“MEDICINE” Case [Towa Pharmaceutical v. Kowa]: A case in which the court denied the establishment of a prior user right, stating that even if a content of a sample drug fells within a numerical range of the invention, there would be no technical idea that the sample drug should contain the content in a limited numerical range (although the foregoing statement was an obiter dictum). This is a practically important case which may be related to the identification of primary/secondary prior art or publicly worked invention.
This is a case relating to the appellee’s patented invention titled “MEDICINE”, in which the court stated that “the technical idea embodied in the appellant’s sample drug should be an invention having the same content as Invention 2 to find that the appellant has a prior user right”, and then denied the establishment of the appellant’s prior user right, for the following reasons: (i) there is no sufficient evidence to find that a water content of the sample drug fell within a numerical range of Invention, (ii) even if a water content of the sample drug fell within such a numerical range, it cannot be said that the appellant controlled it so as to fall within such a numerical range, and (iii) there would be no technical idea to adjust the water content of the sample drug to a certain numerical value within the numerical range.
In the judgment, the court stated the generalization that “‘a person who is preparing a business for the working of the invention’ specified in Article 79 of the Patent Act should be at least a person who, without knowledge of the content of an invention claimed in a patent application, made an invention identical to the said invention, or a person who, without knowledge of the content of an invention claimed in a patent application, learned the invention from a person who made an invention identical to the said invention ⋯. Therefore, the technical idea embodied in a sample drug should be an invention having the same content as Invention 2 to find that the Appellant has a right of prior use.” The court then found the facts, and held that “⋯ as stated above, even though the water contents of sample drugs of tablets which were measured more than 4 years after the date when these tablets were manufactured fell within the range of Invention 2, it cannot be said that the water contents of sample drugs tablets fall within the numerical range of Invention 2 at the time of its manufacturing. ⋯ Therefore, it cannot be said that the water contents of the sample drugs of 2 mg tablets and the sample drugs of 4 mg tablets manufactured by the appellant and subjected to a clinical trial by the filing date fell within the range of Invention 2 (within a range of 1.5 to 2.9 mass%). ”
The court, stating that “even if the sample drugs of 2 mg tablets or the sample drugs of 4 mg tablets fell within the range of 1.5 to 2.9 mass% ⋯”, questioned the technical idea embodied in the sample drugs of tablets. More specifically, the court indicated in the statement, although it was an obiter dictum, that even if the values of water content of the sample drugs of tablets manufactured before the filing date/priority date fell within the numerical range of the Invention, it is not enough reason to find the establishment of the right based on prior use of the “invention”. It is required that the technical idea to keep the water content within the numerical range of the invention is embodied in a sample drug, or, it is required that “the technical idea embodied in a sample drug is an invention having the same content as Invention 2.”
In regard to this point, the court found that “the technical idea of Invention 2” is, “focusing on a water content of a solid preparation comprising pitavastatin or a salt thereof, to suppress production of a lactone form by adjusting the water content at 2.9 mass% or less, to suppress production of a 5-keto form by adjusting the water content at 1.5 mass% or more, and to prevent water entering from the outside of the package by storing the solid preparation in a tight package.”
Then the court found with respect to “the technical idea embodied in the sample drugs” that “(a) it cannot be found that the appellant measured the final water content of the sample drugs before the filing date of the present patent”, “(b) ⋯ it cannot be said that the appellant controlled the water contents of the sample drugs so as to fall within a certain range”, and “(c) ⋯ the numerical range of the water content of granule B was changed from — to — for the sample drugs and for the actual products of the appellant. The appellant did not pay attention to the water content of the sample drug ⋯”, and in conclusion, the court denied the establishment of the prior users right, founding that since “it cannot be found that, when manufacturing the sample drugs of 2 mg tables and the sample drugs of 4 mg tablets before the filing date of the present patent, the appellant controlled the water content of the sample drug so as to fall within the range of 1.5 to 2.9 mass% or a range within it, or a certain numerical value within the range of 1.5 to 2.9 mass%”, “the sample drugs of tablets were prepared with no technical idea to keep the water content within the range of 1.5 to 2.9 mass% or a range within it, or to adjust the water content to a certain numerical value within the range of 1.5 to 2.9 mass%. Therefore, it cannot be said that the technical idea embodied in the sample drugs is identical to that of Invention 2.”
The Appellant (defendant in the first instance): Towa Parmaceutical Co., Ltd.
The Appellee (plaintiff in the first instance): Kowa Company, Ltd. (Patentee)
Writer: Hideki TAKAISHI
Supervising editor: Kazuhiko YOSHIDA
Contact information for inquiries: h_takaishi@nakapat.gr.jp
Hideki TAKAISHI (The person in charge of this Article)
Attorney at Law & Patent Attorney
Nakamura & Partners
Room No. 616, Shin-Tokyo Building,
3-3-1 Marunouchi, Chiyoda-ku
Tokyo 100-8355, JAPAN