If you think it’s easy to determine what’s obvious and what’s not, take a look at the recent Federal Circuit decision in Millennium Pharmaceuticals v. Sandoz. The lower court had determined that a process was obvious. The circuit court held that it was not obvious and that the lower court’s determination of obviousness was clear—in other words, obvious—error.
Millennium is the exclusive licensee of the patent for a compound in its cancer treatment product Velcade. Sandoz and other companies filed applications for FDA approval of generic counterparts of Velcade seeking to invalidate various claims of the patent. When Millennium sued them for patent infringement, they raised the defense of patent invalidity based on obviousness. The district court sided with the defendants, ruling that Millennium’s claims were obvious because they were the inherent result of an obvious process, namely, lyophilizing bortezomib with mannitol.
The circuit court reversed, ruling that the lower court had clearly erred. The correct question, the court held, is whether a person of ordinary skill in the art, seeking to remedy the known problems of instability and insolubility, would have come upon the process. The court answered no, noting that nothing in the prior literature suggested the process.
The court similarly reversed the lower court’s finding of inherency—that the process was “inevitable” or “inherent” and thus not “inventive”—noting that no expert testimony supported the finding.
The case is Millennium Pharmaceuticals v. Sandoz, Case Nos. 2015-2066, and 2016-1009, -1010, -1109, -1110, -1283, -1762 (Fed. Cir. July 17, 2017).