The Commission has declined to enter a consent order, and instead terminated on the basis of a settlement agreement, Inv. No. 337-TA-568, Certain Products and Pharmaceutical Compositions Containing Recombinant Human Erythropoetin. On May 12, 2006 complainant Amgen Inc. filed a complaint against respondents Roche Holding Ltd.; Roche Diagnostics GmbH; and Hoffman La Roche Inc. (collectively “Roche”), which resulted in the institution of the investigation. After separate remands by the Federal Circuit and a parallel civil action involving many of the same patents, on December 18, 2009, the private parties executed a settlement agreement. The parties also agreed to a consent order in the parallel district court action.
On December 22, 2009, Amgen moved to terminate the investigation by entry of an exclusion order based on preclusion caused by the district court judgment. On March 11, 2011, the Commission issued an order to show cause in which it noted that Amgen’s request of an exclusion order appeared to contravene the Commission’s longstanding policy of not reaching an issue of violation in terminating investigations based on settlement agreements. Amgen and Roche subsequently filed a joint response seeking a consent order, rather than an exclusion order.
In its current order, the Commission elected to terminate the investigation based on settlement agreement and declined to exercise its discretion to issue a consent order. The Commission cited several reasons for its opinion. First, the consent order was not pursued by the parties at the time of settlement. Second, it noted the Commission appears to lack jurisdiction to enforce the settlement agreement between the parties, and would therefore likely lack jurisdiction to enforce a consent order to the extent the settlement agreement was involved. Finally, the Commission noted that the proposed consent order contained language typical of cease and desist orders that is not routinely seen in consent orders.