Digest of Senju Pharm. Co. v. Lupin Ltd., No. 2013-1630 (Fed. Cir. Mar. 20, 2015) (precedential). On appeal from D. Del. Before Newman, Plager, and Moore.

Procedural Posture: Senju appealed the district court’s invalidity judgment. CAFC affirmed.

  • Obviousness: CAFC affirmed the district court’s holding that composition claims 12-16 were obvious. The district court properly found that corneal permeability was not relevant in the discussion of these claims because they did not contain the corneal permeability limitation. The district court properly determined that combining the prior art references would have been obvious because there were sufficient reasons to improve upon the prior art references by using gatifloxacin and 0.01 w/v% EDTA.
  • Obviousness: CAFC affirmed the district court’s holding that method claim 6 was obvious. The district court properly found that the references cited by Senju did not teach away from the claimed invention, that the cited references taught that 0.01 w/v% EDTA would be effective to increase corneal permeability, and that the alleged unexpected results were not unexpected or surprising but were a product of routine optimization.
  • Unexpected Results: The district court properly considered evidence of unexpected results and did not err in finding that the increase in corneal permeability using a 0.01 w/v% EDTA was not unexpected or surprising. The district court also properly applied a presumption of validity and properly concluded that the theories presented during reexamination did not rise to the level of unexpected results sufficient to rebut a strong case of obviousness.

Newman, dissenting: 

  • Obviousness: Invalidity of reexamined claim 6 was not proved by clear and convincing evidence in view of the scientific references, the experimental record, and the commercial success. The prior art taught away from the claimed combination when it indicated that higher concentrations of EDTA were needed to enhance corneal permeability. Also, the claimed levels of EDTA were shown in Senju’s experiments to produce a significant increase in the concentration of gatifloxacin in the aqueous humour.