News & Topics

JPO ANNOUNCED THE EXAMINATION GUIDELINE FOR PATENT TERM EXTENSION WILL BE REVISED IN VIEW OF THE NEW SUPREME COURT DECISION
summary:
On May 16, 2011, the JPO announced that part VI: Patent Term Extension(PTE) of current examination guideline will be revised and that the examination of applications for registration of PTE is suspended until the new guideline is become available (expected this autumn).  It should be noted this is not a suspension of acceptance of new PTE applications and a patentee who seeks patent term extension is required to file an application for registration of PTE within the time period required by the current law.
 

Extension of Patent Term in Japan
(Revised in May 2011)

Yasuo TAMURA
AOYAMA & PARTNERS

1.  Products to which the patent term extension is applicable:
 (i) Agricultural chemicals
 (ii) Drugs for humans and other animals

2.  Patents to be applicable:
 All types of the following patents, of which the invention can not be worked for obtaining the marketing approval.

(i) Product patent (e.g. composition, compound, formulation) covering the approved product) (ii) Process patent (e.g. process for preparing the approved product)
(iii) Use patent (e.g. second medical use patent covering the approved use)  

 [Note]:  When the approved product is inclusive, all types of the above product patent and process patent as well as use patent (when the use is the same) can be subjected to the extension of patent term based on a single marketing approval.

3.  Period of time to be extended [Art. 67(2)]:

 Up to 5 years
 [Note]:  This extendable period of time is counted from the later date, either the date of patent registration or the date to start the clinical tests (precisely the next day of the registration or starting of clinical tests), up to the date of approval (precisely the previous day of the approval).

4.  Time limit for filing a request for patent term extension [Art. 67bis(3) and Art. 67bis-bis(2)]:
 Both of the following conditions shall be satisfied:
 (i) within 3 months after obtaining a marketing approval, and
 (ii) before 6 months prior to the date of expiration of the patent term (20 years from the filing date in Japan).
 [Note 1]:  Where it is expected that the marketing approval can not be obtained before 6 months prior to the expiration of the 20 years patent term, the patentee shall notify to the JPO by submitting a document indicating (i) name and address of patentee, (ii) patent number and (iii) contents of the marketing approval [Art. 67bis-bis(1)].    
 [Note 2]:  When the marketing approval will be not obtained before the expiration of the 20 years patent term, no extension of patent term is available [Art. 67bis(3)].  Thus, even when it is sure that the marketing approval will be obtained just after expiration of 20 years patent term, no interim patent term extension is available.  
 [Note 3]:  If the request for patent term extension could not be filed within 3 months after the marketing approval due to any reason beyond control of the patentee (applicant), the request shall be filed within 14 days after the extinguishment of said reason or within 9 months after the approval, whichever earlier. [The proviso of the Patent Law Cabinet Order, Art. 1quater].

5.  Applicant [Art. 67ter(1)(iv) & 67bis(4)]:
 Patentee
 In case of joint patent right, all of the joint owner shall be filed together.  
 [Note]:  The marketing approval shall be obtained by the patentee(s) or by a licensee (exclusive or non-exclusive licensee), and when the marketing approval is obtained by a licensee, the license shall be registered with the JPO within 6 months from filing a request for patent term extension [Art. 67(1)(ii)].

6.  Approval enjoyable
 First approval with respect to the active ingredient and efficacy/effect (Drastically changed by the decision of Supreme Court of Japan dated April 28, 2011, and hence, the Examination Guideline will be revised at around Autumn in 2011)
 [Note]:  According to the examination practice in the JPO until the new decision of Supreme Court (Takeda case) (cf. the attached copies of my papers), the marketing approval enjoyable the patent term extension shall be the first approval with respect to the active ingredient and efficacy/effect of the product, but the requirement will be drastically changed in view of the decision of Supreme Court of Japan, decided on April 28, 2011, while it is not yet know how the JPO will change the current examination practice.  
 That is, under the current examination practice in the JPO, the subsequent approval to make a partial change in formulation, doses, etc. is excluded, because it is not the first approval as far as the active ingredient and efficacy/effect are concerned.
 However, according to the decision of Supreme Court, it is stated as “even where an approval for manufacturing and selling under the Pharmaceutical Affairs Law, Article 14 has been obtained with respect to a drug (preceding drug ) comprising the same active ingredient and having the same efficacies・effects as those of the drug (later drug) of which the marketing approval was obtained, when the preceding drug is not inclusive within the scope of any of the claims of the patented invention of the patent for which an application for a patent term extension was filed, it can not be said that there was no necessity of obtaining the approval in order to work the patented invention.”  This means that based on the second or third approval with respect to a drug of the same active ingredient with the same efficacies・effects, and a patent term extension can be obtained when the formerly approved product is not inclusive within the scope of the patent in question.  
 Thus, the current examination practice (guideline) taken by the JPO for a long period of time was completely denied by the decision of Supreme Court, and it will no more required to be the first approval as to the active ingredient and efficacies・effects unless the formerly approved product is inclusive within the scope of the patent to be subjected to the later patent term extension.
 [Note]  Since it is not yet announced by the JPO how the current examination guideline is revised due to the decision of Supreme Court, it is not sure whether the substance to be approved (to be obtained the disposition as provided for in the Cabinet Order referred to in Patent Law, Article 67, Paragraph 3) is limited to the approved product (preparation or formulation) (not the active ingredient), or it is still acceptable to indicate the active ingredient and efficacies・effects as the substance to be approved.  However, the latter feature will unlikely be accepted in view of the issue in the original decision by IP High Court.  In the case of appeal to IP High Court, the appellant has disputed that the substance to be obtained the disposition as provided for in the Cabinet Order referred to in Patent Law, Article 67, Paragraph 3 shall be the drug approved, i.e. the preparation or formulation, but not the active ingredient in view of the terminology of the provision for approval for manufacturing and selling under the Pharmaceutically Affairs Law, Article 14, wherein it is indicated as “drug”, but not “active ingredient” of the drug.  In the decision of IP High Court, the judges have admitted the argument of the appellant and affirmed that the substance to be obtained the disposition shall be the approved drug but not the active ingredient.  This is very important because it gives much effects on the interpretation of the effects of the patent right of which the application for a patent term extension is filed.  Any how, an attention shall be given to the possible announcement of the JPO as to the revision of the Examination Guideline with respect to procedure for the patent term extension.        

 By the way, without relation to the above decision of Supreme Court, even under the current examination practice of the JPO, the subsequent (second) approval is concerned with new use (e.g. second medical use), a further extension of patent term can be required based on the second approval as to the product patent and process patent, as well as use patent covering the newly approved use.

7.  Plural extensions available
 As mentioned above, under the current examination guideline, the approval enjoyable the patent term extension shall be, in principal, the first one with respect to an active ingredient (product) and efficacy/effect (use), and as far as the same product and same use are concerned, subsequent approval can not be subjected to a further extension of patent term, while the current practice of the JPO will be changed in future in view of the decision of Supreme Court of Japan dated April 28, 2011 (Takeda case).    
 Apart from the change of practice due to the Takeda case, even under the current practice, when two or more marketing approvals are obtained with respect to two or more different active compounds inclusive in a single patent, plural extensions of patent term can be obtained with respect to the single patent.  When applicable, the plural extensions are available also for process patent and use patent as well.  
 Besides, with respect to a single active ingredient, plural extensions are also available, when the marketing approvals are obtained for different use, as mentioned in the above item 7.

8.  Documents necessary for request of patent term extension
    (1) Application form (petition for request of patent term extension)
 indicating the following:
 (i) Patent No.
 (ii) Title of Invention
 (iii) Period to be extended (within 5 years)
 (iv) Date of approval (the exact day on which the applicant (or licensee in Japan) received the approval)
 (v) Applicant (= patentee) (name and address)
 (vi) Contents of approval*1)
 (vi) Attachments
    (a) Reasons for requesting the patent term extension, which shall be attached with evidences supporting the reasons*2)

[Notes]:
*1: Particulars of the disposition (approval) as provided for the Cabinet Order referred  to in Sec. 67(2)
 (a) The contents of the approval constituting the grounds for extension (e.g. approval under the Pharmaceutical Affaires Law Section 41(1) for pharmaceuticals)
 (b) The approval number
 (c) The approved product (active ingredient*) (*: it will be changed by the decision of Supreme Court (Takeda case) as  mentioned above)
 (d) The use for the approved product (i.e. efficacy/effect specified in the approval)
*2: The documents include
 (i) a copy of patent registration (indicating date of registration, date of expiration, payment of annuities, etc.),
 (ii) a document indicating when the clinical study was started,
 (iii) a copy of application for approval (indicating the product and efficacy/effect),
 (iv) a copy of document for proving who has obtained the approval, whether the person is an excusive licensee or a registered non-exclusive licensee, or the patentee.  
(When a licensee has obtained the approval, the license shall be  registered before the JPO)

9.  Examination
 The application is examined about that all documents are compatible with the requirements under Patent Law, Section 67, Section 67bis, and section 67bis-bis (formality) as well as the reasons for applying the patent term extension are compatible with the requirements under Patent Law, Section 67ter(1).
 When the application does not satisfy those requirements, an Office Action is issued to give the applicant an opportunity to response thereto as like in the examination of a usual patent application.  
 When the reasons of rejection would not be remedied by a response, a decision of refusal is issued.  Against the decision of refusal, an appeal can be filed to the Trial Board of the JPO, and when a decision of dismissing the appeal is issued, the applicant can further appeal to IP High Court, and further to Supreme Court, like the examination procedure in a usual patent application.