Pharma, you were warned.
Only two months after the Federal Trade Commission (FTC) said it was eyeing a crackdown on “improper” patents listed at the FDA, the agency has filed a challenge against more than 100 patents in the agency’s Orange Book.
The patents cover drugs marketed by the likes of AbbVie, AstraZeneca, Boehringer Ingelheim, GSK and Teva, among other companies, the FTC said in a Tuesday release. In all, the commission has sent letters to 10 companies notifying them of the patent disputes.
The FTC argues “improper” listings in the FDA’s Orange Book—the registry of patents on approved medicines—can throw up hurdles to competition in the drug industry. Specifically, improper patents can trigger regulatory delays for would-be generics challengers and throw up legal hurdles for generics players, the commission says.
Some of the medicines targeted in this crackdown include AbbVie’s Restasis and Viatris’ EpiPen autoinjectors.
As the antitrust agency points out, FDA regulations permit the public to challenge patents in the Orange Book. The FTC is following this process, but it said it’s also reserving the right to lob future actions against the companies involved.
With the challenges, the relevant drugmakers have 30 days to withdraw or amend their patent listings, or “certify under penalty of perjury” that the patents are proper, the FTC said.
The move comes after the FTC in September issued a policy statement warning pharmaceutical companies about “improper” listings in the FDA’s Orange Book.
Meanwhile, the patent play marks just one of the FTC’s biopharma crackdowns as of late. In 2021, the agency said it’d take a closer look at proposed M&A deals in the industry. At the time, the FTC argued a wave of consolidation among drugmakers played a role in rising U.S. drug prices.
On that front, the FTC this year challenged Amgen’s large buyout of Horizon Therapeutics. In a lawsuit, the agency argued Amgen’s history indicated the company might try to “bundle” its existing blockbuster meds with Horizon’s rare disease products in reimbursement talks to gain an advantage in the market.
Amgen fought back, ultimately leading the sides to settle and allow the deal to proceed.