The US FTC adopts new rules clarifying HSR filing requirements for transfers of pharmaceutical patent rights

On November 6, the Federal Trade Commission (“FTC”) amended the implementation rules of the Hart Scott Rodino Antitrust Improvements Act (the “HSR Act”) to specify when parties to pharmaceutical patent license agreements must observe the HSR Act’s notification and pre-closing waiting period requirements. Under the new rules, pharmaceutical patent licenses that transfer “all commercially significant rights to a patent . . . for any therapeutic area (or specific indication within a therapeutic area)” will be considered asset acquisitions reportable under the Act if the notification thresholds are met and no exemption applies. The FTC developed the new rules in conjunction with the Antitrust Division of the Department of Justice. The new rules were presented for public comment in August 2012