July 2,2021
―Tokyo District Court Case No. 2019 (Wa) 1409 of July 22, 2020 (Presiding Judge SATO)
(1) Article 69, Paragraph 1 of the Patent Act
It is provided that: “A patent right is not effective against the working of the patented invention for experimental or research purposes.”
(2) The Supreme Court Decision of April 16,1999 (Case No. 1999 [Ju] 153)
Experiments or research conducted to obtain marketing approval for a “generic” medicine correspond to the “working of the patented invention for experimental or research purposes” set forth in Article 69, Paragraph 1 of the Patent Act.”
(An excerpt from the judgment)
“In a case where a person has a patent for an invention regarding a chemical substance or a medicinal product containing the chemical substance as an active ingredient, if a third party produces a chemical substance or a medicinal product which falls within the technical scope of the patented invention, and conducts testing which is needed for obtaining materials to be attached to an application form for marketing approval by using such a chemical substance or a medicinal product during the term of the patent in order to apply for the marketing approval as provided for in Article 14 of the Pharmaceutical Affairs Law with the aim of marketing so-called generic medicinal products (hereinafter ‘generic products’), which have the same active ingredients as that of the medicinal product resulting from the patented invention, after the expiration of the term of the patent, such acts of a third party correspond to the ‘working of a patented invention for experimental or research purposes’ as provided for in Article 69, Paragraph 1 of the Patent Act, and should be considered not to be an infringement.”
(3) The decision of the present case
Experiments or research conducted to obtain marketing approval for a “new (original)” medicine also correspond to the “working of the patented invention for experimental or research purposes” set forth in Article 69, Paragraph 1 of the Patent Act.”
(An excerpt from the judgment)
“T-VEC, which is to be subjected to the clinical trial, is a new (original) medicinal product which has received approval from a foreign drug regulatory authority and is undergoing a bridging test in Japan…, and as stated below, the purport of the Supreme Court Decision of 1999 is considered to be applicable to the present clinical trial.…It can be said that, as is the case for a generic medicinal product,…for T-VEC which corresponds to an original medical product, it is required to conduct in advance predetermined testing for a fixed period of time in order to apply for marketing approval thereof, and for conducting the predetermined testing, it is required to produce a medical product which falls within the technical scope of the patented invention”.
(4) A case in which the court rendered a decision to the same effect as the present court decision
Tokyo District Court Decision of February 9, 1998 (Case No. 1996 [Wa] 8627; Presiding Judge TAKABE)
Writer: Hideki TAKAISHI
Supervising editor: Kazuhiko YOSHIDA
Contact for inquiries: h_takaishi@nakapat.gr.jp
Hideki TAKAISHI
Attorney at Law & Patent Attorney
Nakamura & Partners
Room No. 616, Shin-Tokyo Building,
3-3-1 Marunouchi, Chiyoda-ku
Tokyo 100-8355, JAPAN
