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 ...

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 ...

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 ...

The Orange Book lists all nonbiologic drug products approved by the FDA on the basis of safety and effectiveness, along with approved generic versions and any IP rights associated with the drug or its ...