Upsher-Smith Laboratories, Inc. v. Pfizer Inc., 995 F.3d 1040 (Fed. Cir. 2021)
The case of Upsher-Smith Laboratories, Inc. v.
Whether the patents held by Pfizer on the pharmaceutical formulation were valid and if Upsher-Smith Laboratories infringed on those patents by their formulation.
Under 35 U.S.C. §§ 102 and 103, a patent may be invalidated if it is found to be anticipated by prior art or obvious to someone skilled in the art. Additionally, a determination of patent infringement involves assessing whether the accused product or process infringes one or more claims as defined in the patent.
The Federal Circuit held that the patents were valid, rejecting claims of obviousness, and affirmed that Upsher-Smith's formulation did indeed infringe on the patented claims of Pfizer.
This case exemplifies the dual aspect of defending against patent infringement claims and challenging the validity of a patent through assertions of obviousness and prior art. It offers valuable insights into the judiciary's approach to evaluating pharmaceutical patents' validity, crucial for law students aiming to specialize in patent law or intellectual property rights within the pharmaceutical sector.