March 2016

Extensions of Patent Terms: Revised JPO Examination Guidelines

Art. 67 (2) Patent Act: extension for inventions underlying approval procedure

 

Following the decision of the Supreme Court of Japan (Decision of the Third Petty Bench of the Supreme Court, Nov. 17, 2015 (2014 (Gyo Hi) No. 356)), the Japanese Examination Guidelines for Extension of Patent Terms were revised. The JPO started examinations based on the revised Guidelines by the end of April 2016.

 

According to Article 67 (2), when there is a period during which a patented invention cannot be implemented, the term of the patent right may be extended by filing a request for a patent term extension for a period, however, not to exceed five years. A patented invention may be unable to be implemented if it is necessary to obtain approvals or any other dispositions* as designated by the Cabinet Order under Article 67 (2) of the Patent Act.

 

According to Article 67ter(1)(i) of the Patent Act, the examiner shall reject a request for a pa-tent term extension, if the disposition designated by Cabinet Order under Article 67 (2) is not deemed to have been necessary for the patented invention to be implemented.

 

In the case, where there has been a prior disposition and there is a request for extension based on a further disposition (the current disposition), under the past guidelines a reason for refusal would have been issued according to Article 67ter(1)(i) of the Patent Act, if the scope of the current disposition could have been implemented within the scope of the prior disposition. The scope of a disposition is defined by the features of the pharmaceutical product or agricultural chemical, which correspond to the features of the granted claims, as well as is defined by the use of the pharmaceutical product or agricultural chemical (even if the use in question is not part of the features of the granted scope of protection).

 

An example of a request for extensions of a pharmaceutical product that will be refused under the past guidelines is:

EN_example_dosage

Although the current disposition has different dosage/administration, since the active ingredient and the use (i.e., the features of the granted claims) of the current disposition is the same as that of the prior disposition, the request for extension based on the current disposition would be rejected.

 

Supreme Court Decision

In the Supreme Court’s November 15, 2015 decision, the Court looked at the comparison of prior and current dispositions and held that the comparison shall no longer be based strictly on the features of the granted claims, but will be based on the “examination matters related directly to substantial identity” of the pharmaceutical product or agricultural chemical in accordance with the types of the patented invention.

 

Guidelines

The revised Guidelines follow the Supreme Court’s decision, and explain that when the manufacture and sale of pharmaceutical products or the manufacture or import of agricultural chemicals of the prior disposition include that of the current disposition, then there will be a reason to reject the application for extension based on the current disposition. Whether or not the manufacture and sale of pharmaceutical products or the manufacture or import of agricultural chemicals of a prior disposition include that of the current disposition is determined by comparing the two dispositions with respect to the “examination matters related directly to substantial identity” of the pharmaceutical product or agricultural chemical.

 

Example of “the Examination Matters Related Directly to Substantial Identity” from the revised Guidelines

The following examples is a copy from the revised Guideline and includes the particular disposition as well as “the examination matters related directly to the substantial identity” in accordance with types of the patented invention (see the matters in red marked frame):

EN_cabinet_order

Therefore, in the aforementioned example where the dosage/administration is different in the prior and current dispositions (i.e., increase to 5 mg/use), under the revised Guidelines, this is considered different examination matters and will not likely lead to a reason to reject this request for a patent term extension. The revised Guidelines also allow such differences in the dispositions be clarified in the request document, for example, by stating the differences in dosage and administration.

* The following are dispositions to be designated by Cabinet Order:
(i) a registration related to agricultural chemicals based on the provisions of the Agricultural Chemicals Regulation Act; and
(ii) an approval and certification based on the provisions of the “Pharmaceutical products and Medical devices Act” concerning pharmaceutical products, pharmaceutical products for in vitro diagnosis, products for regeneration medicine and the like.

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March 30, 2016: “The Employment Agreement in Japan” – Seminar at the GCC

The complexities of Japanese labor law affect all companies doing business and hiring people in Japan. Understanding the regulations and recent reforms thereof can be particularly challenging for subsidiaries of foreign firms. In this seminar in the German Chamber of Commerce’s Human Resources Event Series, Mr. Makoto Ohsugi and Mr. Nobuchika Mamine will give an overview over the complex laws governing Japanese employment contracts, alongside a comparison with German labor regulations.

For more information and to register for this event please refer to the website of the German Chamber of Commerce in Japan. The event will be held in English.

Date & Time:      Wednesday, March 30th 2016, 18.30-21.00

Venue:                  The German Chamber of Commerce and Industry in Japan (map)

       Sanbancho KS Bldg. 5F, 2-4 Sanbancho, Chiyoda-ku, Tokyo

Fee:                      JPY 5,400 (members), JPY 8,640 (non-members)

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Sonderhoff & Einsel News Update – March 2016

We would like to inform you about recent and upcoming revisions by the Japan Patent Office.

The first article of this Sonderhoff & Einsel News Update looks at the revision of the “Examination guidelines for Patents and Utility Models in Japan”. The second article outlines the upcoming revision of fees for patent and trademark applications, as well as the handling of extensions for office actions from April 1st, 2016.

Please click the links above to read the articles online in our Info Center or refer to the PDF below. As always, feel free to contact us if you have any questions with regards to the topics covered in this news update.

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Revision of Fees for Patents and Trademarks and Handling of Extensions for Office Actions

As part of the enforcement of the Amended Patent Act and Other Acts etc. of 2015, the official fees of the Japan Patent Office related to patents and trademarks were revised as of April 1, 2016 (the “Effective Date”). In addition, the handling of extensions of the responding period for Office Actions related to patent and trademark applications were also changed. We have highlighted the key revisions below.

 

I. Revision of Fees

(1) Patent-related fees

i) Filing fees

 

 

ii) Patent annual fees

a) Patents where the request for examination was filed on or after April 1, 2004

 

 

b) Patents where the request for examination was filed by March 31, 2004

(2) Trademarks

Trademark registration and renewal fees were reduced by approximately 25% and 20%, respectively.

Registration fees, renewal fees for Trademarks

Registration and renewal fees for trademarks

 

 

Individual fees for IR marks 

The revised fees apply to:

  • Registration fee payments (including for IR marks) where the due date had been extended, had become due on or after the Effective date of the law revision (April 1, 2016), and were to be made on or after the Effective Date;
  • Renewal applications (including for IR marks) that became due (i.e., where the valid period of trademark registrations expires) and were to be filed on or after the Effective Date; and
  • Renewal fee payments for the second term where the renewal applications had been filed (i.e., the first installment of the renewal fees has been paid) on or after the Effective Date.

 

In connection with the aforementioned revisions, we would also like to note that the previous fees still apply to:

  1. Registration fee payments (including those for which the due date has been extended) that became due before the Effective Date, or renewal applications that became due (i.e., the valid period of trademark registration has expired) before the Effective Date or were filed on or after the Effective Date with payment of double the ordinary renewal fees;
  2. Registration fee payments that were made before the Effective Date which were due on or after the Effective Date, or renewal applications made before the Effective Date which became due (i.e., the valid period of trademark registrations expires) on or after the Effective Date; and
  3. Renewal fee payments for the second term that became due on or after the Effective Date where the renewal applications have been filed (i.e., the payment of the first installment of the renewal fees has been made) before the Effective Date.

Requests for trademark registrations or renewal applications subject to the revised fees that have been received by our firm from January 19, 2016 (when the JPO announced the Effective Date) to March 31, 2016, will, in terms of cost efficiency, be carried out for payment or renewal procedures before the JPO on or after the Effective Date, unless otherwise requested by clients or there are special reasons not to do so.

 

(3) Fees applicable to individual cases

Please contact us if you have any questions or need clarification on actual fees applicable to individual cases.

 

II. Extensions of Response Periods to Notifications of Reasons for Refusal of Patent and Trademark Applications

1.       Patent applications

(1) Requesting an extension of time for a Notification of Reasons for Refusal
within the response period

Before April 1, 2016, extensions to response periods were allowable for a month per a request when there wass a justifiable reason for being unable to respond to a Notification of Reasons for Refusal within the time period. However, the extensions were changed as follows.

 

<For applicants residing abroad >

The response period may be extended for two months by submitting a first request, and may be further extended for another one month by submitting a second request (for a maximum time extension of three months). Both the first and second requests for extension may be submitted at the same time. Moreover, providing a justifiable reason for submitting a request will no longer be necessary.

 

(2) Requesting an extension of time for a Notification of Reasons for Refusal
whose response period has lapsed

After the Effective Date, an extension of time for a Notification of Reasons for Refusal whose response period has lapsed may be made if a request is submitted within an allowable time period (two months).  Regardless of whether the applicant resides in Japan or abroad, the response period may be extended for two months by submitting a request. Providing a justifiable reason for submitting a request is no longer necessary, and a fee (51,000 JPY) higher than the fee for an extension request (2,100 JPY) for (1) above is incurred when requesting this extension of time.

However, an extension under the lapsed response period cannot be requested when an extension of (1) above is granted; nor can it be requested when having responded within the original response period.

 

2.       Trademark applications

Requesting an extension of time for a Notification of Reasons for Refusal
whose response period has lapsed

Similar to patents, on the Effective Date, an extension of time for a Notification of Reasons for Refusal for trademark applications whose response period has lapsed can now be made if a request is submitted within an allowable time period (two months) by paying 4,200 JPY.  Refer to paragraph II. 1.(2) above for details.

 

(The aforementioned also now applies to requests for extensions of time for Notifications of Provisional Refusal of international trademark registration applications.)

 

3.       Cases to which the new changes will be applied

Paragraphs 1. and 2. above are applied to cases in which the response periods of Notifications of Reasons for Refusal (including those issued prior to the Effective Date) lapse on or after the Effective Date, and requests to extend a response period were submitted on or after the Effective Date (in the above 1.(1), this will be for the first request if the applicant resides abroad).

However, from the Effective Date and onwards, there will be no change to the current response periods for:

(i) Notifications of Reasons for Refusal issued after Appeal Requests against Decisions of Refusals (including those in the Internal Reconsideration Examination stage), and
(ii) Notifications of Reasons for Refusal issued against an Application for Registration of Extension of the Duration of a Patent Right.

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