The Federal Trade Commission has proposed a rule requiring drug companies to report transactions in which a drug company licenses another to exclusively market and sell a drug while retaining the right to manufacture it. Historically, the sale of a patent was a reportable transaction under the Hart-Scott-Rodino Pre-merger Notification Act, which requires the reporting of mergers and acquisition exceeding certain dollar thresholds. But exclusively licenses to market and sell were not deemed reportable. If the FTC’s rule is accepted, exclusive licenses will have to be brought to the regulators attention.
This proposal is part of a broader effort by the FTC to keep closer tabs on the drug industry.