by Dennis Crouch
This post follows-up on my recent essay on Novartis v. Torrent Pharma. If you recall, that decision by Judge Chen affirmed an IPR trial decision cancelling the claims of the Novartis patent as obvious.
I did not previously discuss the portion of the case focusing on Novartis’ objective evidence of non-obviousness. Novartis argued that its drug (1) met a long-felt but unsolved need, (2) received substantial industry praise, and (3) enjoyed commercial success. The Supreme Court has accepted this type of evidence as relevant based upon the theory that an obvious invention (1) would have already been invented; (2) would not b praised by the industry as groundbreaking; and (3) would have its commercial success undermined by the similar prior art.
In recent years, however, the courts have also pushed a strong nexus doctrine — requiring a nexus or causal relationship between the objective evidence and the claimed invention. In other words, the patentee must show that it was the invention (as claimed) that led to the commercial success and not something else such as marketing. Because this evidence is used to rebut a prima facie case of obviousness, the burden shifts to the patentee to prove the nexus, although at times the court will presume a nexus.
Here, the court explains that the nexus requirement actually goes an important step further. The secondary indicia of nonobviousness must be tied to the inventive step itself – i.e., what was claimed an not known in the art.
For objective indicia evidence to be accorded substantial weight, we require that a nexus must exist “between the evidence and the merits of the claimed invention.” Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010). “Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.” In re Kao, 639 F.3d 1057 (Fed. Cir. 2011). . . In evaluating whether the requisite nexus exists, the identified objective indicia must be directed to what was not known in the prior art—including patents and publications—which may well be the novel combination or arrangement of known individual elements.
FDA Approval: Moving back to the facts of Novartis, the patentee argued that its commercial success was based upon “Gilenya being the first commercially-available solid oral multiple sclerosis treatment.” Although that statement is true, the court found the commercial-availability focus misplaced for a non-obviousness argument. Rather than first-commercial-availability, the focus should be based upon first-invention or disclosure.
The fact that Gilenya was the first to receive FDA approval for commercial marketing does not overcome the fact that solid multiple sclerosis compositions were already known.
With that framework, the court held that the “proffered evidence is not probative of the nonobviousness inquiry.”