PIJIP Senior Policy Fellow Charles Duan recently co-authored an op-ed in the Los Angeles Times with Michael Carrier and Sean Tu. The op-ed describes how method of use patents can block generic drugs from the U.S. market, in some cases long after the original product patents have expired. Congress created an approval pathway based on "skinny labels" to allow generic approvals for uses not covered by method of use patents, but recent litigation overlooked the use of a skinny label on a drug first invented in 1978 - and the generic firm was found guilty of infringement:

"Generic carvedilol manufacturer Teva Pharmaceuticals followed the skinny labeling pathway to a T. Yet a federal appeals court said that Teva violated the patent. That decision leaves the skinny labeling law so meaningless that it might as well not exist, calling into question the legal status of potentially thousands of widely used generics.

"Worse yet, the basis for Teva’s violation was the packaging label text on the dosing and use of the drug. Changing that text would potentially have rendered Teva’s carvedilol product less safe for use, and most likely unfit for approval. Thus Teva was placed in a catch-22. It could comply with federal drug labeling mandates but only by infringing the patent. This is the exact situation that skinny labeling was designed to prevent."

Click here for the full op-ed on the Los Angeles Times website.