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June 13, 2014

Drug Obviousness

The CAFC, like other courts, decides how to rule, then fits the law to suit the ruling. The same judges on a CAFC panel that were at diametric ends over the same issue in Allergen v. Apotex were happy to affirm an obviousness finding of the district court in Bristol-Myers Squibb v. Teva. In doing so, it summarized case law in this area, if only in this case.

Bristol-Myers Squibb v. Teva (CAFC 2013-1306) precedential; Judges Prost, Plager, and Chen (author)

The court begins with the standard disclaimer that it does as it damn well pleases.

Obviousness is a question of law with underlying factual findings. Honeywell Int'l, Inc. v. United States, 609 F.3d 1292, 1297 (Fed. Cir. 2010). We review the conclusion of obviousness de novo, and the trial court's factual findings for clear error. Id.

Then the boilerplate that is actually the law, at least according to the Supreme Court, which is almost never overturned, except by itself when the court's political composition changes.

Obviousness requires assessing (1) the "level of ordinary skill in the pertinent art," (2) the "scope and content of the prior art." (3) the "differences between the prior art and the claims at issue," and (4) "secondary considerations" of nonobviousness such as "commercial success, long-felt but unsolved needs, failure of others, etc." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)).

On to the CAFC's own brew of chemical compound obviousness. Basically, find a "lead" prior art reference that lays the foundation via similarity, then tack on, Lego-like, the incremental bit that was the claimed novelty. Evidence is unnecesary. All that is needed is a subjective "expectation," which is simply the court's desire to support a particular party.

A party seeking to invalidate a patent as obvious must demonstrate "'by clear and convincing evidence that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success from doing so.'" Proctor & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)).
To establish obviousness in cases involving new chemical compounds, the accused infringer must identify some reason that would have led a chemist to modify a known compound. Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007). Generally, an obviousness inquiry concerning such "known compounds" focuses on the identity of a "lead compound." Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353, 1359 (Fed. Cir. 2008).
A lead compound is a compound in the prior art that would be "a natural choice for further development efforts." Altana Pharma AG v. Teva Pharms. USA, Inc., 566 F.3d 999, 1008 (Fed. Cir. 2009). The motivation to modify that lead compound can come from any number of sources and need not necessarily be explicit in the art. "[I]t is sufficient to show that the claimed and prior art compounds possess a 'sufficiently close relationship . . . to create an expectation,' in light of the totality of the prior art, that the new compound will have 'similar properties' to the old." Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1293 (Fed. Cir. 2012) (quoting In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990) (en banc)). Whether a lead compound and a claimed compound have a sufficiently close relationship frequently turns on their "structural similarities and differences." Daiichi Sankyo Co. v. Matrix Labs., Ltd., 619 F.3d 1346, 1352 (Fed. Cir. 2010).
Unexpected results do not per se defeat, or prevent, the finding that a modification to a lead compound will yield expected, beneficial properties.We have held an invention to be obvious despite findings of unexpected results. See, e.g., Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1293 (Fed. Cir. 2013); Alcon Research, Ltd. v. Apotex, Inc., 687 F.3d 1362, 1365, 1369- 70 (Fed. Cir. 2012); Pfizer, 480 F.3d at 1372.

Obviousness affirmed.

Posted by Patent Hawk at June 13, 2014 2:56 PM | Prior Art