News

Submission of foreign language patent applications since April 1, 2016

Until March 31st, 2016 it was only possible to file a foreign language patent application in English. However, in accordance with revisions by the JPO, from April 1, 2016 it became possible to file a foreign language patent application with documents in other foreign languages as well and submit the Japanese translation thereof within one year and four months from the priority date.

  • The possible benefits of said new procedure are the following;
  • Applicants can decide on short notice whether to file an application in Japan
  • Applicants can file patent applications before the JPO with the original document filed in any other country
  • Applicants do not have to prepare English documents to be filed as the foreign language patent application
  • No surcharge for preparing the translation of the application documents shortly before the filing date
  • If a mistranslation is found later on, it is possible to correct the same based on the filed foreign language document

 

Accordingly, we started filing all patent applications from April 1, 2016 in the form of a foreign language patent application unless otherwise specified by our clients.

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Public Holidays – May 2016

Please note that the following days are public holidays in Japan, the so-called “Golden Week”. Our office will therefore be closed on:

  • Friday, April 29, 2016
  • Tuesday, May 3rd to Thursday, May 5th, 2016

 

Since the Patent Office is also closed on these days, all official terms being due during this period will expire on the next working day.

A list of all Japanese public holidays for the remaining year can be found on our contact page.

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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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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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Revision of the ‘Examination Guidelines for Patent and Utility Model in Japan’

As announced on 16 September 2015, the revised ‘Examination Guidelines for Patent and Utility Model in Japan’ (henceforth ‘Revised Examination Guidelines’) and the revised ‘Examination Handbook for Patent and Utility Model in Japan’ (henceforth ‘Revised Examination Handbook’) has been be applied to the examination of patents and utility models on or after 1st October 2015.

The ‘Revised Examination Guidelines’ are explained below.

The basic principles for this revision are:

  • Making descriptions in the Examination Guidelines clear and concise.
    • Ensuring suitable translation into foreign language.
  • Providing enough case examples and court precedents, in order to make the Examination Guidelines easier to understand.
  • Making the Examination Guidelines internationally acceptable.

 

So that case studies and court cases can be suitably added and updated, these have been moved to the ‘Revised Examination Handbook’, together with the former ‘Examination Guidelines for Specific Technical Fields’ (e.g. computer software, biological, and medical related fields).

Some of the major points of revision related to the examination proceedings in the ‘Revised Examination Guidelines’ are mentioned as follows.

  • Clarification of the basic principle of the examination:
  • Addition of a more ‘applicant-friendly’ examination procedure:
  • Clarification of the correlation between the Sufficiency of Disclosure Requirement and Support Requirement:

 

In relation to the Clarity of Claims Requirement:

  • Clarification of the examination manual for expressions which render the scope unidentified (e.g. expressions such as ‘about’, ‘roughly’, ‘approximately’, ‘substantially’ and ‘essentially’),
  • Clarification of the examination manual for a description which specifies an invention of a sub-combination specified by a feature of ‘another sub-combination’, and
  • Revision of the examination manual for descriptions which specify a product by a process.

 

In relation to Novelty and Inventive Step:

  • Clarification that the basic idea of determining an inventive step is the comprehensive assessment of factors which do not support an inventive step and factors which support an inventive step.
  • Clarification that an obstructive factor (i.e. a factor which teaches away from an inventive step) is taken into consideration as a factor which supports an inventive step
  • Clarification of matters to bear in mind in determining an inventive step in relation to hindsight, object of the primary prior art etc., secondary considerations; and
  • Clarification of the manuals for the determination of an invention and for the determination of the novelty thereof, when specifying the invention of a sub-combination by a feature relating to ‘another sub-combination’.

 

The aforementioned major points of revision are divided into three sections (which correspond to Part I, Part II and Part III in the Guidelines), which are further explained in detail as follows.

NB: Sonderhoff & Einsel Law and Patent Office have underlined as required the below sections of the ‘Revised Examination Guidelines’.

 

Part I   – Outline of Examination

The basic principle of examination has been clarified as: ‘On the premise that it is primarily the burden of the applicant, etc. to proceed with the prescribed procedures to obtain the patent right taking his/her own initiatives, the examiner should take into account the purport of establishment of high-quality patent right.’

 

Furthermore, the following procedures in relation to the examination, which are regarded to be more ‘applicant friendly’, have been added.

a) Regarding the subject of prior arts search:

‘The examiner takes into consideration the matters reasonably expected to be added to claims by an amendment as the subject of search, in view of the efficiency of the examination procedures until a decision to grant a patent is rendered.’ (Refer to 2.2 (2) in Section 2, Chapter 2, Part I); and

‘The examiner should give due consideration such that the least number of inventions are excluded from the subject of prior art search’ (Refer to 2.3 in Section 2, Chapter 2, Part I).

 

b) Regarding procedures when a reason for refusal has not been overcome:

In principle, a Decision of Refusal is issued.

However, ‘even when the notified reasons for refusal are unresolved, when it is determined that the examiner can show countermeasures available for the applicant to resolve the reasons for refusal and that it is likely to reach an agreement with the applicant for taking such countermeasures, the examiner shall communicate with the applicant and notify reasons for refusal if an agreement is reached. This notice of reasons for refusal shall be in principle issued as a “Final Notification of Reasons for Refusal”.’ (Refer to 3 in Section 5, Chapter 2, Part I).

It is explained that a ‘Final Notification of Reasons for Refusal’ could be issued also in the Internal Reconsideration Examination for similar cases (refer to 2. in Section 7, Chapter 2, Part I).

 

c) Regarding suggestions for amendments and divisional applications:

If the Examiner is able to indicate a way for the Applicant to respond in order to overcome the reasons for refusal, the Examiner shall proactively suggest to the Applicant any amendments or recommendation to file divisional applications etc.
(refer to 2.1 in Section 8, Chapter 2, Part I)

 

Part II  – Description and Claims

a) Regarding the Sufficiency of Disclosure Requirement and Support Requirement:

(1) The correlation between the Sufficiency of Disclosure Requirement and Support Requirement has been clarified.
‘Both requirements are different in their contents and also in gist thereof’ (refer to 4.1.2 in Section 1 in Chapter 1, Part II).

(2) When a reason for refusal is issued for not satisfying the Sufficiency of Disclosure Requirement or the Support Requirement, it has been set forth that it would not be appropriate for [the examiner] to ‘argue based only on a general argument such as “it is difficult make a prediction in the relevant technical field” without specific explanation of reasons, because this may make it difficult for the applicant to present effective counterarguments, or to understand the amendments to be made to overcome the reasons for refusal’ (refer to: 4.1.1 in Section 1, Chapter 1, Part II; and to 3.1.1 in Section 2, Chapter 2, Part II).

 

b) Regarding the Clarity of Claims Requirement:

(1) When there are expressions which render the scope unidentified:
It is explained [in these guidelines] that even if there are expressions which render the scope unidentified (e.g. expressions such as ‘about’, ‘roughly’, ‘approximately’, ‘substantially’ and ‘essentially’), it will not be immediately determined that the scope of an invention is unclear.

‘The examiner shall evaluate whether a person skilled in the art can understand the scope of a matter specifying the invention including the relevant expression by considering the description and drawings as well as the common general knowledge as of the filing.’ (refer to 2.2(5) in Section 3, Chapter 2, Part II).

 

(2) When an invention of a sub-combination is specified by a feature of ‘another sub-combination’:
Two types of unclear inventions are explained as follows.

(i) The case where the person skilled in the art cannot understand a feature of ‘another sub-combination’ based on the matter stated in a claim, even by considering the disclosure of the description and drawings, as well as the common general knowledge as of the filing, and as a result the invention is unclear.

(ii) The case where the person skilled in the art cannot clearly understand whether or how an invention of a sub-combination is specified by a feature of ‘another sub-combination’, even by considering the statements of the description and drawings as well as the common general knowledge as of the filing, and as a result the invention is unclear. (refer to 4.2 in Section 3, Chapter 2, Part II)

 

(3) When a process of production of a product is described in a claim for an invention of a product:

In light of the decisions of the Second Petty Bench of the Supreme Court of June 5, 2015 (case numbers 2012(ju)1204 and 2012(ju)2658) in the “pravastatin sodium” case, a revised procedure for [examining] the so-called product-by-process claim is explained [as follows in these guidelines].

‘When a production process of a product is described in a claim for an invention of a product, the description of such a claim can be said to satisfy the requirement that “the invention must be clearly described” in the claim solely in cases in which there were circumstances under which it was impossible or utterly impractical to directly define the product by its structure or properties at the time of filing the application. Otherwise, said invention of a product will be determined to be unclear.

The following can be mentioned as the aforementioned circumstances:

(i) where an analysis of the structure or property of the product was technically impossible at the time of filing; or

(ii) where, in view of the necessity to quickly file due to the nature of a patent application etc., a remarkably huge expenditure or amount of time would have been required to identify the structure or property of the product.

The Applicant can provide an explanation in the Detailed Description of the Invention, Written Argument etc. about the existence of the aforementioned circumstances.’
(refer to 4.3 in Section 3, Chapter 2, Part II)

Specific examples which fall under the aforementioned product-by-process claim and aforementioned circumstance may be found on items 2204 to 2205 of the ‘Revised Examination Handbook’.

 

Part III – Requirements for Patentability

The major points of revision in relation to novelty and inventive step are as follows.

a) It has been clarified [in the guidelines] that the basic idea of determining an inventive step is the comprehensive assessment of factors which do not support an inventive step, and factors which do support an inventive step.

1) ‘The examiner determines whether it can be reasoned that a person skilled in the art could have easily arrived at the claimed invention based on the prior art (hereinafter referred to as ‘reasoning’ in this Chapter), by adopting other prior art (hereinafter referred to as ‘secondary prior art’ in this Chapter) or considering the common general knowledge, in light of the various factors which do not support an inventive step (such factors are shown in the left column in the following Figure).

2) If the examiner determines that this reasoning is impossible based on the above step (1), he/she determines that the claimed invention has an inventive step.

3) If the examiner determines that the reasoning is possible based on the above step (1), he/she determines whether the reasoning is still possible by comprehensively assessing various factors, which includes factors which support an inventive step (such factors are shown in the right column in the following Figure).

4) If the examiner determines that the reasoning is impossible based on the above step (3), he/she determines that the claimed invention has an inventive step. 

If the examiner determines that the reasoning is possible based on the above step (3), he/she determines that the claimed invention does not have an inventive step.’
(Refer to 3. in Section 2, Chapter 2, Part III).

Main_factors_for_reasoning_EN

b) It has been explained in these guidelines that the examiner will determine viewpoints for motivation as shown as (1)-(4) in the Figure by comprehensively consideration.

‘It is determined whether or not there is motivation for applying the secondary prior art to the primary prior art by comprehensively considering the viewpoints (1) to (4) in the above Figure: (1) Relation of technical fields; (2) Similarity of problems to be solved; (3) Similarity of operations or functions; and (4) Suggestions shown in the content of prior art. The examiner should note that it is not always possible to determine whether there is motivation by paying attention to only one of these viewpoints.’

It is particularly stated in regards to (1) ‘Relation of technical fields’, that in principle, ‘other viewpoints for motivation must be taken into consideration.’ (Refer to 3.1.1 in Section 2, Chapter 2, Part III).

 

c) It has been clarified [in the guidelines] that an obstructive factor is taken into consideration as a factor which supports an inventive step.

A factor which obstructs the application of the secondary prior art to the primary prior art (obstructive factor) supports the existence of an inventive step. However, if it is sufficiently reasoned that a person skilled in the art would easily conceive the claimed invention even after considering the obstructive factor, then the claimed invention does not have an inventive step. The following secondary prior art can be mentioned as examples of obstructive factors.

(i) secondary prior art which is applied to the primary prior art, whereupon the primary prior art cannot achieve its purpose

(ii) secondary prior art which is applied to the primary prior art, whereupon the primary prior art cannot function

(iii) secondary prior art which is considered to be excluded from the primary prior art, and unable to be adopted by the primary prior art

(iv) secondary prior art which a person skilled in the art would not apply due to a publication disclosing that the secondary prior art is inferior to the other embodiment with respect to operations and effects of the primary prior art’ (Refer to 3.2.2 in Section 2, Chapter 2, Part III).

 

d) Matters to bear in mind in determining an inventive step

Matters to bear in mind in relation to hindsight, object of the primary prior art etc., well-known technique, secondary considerations etc. have been clarified.

1) Regarding hindsight

The examiner should take note to avoid hindsight after acquiring knowledge of the claimed invention to determine an inventive step, such as in the following cases (i) or (ii).

(i) The examiner assumes that a person skilled in the art would have easily arrived at the claimed invention.

(ii) During determination of the cited invention, the examiner became influenced of the claimed invention.

 

2) Regarding the object etc. of the primary prior art:

‘The examiner will generally select the primary prior art which is same as or close to the claimed invention  from the aspect of technical field or problem to be solved.
The primary prior art of which technical field or problem to be solved is considerably different from that of the claimed invention is likely to make the reasoning difficult. In this case, it should be noted that the examiner is required to reason more deliberately whether or not a person skilled in the art would arrive at the claimed invention starting from the primary prior art.
Moreover, where the problem to be solved of the claimed invention is novel …, and usually inconceivable by a person skilled in the art, may be a factor in support of the existence of an inventive step.’

3) Regarding well-known technique:

‘The examiner should not fail to consider whether reasoning is possible (i.e. to consider whether there is a factor teaching away from applying the well-known technique), merely because a given technique is well-known.’

4) Regarding secondary considerations:

‘The examiner may consider circumstances such as commercial success and attainment of a long felt need as a secondary consideration for supporting an inventive step. However, the Examiner may take this circumstance into consideration only when the examiner is convinced by the Applicant’s arguments and evidence that those circumstances are attributed only to the technical features of the claimed invention according to, and not to other factors such as sales promotion or advertisements and the like.’ (3.3 in Section 3, Chapter 2, Part III).

 

e) Examination manual for the determination of an invention and for the determination of the novelty thereof, when a description specifies an invention of a sub-combination by a feature relating to ‘another sub-combination’:

In this case, when it is understood that a structure, function etc. of a claimed sub-combination invention is specified by a feature of ‘another sub-combination’, ‘the Examiner shall find that the claimed sub-combination invention comprises such a structure, function etc.’. Moreover, the Examiner shall determine that this invention of a sub-combination has novelty when there is a difference between the invention of a sub-combination and a cited invention. (Refer to 4. in Section 4, Chapter 2, Part III).

 

A PDF version of this article is available for download here

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Revision of the “Examination Guidelines for Patents and Utility Models in Japan”

As announced on 16 September 2015, the revised ‘Examination Guidelines for Patent and Utility Model in Japan’ (henceforth ‘Revised Examination Guidelines’) and the revised ‘Examination Handbook for Patent and Utility Model in Japan’ (henceforth ‘Revised Examination Handbook’) has been be applied to the examination of patents and utility models on or after 1st October 2015.

 

The ‘Revised Examination Guidelines’ are explained in more detail in this article in our info center.

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Supreme Court’s Opinion in Genentech v. JPO

Insight on Potential  Extension of Patent Term for Pharmaceutical Products

On 17 November, 2015, the Supreme Court of Japan released a key decision that highlighted certain criteria which would allow an owner of a pharmaceutical patent to extend the term of its patent based on the time taken to obtain approvals from the Ministry of Health, Labour and Welfare under the Pharmaceuticals and Medical Devices Act (formerly known as the Pharmaceutical Affairs Act) (“PMDA”).

Background:

A patent term under the Patent Act (“Act”) of Japan is maximum twenty years from the date of the patent application.  However, a patentee may request the Japan Patent Office (“JPO”) to extend such term for up to five years if the patentee is not working the patented invention for a certain period during the twenty-year term, because it needs to obtain government approval to work the patented invention (the JPO may reject such request if it finds that it is not necessary to obtain such approval to work such patented invention).

For pharmaceutical products, if a company intends to manufacture and sell them, it is required to obtain approval for the manufacture and sale of the product under the PMDA.  Such approval focuses on items concerning the product’s quality, effectiveness and safety such as the ingredients, quantity, dosage, administration, effects, and side effects.  Further, if the company intends to change these items, it is required to obtain additional approval for such change of the product.

In Genentech v. JPO, a U.S.-based pharmaceutical company (“Plaintiff”) applied for a patent (“Patent”) on 28 October, 1992 for a pharmaceutical product (genetic name: bevacizumab) (“Product”) and such Patent was registered on 14 February, 2003.  On 18 April, 2007, the Plaintiff obtained the manufacture and sales approval of the Product under the PMDA (“Prior Approval”).  In the Prior Approval, the Product’s dosage and administration for adults was to give an intravenous drip of 5 mg/kg of a patient’s body weight or 10 mg/kg of body weight and its dosage interval was two weeks or more.  Based on the Prior Approval, the JPO, upon the Plaintiff’s request, extended the term of the Patent by four years, two months, and three days – i.e., the time it took to obtain approval from MHLW after the patent was registered.

On 18 September, 2009, the Plaintiff obtained subsequent approval (the “Subsequent Approval”) from MHLW to add a new dosage and administration of the Product.  The new dosage and administration for adults was to give an intravenous drip of 7.5 mg/kg of patient and the amended dosage interval was three weeks or more.

On 17 December, 2009, the Plaintiff again applied to the JPO for an extension of the term of the Patent.  The Plaintiff asserted that they had not utilized the Patent to manufacture and sell the Product under the dosage and administration stated in the Subsequent Approval for a certain period.  The JPO, however, rejected the Plaintiff’s request on 6 January, 2011 on the ground that it was not necessary for the Plaintiff to obtain such Subsequent Approval since although the dosage and administration of the Prior Approval was different from that of the Subsequent Approval, the active ingredients and effects were identical, and therefore, the Plaintiff was able to use the Patent.  On 18 April, 2011, the Plaintiff made an objection to the JPO, but the JPO did not change its position.  The Plaintiff then appealed the JPO’s rejection to the Intellectual Property High Court (“IPHC”).

Intellectual Property High Court’s Decision:

On 30 May, 2014, the IPHC held in favor of the Plaintiff and determined that the purpose of the extension of a patent term under the Act is to prevent a patentee from suffering any disadvantages (e.g., the patentee would not likely be able to recoup any R&D expenses if the patent term was shortened due to the need of obtaining government approval).  Also, since the dosage and administration of the Prior Approval were different from that of the Subsequent Approval, the Plaintiff could not manufacture and sell the Product under the dosage and administration written in the Subsequent Approval until the Subsequent Approval was obtained, and therefore, the JPO should have extended the term of the Patent based on the Subsequent Approval.

Supreme Court’s Decision:

On 17 November, 2015, the Supreme Court affirmed the IPHC’s decision and focused on: 1) comparing the substantial identity of a pharmaceutical product in a prior approval versus the identity of the product in a subsequent approval, and if the substantial identity was different; 2) whether the manufacture and sale of a pharmaceutical product under a prior approval would cover the manufacture and sale of the product under a subsequent approval.

Here, the Supreme Court ruled that with respect to a product invention which focuses on a pharmaceutical ingredient, the substantial identity of such pharmaceutical product should be determined by its ingredients, quantity, dosage, administration, and efficacy.  The Supreme Court also found that the Product’s substantial identity was different (based on its dosage and administration) in the Prior Approval and Subsequent Approval, and since based on such difference the Product was not manufactured or sold during the period of trying to obtain the Subsequent Approval, the Supreme Court concluded that the request for extending the term of the Patent for the Subsequent Approval should be permitted.

In response to the Supreme Court decision, the JPO has announced that by spring 2016, it will consider revising their guidelines for the extension of a patent term.

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