Even though the U.S. FTC recently claimed a court victory in its campaign to shut down the listing of device patents for drugs in the FDA’s Orange Book, 80% of the listings targeted in the commission’s first round of warning letters remain in place more than seven months later.
The U.S. FTC’s campaign against the Orange Book listing of patents claiming device components gained momentum when a federal judge in New Jersey ordered Teva Pharmaceuticals USA Inc. to delist five device patents pertaining to its Proair HFA (albuterol sulfate) inhaler.
Buyers challenging patent settlements involving Forest Laboratories LLC’s blood pressure drug, Bystolic (nebivolol), failed to show the deals were illegal pay-for-delay arrangements, the U.S. Court of Appeals for the Second Circuit said in unanimously affirming a lower court’s two-time dismissal of the buyers’ antitrust suit.
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
Life science companies and the Office of the U.S. Trade Representative have not always seen eye to eye on issues such as compulsory licensing, but industry might be supportive of a remark by U.S. Trade Representative Katherine Tai about companies that are provided with anticompetitive breathing by their host governments with noticeable anticompetitive effect.
Real life economics, not functionality, is the standard for determining a relevant antitrust market for distinct versions of a prescription drug, the U.S. Court of Appeals for the Second Circuit said as it schooled a lower court and handed Regeneron Pharmaceuticals Inc. a win in its ongoing litigation with Novartis AG and Vetter Pharma International GmbH over the prefilled syringe market for eye drugs Eylea (aflibercept) and Lucentis (ranibizumab).
What’s the status of the U.S. FTC’s investigation into pharmacy benefit managers’ (PBMs) role in prescription drug prices? Inquiring minds in the Senate really want to know, especially since the investigation began more than 18 months ago. “We urge the FTC to complete its 6(b) study in a timely manner,” 14 senators, led by Sens. Chuck Grassley (R-Iowa) and Maria Cantwell (D-Wash.), wrote in a Jan. 22 letter to FTC Chair Lina Khan.
The U.S. FTC’s policing of Orange Book patent listings begs the question of when, and whether, the FDA will deliver on its commitment to provide more clarity on the types of device patents that can be listed as covering a “drug product.”
Carrying through on a policy it adopted a few months ago to crack down on potentially anticompetitive FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process.
The U.S. FTC put brand drug companies on notice Sept. 14 when the commissioners unanimously voted, 3-0, to issue a policy statement recognizing that improperly listed patents in the FDA’s Orange Book “may constitute an unfair method of competition.”
