(CN) – A generic drug maker won the right to exclusively market generic hypertension drugs for six months as part of a congressional incentive program. The D.C. Circuit struck down a Food and Drug Administration policy that diluted those incentives by allowing Merck and other brand-name drug makers to “delist” challenged patents.
The FDA policy was challenged by Teva Pharmaceuticals, maker of a generic version of Merck’s Cozaar and Hyzaar hypertension drugs.
Merck’s exclusive patent rights are set to expire in April, after which Teva claims it’s entitled to a six-month period of marketing exclusivity based on the incentive program.
In some cases, generic drug makers can earn exclusive selling rights by successfully challenging the validity of a brand-name drug maker’s patent. Market exclusivity is the reward for assuming the risks and costs of battling the brand-name drug maker.
But Teva says the FDA’s interpretation of federal law would allow other generic drug makers to sell their approved generic versions right out of the gate, instead of giving Teva the six-month window of exclusivity. This can happen when a brand-name drug maker like Merck asks the FDA to “delist” a challenged patent, “thus purporting to pull the rug from under” the generic challenger, the ruling states.
Teva claims this policy would strip it of the competitive advantage that Congress meant for it to enjoy.
The district court agreed with the FDA’s interpretation, but the D.C. Circuit reversed. The agency’s policy “is inconsistent with, and thus foreclosed by, the statutory scheme,” Judge Stephen Williams wrote, referring to amendments to the Food, Drug, and Cosmetic Act.
“We see nothing in the 2003 amendments … that changes the structure of the statute such that brand companies should be newly able to delist challenged patents, thereby triggering a forfeiture event that deprives generic companies of the period of marketing exclusivity they otherwise deserve,” Williams concluded.
Judge Karen LeCraft Henderson dissented, saying the appeal isn’t ripe for review until the FDA issues its final decision either approving or rejecting Teva’s new drug application.