Novo’s Blockbuster Ozempic Among FTC’s Latest Patent Targets

Blockbusters including Novo Nordisk’s Ozempic and Victoza are among 20 branded drugs the Federal Trade Commission is targeting as it challenges more than 300 “junk patent listings” in the FDA’s registry of approved drugs in an effort to accelerate generic competition.

The FTC on Tuesday sent warning letters to 10 companies and told the US Food and Drug Administration the patents were improperly listed in the FDA’s Orange Book. The patents should be removed from entries for drugs treating diabetes, weight loss, asthma, and COPD, the agency said in a statement.

The targeted patents don’t cover actual inventions or aren’t valid, the FTC has said. The delisting of a patent from the Orange Book would allow generic-drug makers to launch cheaper copies of brand-name drugs without having to wait for a 30-month stay on FDA action that accompanies infringement suits brought over Orange Book-listed patents.

“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina M. Khan said in a statement. The agency, through its delisting efforts, “is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need,” Khan said.

The FTC sent letters to units of AstraZeneca Plc and Novo Nordisk for obesity and type-2 diabetes injectable drugs; of Boehringer Ingelheim International GmbH, GlaxoSmithKline Plc, Novartis AG, and Teva Pharmaceutical Industries Ltd. for inhalers used in treating asthma and chronic obstructive pulmonary disease; and of Amphastar Pharmaceuticals Inc. for a nasal spray treating dangerously low blood-sugar levels in type-1 diabetics.

Each company has 30 days to withdraw or amend the challenged listings, or to “certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements,” the FTC said.

The FTC’s first round of warning letters in November challenged 110 Orange Book listings of 69 unique US patents, implicating 18 products. Kaleo Inc., Amneal Pharmaceuticals Inc.’s Impax Laboratories, and GSK later delisted patents the FTC had targeted. AstraZeneca, Boehringer, and GSK subsequently announced commitments to cap inhaler out-of-pocket costs at $35.

Teva’s listings accounted for nearly 40% of the FTC’s initial 110 targets, but the company wasn’t deterred. In February, it sued India’s Cipla Ltd. seeking to block its proposed copy of Teva’s Qvar RediHaler for allegedly infringing 12 patents for the asthma treatment. Seven of the patents were among the FTC’s November targets.

Two Qvar RediHaler patents that were issued after the FTC’s first round of warnings are among those targeted for delisting in Tuesday’s letters. Patents listed in the Orange Book for four more Teva drugs also are in the agency’s crosshairs.

In the wake of the FTC’s November warnings, some experts said the FDA should play a bigger role in policing companies’ submissions. FDA Commissioner Robert M. Califf said companies holding new drug applications for branded treatments are obligated to ensure patent listings comply with statutory and regulatory requirements. The FDA “will continue to engage with the FTC to identify and address potential efforts to impede competition,” Califf said.

Last September, the FTC voted to adopt a policy statement that would put market participants on notice that the agency intends to scrutinize improper listings in the Orange Book and determine whether those constitute unfair methods of competition in the generic-drugs market.