Use Techno Corp. and Futoshi Matsuyama v. Kenko USA, Inc. (PDF) 2007 U.S. Dist. LEXIS 65084 Decided September 4, 2007 Judge LaPorte Plaintiffs’ business concerns studying natural active chemical compounds. Plaintiffs identified corosolic acid as a specific extract of the Banaba plant leaves that helps maintain healthy blood sugar levels in humans, and patented it as the ‘459 patent. Plaintiffs allege that the Defendant is infringing the ‘459 patent by Ã¢â?¬Å?importing, making, using, offering for sale and selling products containing corosolic acid.Ã¢â?¬Â? Part of the patent claims a concentrate having a corosolic acid content of 1 Ã¢â?¬â?? 15%. The Defendant argues that the patent does not enable one skilled in the art to reach the upper limit of this claimed concentration. Judge LaPorte looked to several factors (the Wands factors) to determine what can be considered undue experimentation:
(1) the quantity of experimentation necessary; (2) the amount of direction or guidance presented; (3) the presence or absence of working examples; (4) the nature of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the predictability or unpredictability of the art; and (8) the breadth of the claims
It was undisputed that the method for obtaining the concentrate in the patent would not yield a 15% corosolic acid concentration. The inventor claimed that the 15% could be obtained with some undisclosed Ã¢â?¬Å?special research.Ã¢â?¬Â? The Plaintiffs had little to no evidence indicating that this was the case. The Defendant showed that other researchers had tried to obtain the 15% concentration and could not achieve more than 3%. Judge LaPorte went through all eight Wands factors and determined that all of them, except the fourth factor, which was neutral, weighed in favor of finding undue experimentation. The court then looked to the question of inequitable conduct. The inventor made some contradictory statements concerning clinical studies done or not done prior to the patent application. Judge LaPorte found these misstatements to be highly material. There was, however, no direct evidence of intent. Little circumstantial evidence indicated an intent to deceive. The inventor’s knowledge of the importance of the clinical studies and his lack of ensuring the studies took place was enough for the court to find inequitable conduct.