Hoffmann-La Roche Limited v. Apotex Inc.

Drug: CELLCEPT mycophenolate mofetil

The two issues raised in this prohibition proceeding related to whether the claimed compound’s utility was demonstrated or soundly predicted, and whether the claimed compound was obvious. The Court described the patent as relating to a prodrug of a known compound that could be used as an immunosuppressive drug but had limitations. The Court found that the utility of the invention was demonstrated as of the filing date. The Court further found that the utility was soundly predicted. Finally, the Court found that the claimed compound was not obvious.