Otsuka prevails over Sandoz, Apotex, and Teva at CAFC

In the Otsuka Pharmaceutical case at the Court of Appeals for the Federal Circuit, Judge Lourie concluded For the foregoing reasons, we affirm the judgment of the district court. [of New Jersey]


KSR, and the issue of predictability arose:


As KSR makes clear, predictability is a vital consideration in the obviousness analysis. 550 U.S. at 421; see also Procter & Gamble, 566 F.3d at 996 (“[T]o the extent an art is unpre- dictable, as the chemical arts often are, KSR’s focus on . . . ‘identified, predictable solutions’ may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.” (quoting Eisai, 533 F.3d at 1359)).

As the district court correctly held, the prior art would not have provided a skilled artisan with a reason to make the necessary structural changes to the unsubstituted butoxy to yield aripiprazole. Otsuka, 2010 U.S. Dist. LEXIS 132595, at *91. 

As to double-patenting:

Finally, the nonstatutory double patenting issue in this case is not, as the Defendants argue, controlled by In re Zickendraht, 319 F.2d 225 (CCPA 1963). In Zickendraht, one of our predecessor courts reviewed a decision of the Board of Patent Appeals and Interferences (the “Board”) rejecting a claimed metalliferous azodyestuff compound for nonstatutory double patenting over a similar compound claimed in an issued patent. The two compounds were identical but for the presence or absence of a methyl group. Id. at 1534. In affirming the Board’s rejection, the Zickendraht court noted that “[i]t has not been shown that this [chemical] difference has any effect on the dyeing characteristics of the compound.” Id. at 1531. The court also pointed out that the earlier “patent disclosure would suggest to one skilled in the art” reacting particular starting components, which “should result in production of the dye claimed” in the pending application. Id. at 1532. Unlike in Zickendraht, the evidence here not only demonstrates the unpredictability of minor struc- tural changes on a compound’s antipsychotic properties, but also indicates that the prior art would not have pro- vided the skilled artisan with a reason to make the neces- sary structural changes to the unsubstituted butoxy to yield aripiprazole. Otsuka, 2010 U.S. Dist. LEXIS 132595, at *61, *91. Zickendraht, therefore, is distin- guishable from the present case.