October 20, 2017

Case Name:  Tris Pharma, Inc. v. Actavis Labs. FL, Inc., No. 14-1309-GMS, 2017 U.S. Dist. LEXIS 143299 (D. Del. Sept. 5, 2017) (Sleet, J.) 

Drug Product and Patent(s)-in-Suit: Quillivant XR® (methylphenidate hydrochloride); U.S. Patents Nos. 8,465,765 (“the ’765 patent”), 8,563,033 (“the ’033 patent”), 8,778,390 (“the ’390 patent”), 8,956,649 (“the ’649 patent”), and 9,040,083 (“the ’083 patent”)

Nature of the Case and Issue(s) Presented:  Actavis alleged that the asserted claims were obvious. In particular, Actavis asserted that the prior art taught how to prepare ion exchange resins using methylphenidate as claimed in the patents. Likewise, the prior art taught using various preparation methods to optimize the pH level within the claimed ranges.

Tris argued that the prior art did not disclose the claimed inventions; it, in fact, taught away from the claimed formulations. In particular, Tris argued that one of skill would have conducted unnecessary experiments to arrive at the claimed invention because the art taught away from the claimed pH level in the formulation. Further, Tris argued that secondary indicia of non-obviousness of long felt need, commercial success, unexpected results and copying supported a finding of non-obviousness.

The district court found all asserted claims invalid as obvious.

Why Actavis Prevailed:  The district court held that the claims were obvious because it found that the inventive limitations were taught in the prior art. The prior-art literature disclosed the various ranges of pH level claimed in the patents-in-suit and identified the various ways of formulating the claimed compounds. The court found that Tris had not shown any unexpected results from the narrow pH ranges in its claim from those disclosed in the art. As for the secondary indicia, the court held that Tris had not provided sufficient evidence for each factor. The evidence submitted by Tris was attenuated, at best, and did not include the nexus between the secondary consideration and the claimed invention.  The court discounted any evidence on copying as the evidence was not strong in an ANDA case.