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June 22, 2013

Drugged

The CAFC continues to astonish. Novo Nordisk v. Caraco yielded a 2-1 decision of chemical obviousness. The majority contravenes a well-established trail of precedents, dating at least to In re Papesch (1963). Judge Newman, in dissent, feels the need to remind her colleagues of "real world considerations."

Novo Nordisk v. Caraco Pharmaceutical (CAFC 2011-1223); precedential; Judges Newman (dissent), Dyk and Prost (author)

Newman in dissent:

The section 103 determination in this case relates to a synergistic combination of two diabetes drugs.
"Real world considerations provide . . . a solid evidentiary foundation on which to rest a nonobviousness determination." Minn. Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1575 (Fed. Cir. 1992). These "real world considerations" include the realities and challenges of discovering a new medicinal product. The panel majority discards this principle in concluding that the synergistic combination of metformin and repaglinide would have been obvious to a person of ordinary skill.
The question is not whether it would have been obvious to look for synergistic combinations; the question is whether it was obvious that the combination of metformin and repaglinide would exhibit synergism and that the combination would be 800% more effective than the additive effect of the components separately.
My colleagues reason that because synergism is unpredictable, then if it is found, it is obvious. Maj. Op. at 8. ("It was apparently well-known in the art that two drugs having different mechanisms for attacking diabetes may be more effective than one, and so drugs were often tested in combination."). That is not the meaning of "obvious to try." A new composition is "obvious to try" when it is reasonable to expect that the trial will produce a predictable result. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) ("[T]he fact that a combination was obvious to try might show that itwas obvious under ยง 103" if, among other things, "there are a finite number of identified, predictable solutions"). That situation did not here exist. See Eisai Co. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353, 1359 (Fed. Cir. 2008) ("To the extent an art is unpredictable, as the chemical arts often are, KSR's focus on these 'identified, predictable solutions' may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.").
Patentability is determined not from the position of the inventor, but from the knowledge of the person of ordinary skill. See Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985) ("Inventors, as a class, according to the concepts underlying the Constitution and the statutes that have created the patent system, possess something . . . which sets them apart from the workers of ordinary skill, and one should not go about determining obviousness under ยง 103 by inquiring into what patentees (i.e., inventors) would have known or would likely have done.") (emphases in original).
My colleagues misunderstand and misapply the "obvious to try" criterion of obviousness. The motivation to develop a new pharmaceutical "is not abstract, but practical, and is always related to the properties or uses one skilled in the art would expect the compound to have, if made." In re Gyurik, 596 F.2d 1012, 1018 (CCPA 1979). This expectation must be rooted in the prior art and in the person of ordinary skill, not in the ingenuity or creativity of the inventor.
For questions of biological synergism, predictability is notoriously difficult. In re Luvisi, 342 F.2d 102, 109-10 (CCPA 1965) ("We do not accept the notion that every suggestion of synergism in the art coupled with a finding of synergism in the practice of the invention automatically compels a conclusion of obviousness . . . . [S]ome prior art compositions may show little synergism and others show considerable synergistic effects, with the net result that predictability is impossible save the fact that a synergistic result of some kind will probably be found."); see also Allergan, Inc. v. Sandoz, Inc., ___ F.3d ___, No. 2011-1619, 2013 WL 1810852, at *7 (Fed. Cir. May 1, 2013) (holding combination unobvious because there is "no reason why the success of unrelated drugs would make it obvious to one of ordinary skill that a fixed combination of brimonidine and timolol could be dosed twice per day without loss of efficacy"). My colleagues contravene precedent, and hold that because some synergism has been observed in some combinations with metformin, any discovery of a unique synergistic combination with unusual properties would have been obvious.
The PTO granted this patent based on the synergistic effect that these inventors discovered and established. This activity was not suggested in the prior art, was not predictable, and was not obvious. The court errs in holding otherwise.

Posted by Patent Hawk at June 22, 2013 1:27 AM | Prior Art