Determination of level of ordinary skill in the art erroneous, leads to finding of obviousness
July 11, 2007

In a nonprecedential ruling today, the Federal Circuit held that the district court incorrectly determined the level of ordinary skill in the art, and that when the level of skill was determined correctly, the invention was obvious based on a prior art reference that was directed toward those having greater skill than the district court determined.

The patented invention related to the use of gyrase inhibitors in ear drops to treat bacterial infections without ototoxicity. The district court determined the level of ordinary skill in the art to be someone with:

a medical degree, experience treating patients with ear infections, and knowledge of the pharmacology and use of antibiotics. This person would be . . . a pediatrician or general practitioner—those doctors who are often the "first line of defense" in treating ear infections and who, by virtue of their medical training, possess basic pharmacological knowledge.

Based on this determination, the district court found the patent at issue nonobvious, even in light of a prior art reference that disclosed many of the features of the invention, because that reference stated that the ear drop substance "should be used only in difficult cases and exclusively by the otologist."

The Federal Circuit disagreed with this assessment. First, the court noted the list of factors that may be considered when determining the level of ordinary skill in the art:

(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.

Here, the court noted that the inventors "specialists in drug and ear treatments—not general practitioners or pediatricians." Further, the problem sought to be solved was "to create a topical antibiotic compound to treat ear infections (otopathy) that did not have damage to the ear as a side effect." The court therefore determined the proper level of skill to be:

that of a person engaged in developing pharmaceutical formulations and treatment methods for the ear or a specialist in ear treatments such as an otologist, otolaryngologist, or otorhinolaryngologist who also has training in pharmaceutical formulations.

(emphasis added). The court found the invention to be obvious based on this heightened level of ordinary skill. This was because, as noted previously, the reference noted that the substance should be used "exclusively by the otologist," which based on the Federal Circuit's new determination of the level of ordinary skill in the art, is just who such a person would be. As a result, given the heightened level of ordinary skill in the art, the inveniton was obvious.

This case may indicate a shift in how obviousness is argued in patent infringement cases: with the threshold for obviousness arguably lowered by KSR, patentees and accused infringers may well debate the level of skill in the art as an alternative way to show that an invention was more or less likely to be obvious.

To read the full decision in Daiichi Sankyo Co. v. Apotex, Inc., click here.

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