Federal Circuit Affirms PTAB’s Unpatentability Finding on Sterilization Products

In Sage Products, LLC v. Stewart, Nos. 23-1603, 23-1604 (Fed. Cir. Apr. 15, 2025), the Federal Circuit affirmed a Patent Trial and Appeal Board (Board) decision that found Sage’s U.S. Patent Nos. 10,398,642 (the ’642 patent) and 10,688,067 (the ’067 patent) unpatentable.

The ’642 patent and the ’067 patent claim a “sterilized chlorhexidine product” that is packaged as a skin disinfectant. Becton, Dickinson and Co. (BD) filed an IPR, asserting that the patents were anticipated and obvious over prior art, including a publication that labeled its medical product, ChloraPrep, as “a sterile alcoholic antiseptic solution containing chlorhexidine gluconate and isopropyl alcohol in an applicator.” The Board found that “sterile” as used in the prior art was equivalent to “sterilized” as used in the patents.

On appeal, the Federal Circuit affirmed, finding the Board’s unpatentability determination was supported by substantial evidence. The Court noted that the Board’s factual findings, including its definition of a skilled artisan, supported the conclusion that a skilled artisan would, in this particular case, equate “sterile” and “sterilized.” Because the Board “surveyed all of the competing evidence,” including the prior art and expert testimony, the Court affirmed the decision.