8 8
A year later, the Third Circuit affirmed
summary judgment for a branded
manufacturer, despite a 'hard switch,'
on grounds that the generic still had
access to the market and the product
withdrawal was not a pretext for anti-
competitive results.
5
Mylan, a competitor
preparing to launch a generic Doryx
product, claimed that Warner Chilcott
aggressively repurchased and destroyed
inventory, developed a new formulation
with no patient benefits, and withdrew
the original Doryx from the market as
it launched the new formulation. The
Third Circuit differentiated Namenda
on grounds that generic competition
existed for Doryx, that patents were
not blocking competition and the new
formulations were not patent-based,
and that Namenda was on a preliminary
injunction rather than on a full record at
summary judgment. Importantly, Warner
Chilcott built a record that its actions in
withdrawing products from the market
were tied to patient safety because the
capsules caused esophageal problems
that the tablets were designed to remedy,
and the different dosages and tablet
scoring allowed Doryx to compete
with other acne products such as
Adoxa and Solodyn, which were both
offered in several dosage levels to
allow precision treatment.
6
COMPLIANCE
16
W A R N E R C H I L C O T T
B U I LT A R E C O R D
T H A T I T S A C T I O N S
I N W I T H D R A W I N G
P R O D U C T S F R O M T H E
M A R K E T W E R E T I E D
T O PA T I E N T S A F E T Y
Moving Past Actavis
with Evolving Lifecycle
Management Strategies