Sanofi-Aventis U.S., LLC v. Fresenius Kabi USA, LLC, No. 18-1804 (Fed. Cir. 2019)Annotate this Case
Sanofi’s 170 and 592 patents respectively claim the compound cabazitaxel and methods of using it. Sanofi markets cabazitaxel under the trade name Jevtana® to treat certain drug-resistant prostate cancers. Both patents are listed in the Orange Book as covering cabazitaxel. Cabazitaxel belongs to a family of compounds called taxanes and is the third and most recent taxane drug to gain FDA approval. The others are paclitaxel, approved in 1992, and docetaxel, approved in 1996. Defendants filed Abbreviated New Drug Applications to market generic versions of cabazitaxel
before the expiration of the patents, prompting Sanofi to sue for infringement. Defendants sought a declaration of invalidity. The district court found claims 7, 11, 14–16, and 26 of the 592 patent invalid as obvious and claims 1 and 2 of the 170 patent not invalid as obvious. The Federal Circuit vacated as to claims 7, 11, 14–16, and 26 of the 592 patent because there was no case or controversy with respect to those claims when the district court issued its decision. Sanofi’s disclaimer of the disclaimed claims mooted any controversy over them. The court affirmed that the 170 patent is not invalid as obvious over docetaxel.