Patent Prosecution Procedures under the Japanese Patent Law. Sera, Toyama, Matsukura & Kawaguchi

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1 Patent Prosecution Procedures under the Japanese Patent Law Sera, Toyama, Matsukura & Kawaguchi

2 General Procedures for Patent Prosecution in Japan Application 1) Direct Japanese application Filing in English is OK. Japanese translation should be filed within 14 months from the filing date. 2) Japanese application claiming a conventional priority Filing in English is OK. Japanese translation should be filed within 14 months from the priority date. 3) PCT national phase application National form (written request for entering Japanese national phase) should be filed within 30 months from the priority date of the PCT application. Japanese translation should be filed within 2 months from filing the national form.

3 General Procedures for Patent Prosecution in Japan Request for examination Within 3 years from the filing date Option 1: Accelerated Examination (will be explained later) Option 2: Patent Prosecution Highway (will be explained later) First Office Action arguments & amendments 3month response period (extendible more 3months) Final Office Action 3month response period (extendible more 3months) arguments & amendments* Decision of Rejection Notice of Appeal Within 4 months after receiving the Decision Amendments* At the same time with the Notice of Appeal Appeal Brief Within 30days after receiving an Invitation for an Appeal Brief * : scope of amendments is limited Amendments can also be filed at any time before receiving the first OA.

4 Amendments should be made within the scope described in the original documents (specification, claims and drawings), or within the scope which is obvious to a person skilled in the art from the original documents. After final or upon filing an Appeal, amendments to claims are limited to (1) Cancellation of claims, (2) Reductive restriction of the scope of claims, (3) Correction of errors, or (4) Clarification of ambiguous recitations. For the applications filed on or after April 1, 2007 Requirements for amendments in response to the Office Action becomes more strict. Amendments to claims should be made such that the amended claims meet unity with the claims examined in the outstanding Office Action.

5 Amendments in the applications filed on or after April 1, 2007 Example 1 Claim 1 A (genus) Claim 2 A 1 (species 1) Claim 3 A 2 (species 2) 1 st Office Action (OA) When the Examiner judges that claim 1 does not have a novel technical feature, but claim 2 has a novel technical feature, it is judged that claim 2 and claim 3 do not have unity, and only claims 1 and 2 are examined. In response to the 1 st OA, an amendment to cancel claims 1 and 2 and maintain claim 3 is not allowed. If the applicant desires to prosecute claim 3, the applicant should file a divisional application.

6 Example 2 Claim 1 A Claim 2 A+B Claim 3 A+C 1 st OA Amendments in the applications filed on or after April 1, 2007 When the Examiner judged that claim 1 does not have a novel technical feature, but claim 2 has a novel technical feature, it is judged that claim 2 and claim 3 do not have unity, and only claims 1 and 2 are examined. In response to the 1 st OA, an amendment to cancel claims 1 and 2, and maintain claim 3 is not allowed. If the applicant desires to prosecute claim 3 (A+C), the applicant should file a divisional application. Notes: In the applications filed on or after April 1, 2007, amendments to claims should be made such that the amended claims meet unity with the claims examined in the Office Action.

7 We suggest to reformulate claims at or before filing a request for examination, based on (1) which claim is most important for the applicant, and (2) the result of International Search Report (ISR) If ISR says that the application does not meet unity, the important group of claims should be presented first, because group I (claims presented first) is automatically elected for examination. If ISR says that claim 1 is not novel, Claim 1 should be amended to have novel technical feature, and other claims should be also amended to recite the novel technical feature of the amended claim 1. We will make an advice how to reformulate the claims before filing a request for examination in each case.

8 Divisional application Under the Japanese patent practice, a divisional application can be filed: (1) before receiving the 1 st office action, (2) in response to the office actions, (3) At the same time with the Notice of Appeal (Notice of Appeal should be filed within 4 months after receiving the decision of rejection ), and (4) within 30days after the Notice of Allowance or within 4 months after the Notice of Decision of Rejection. [(4): only for the application having a filing date of April 1, 2007 or later] Note that a divisional application cannot be filed if the decision of rejection is irrevocably established in an appeal. At the same time with the Notice of Appeal may be the last chance for filing a divisional application. Safety divisional is recommended, especially for an important application.

9 Accelerated Examination is available if the application has a corresponding application in a country other than Japan. Applicant can generally receive a first office action within 6 months to one year after filing the request for the Accelerated Examination. Documents required 1. Documents cited in the International Search Report 2. Comparison between the cited documents and the claimed invention to show that the claimed invention is novel and inventive over the cited documents 3. Amendments if any If the corresponding application in a country other than Japan such as US, EP, GB, DE, CN, KR has been granted or indicated to have allowable claims, the applicant can request for Patent Prosecution Highway (PPH) as one option of the Accelerated Examination.

10 PPH in JPO based on allowed claims in the corresponding application The applicant can request the examination with the claims amended to conform to the claims allowed in the corresponding application in a country other than Japan (first country). PPH is available if (a) the JPO application (including PCT national phase application) is (i) an application which validly claims priority under Paris Convention to the corresponding application(s), (ii) an PCT national phase application without priority claim, or (iii) an application which validly claims priority under Paris Convention to the PCT application(s) without priority claim. (b) At least one corresponding application exists in the first country and has one or more claims that are determined to be allowable in the first country. (c) All claims in the JPO application for PPH must sufficiently correspond to one or more of those claims indicated as allowable/patentable in the first country. (d) The JPO has not begun examination of the application. Documents to be filed (a) Copies of all office actions in the first country (including Notice of Allowance) (b) Copies of all claims determined to be allowable in the first country (c) Copies of references cited in the first country (d) Claim correspondence table (JP vs. the first country)

11 Method of treatment claim is not allowed under the Japanese Patent Practice. Method of treating diabetic subject comprising administering compound A A medicament (pharmaceutical composition) for treating diabetes comprising compound A. A method of producing a medicament (pharmaceutical composition) for treating diabetes comprising formulating compound A. Use of compound A in production of a medicament (pharmaceutical composition) for treating diabetes. Method comprising a surgical step is not allowed. A method of testing diabetic risk, comprising isolating a blood sample from a subject, and measuring a protein X level in the blood sample. A method of testing diabetic risk, comprising measuring a protein X level in a blood sample isolated from a subject. Working examples (preferably in vivo data) showing the effect of the claimed compound (composition) should be presented in the original specification. A chemistry or biotechnology invention having no data in the original specification will be rejected. In such cases, experimental data showing the effect are not considered by the Examiner even if they are filed in response to an Office Action.

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