Level of Skill in the Art Dipositive on Obviousness Question

Daiichi Sankyo Co. v. Apotex, [2006-1564](July y11, 2007)[ARCHER, Michel, Dyk] NON-PRECEDENTIAL The Federal Circuit reversed the finding that Daiichi Sankkyo's U.S. Patent No. 5,401,741 was not valid, finding that the invention would have been obvious in view of the prior art.

BRIEF: The case turned on the level of ordinary skill in the art, the district court finding the level of ordinary skill was a person with a medical degree and experience treating persons with ear infections, while Apotex argued that the proper level was a person engaged in developing new ear pharmaceuticals or a specialist in ear treatments with training in pharmaceutical formulations. The factors that are considered in determining the level of ordinary skill in the art include (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field. The Federal Circuit noted that the inventors were an otorhinolaryngologist and a drug development specialists, and that others in the field were of the same level of skill. The Federal Circuit also noted that the problem was to develop an antibiotic to treat ear infections that did not damage the ear. The Federal Circuit noted that this frequently involved animal testing, which was outside the realm of regular physicians. Accordingly the Federal Circuit found that the level of skill was higher than the trial court found. The patentee discounted the defenses expert testimony because the reference did not convey the same teaching to one of lower skill in art. Because the Federal Circuit found a higher level of ordinary skill in the art, the prior art make the invention obvious to a person of ordinary skill in the art.

SIGNIFICANCE: Although non-precedential the case is significant in that the level of ordinary skill in the art was dispositive on the question of obviousness.