions of the products that they cover,” a GSK spokesperson said in a statement to Fierce Pharma. “GSK will continue to review our patent listings and make additional changes as appropriate and as the law develops.”

The Orange Book records patents on branded drugs and serves as a reference for generic manufacturers. If a brand-name pharma company brings a lawsuit asserting infringement, a regulatory stay prevents the FDA from approving that generic drug for 30 months. The FTC argues that some drug developers leverage this dynamic by claiming sham patents to delay competition.

An FTC spokesperson called the Orange Book withdrawals “a big FTC win on patent abuse.” Withdrawing from the Orange Book doesn’t preclude a legal battle once a generic reaches the market, but a patent outside the FDA database won’t trigger the 30-month stay.

“The delays in generics coming to the market that can be caused by these illegal listings raise drug prices on millions of Americans who rely on these medicines,” the FTC spokesperson said.

Meanwhile, the FTC has also challenged patents on AstraZeneca’s blockbuster asthma and COPD inhalation Symbicort, Teva’s ProAir and QVAR inhaler, plus offerings from Boehringer Ingelheim. Four patents for Mylan’s EpiPen and four for AbbVie’s Restasis Multidose eye drop are also in the FTC’s crosshairs.

“We are discussing next steps for the companies that ignored our warning letters and did not remove their patents,” the FTC spokesperson said.

Disputing patents in the Orange Book is only one of several measures that the Biden administration has adopted under the banner of controlling U.S. drug costs. The FTC has increased its scrutiny over Big Pharma’s acquisitions, leading to delays, asset divestitures and deal terminations.

Under the Inflation Reduction Act, Medicare is imposing rebates against 48 drugs whose prices grew faster than inflation. In the coming years, the U.S. government is also slated to directly negotiate drug prices for the first time.