Erroneous "Skill in the Art" Triggers Obviousness

Daiichi Sankyo Co., Ltd. v. Apotex, Inc. (06-1564) July 11, 2007 (non-precedential)

Daiichi held a patent drawn to a method for treating bacterial ear infections by topically administering the antibiotic ofloxacin into the ear. During litigation, a dispute arose over the skill in the art when considering obviousness. Apotex argued that the skill in the art would be:

"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."

Instead, the district court concluded 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. 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."

When considering the prior art, the district court concluded that the teachings fell outside the skill in the art of an otologist with only basic pharmacological knowledge, and held the patent nonobvious. The CAFC disagreed.

The inventors of the ’741 patent were specialists in drug and ear treatments—not general practitioners or pediatricians. At the time of the invention, Inventor Sato was a university professor specializing in otorhinolaryngology; Inventor Handa was a clinical development department manager at Daiichi, where he was involved with new drug development and clinical trials; and Inventor Kitahara was a research scientist at Daiichi engaged in the research and development of antibiotics. Additionally, others working in the same field as the inventors of the ’741 patent were of the same skill level.

[M]ost of the written description details the inventors’ testing ofloxacin on guinea pigs and their findings that ototoxicity did not result from the use of their compound. Such animal testing is traditionally outside the realm of a general practitioner or pediatrician. Finally, while a general practitioner or pediatrician could (and would) prescribe the invention of the ’741 patent to treat ear infections, he would not have the training or knowledge to develop the claimed compound absent some specialty training such as that possessed by the ’741 patent’s inventors.

[T]he district court’s error in determining the level of ordinary skill in the art of the ’741 patent tainted its obviousness analysis. In view of the correct level of skill in the art and the evidence of record, we conclude that as a matter of law the ’741 patent is invalid as obvious.

REVERSED

Interestingly, KSR was not invoked in the opinion. This is now the 7th opinion (eight, if you count the Pfizer v. Apotex denial of en banc) on obviousness from the CAFC after KSR. So far, the CAFC has not explained in any of the opinions how KSR may have changed the outcome of a case, even though most of the lower court decisions came before KSR. Including Daiichi, the outcomes at the CAFC favor obviousness by a 6-1 margin:

Syngenta Seeds, Inc. v. Monsanto Co. - affirmed obviousness

Leapfrog Enterprises, Inc. v. Fisher-Price, Inc. - affirmed obviousness

Omegaflex, Inc. v. Parker-Hannifin - reversed SJ of non-obviousness

Takeda Chemical Indus. v. Alphapharm Pty., Ltd. - affirming non-obviousness

Frazier v. Layne Christensen Co. - affirming JMOL on obviousness

Pharmastem Therapeutics, Inc. v. Viacell, Inc. - reversing jury verdict and JMOL of non-obviousness