United States DC Circuit

In an action challenging the FDA's policy that would allow not only plaintiff, but all generic manufacturers, to sell their approved losartan potassium products right out of the gate, summary judgment for the FDA is reversed where: 1) there was nothing in the 2003 amendments to the Food, Drug, and Cosmetic Act that changed the structure of the statute such that brand companies should be newly able to delist challenged patents, thereby triggering a forfeiture event that deprived generic companies of the period of marketing exclusivity they otherwise deserved; and 2) thus, the interpretation of the statute that the FDA has adopted in two recent adjudications, and that it regards itself as bound by law to apply to plaintiff's ANDAs for losartan products, fails at Chevron step one.

Appellate Information

• Decided 03/02/2010
• Published 03/02/2010

Judges

Court

• United States DC Circuit

Counsel