Wednesday, May 18, 2005

CAFC on obviousness in Syntex v. Apotex

After the brief of 24 law professors on how the CAFC is lax on obviousness, we have another case where the the CAFC is strong on obviousness, Syntex v. Apotex.

I discuss other problematic aspects of the law professors' brief in the June 2005 issue of Intellectual Property Today [PATENT REFORM 2005: CAN YOU HEAR ME, MAJOR TOM?]

From Syntex v. Apotex, 2005 U.S. App. LEXIS 8863:

This court reviews for clear error the district court's
determination of the factual inquiries underlying obviousness, while it reviews de novo the legal conclusion that a claim is invalid as obvious. McNeil-PPC, Inc. v. L.Perrigo Co., 337 F.3d 1362, 1368 (Fed. Cir. 2003), cert. denied, 540 U.S. 1107, 157 L.
Ed. 2d 893, 124 S. Ct. 1068 (2004). The factual determinations relevant to the
obviousness inquiry include:
(1) the scope and content of the prior
(2) the differences between the claimed invention and the prior art;
(3) the level of ordinary skill in the art; and
(4) secondary considerations, if any, such as
commercial success, unexpected results, copying, long-felt but
unresolved need, and the failure of others to develop the invention. Graham v. John Deere Co., 383 U.S. 1, 17-18, 15 L. Ed. 2d 545, 86 S. Ct. 684 (1966).

At trial, Apotex argued that based on the prior art, a person of
ordinary skill in the art would expect to succeed in stabilizing a formulation containing an NSAID and BAC with a nonionic surfactant. Contending that the formulation claimed in the '493 patent is just such a formulation, Apotex argued that it is legally obvious.
Further, the court was under the impression that, in the absence of evidence that those references teach away from combination, there was a failure of proof that there would have been any motivation by one of ordinary skill in the art to use octoxynol 40 in the claimed formulations.
Finally, we feel the district court should reconsider the significance of the commercial success of the patented formulation in light of our recent decision in Merck & Co. v. Teva
Pharms. USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005).

***Of relevance to the brief of the law professors-->

What a reference teaches a person of ordinary skill is
not, as Syntex's expert appears to believe, limited to what a reference specifically "talks about" or what is specifically "mentioned" or "written" in the


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