Given that a relatively minor amendment to the Hatch-Waxman Act could give the FDA the authority it requires to assess patents submitted for Orange Book listing and to reject inappropriate patents ...

The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva filed a complaint for ...

About Evoke Pharma, Inc. Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat ...

Yesterday, the Federal Trade Commission (FTC) sent a series of seven warning letters to several pharmaceutical companies renewing the agency’s challenge to dozens of patent listings in the U.S ...

Evoke Pharma shares surged after the company received a notice of allowance for a U.S. patent application for Gimoti extending Orange Book listings to 2036.

Improper Orange Book listings may have distorted the pharma market for decades, the policy statement said. An FTC review of the potential effects of improper Orange Book listings was included in a ...

The Federal Circuit affirms a decision to delist certain Teva patents from the FDA Orange Book, clarifying patent listing criteria for drug-device combinations ...