Finding clear error in a district court’s determination of the level of ordinary skill in the art, one of the Supreme Court Graham v. John Deere factors, the U.S. Court of Appeals for the Federal Circuit reversed the lower court’s validity finding. Daiichi Pharm. Co. v. Apotex, Inc., Case No. 06-1564 (Fed. Cir., July 11, 2007, nonprecedential opinion; Sept. 12, 2007, reissued as precedential opinion) (Archer, J.).

The patent claims in issue were directed to a method for treating bacterial ear infections by topically administering the antibiotic ofloxacin marketed by Daiichi as Floxin Otic solution, 0.3 percent. Apotex had filed an Abbreviated New Drug Application (ANDA) for a generic version Floxin Otic, certifying under Paragraph IV that the patent is invalid. Daiichi sued Apotex for infringement. At trial, Apotex argued that a prior art reference that taught the use of ear drops containing the gyrase inhibitor ciprofloxacin to treat middle ear infections rendered obvious the use of ofloxacin, also a gyrase inhibitor. The district court determined that a person of ordinary skill in the art “would have a medical degree, experience treating patients with ear infections, and knowledge of the pharmacology and use of antibiotics,” and thus, would be “a pediatrician or general practitioner.” The prior art reference recommended that “[gyrase inhibitors] should be used only in difficult cases and exclusively by the otologist.” Accordingly, the district court rejected Apotex’s argument that the use of the gyrase inhibitor ofloxacin to topically treat bacterial ear infections was obvious. Apotex appealed.

On appeal, Apotex argued that the district court erred in its determination that one having ordinary skill in the relevant art is properly defined as a pediatrician or general practitioner. Rather, Apotex argued that one having ordinary skill in the relevant art is properly defined as “a person engaged in developing new pharmaceuticals, formulations and treatment methods, or a specialist in ear treatments such as an otologist, otolaryngologist, or otorhinolaryngologist who also has training in pharmaceutical formulations.” The Federal Circuit commenced its review by noting that the technology art of the patent is the creation of a compound to treat ear infections without damaging a patient’s hearing. The Court pointed out that the named inventors were specialists in drug and ear treatments—not general practitioners or pediatricians. The Court also noted that the patent described the testing of ofloxacin on animals and that animal testing was traditionally outside the realm of a pediatrician or general practitioner. Finally, the Federal Circuit stated that while a pediatrician or general practitioner could prescribe ofloxacin, he or she would not have the training or knowledge to develop the claimed compound. The Court concluded, “Daiichi’s evidence as to why this reference did not render the invention of the … patent obvious was based on an improper determination of the level of skill in the art,.” and reversed the district court’s validity finding.