Addressing the issue of whether a topical gel with an increased
concentration of active ingredient would have been obvious over a
prior art liquid product, the US District Court for the District of
New Jersey concluded that the claimed formulation was not
predictable and exhibited unexpected results. Horizon Pharma
Ireland Ltd. v. Actavis Labs., UT, Inc., Case No. 14-7992
(D.N.J., May 12, 2017) (Hillman, J).
Actavis filed an abbreviated new drug
application (ANDA) seeking to market a generic version of
Horizon's PENNSAID® 2%, which is a topical diclofenac
sodium formulation indicated for treating the pain associated with
osteoarthritis of the knees. Horizon asserted a method of treatment
claim that required twice daily administration of a 2 percent
diclofenac sodium formulation having a particular viscosity and
further containing particular amounts of dimethyl sulfoxide (DMSO),
ethanol, propylene glycol, hydroxypropylcellulose (HPC) and water.
Actavis stipulated
