“Equol-containing Extract and Manufacturing Method Thereof, Equol Extraction Method, and Food Containing Equol”
The Intellectual Property High Court (IP High Court) upholds a prior decision rendered by the Japanese Patent Office (JPO) in an invalidation trial, which had held a patent valid further to approving a claim correction.
Whether the claimed subject matter satisfies the support requirements, and namely, whether ornithine/equol-producing microorganisms other than the Lactococcus 20-92 strain, disclosed in the examples and introduced in the claim correction, satisfies the support requirement based on a known screening method.
Summary of Conclusions:
The court established that many microorganisms having an equol-producing function had been discovered besides the Lactococcus 20-92 strain up until the time of filing the patent application, and that ornithine/equol-producing microorganisms could be obtained by a screening method that targets those microorganisms having an equol-producing function and using the method of investigating ornithine production capability in such microorganisms.
With respect to investigating ornithine/equol-producing microorganisms, which had yet to be discovered at the time of filing the application for this case, paragraph 0036 of the specification for this case discloses that ornithine/equol-producing microorganisms could be obtained by “a publicly-known screening method”. As mentioned above, typical means of searching by screening microorganisms (bacteria) having specific characteristics had become common technical knowledge at the time of filing the application, according to the court.
It was held that once an equol-producing microorganism has been isolated/identified, obtaining ornithine/equol-producing microorganisms by targeting the same microorganism and further adopting transformation capacity from arginine to ornithine as an index is similar to using a known equol-producing microorganisms, and that it cannot be said that there would be any difficulty in obtaining ornithine/equol-producing microorganisms.
The court found that the mere absence of any example disclosing a concrete screening method or the like for ornithine/equol-producing microorganisms yet to be discovered at the time of filing, does not constitute sufficient grounds for lack of support of the claimed subject matter, as corrected.
Accordingly, the court held that the claimed subject matter satisfies the support requirement based on the known screening method that targets ornithine/equol-producing microorganisms other than the Lactococcus 20-92 strain.
The plaintiffs had asserted that searching for a rare equol-producing microorganism from among the innumerable intestinal microorganisms, as well as establishing culturing conditions present a high level of difficulty. However, the court rejected the plaintiffs’ assertions, stating that the searching method was neither specific nor was it possible to recognize special culturing conditions for each bacterium, and that searching for equol-producing microorganism was not considered as requiring excessive trial and error because equol-producing microorganisms, which had been discovered prior to the filing of the application, would include those that are isolated/identified in a short period of time.