1. Utility Requirement in Japan Makoto Ono, Ph.D. Anderson, Mori & Tomotsune E-mail: makoto.ono@amt-law.com Website: http://www.andersonmoritomotsune.com/

2. 1 Utility Requirement in Japan In Japan, the body of Article 29 of the Patent Law defines what is patentable. To satisfy the Enablement Requirement under Article 36 (4), Applicants are required to show how the claimed invention works in practice. Written Description Requirement under Article 36 (6)-(i) requires that, in the original specification as filed, Applicants must provide a proof that the inventors, at the time of the application was filed, had possession of the claimed invention.

3. 2 Article 29 of Japanese Patent Law In the body of Article 29 of the Patent Law provides: “Any person who has made an invention which is industrially applicable may obtain a patent therefor.” Therefore, the requirements are: 1)“industrially applicable” 2)“invention”, and 3)“has made”

4. 3 Article 29 of Japanese Patent Law 1) What is industrially applicable? ■The Japan Patent Office (JPO) interprets it in the broadest sense. ■The requirement will be met if the invention relates to a commercial activity. ■The provision of “industrially applicable” is generally used to reject the claims drawn to a method of treating or diagnosing human patients *. * A method of treating/diagnosing non-human animal, which may be used in livestock industry, is a patentable subject matter in Japan.

5. 4 Article 29 of Japanese Patent Law 2) What is the invention? ■Article 2 (1) of the Patent Law provides: “Invention in this Act means the highly advanced creation of technical ideas utilizing the laws of nature.” ■The technical idea is interpreted to mean that the idea must be reduced to practice in an operative embodiment, i.e. a product, method or process that achieves a practical goal or object. ■The practical goal or object must be understandable from the specification and in light of common technical knowledge, which is provided in Article 36 (4) of the Patent Law.

6. 5 Article 29 of Japanese Patent Law 3) When the inventor “has made” it? ■En banc IP High Court stated: “The applicant should have proved in the specification as filed that the claimed parameter was not based on mere speculation, but was based on the result of experiments. Additional experimental data submitted after the filing of the application cannot be taken into account when determining whether or not the claimed invention is described in the specification as filed.” (in JSR v. JPO, handed down Nov. 11, 2009) ■Article 36 (6)-(i) provides that “the invention for which a patent is sought has to be described in the specification.”

7. 6 Article 29 of Japanese Patent Law Article 29: “Any person who has made an invention which is industrially applicable may obtain a patent therefor.” 1) “industrially applicable” is to exclude a method of treating/diagnosing human patients from the patentable subject matters. 2) “invention” is an idea that can be embodied in a product, method or process that achieves a practical goal or object. (related to Article 36 (4) of the Patent Law) 3) “has made” means that the claimed invention cannot be based on mere speculation alone. (related to Article 36 (6)-(i) of the Patent Law)

8. 7 Article 36 (4) of Japanese Patent Law The “invention” in the sense of Patent Law, is an idea that can be embodied in a product, method or process that achieves a practical goal or object. Article 36 (4), i.e. Enablement Requirement provides: “The specification should describe the claimed invention in a manner sufficiently clear and complete for the invention to be carried out by a person having ordinary skill in the art to which the invention pertains.” In connection with Enablement Requirement, Examination Guidelines states that the specification should explain how to make and how to use the claimed invention.

9. 8 Article 36 (4) of Japanese Patent Law Enablement Requirement: Examination Guidelines regarding Article 36 (4) states that the specification should explain how to make and how to use the claimed invention: “The specification shall be stated so as to enable a person skilled in the art to make the product. … In the technical field where it is difficult to predict the structure, etc. of a product from the function or characteristic, etc. of the product (e.g. chemical substances), unless a person skilled in the art cannot understand how to make another product defined by its function or characteristic, etc. other than products of which manufacturing method is concretely described in the detailed description of the invention (or those which can be made from these products taking into consideration the common general knowledge), the specification regarding the detailed description of the invention is violating the enablement requirement.”

10. 9 Article 36 (4) of Japanese Patent Law Enablement Requirement: Examination Guidelines regarding Article 36 (4) states that the specification should explain how to make and how to use the claimed invention: “The specification shall be stated in the detailed description of the invention so as to enable a person skilled in the art to use the product. To meet this, the way of using the product shall be concretely described except where the product could be used by a person skilled in the art without such explicit description when taking into account the overall descriptions of the specification (excluding claims), drawings and the common general knowledge as of the filing. For example, in the case of the invention of a chemical compound, it is necessary to describe more than one specific use with technical significance in order to show that the chemical compound concerned can be used.”

11. 10 Article 36 (4) of Japanese Patent Law Enablement Requirement: Examination Guidelines further states about how to use regarding pharmaceutical inventions: “Description of the Result of the Pharmacological Test: Since the result of the pharmacological test is to confirm the pharmacological effect of compounds of the claimed pharmaceutical invention, all of the followings should be made sufficiently clear, in principle; (i) which compounds were (ii) applied to what sort of the pharmacological test system, (iii) what sort of result was obtained, and (iv) what sort of relationship the pharmacological test system has with the medicinal use of the claimed pharmaceutical invention.”

12. 11 Article 36 (4) of Japanese Patent Law Accordingly, ■Regarding Pharmaceutical Invention, the Enablement Requirement is met if the specification as filed describes Results of the Pharmacological Test. ■The Results of Pharmacological Test have to be sufficiently disclosed with regard to; (i) the compounds actually tested, (ii) the detailed protocol of the pharmacological test employed, (iii) the results of pharmaceutical test in numerical value *, and (iv) the relationship between the pharmacological test and the intended use as claimed. * Examination Guidelines states: “It should be noted that the results of pharmacological test should be described with numerical data as a general rule.”

13. 12 Article 36 (4) of Japanese Patent Law Tokyo High Court Judgment regarding Enablement (1996 (gyou-ke) No. 201, handed down October 30, 1998) Backgrounds: Claim of the Contested Patent Application: An antiemetic comprising compound A as an active ingredient. Description of the Specification: Compound A was known. The inventors discovered the new therapeutic use of the compound A. The effective dose, method of administration, and the formulation were disclosed in the specification as filed, whereas the employed pharmacological test and the results thereof were not disclosed.

14. 13 Article 36 (4) of Japanese Patent Law The Tokyo High Court Judgment (1996 (gyou-ke) No. 201, handed down October 30, 1998) : “While an invention relating to an antiemetic drug comprising a compound A as an active ingredient is claimed, the specification does not disclose any pharmacological test method and the results thereof which could support the use of compound A in the antiemetic drug. Further, as the use of compound A in the antiemetic drug cannot be presumed from the common general knowledge as of the filing date, the specification cannot be regarded as disclosing the invention in such a way that a person skilled in the art could recognize that the problem of providing an antiemetic drug would be solved by the invention, and therefore the claimed invention is not described in the specification. This failure cannot be remedied by demonstrating the effect after the filing of the application.”

15. 14 Article 36 (6)-(i) of Japanese Patent Law In Japan, the phrase “who has made an invention” means that the claimed invention cannot be based on mere speculation alone. ■Article 36 (6)-(i), i.e. Written Description Requirement provides: “The invention for which a patent is sought has to be described in the specification as filed.” ■Accordingly, the specification as filed has to show that the claimed invention is not based on mere speculation. ■En banc IP High Court stated: “The applicant should have proved in the specification as filed that the claimed parameter was not based on mere speculation, but was based on the result of experiments.” (in JSR v. JPO, handed down Nov. 11, 2009)

16. 15 Article 36 (6)-(i) of Japanese Patent Law In connection with Written Description Requirement, Examination Guidelines quotes the Tokyo High Court’s judgment above: “While an invention relating to an antiemetic drug comprising a compound A as an active ingredient is claimed, the specification does not disclose any pharmacological test method and the results thereof which could support the use of compound A in the antiemetic drug. Further, as the use of compound A in the antiemetic drug cannot be presumed from the common general knowledge as of the filing date, the specification cannot be regarded as disclosing the invention in such a way that a person skilled in the art could recognize that the problem of providing an antiemetic drug would be solved by the invention, and therefore the claimed invention is not described in the specification. ”(1996 (gyou-ke) No. 201. handed down October 30, 1998) Accordingly, the Results of Pharmacological Test should be described in the specification as filed to meet the Written Description Requirement as well.

17. 16 Patent Drafting Practice in Japan ■The specification as filed should disclose at least one Working Example showing the effect of the claimed compounds. ■The level of disclosure depends on what is claimed, i.e. Compound Claims or Medical Use Claims (including first and second medical uses * ). * The JPO does not distinguish the first medical use claims from the second medical use claims when examining Enablement and Written Description Requirements.

18. 17 Patent Drafting Practice in Japan Compound Claims ■It would generally be sufficient to describe the results of in vitro screening assays for the ability of some (but, preferably as much as possible) of the compounds. ■The reasons are: 1) Examination Guidelines states: “In the case of the invention of a chemical compound, it is necessary to describe more than one specific use with technical significance in order to show that the chemical compound concerned can be used.” 2) Japanese Examiners generally consider that the major contribution to the art would be the provision of new compounds that may be useful. Therefore, it is sufficient to know that the claimed compounds may be useful.

19. 18 Patent Drafting Practice in Japan Medical Use Claims ■In Japan, a medical use may be claimed as “a pharmaceutical composition for use in the treatment of …”, or in a Swiss- style format. ■The specification as filed must disclose the Results of the Pharmacological Test. ■Examination Guidelines states that the Pharmacological Test should be “a clinical test”, “an animal experiment” or “an in vitro test” provided that the “relationship between the pharmacological test and the intended use” has been established *. * A prior art reference clearly describing the correlation should be referred to in the specification, especially in the case of in vitro test.

20. 19 Patent Drafting Practice in Japan Medical Use Claims ■The Pharmacological Test should be “a clinical test”, “an animal experiment” or “an in vitro test” provided that the “relationship between the pharmacological test and the intended use” has been established. ■The reasons are: 1) Examination Guidelines states: “The result of the pharmacological test is to confirm the pharmacological effect of compounds of the claimed pharmaceutical invention.” 2) Japanese Examiners consider that what was discovered by the inventors must be the pharmaceutical effect of the claimed compounds.

21. 20 Patent Drafting Practice in Japan Priority Application ■What happens if a priority application had not described any results of the pharmacological test, and if the results were added to the specification when filing a PCT application claiming the priority from the prior application? ■In Japan, the PCT application may not enjoy the benefit of the filing date of the priority application.

22. 21 Patent Drafting Practice in Japan Priority Application ■Examination Guidelines states: “Where the invention that was impossible to be carried out by a person skilled in the art based on the matters disclosed in the priority application comes to be carried out by the addition of modes for carrying out the claimed invention, the effects of priority claim cannot be recognized because the claimed invention of the application in Japan come not to be within the scope of the matters disclosed in the whole filing documents of the priority application.” ■That is, the JPO may not recognize the priority claim to be valid if the priority application does not meet the Enablement and Written Description Requirements, i.e. when the priority application does not describe the results of the pharmacological test. ■Therefore, the priority application should also describe at least one Working Example showing the pharmacological effect.

23. 22 Thank you! Makoto Ono, Ph.D. Anderson, Mori & Tomotsune E-mail: makoto.ono@amt-law.com Website: http://www.andersonmoritomotsune.com/