Orange Book Blog

Eurand v. Impax Labs., No. 2012-1280 (Fed. Cir.)   

    by Alex Menchaca

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.