Chapter §9.05 Graham Factor (3): Level of Ordinary Skill in the Art

• Jurisdiction: United States

§9.05 Graham Factor (3): Level of Ordinary Skill in the Art

In litigation challenging a patent's validity under 35 U.S.C. §103, both parties will typically introduce evidence (often in the form of expert witness testimony) attempting to establish the level of ordinary skill in the technology of the invention. It is from this perspective and skill set, possessed by the hypothetical PHOSITA, that the question of nonobviousness must be resolved.¹⁷⁹ The proponent of validity usually will attempt to establish as low or unsophisticated a level of ordinary skill as possible, such that the invention would have been considered nonobvious by the largest possible number of persons. Correspondingly, the challenger of validity typically will seek to raise that level.¹⁸⁰

In making a finding on the level of ordinary skill in the art, courts or juries will take into consideration some or all of the following types of evidence:¹⁸¹

• the education level of the inventor;

• the education level of a typical worker in this field (e.g., whether the PHOSITA would have possessed a high school degree, college undergraduate degree, or graduate degree such as a master's or Ph.D.);

• the type of problems encountered in this technology and previous solutions to such problems;

• how quickly new innovation occurs in this technology; and

• the sophistication of the technology (e.g., is the invention a fishing lure or a method of manipulating DNA?).

The educational level and expertise of the inventor do not necessarily equate to the level of ordinary skill of a hypothetical PHOSITA, for the inventor may (or may not) be a person of extraordinary skill. Nevertheless, the inventor's qualifications can sometimes play a central role in the nonobviousness analysis. For example, in Daiichi Sankyo Co. v. Apotex, Inc.,¹⁸² validity challenger Apotex convinced the Federal Circuit that a district court's determination of the level of ordinary skill was too low, and that this error permeated the lower court's ultimate conclusion of nonobviousness. The Federal Circuit's reversal in Daiichi turned on its agreement that the district court had clearly erred in finding too low a level of ordinary skill in the pertinent art.¹⁸³ The Federal Circuit concluded that that error had tainted the entirety of the district court's nonobviousness analysis.¹⁸⁴

Daiichi's patent addressed the problem of creating a topical antibiotic compound for treatment of ear infections that would not risk damage to the ear.¹⁸⁵ Claim 1 recited "[a] method for treating otopathy which comprises the topical otic administration of an amount of ofloxacin or a salt thereof effective to treat otopathy in a pharmaceutically acceptable carrier to the area affected with otopathy."¹⁸⁶ The district court found that a hypothetical person of ordinary skill in the art pertinent to this invention would have had a medical degree, experience treating patients with ear infections, and basic knowledge about pharmacology and the use of antibiotics. Such a person would have been a pediatrician or general practitioner, doctors who are often the " 'first line of defense' " in treating ear infections.¹⁸⁷

The Federal Circuit disagreed, concluding that the person of ordinary skill in the art would have been a specialist in the treatment of ear disease with advanced knowledge of pharmacology. Deeming the district court's contrary finding clearly erroneous, the Federal Circuit found that "[t]he level of ordinary skill in the art of the [] patent is 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."¹⁸⁸

§9.05 LEVEL OF ORDINARY SKILL IN THE ART

Although the Federal Circuit enumerated several factors relevant to the determination of ordinary level of skill in the art,¹⁸⁹ the dispositive factor in Daiichi was the level of skill of the inventors.¹⁹⁰ The patent's inventors were specialists, not generalists: a university professor specializing in otorhinolaryngology plus two Daiichi employees, one a clinical development department manager and another a research scientist.¹⁹¹ The patent described the inventors' tests of ofloxacin on guinea pigs to...