Horizon Pharma Ireland Ltd. v. Actavis Laboratories, UT, Inc.

The formulation of Pennsaid 2% was not a result of routine optimization of the formulation of Pennsaid 1.5%, therefore the claims were not obvious.

July 14, 2017

GENERICally Speaking

Case Name: Horizon Pharma Ireland Ltd. v. Actavis Laboratories, UT, Inc., No. 14-7992 (NLH/AMD) (D.N.J. May 12, 2017) (Hillman, J.)

Drug Product and Patent(s)-in-Suit: Pennsaid® 2% (diclofenac sodium topical solution); U.S. Patent No. 9,066,913 (“the ’913 patent”)

Nature of the Case and Issue(s) Presented: Whether the ’913 patent was obvious in light of the prior art Pennsaid 1.5% and other references. Pennsaid 2% is a topical medication for the treatment of knee pain due to osteoarthritis. As claimed, it is applied twice a day and has thickening agents making it more viscous than Pennsaid 1.5%, the viscosity of which is similar to that of water.

Why Horizon Prevailed: The court found the ’913 patent non-obvious. Defendants argued that three changes to Pennsaid 1.5%--and leaving two ingredients unchanged—were obvious optimizations of result-effective variables that produced a predictable result.

The court said that the asserted claim was not a result of routine optimization of Pennsaid 1.5%, as “general principles and ranges of permissible concentrations would not have predicted the exact formulation and dosing frequency that resulted in Pennsaid 2%.” In so concluding, it attacked defendants’ expert testimony based on adjusting the tone of a stereo receiver:

[The expert] testified that drug formulation is like adjusting a stereo receiver, and the formulation of Pennsaid 2% from the Pennsaid 1.5% chassis was simply like turning the knobs to adjust the bass and treble to achieve the desired result, in this case the delivery of the active agreement to the desired spot under the skin and at the knee at a reduced dosing regimen…. [The expert] explained that a POSA would have used her own knowledge about drug formulations and the available literature to perform a routine optimization of Pennsaid 1.5% by turning up the dial for a little more diclofenac sodium, turning up the dial for ethanol by double, turning off the dial for glycerin, turning on the dial for HPC, leaving the dials for DMSO and propylene glycol at their current setting, and turning the dial for water to sufficiently fill in the remainder.

The court rejected this analogy for three reasons. Firstly, the expert did not explain the difference between the analogy, where the stereo knobs are independently adjustable, and the claimed medication formulation, where the totals must add up to one-hundred percent. Secondly, the analogy failed to consider the need for the API to pass through many layers of tissue before reaching its target. And thirdly, the court concluded that there was insufficient record evidence to support the Defendant’s legal argument the three changes to the Pennsaid 1.5% formulation—and the two ingredients left unchanged—would produce a predictable result, particularly as to the formulation's absorption, thickness, and drying time.

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