Eurand v. Impax Labs., No. 2012-1280 (Fed. Cir.)
In Eurand v. Impax, decided last week by the Federal Circuit, a generic defendant, Impax, settled with the patent owner, Cephalon, and a settlement agreement provided for Impax's entry date into the market.
One of the entry date triggers occurred if Cephalon licensed or authorized a third party, not entitled to first-to-file exclusivity, to sell a generic--i.e., an authorized generic. Cephalon entered into a Sales Agent Agreement with Watson, which "appointed" Watson as a sales agent to "solicit" orders for Cephalon's generic version of AMRIX®, and required Watson to notify any potential customers that it was acting as Cephalon's sales agent. Under the agreement, Cephalon maintained the right to set the floor on prices, retained title to the generic drugs until they were transferred to the customer, and the generic products were to be sold solely under Cephalon's labeling and trademarks.
Impax argued that Watson was a licensed third party under the settlement agreement, thereby triggering Impax's early entry. The Federal Circuit rejected Impax's argument and confirmed that Watson was a mere sales agent and not a third party. Thus, no early entry was triggered.
Of particular interest here is that the parties' Settlement Agreement is publicly available. We have received a few requests for examples of settlement agreements in ANDA cases. Here is one.