“Transfusion Formulation Comprising Sulfur-containing Compound and Trace Metallic Elements”

Overview:
In this case, the plaintiff appealed a decision from an invalidation trial that held the defendant’s patent valid. The Intellectual Property (IP) High Court upheld the trial decision.

Main Issue:
Whether the invention of this case is patentably distinct over a prior art reference.

Summary of Conclusions:
Regarding a prior art reference identified as “Evidence 1”, the IP High Court held that (i) Evidence 1 neither teaches nor suggests the technical concept that forms the basis of the patent in question, i.e., “a solution containing a compound comprising sulfur atoms is stored in one chamber and the trace metallic element storage container is stored in another chamber, such that the solution containing trace metallic elements is stable”; that (ii) whether the amino acid transfusion contains cysteine or N-acyl is optional in Evidence 1; and that (iii) Evidence 1 includes a plurality of unspecified options relating to the storage area of the trace metallic elements. Consequently, the IP High Court found that one of ordinary skill in the art would not have been aware, based on Evidence 1, of the configuration as a unified technical concept in which cysteine or N-acyl is stored in storage chamber 23 and the trace metallic elements are stored in partition chamber 28, such that the solution containing trace metallic elements is stable.
The court found the following differences between claim 1 of the defendant’s patent and the transfusion formulation disclosed in Evidence 1.

Difference 1-1:
According to claim 1 of the patent in question, the trace metallic elements are stored in the trace metallic element storage container accommodated in a chamber other than the chamber filled with the solution containing at least one selected from the group consisting of a sulfur-containing amino acid and a salt of sulfurous acid.

Difference 1-2:
Concerning the components present in the plurality of chambers, claim 1 of the patent discloses an amino acid transfusion in which the solution contained in one of the chambers comprises acetylcysteine, and the trace metallic element storage container is accommodated in another one of the chambers, the trace metallic element container storing the solution comprising at least one type of the trace metallic elements selected from the group consisting of iron, manganese and copper.

The court reasoned that the “acetylcysteine” recited in claim 1 is a cysteine N-acyl, and that therefore Differences 1-1 and 1-2 are considered to be substantial differences from the prior art reference.
The court concluded, in view of the above, that claim 1 of the defendant’s patent recites subject matter that is distinct from the transfusion formulation described in Evidence 1, and therefore found it unnecessary to make determinations on the remaining points, holding that the plaintiff had no grounds to support a reversal of the decision rendered by the trial court.

Comments:
The plaintiff distinguished some claim features as features relating to the problems to be solved by the invention, asserting that these features do not form substantial differences. However, the IP High Court rejected the plaintiff’s argument on this matter, holding that claim features are not required to relate to the means for solving the problems, in order to present substantial differences from the prior art.