FTC orders Teva to delist inhaler patents

The US Court of Appeals for the Federal Circuit on Friday affirmed a lower district court order against Israeli pharmaceutical maker Teva Pharmaceutical Industries (NYSE: TEVA) requiring its US subsidiary to delist several asthma inhaler patents from the Food and Drug Administration’s (FDA) Orange Book.

The appellate court order stems from a case brought by Teva against drugmaker Amneal Pharmaceuticals (NYSE: AMRX) after the latter sought Food and Drug Administration (FDA) approval to bring a generic version of the asthma inhaler ProAir HFA to market. The Federal Trade Commission (FTC) had previously submitted amicus briefs in this case, with both the appellate and district courts, urging the delisting of Teva’s patents because they are improperly listed in the FDA’s Orange Book, which can ultimately harm competition by delaying or deterring the entry of cheaper generic products. The FTC also previously challenged Teva’s inhaler patents via the FDA’s Orange Book dispute process, as well as hundreds of other similar device patent listings by major pharmaceutical manufacturers.

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