Premerger Notification; Reporting and Waiting Period Requirements

The Commission is proposing amendments to the premerger notification rules (``the Rules'') to provide a framework for determining when a transaction involving the transfer of rights to a patent in the pharmaceutical, including biologics, and medicine manufacturing industry (North American Industry Classification System Industry Group 3254) (``pharmaceutical industry'') is reportable under the Hart Scott Rodino Act (``the Act'' or ``HSR''). The Act and Rules require the parties to certain mergers and acquisitions to file reports with the Federal Trade Commission (``the Commission'') and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice (``the Assistant Attorney General'') (collectively, ``the Agencies'') and to wait a specified period of time before consummating such transactions. The reporting and waiting period requirements are intended to enable these enforcement agencies to determine whether a proposed merger or acquisition may violate the antitrust laws if consummated and, when appropriate, to seek a preliminary injunction in federal court to prevent consummation. This proposed rulemaking uses the concept of ``all commercially significant rights'' as the basis to determine whether there is a transfer of exclusive rights to a patent in the pharmaceutical industry resulting in an asset acquisition that may be reportable under the Act.

Agency Contact: Robert L. Jones, Deputy Assistant Director, Premerger Notification Office, Bureau of Competition, Room 302, Federal Trade Commission, Washington, DC 20580. Telephone: (202) 326-3100.