Following a bench trial, the district court held that Allergan’s glaucoma drug patent was not invalid as being obvious and that it did not violate the written description or enablement requirements. The patent claimed the use of two ingredients in certain percentages and the prior art relied on disclosed the use of ranges of the two ingredients which covered the actual claimed percentages. Where there is a range disclosed in the prior art, and the claimed invention falls within that range, “a relevant inquiry is whether there would have been a motivation to select the claimed composition from the prior art ranges.” (citing Galderama Laboratories, L.P. v. Tolmar, Inc., 737 F.3d 731, 737-38 (Fed. Cir. 2013)). In those circumstances, “the burden of production falls upon the patentee to come forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary considerations.” Id. at 738. Here, the court did not err by finding that the prior art taught away from the claimed ranges or that the claimed formulation exhibited “unexpected results.”
The district court further did not err by holding that the patent claims did not violate the written description requirement, because the specification discloses exact formulation that was claimed as a best mode of the invention and that it exhibited the claimed clinical results. It was not fatal that the specification did not explicitly describe the clinical efficacy and hyperemia profile of the claimed formulation, because “[a] claim that recites a property that is necessarily inherent in a formulation that is adequately described is not invalid as lacking written description merely because the property itself is not explicitly described.”
Lastly, the district court did not err in holding that the enablement requirement was not violated. Defendants argued that the asserted claims lack enablement because the specification contains no actual efficacy and hyperemia data. This is not an enablement violation, because a patent does not need to guarantee that the invention works for a claim to be enabled and efficacy data are generally not required in a patent application. Only a sufficient description enabling a person of ordinary skill in the art to carry out an invention is needed. A patentee is also not required to provide actual working examples.
Allergan, Inc. v. Sandoz Inc., Case No. 2014-1275 (August 4, 2015); Opinion by: Lourie, joined by Linn and Hughes; Appealed From: District Court for the Eastern District of Texas, Schneider, J. Read the full opinion here.