Sunday, December 1, 2024

Ongoing Drug Clashes Persist as Patent Listings are Targeted in Registry Crackdown

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No company was hit harder by the US Federal Trade Commission’s crackdown on patents listed on the federal registry of approved drugs than Israeli drugmaker Teva Pharmaceutical Industries Ltd.—and few companies have responded as aggressively.

The FTC warned eight companies to pull dozens of improperly listed entries from the US Food and Drug Administration’s Orange Book registry. Their goal: accelerating the approval of cheaper versions of branded drugs, including asthma inhalers and epinephrine autoinjectors. Three companies have pulled most or all of their FTC-targeted listings. But Teva—whose listings accounted for nearly 40% of the FTC’s 110 targets—wasn’t deterred.

The FDA’s Orange Book helps generic-drug makers determine which brand-name drugs can be substituted with safe and effective generic alternatives. But makers of generics have long been concerned about the number and nature of patents that brand-drug makers submit for inclusion. They argue some of the patents may be irrelevant or strategically listed to create hurdles for rivals.

Instead of complying with the federal warnings targeting their questionable Orange Book listings, Teva fired off one of the first disputes asserting patents the FTC marked for delisting. Although Teva’s legal strategy flouts the spirit of the FTC’s challenges, the company is risking little more than the cost of litigation, thanks to US patent law, said Arti Rai, an intellectual property professor at Duke Law School.

The Israeli company on Feb. 16 sued Cipla Ltd., an Indian generic-drugs maker, seeking to block its proposed copy of Teva’s Qvar RediHaler for allegedly infringing 12 patents for the asthma treatment. Seven of the patents are among the FTC’s targets.

Central to Teva’s strategy is an aspect of the Hatch-Waxman Act that’s meant to accelerate access to affordable drugs while still rewarding innovation. In this pharmaceutical peace treaty, generics get a shortcut to market using brand research, while branded drugs score what Rai called an “unusual bonus”—a 30-month stay of FDA approval of generic competition while courts consider infringement claims.

Teva is doing just that.

Having submitted patents for listing in the Orange Book, including two in the first three months of 2023, Teva responded to Cipla’s Jan. 4 notice letter by suing within the 45-day window that triggers the FDA delay. That effectively blocked approval of Cipla’s generic until July 4, 2026, unless Cipla prevails before then.

“In other words, the equivalent of a 30-month preliminary injunction with no requirement to prove, as one ordinarily would, that one’s case has merit,” Rai said. Despite the FDA’s warning, what Teva’s doing is “the sort of thing that any aggressive litigator would do given the structure of the Hatch-Waxman scheme.”

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