GuidebookforJapaneseIntellectualPropertySystem2nd Edition

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Preface This Guidebook (English text) is prepared to help attorneys-at-law, patent attorneys, patent agents and any persons, who are involved or interested in the practice of intellectual property matters, to grasp an overall image of the procedures and practice of the Intellectual Property System in Japan (hereinafter will be called "the IP System"). This text is focused on the Patent System, the Utility Model System and the Trademark System, effective as of April 1, 2012. Specifically, by referring to the Examination Guidelines issued by the Japan Patent Office, the text is written regarding the stages of acquiring an IP right (the stages of filing and prosecuting IP applications) and the stages of enforcement of the acquired IP right by a right holder, in Japan. We sincerely hope that this text will enable a reader to obtain sufficient knowledge about the aspects of the IP System which is characteristics of Japan and to understand points of difference from the systems of the reader's country, and it would be our great pleasure that this text will be of some help to the reader in acquiring the IP right and making the best use thereof in Japan.

April, 2012Yoshiyuki KAWAGUCHI, Ph.D., Patent Attorney

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2nd Edition Revision of the Patent Act of Japan, signed into law in 2014, will take effect on April 1, 2015. The Revision includes major changes such as reintroduction of the post-grant Opposition system. To conform to the Revision, we have now prepared the 2nd Edition of our Guidebook for Japanese IP system. This new edition, remaining focused on the whole Japanese IP system, updates you on the revised Patent Act effective as of April 1, 2015.

We sincerely hope that our Guidebook will enable a reader to obtain latest and sufficient knowledge about the aspects of the IP System and to understand points of difference from the systems of the reader’ s country, and it would be our great pleasure that this book will be of some help to the reader in acquiring the IP right and making the best use thereof in Japan.

April 2015Akira HIRAKAWA, Patent Attorney

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Table of Contents

1. Patentability1-1. Industrially Applicable Invention (Article 29, Paragraph 1, Patent Act) 111-1-1. An Invention which is industrially applicable. 111-1-2. Inventions which cannot be industrially applicable (Medical Acts) 121-1-3. Patentability of computer software-related inventions 131-1-4. Patentability of Business Method Inventions 14

1-2. Novelty (Article 29, Paragraph 1, Patent Act) 151-2-1. Publicly Known Invention 161-2-2. Publicly Worked Inventions 171-2-3. Invention Described in a Distributed Publication 171-2-4. Exception to Lack of Novelty of Invention (Article 30, Patent Act) 181-2-5. Method of determining novelty 191-2-6. Selection Invention 201-2-7. Use Invention 21

1-3. Inventive Step (Article 29, Paragraph 2, Patent Act) 221-3-1. Criterion for Determining Inventive Step 221-3-2. Motivation 241-3-3. Advantageous Effects 25

Ⅰ Patent

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1-3-4. Obstructive Factors (Teach away) 26

1-4. Prior Application Effect (Article 29-2, Patent Act) 26

1-5. Description Requirements 271-5-1. Enablement Requirements (Article 36, Paragraph 4, Item 1, Patent Act) 281-5-2. Support Requirements (Article 36, Paragraph 6, Item 1, Patent Act) 291-5-3. Clarity Requirements (Article 36, Paragraph 6, Item 2, Patent Act) 30

1-6. Prior Application (Double Patenting) (Article 39, Paragraph 1, Patent Act) 311-6-1. Determination of "the earliest date" 321-6-2. Determination of subject matter a prior application and a later filed application. 321-6-3. Determination of identicalness of the subject matter 32

1-7. Right to obtain a patent 331-7-1. Transfer of, and granting a license under, the right to obtain a patent 341-7-2. The right to obtain a patent for a joint invention. 34

2. Procedures: from filing a patent application to obtaining a Patent Right 2-1. Flow Chart 35

2-2. Requirements for Patent Application 37

2-3. Laying-Open of Unexamined Patent Application 38

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2-4. Request for Examination of Application 39

2-4-1. Accelerated Examination 392-4-2. Patent Prosecution Highway 40

2-5. Amendments of Application (Article 17-2, Patent Act) 412-5-1. Timing and the Scope for making amendments 41

2-6. Claim dependency 42

2-7. Having a Personal Interview with the Examiner 42

2-8. Presentation of Information by a Third Person (Article 13-2, Regulations under the Patent Act). 432-8-1. Timing of Presentation of Information 432-8-2. The Information that Can Be Presented. 43

2-9. Division of Patent Application 442-9-1. Timing for Filing a Divisional Application 442-9-2. Requirements for Divisional Application 45

2-10. Demanding Appeal against the Decision of Rejection of the application. 462-10-1. Summary 462-10-2. Grounds for Demanding Appeal against the Decision of Rejection of the application. 462-10-3. Flow of Appeal Proceedings 47

2-11. Suit against Appeal Decision 47

2-12. Topics of Different Technical Fields 482-12-1. Medicinal Inventions 482-12-2. Genetic Engineering-Related Inventions 48

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3. Post-Grant Procedures 3-1. Opposition Procedure 493-1-1. Details of Opposition 493-1-2. Periods for Filing Opposition 493-1-3. Grounds for Filing Opposition 493-1-4. Procedures of Opposition 503-1-5. Effects of a decision of opposition 503-1-6. Lawsuit against trial decision 51

3-2. Trial for Patent Invalidation 513-2-1. Grounds for Patent Invalidation 513-2-2. Person who can request for a trial for patent invalidation 523-2-3. Term for requesting for a trial for patent invalidation 523-2-4. Effects of a trial decision of invalidation 523-2-5. Lawsuit against trial decision 533-2-6. Request for correction of the description, claims and/or drawings during a trial for patent invalidation 533-2-6-1. Requirements for request for correction 533-2-6-2. Term for filing a request for correction (Article 134-2, Paragraph 1, Patent Act) 543-2-6-3. Effects when the correction is approved 54

3-3. Trial for Correction 54

3-4. Extension of the Duration of Patent Right (Article 67, Paragraph 2, Patent Act) 553-4-1. What is the system of extension of the duration of patent right? 553-4-2. Procedures for obtaining the extension of the duration of patent right (Article 67-2, Article 67-2-2, Patent Act) 563-4-3. Requirements for obtaining the extension of the duration of patent right 573-4-4. Trial for invalidation of registration of extension of the duration of patent right (Article 125-2, Patent Act) 58

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4. Patent Right 4-1. Patent Right 594-1-1. Effects of patent right 594-1-2. Limits of patent right 594-1-3. Technical scope of patented invention 604-1-4. Indirect Infringement 60

4-2. Licenses 614-2-1. Exclusive License 614-2-2. Non-Exclusive License 624-2-3. Non-exclusive license based on prior use 62

4-3. Enforcement 634-3-1. Demand for injunction and disposal of infringing products 634-3-2. Claim for damages, etc. 634-3-3. Presumption of Amount of Damage 644-3-4. Presumption of Negligence 644-3-5. Right to claim compensation (Article 65, Patent Act) 65

4-4. Jointly owned patent rights 65

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1. Requirements of Application for Utility Model Registration1-1. Japanese National Phase Utility Model Application of a PCT application (filing a National Form and a Japanese translation) 68

2. Utility Model Registration 683. Correction of the Scope of Claims 694. Report of Utility Model Technical Opinion 695. Responsibility of holder of Utility Model Right 706. Patent Applications based on Utility Model Registration (Conversion of Application) 70

Ⅱ Utility Model

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1. The procedures for obtaining a trademark right 722. Points to remember 733. Examination 75

Ⅲ Trademark

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Ⅰ

Patent1. Patentability

1-1. Industrially Applicable Invention (Article 29, Paragraph 1, Patent Act)

1-1-1. An Invention which is industrially applicable.

The Japanese Patent Act provides that an invention which is industrially inapplicable cannot be patented. Here, the term "industry" covers a broad range including "industries", "manufactures", "mining industry", "agricultural (farming) industry", "fisheries", "transportation services", "communications services", etc. But, whether such "industry" has the economical power or not is not questioned.

An invention which does not meet the requirement of "industrially applicable invention" includes "an invention which is impractical to utilize as a business", "an invention which practically cannot be actually performed", and "medical acts" which are mentioned in the EXAMINATION GUIDELINES of the Patent Office, and which will be explained in the next paragraph.

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1-1-2. Inventions which cannot be industrially applicable (Medical Acts)

In Japan, a patent cannot be granted for an invention of performing a surgical operation on a human, a method of performing a medical treatment or a medical diagnosis on a human (namely, the medical acts). Although the Patent Act does not expressly provide that such medical acts cannot be patented, in the practice of examination of patent applications by the Patent Office, the above-mentioned medical acts are not accepted as industrially applicable inventions.

While an invention of "performing a surgical operation on a human", "a method of performing a medical treatment on a human", or "a method of performing a medical diagnosis on a human" cannot be patented from a political consideration on a humanitarian ground. However, patentability of inventions is not denied for inventions in the entire medical business field. For example, inventions of medicines and medical instruments are accepted as patentable inventions of products. Further, methods of producing medicines, methods of manufacturing medical instruments, methods of operating medical instruments, and methods of processing and analyzing substances collected from a human are accepted as a patentable method invention. However, regarding the substance collected from a human, the method of processing and analyzing it on a prerequisite that it should be returned to the same human for medical treatment (for example, a method of hemodialysis) cannot be accepted as the industrially applicable invention. However, a method of producing a medicine or a medical material using a substance collected from a human as a raw material (for example, a method of making an artificial bone, a method of making a cultured skin sheet, and the like) is accepted as the industrially applicable invention, even though the method of processing such medicine or medical material is performed on the prerequisite that such medicine or medical material is returned to the same human. Therefore, a careful attention should be made to patentability of the subject matter of an invention.

It should be noted that even in the case where an invention is a method of performing a surgical operation, a method of performing a medical treatment or a method of performing an analysis, when the method of performing such medical act is made on animals (excluding a human), the invention is accepted as the

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industrially applicable invention.

1-1-3. Patentability of computer software-related inventions

The Japanese Patent Act provides a definition of "invention" such that "invention should be the highly advanced creation of technical ideas utilizing the laws of nature" (Article 2, Paragraph 1, Patent Act).

According to the Patent and Utility Model Examination Guidelines (Part VII, Chapter 1) of Patent Office, it states that the computer software-related invention where "information processing by software is concretely realized by using hardware resources", the said software is deemed to be "a creation of technical ideas utilizing a law of nature", that is, the software is "the invention" in terms of the Patent Act, and it can be patented.

The JPO Examination Guidelines explain that "information processing by software is concretely realized by using hardware resources" means that, as a result of reading the software into the computer, the information processing equipment (machine) or operational method thereof particularly suitable for a use purpose is constructed by concrete means in which software and hardware resources are cooperatively working so as to realize arithmetic operation or manipulation of information depending on the use purpose.

Software-related inventions are categorized as follows.

- Invention of a product: When a software-related invention is expressed as a combination of multiple functions performed by the invention, the invention can be defined as an invention of a product by specifying such functions.

A program or data can be defined in the following manners:(a) "A computer-readable storage medium having a program recorded thereon"

can be defined as "an invention of a product." "A computer-readable storage medium having structured data recorded thereon" can also be defined as an invention of a product, where processing performed by a computer is specified

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by the data structure recorded thereon.(b) "A program" which specifies a multiple of functions performed by a computer

can be defined as "an invention of a product."

- Invention of a method: When a software-related invention is expressed in a sequence of processes or operations connected in time series, namely procedure, the invention can be defined as an invention of a process (including an invention of a process of manufacturing a product) by specifying such a procedure.

The Old Japanese Patent Act defined "a product" by bearing in mind that the product is practically used as a tangible body. Hence, it was not always clear that a computer program itself, which is intangible, can be protected by the Patent Act. However, there has been a great demand for more clear and strong protection of software, and with this background, the 2002 Amendment of Patent Act was enacted. The 2002 Amendment provides "an invention of a product" includes a computer program, etc (Article 2, Paragraph 3, Item 1, Patent Act). Further, the 2002 Amendment provides a "computer program, etc." in this Act means a computer program (a set of instructions given to an electronic computer which are combined in order to produce a specific result) and any other information that is to be processed by an electronic computer equivalent to a computer program (Article 2, Paragraph 4, Patent Act).

Consequently, in Japan, with respect to a computer software-related invention, a patent is granted on not only a pure product and a process but also a program. In other words, an applicant can obtain a patent on a computer software-related invention at various forms, such as a "machine (equipment, apparatus, device)", a "process (method)", a "program", a "computer readable recording medium having a program", and "a computer readable recording medium on which a data having (a specific) structure is recorded", etc.

1-1-4. Patentability of Business Method Inventions　 Taking into account the Case, Re: State Street Bank (State Street Bank & Trust Co. vs. Signature Financial Group Inc., 149 F. 3rd 1368 (Fed. Cir. 1998), in which

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patentability was approved in the US., as a turning point in Japan, trying to obtain a so-called "Business Model Patent" was in fashion. However, under the Japanese Patent Act, an invention to be protected is "an invention which utilizes a law of nature" as provided in Article 2, Paragraph 1, Patent Act. Hence, a pure business method, which does not meet the requirement of "utilizing a law of nature," cannot be accepted as "the invention" in terms of the Patent Act. "Examples of business-related inventions which cannot be patented" as officially announced by the Japan Patent Office, exemplify the following inventions as not the inventions protected by the Patent Act:

(a) an invention claiming a business method as such,(b) an invention in which a business is performed by using a computer and the like

as a mere tool, and(c) an invention in which information processing by software is not concretely

realized by using hardware resources.

Conversely, it can be said that a business method utilizing a law of nature, for example, a business system utilizing a computer program may be regarded as "a patentable invention." An application for a business-related invention is examined as an application for a computer software-related invention according to a guideline published by the Japan Patent Office ("Handling applications for business-related inventions in examination thereof", December 22, 1999). 1-2. Novelty (Article 29, Paragraph 1, Patent Act)

Inventions which were publicly known, inventions which were publicly worked, or inventions which were described in a distributed printed publication or made available to the public through telecommunication lines "in Japan or elsewhere (any foreign countries)" prior to the filing of the patent application, serve as providing a basis for lack of novelty of the invention. However, it should be noted that examination of novelty of an invention is performed based on the original filing date of its application (for a PCT application, it is the International Filing Date), but not based on a time unit, that is, in the case where the filing date of a patent application is the same as the date of the publication, the time of distribution is not deemed

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prior to the filing of the patent application, except when the filing time of application is clearly after the time of publication.

Regarding novelty of an invention, Article 29, Paragraph 1, Patent Act, provides as follows:

"An inventor of an invention that is industrially applicable may be entitled to obtain a patent for the said invention, except for the followings:"

Here, regarding the "except for the followings", it is defined in this Article in Items (i), (ii) and (iii), respectively. An explanation of each Item will be made below.

1-2-1. Publicly Known Invention　 Article 29, Paragraph 1, Item (i), Patent Act, defines the "publicly known inventions" which provide a basis for lack of novelty of an invention of the patent application, so that the invention cannot be patented, as follows.

"(i) Inventions that were publicly known in Japan or a foreign country, prior to the filing of the patent application."

Regarding the meaning of "Publicly Known Inventions", the JPO Examination Guidelines explain it as follows.

"An invention the contents of which have been known to an unspecified person without obligation of secrecy results in the "publicly known invention", irrespective of the inventor's or the applicant's intent to keep it secret. However, a manuscript for a journal of an academic society, in general, is usually kept secret against a third party, even after the receipt of the manuscript by the academic society. Therefore, the invention described in that manuscript is not considered a publicly known invention, until the contents are released."

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1-2-2. Publicly Worked Inventions

Article 29, Paragraph 1, Item (ii), Patent Act, defines the "publicly worked inventions" which provide a basis for lack of novelty of an invention of the patent application, so that the invention cannot be patented, as follows.

"(ii) Inventions that were publicly worked in Japan or a foreign country, prior to the filing of the patent application."

Regarding the meaning of "publicly worked inventions", the JPO Examination Guidelines explain it as follows.

"An invention which has been worked under the conditions where the contents of the invention are to be publicly known or can potentially be publicly known."

"Conditions where the contents of the invention are to be publicly known" include, for example, a situation where a person skilled in the art may easily understand the contents of the invention by observing the manufacturing process associated with the invention at a plant that is exposed to an unspecified person. "Conditions where the contents of the invention are to be publicly known" include，for example, a situation where, although inner parts of the manufacturing facility cannot be known to an unspecified person (a visiting inspector) by merely observing the exterior view and the person cannot know the invention as a whole without knowing such inner parts, the person is allowed to observe the inner parts or can have the inner parts explained (i.e., the request for observation or explanation is not to be refused by the plant.)

1-2-3. Invention Described in a Distributed Publication

Article 29, Paragraph 1, Item (iii), Patent Act, defines the "inventions described in a distributed publication" which provide a basis for lack of novelty of an invention of the patent application, so that the invention cannot be patented, as follows.

"(iii) Inventions that were described in a distributed publication, or inventions that

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were made publicly available through an electric telecommunication lines in Japan or a foreign country, prior to the filing of the patent application." Regarding the meaning of "Distributed Publication", the JPO Examination Guidelines explain it as follows.

A "publication" is a document, a drawing or other similar medium for the communication of information, duplicated for the purpose of disclosing the contents to the public through distribution. A "Distribution" in the working of "inventions described in a distributed publication" means placing a publication as defined above in the condition where unspecified persons can read or see it. It does not necessitate the fact of a certain person's actual access to such a publication.

Further, by the 1999 Amendment of the Patent Act, the technical information which is disclosed in such a state where the public can access to such technical information on internet, provides a basis for lack of novelty of an invention of the patent application.

Regarding the term of "inventions that were made publicly available through electric telecommunication lines" which specifies the above-mentioned state, the Examination Guidelines explain this term as follows.

"It indicates the state where an invention can be observed by unspecified persons. It does not necessitate the fact of a certain person's actual access to such technical information. Specifically, in the case where, on internet, a link is extended and the technical information is registered in a retrieval search engine, or an address (URL) is described in a medium of transmission of information to the public (for example, broadly, newspapers, magazines, etc., which are widely known publicly in general), and there is no restriction to access thereto by the public. This state is "publicly available."

1-2-4. Exception to Lack of Novelty of Invention (Article 30, Patent Act)

In Japan, even when an invention has lost novelty, the Japanese Patent Act

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provides "Exception to lack of novelty of invention" to give relief to such invention under the required conditions.

The "Exception to lack of novelty of invention" can be applied to an invention which meets any of the following requirements:

(a) The person having the right to obtain a patent has disclosed the invention by himself/herself within one year before the filing date of the patent application (Article 30, Paragraph 2, Patent Act).

(b) An invention which has been caused to "lack of novelty" by a third party against the will of the person having the right to obtain a patent within one year before the filing date of the patent application (Article 30, Paragraph 1, Patent Act).

Any person who desires to obtain application of any of the above-mentioned relief provisions of "Exception to lack of novelty of invention", the person (the applicant) must file a patent application within one (1) year from date on which novelty was lost, and must take the necessary procedures as specified in Article 30, Paragraph 3, Patent Act. However, in the case of the above requirement (b), the person can simply file a patent application within one (1) year from the date on which novelty of invention was lost, and not required to take the procedures of submitting the documents, such as, evidence, written explanation, etc.

In determining novelty and inventive step under the provisions of Article 30, Patent Act, the application of "Exception to lack of novelty" would merely be regarded that the invention has not lost its novelty by the reason (own disclosure or unexpected disclosure). Hence, if, within one (1) year from occurrence of the reason for requesting application of "Exception to lack of novelty", another reason(s) occur(s) to cause the lack of novelty of the invention, no relief can be given to the invention. Applicants should bear this point in mind.

1-2-5. Method of determining novelty

To determine whether a claimed invention falls under Article 29, Paragraph 1, any of Items of Patent Act, is performed by the following procedures:

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(i) Finding of a claimed invention: The finding of a claimed invention is made on the basis of the statement of the claim(s), by taking into consideration the description in the specification and drawings and the common general technical knowledge as of the time of the filing, and construe the meaning of each of matters (terms) stated in the claim(s).

(ii) Finding of a cited invention: The finding of a cited invention is made from the fact indicating that the invention is actually publicly known and publicly worked, and from the fact that the invention described in a printed publication is actually described or it is regarded as equal to be described in the printed publication, by considering the common general technical knowledge.

(iii) Comparison of a claimed invention with a cited invention: The finding of the identicalness and the difference between a claimed invention and a cited invention is conducted by comparing the specified matters to define the invention according to claim(s) and the specified matters to define the invention of the cited invention.

(iv) Determining novelty of a claimed invention: As a result of the comparison of (iii), when there is no difference between the specified matters to define the invention according to claim(s) and the specified matters to define the invention of the cited invention, the claimed invention is determined as lack of novelty. When there is a difference, the claimed invention is determined as having novelty.

1-2-6. Selection Invention

Regarding an opinion about novelty of selection invention, the JPO Examination Guidelines explain it as follows.

"Selection invention is an invention that pertains to a technical field in which an effect of a product is difficult to understand from its structure. Further, in the invention described in a printed publication where the invention is expressed in the generic concept or the invention is actually expressed in the matter of selection in the form, and where it is assumed that an invention is expressed in the more

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specific concept encompassed by the generic concept of the former invention, or an invention specifying part of the above- mentioned matter of selection as the matter specifying the invention, and novelty of the latter invention is not denied by the former invention. Consequently, such latter invention can be said the invention which is not described in the printed publication, and this latter invention can be selection invention."

Further, regarding an opinion about inventive step of a selection invention, which will be explained later, the JPO Examination Guidelines explain it as follows.

"An selection invention generates an advantageous effect, not disclosed in a cited publication, the effect is different from the effect of the invention expressed in the generic concept in the cited publication, or even the effect is in the same nature but prominent in comparison with that of the invention expressed in the generic concept, and the effect cannot be foreseen by a person skilled in the art from the state of the art. Then the selection invention has inventive step."

1-2-7. Use Invention

When an invention of a product includes a limitation of use thereof, and when the claimed invention is based on discovering an unknown attribute of a product and finding that the product is suitable for new use due to the presence of such attribute, this invention is regarded as a use invention. With the use invention, the limitation of use is regarded as having the meaning of specifying feature of the claimed invention. The idea of a use invention is generally applied to the technical field in which it is comparatively difficult to understand how to use a product of a claimed invention from its structure or the name thereof (for example: the technical field of use of a composition comprising chemical substances).

A claim(s) may be stated in the form of a limitation of use, and, also, in the form of so-called a pharmaceutical agent or in the form of a method of using.

Regarding an opinion about novelty of the use invention, the JPO Examination Guidelines explain it as follows.

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"Even if the product per se is already known, the claimed invention can be novel as a use invention. However, even when an unknown attribute has been discovered, if the claimed invention is not considered to provide new use for the product by taking into account the common general technical knowledge in the relevant technical field at the time of the filing, novelty of the claimed invention is denied. In addition, even when the claimed invention and a cited invention are inventions of products defined by different workings in the limitation of use, novelty of the claimed invention is denied, if the two inventions cannot be distinguished in terms of their use by taking into account the common general technical knowledge in the relevant technical field at the time of the filing."

Concerning an opinion about inventive step of an invention, which will be explained below, the JPO Examination Guidelines explain it as follows.

"Even when the claimed invention provides a new use based on an attribute of the product, if a person skilled in the art could have easily arrived at such use based on known attributes or known product structures, inventive step of the claimed invention is denied." 1-3. Inventive Step (Article 29, Paragraph 2, Patent Act)

1-3-1. Criterion for Determining Inventive Step

A criterion for determining inventive step in Japan, Article 29, Paragraph 2, Patent Act provides as follows. "Where, prior to the filing of the patent application, a person ordinary skilled in the art of the invention would have been able to easily make the invention based on a publicly known invention, a patent shall not be granted for such an invention."

With respect to the terms of "an invention prescribed in any of the Items of the preceding Paragraph", and "a person ordinary skill in the art of the invention", the JPO Examination Guidelines explain each term as follows.

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"An invention prescribed in any of the Items of the preceding Paragraph" means any of the inventions which were publicly known or publicly worked in Japan, and inventions described in a distributed publication in Japan or elsewhere prior to the filing of the patent application." "A person ordinary skill in the art of the invention" (hereinafter referred to as "a person skilled in the art") means a hypothetical person who has the common general knowledge as of the time of filing in the art to which the claimed invention pertains, and has ability to use ordinary technical means for research and development; who has ability to exercise ordinary creativity in selecting materials and changing designs; and who is able to comprehend as his/her own knowledge all technical matters in the state of the art in the field to which a claimed invention pertains at the time of filing a patent application. In addition, a person skilled in the art is supposed to be able to comprehend as his/her own knowledge all technical matters in the field of technology relevant to a problem to be solved by an invention"

Regarding determination of "whether or not a claimed invention could easily have been made", the JPO Examination Guidelines explain that whether the below-mentioned "reasoning" can be made.

"Determination of inventive step is made whether the reasoning that a person skilled in the art could have easily arrived at a claimed invention based on cited inventions can be made by considering what a person skilled in the art could do after precisely comprehending the state of the art in the field to which the claimed invention pertains at the time of the filing." "Concretely, after finding of a claimed invention and one or more cited inventions, one cited invention most suitable for the reasoning is selected, and comparison of the claimed invention with the cited invention is made, and the identicalness and its difference in matters defining the invention are clarified. Then, the reasoning for lack of inventive step of the claimed invention is attempted on the basis of the contents of the selected invention, other cited inventions (including well-known or commonly used art) and the common general knowledge. The reasoning can be made from various and extensive aspects. For example, the Examiner evaluates whether a claimed invention falls under a selection of an optimal material, a workshop modification of design, a mere juxtaposition of features on the basis

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of cited inventions, or whether the contents of cited inventions disclose a cause or motivation for a person skill in the art to arrive at the claimed invention.If advantageous effects of the claimed invention over the cited invention can be clearly found in the description in the specification, etc., it is taken into consideration as facts to support to affirmatively infer the involvement of inventive step." "As a result of the above method, when the reasoning can be made, inventive step of the claimed invention should be denied. When the reasoning cannot be made, inventive step of the claimed invention should not be denied."

In other words, the determination step includes the following steps: (i) Selection of one cited invention most suitable for the reasoning (selection of the

main cited invention).(ii) Finding of differences between the claimed invention and the main cited

invention.(iii) Studying whether "motivation" to fill-in the above-mentioned difference is

present in the main cited invention or in the other cited inventions.

1-3-2. Motivation

For motivation, the JPO Examination Guidelines exemplify the following items.

• Relatedness of the technical field.• Commonality in problems to be solved by the invention.• Commonality in operation and/or function.• Suggestions in the disclosure of a cited invention.

As a recent trend, the Japanese courts have a view regarding the JPO Examiner's denying inventive step of a claimed invention, as follows. For the JPO Examiner to deny inventive step, "the Examiner's ex post facto analytical and illogical thinking should be excluded."

An example of a preceding case before the Intellectual Property High Court is shown below. "In the process of determining whether a claimed invention could have been

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easily arrived, the Examiner's ex post facto analytical and illogical thinking should be excluded. For this purpose, in adequately grasping "the problems", which are objects of the claimed invention, the Examiner needs to be careful so that the element of "solving means" or "solved results" does not unconsciously enter into the Examiner's thinking. Further, in order to determine that the claimed invention is "easily arrived", in studying the contents of a cited prior art, it is not sufficient to establish that the inventor is assumed to have tried to arrive at characteristic features of the claimed invention, but the presence of suggestions and the like are required to indicate that the inventor should have made the invention to arrive at the characteristic features of the claimed invention." (Reference: Hei 20 (2008) (Gyo Ke) 10096, The Intellectual Property High Court.)

1-3-3. Advantageous Effects Even when a matter, which can serve as a motivation, is present in a cited invention, if advantageous effects (the effects, which cannot be expected by a person of ordinary skill in this art from the cited invention) are present in a claimed invention as a result of comparing the claimed invention with the cited invention, the claimed invention could be recognized as having inventive step.

Further, it is possible to argue in a written argument about the effects of the claimed invention which cannot be predicted by a person of ordinary skill in this art from the cited invention. However, when such effects are not described in the specification, or a person of ordinary skill in this art cannot derive such effects from the specification or drawings, the effects cannot be taken into consideration by the Examiner.

Examples, which can be regarded as advantageous effects, are listed below:• Effects which are of different nature from that of the effects provided by the

cited invention.• Even though the effects are of the same nature as that of the effects

provided by the cited invention, but the effects of the claimed invention are remarkably excellent.

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1-3-4. Obstructive Factors (Teach away)

Even when the cited invention is recognized as having a matter which serves as motivation, if the specification of the cited invention contains a description which is obstructive to "be easily arrived at the claimed invention", the qualification of the cited invention as a cited invention against a claimed invention is denied as the cited invention has the "obstructive factors", and, as a result, inventive step of the claimed invention can be recognized. An example of a preceding case before the Tokyo High Court is shown below, wherein a cited invention was recognized as having the obstructive factors, and the claimed invention was affirmed as having inventive step. "The cited invention 1 is a device for mounting a transformer for the object of making a terminal pin in a thin form by contriving a manner of providing the terminal pin. However, when the structure of the cited invention 2 is applied to the terminal pin of the cited invention 1, it results in changing the terminal pin in a direction contrary to the object of contrivance in which the terminal pin is made in the thin form by contriving the manner of providing the terminal pin, especially, even providing a cut-off port. Hence, even when it is taken into account that the claimed invention and the cited inventions are having the common point where the level mounting is possible, the claimed invention cannot be regarded as the invention which could have been easily arrived by a person of ordinary skill in the art." (Reference: Hei 8 (1996) (Gyo Ke) 91, The Tokyo High Court.)

1-4. Prior Application Effect (Article 29-2, Patent Act)

According to the Japanese Patent Act, even when an invention has novelty at the time of filing, if the claimed invention is identical with the invention of an earlier application which is not laid-open at the time of filing, then the claimed invention cannot be patented. However, this provision shall not apply in the case where the applicant of the claimed invention and the applicant of the earlier application are the same person. However, in the case where the applicant is in plural in both the earlier application and the latter application, a complete identicalness of the respective applicants is required.

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Regarding the term "identical invention", the JPO Examination Guidelines explain it as follows. "Where there is found no difference between the matters defining the claimed invention and the matters defining the cited invention as a result of the comparison, the claimed invention and the cited invention are identical. Even where there is a difference between the two, they are deemed to be identical if the difference is considered to be a very minor difference (addition, deletion, or replacing of well-known or commonly used art, generating no new effects) in the embodied means to solve a problem (i.e., substantially identical)."

1-5. Description Requirements

The description requirements under Article 36, Patent Act include the enablement requirement concerning the specification; the support requirement and the clarity requirement concerning the claim(s). Further, the enablement requirements of the specification and the description requirement of claim(s) are closely related to one another. Therefore, it is necessary to describe claim(s) and the specification in such manner as to obtain the patent right having the practical effect, from the viewpoint of strong validity of the patent right and whether the patent right is strong enough against an infringement. For a format of statement of claim(s), either an enumeration form in which constituting elements are enumerated, or a Jepson type claim form, can be selected. Further, a Markush form claim is also accepted. It is not necessarily be required to write reference numerals of drawings for the matters defining the invention in claim(s). Further, when a person seeking to obtain a patent for a claimed invention is aware, at the time of filing, of prior art documents and/or publicly known invention(s), the person is required to describe briefly these prior art documents disclosing the prior inventions and/or publicly known invention(s), in the specification. Different from the IDS practice in USA, the information of prior art related to the claimed invention must be described in the specification. Further, in Japan, failure to describe known prior art in the specification provides a basis for reason for rejection, but cannot serve as grounds for invalidation of a patent, and a utility model registration. Accordingly, failure of describing known prior art in the

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specification does not make any effect on enforcement of the patent right.

1-5-1. Enablement Requirements (Article 36, Paragraph 4, Item 1, Patent Act)

Regarding the enablement requirements, Article 36, Paragraph 4, Item 1, Patent Act, provides as follows. "The statement of the detailed explanation of the invention (specification) shall be clear and sufficient as to enable any person ordinarily skilled in the art to which the invention pertains to work the invention." In other words, the detailed description of the invention must be described clearly and sufficiently to the extent of enabling a person, who can exhibit an ordinary creative ability and use an ordinary technical means for performing research and development in the technical field to which the invention pertains (a person skilled in the art), to work the claimed invention based on the matters described in the specification and drawings, and the common general technical knowledge at the time of filing the patent application. In the case where the invention is a product, the applicant must describe the specification by clearly explaining the product and enabling a person skilled in the art to make the product based on the description in the specification and the common general technical knowledge. In the mechanical and electric fields, in many cases, when the structure of a mechanical product or an electrical product is clearly described, a method of manufacture or use thereof is clearly understood. However, in the chemical field, in many cases, it is required to clearly describe a method for producing a product of the claimed invention. Further, in the field of medicines, the majority of cases requires the description of a method of using the product of the claimed invention. Concerning a method invention, the specification is required to clearly describe the method and sufficiently to enable a person skilled in the art to use the method. The applicant should pay attention to the fact that the enablement requirements are required for the whole scope of claim(s). That is, when the matters defining the invention which belong to the generic concept are stated in a claim, and only one embodiment/example of the more specific concept is described in the specification, the enablement requirements may not be satisfied. This point is particularly important in the case where a claim is defined by a function, a property or a result

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to be achieved, or defining parameters or numerical values. In this sense, the enablement requirements are in a close relation, like two sides of the same coin, with the support requirements which will be explained below. Further, when the specification describes a specified embodiment as the enabled embodiment, and this embodiment is a unique point included in the invention claimed by a claim, and when a person of ordinary skill in this art cannot work another embodiments of the invention claimed by the claim, the claim is regarded as not in compliance with the enablement requirements.

1-5-2. Support Requirements (Article 36, Paragraph 6, Item 1, Patent Act)

Article 36, Paragraph 6, Item 1, Patent Act, specifies as follows. "The invention recited in a claim(s). . . . is the invention for which a patent is sought is stated in the detailed description of the invention." Examination of this support requirements is performed as follows. "Determination of whether the recitation of claims meets this provision is made by comparing and reviewing the invention claimed by claims and the invention described in the detailed description of the invention." "In performing comparison and studying, the substantial corresponding relationship is examined without adhering to the matching of wordings."

When a claim is recited in the form of a generic concept, the applicant should describe embodiments fully so as not to fall under any of the below-mentioned patterns of failing to meet the support requirements.

(a) The following pattern frequently occurs as failing to meet the support requirements. "It cannot be said that the contents disclosed in the detailed description of the invention can be expanded or generalized to the scope of the invention claimed by the claims, even in view of the common general technical knowledge at the time of filing this application." This is the case where the scope of the invention claimed by claims is broader than the invention disclosed in the detailed description of the invention. To avoid this, the applicant should describe embodiments fully to correspond

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to the invention recited in claims. Particularly, the applicant should be careful especially when the claim is defined by parameters and numerical values, or functions and properties are specified as the matters defining the invention. It is usually difficult to solve the failure of meeting the support requirements by an invention of parameters, by submitting certified experimental results not disclosed in the specification after filing the patent application.

(b) The next pattern also frequently occurs as failing to meet the support requirements. "The recitation of claims does not reflect the means for solving the problems described in the detailed description of the invention, and, therefore, a patent is sought in the scope beyond the scope of the detailed description of the invention." This pattern is the case where the structure which is essential and indispensable to constitute the invention is not recited in the claims. The applicant should analyze what is the means for solving the problems and recite the required means fully, that is, without any omission, as the matters defining the invention.

(c) Further, there is another pattern as follows. "The terms recited in the claims and the terms described in the detailed description of the claims are not consistent, and, as a result, the corresponding relationship between them becomes unclear."

1-5-3. Clarity Requirements (Article 36, Paragraph 6, Item 2, Patent Act)

Article 36, Paragraph 6, Item 2, Patent Act, specifies as follows. "The invention recited in a claim(s). . . . is the invention for which a patent is sought is clear."

The applicant must write the scope of claims so that one invention can be clearly grasped from one claim, thereby accurate determination of patentability such as novelty and inventive step becomes possible and the technical scope of the invention can be determined. The applicant should recite the matters defining the invention clearly. In construing the meaning and contents of the matters defining the invention during

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examination, not only the recitation of claims, but also the description in the specification and drawings, and, also, common general technical knowledge at the time of filing the patent application, will be considered. Namely, when the recitation of the claims itself is not clear, study is made to determine whether terms recited in the claims are explained or having definitions in the specification or drawings, then such definition or explanation are considered in terms of the common general technical knowledge at the time of filing the patent application to construe the terms in the claims, thereby to determine whether the recitation of claims can be said clear or not.

In reciting a claim(s), the applicant must pay attention to clearly define the scope of invention. Needless to say, the claim(s) must be stated technically clear and without any deficit, and the various matters defining the invention should be matching with one another and having technical correlation between them.

The applicant should make the best efforts to avoid using ambiguous expressions or wordings in the claim(s) which render the invention unclear. Undesirable expressions are, for example, a negative expression ("except. . .."); defining a range by a numerical value by indicating only the upper limit or the lower limit; unclear expressions ("about", "slightly", "high temperature", "difficult to slide", and the like) in indicating a reference or degree for comparison; expressions which can be optionally added ("as desired", "for example, for instance", etc.), and use of "substantially", "preferably", should also be avoided.

Further, when the scope of claims is defined by matters defining the invention, such as functions and properties of a product, the applicant should bear in mind that, in many cases, the scope of invention becomes unclear in the technical field where it is difficult to ascertain the structure of the product from its functions and properties, such as a chemical substance.

1-6. Prior Application (Double Patenting) (Article 39, Paragraph 1, Patent Act)

Like most of the other countries, the Japanese Patent Act employs the first-to-file system. Article 39, Paragraph 1 Patent Act, provides as follows.

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"Where two or more patent applications claiming identical inventions have been filed on different dates, only the applicant who filed the patent application on the earliest date shall be entitled to obtain a patent for the invention claimed."

1-6-1. Determination of "the earliest date"

For a patent application without claiming a priority, determination is made by the filing date in Japan. For a PCT application, its international filing date is regarded as the filing date. For a patent application claiming a priority under Paris Convention, the filing date in a first country where a first patent application was filed is regarded as the filing date if priority is valid.

Note that a basis for determination is "a date", and where two or more patent applications claiming identical inventions have been filed on the same date, only one applicant, who was selected by consultations between the applicants who filed said applications, shall be entitled to obtain a patent for the invention claimed.

1-6-2. Determination of subject matter a prior application and a later filed application.

Determination of identicalness of inventions between the prior application and the later filed application is made based on "a claimed invention." Hence, the claim(s) of the prior application and the claim(s) of the later filed application are compared with one another. In the case of a patent application in the English language, namely, a PCT application, a Japanese translation of claim(s), or a Japanese translation of claim(s) as amended under PCT Article 19, is the object of comparison. In the case of filing an application in a foreign language, a Japanese translation of the claim(s) is the object of comparison.

1-6-3. Determination of identicalness of the subject matter

Comparison of inventions is performed by finding points of difference and points of coincidence between the matters defining the invention of each of applications.

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When there is no point of difference between the matters defining the invention of the prior application and the later filed application, the inventions of two applications are identical. However, even when there is no difference between the matters defining each of the inventions, if the matters defining the invention of the later filed application fall under any of the following (a) – (c), the inventions of the two applications are determined identical.(a) Where the matters defining the invention of the later filed application are merely

the results of applying a well-known art; addition, deletion, and/or conversion of commonly used art; and no new or remarkable effects are provided.

(b) The difference is caused in such manner that the claim(s) of the later filed application states the matters defining the invention, which are the more specific concept of the invention of the prior application, as the generic concept of the invention of the later filed application.

(c) Where the difference between the invention of the prior application and the invention of the later filed application is only in category of the invention stated in different expressions.

1-7. Right to obtain a patent

Article 29, Main Paragraph (Paragraph 1), Patent Act, provides as follows. "An inventor of an invention that is industrially applicable may be entitled to obtain a patent therefor."

That is, in Japan, the right to obtain a patent primitively attribute to the inventor who is a natural person. This remains unchanged in the case of an employee's invention. The right to obtain a patent is the right prior to registration of a patent, and one aspect of this right is the civil rights to request the Government (the State of Japan) to grant a patent, and the other aspect is the property right. When a person who does not have the right to obtain a patent filed a patent application, this act provides a basis for the reason for rejection of the application, and even if such a person acquired a patent right, a person who has the right to obtain a patent can demand a transfer of the patent right, or demand a trial for invalidation of the patent right (invalidation proceedings in the Patent Office).

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1-7-1. Transfer of, and granting a license under, the right to obtain a patent

The right to obtain a patent can be transferred. Further, a juristic person (a legal entity: company, corporation, incorporated, etc.) can have the right to obtain a patent by succession. Further, when a person who has the right to obtain a patent grants a license of the invention under said right, the license can be registered in the Patent Office.

1-7-2. The right to obtain a patent for a joint invention.

When an invention is made jointly by a plurality of inventors, the right to obtain a patent for the invention is jointly owned by all the inventors. In this case, a patent application for the invention must be filed jointly in the names of all inventors. If one of the joint inventors violates this rule and obtains a patent right, the person who has the right to obtain a patent can demand transfer of the patent right. Each of the joint inventors cannot assign or transfer his/her share of the right to a third person without obtaining the consent of all other joint inventors.

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2. Procedures: from filing a patent application to obtaining a Patent Right

2-1. Flow ChartProcedures for Obtaining a Patent Right

1 Application

3 Publication of Unexamined Application2 Formality Examination

4 Request for Examination

6 Substantive Examination

No Request for Examination

5 Deemed Withdrawal

[18 months after filing]

7 Notification of Reasons for Refusal

8 Written Argument / Amendment

10 Decision of Refusal9 Decision to Grant a Patent

11 Appeal against Decision of Refusal

12 Appeal Examination

Appeal Decision to Grant a Patent

Appeal Decision of Refusal

13 (Patent Fee payment) Registration

14 Publication of Patent Gazette

Decision of Revocation Decision of Invalidation

15 Opposition 16 Trial for Invalidation

17 Intellectual Property High Court

Supreme Court

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Procedures from filing a patent application to obtaining a patent right (registration of a patent) are as follows.(1) Filing a patent application(2) Formality Examination(3) Laying-open of unexamined application. The content of the application is laid-

open to the public after the lapse of 18 months from the filing date.(4) Request for Examination of the application. A request for substantive

examination of the application must be filed within three (3) years from the filing date. The due date for requesting examination is inextensible.

(5) When a request for examination is not filed by the due date, the application shall be deemed to have been withdrawn.

(6) Substantive Examination shall be made by the JPO Examiner.(7) Notification of Reasons for Refusal, Notice of Rejection. The applicant is

notified of reasons for rejection when his/her application contains reasons for rejection.

(8) Written Argument/Amendment. In response to the Notice of Rejection, the applicant can file a written argument stating the applicant's arguments against the Examiner's opinion. Further, the claims, specification and/or drawings can be amended to overcome the Examiner's reasons for rejection. The argument with the amendment must be filed within the specified time limit.

(9) Decision to Grant a Patent. When no reason for rejection is found, a Notice of Decision to Grant a Patent is served on the applicant.

(10) Decision of Rejection/Refusal. When the reasons for rejection have not been overcome, the application is decided to be finally rejected.

(11) Appeal against Decision of Rejection/Refusal. The applicant can file an appeal against the Decision of Rejection of the application within the specified time limit.

(12) Appeal Examination When the designated Appeal Board (three or five designated Appeal Examiners) finds that the application is allowable, an Appeal Decision to Grant a Patent will be served on the applicant. On the other hand, when the application is found by the Appeal Board to be rejected, an Appeal Decision of Rejection/Refusal of the application will be served on the applicant.

(13) Payment of Patent Registration Fee and Registration of a Patent Right

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Upon receipt of a Decision to Grant a Patent, the Applicant must pay the patent registration fee (1st to 3rd annuities in lump sum) within the specified time limit. Thereupon, a patent right thereof will be registered in the Patent Register.

(14) Publication of Patent Gazette The contents of a patent are published by the JPO in the Patent Gazette.

(15) Opposition Any party may file an opposition to revoke a patent within six month period after issuance of Patent Gazette. As a result of opposition proceedings by the designated Opposition Board (three or five designated Trial Examiners), the patentee will receive an Opposition Decision to revoke the Patent, or an Opposition Decision to Maintain the Patent.

(16) Trial for Invalidation of Patent An interested party may demand a trail for invalidation of a patent. As a result of invalidation proceedings by the designated Trial Board (three or five designated Trial Examiners), the patentee will receive a Trial Decision to Invalidate the Patent, or a Trial Decision to Maintain the Patent.

(17) Filing a Lawsuit in the Intellectual Property High Court. When the patentee is dissatisfied with the Patent Office Opposition/Trial Decision, the patentee can file a lawsuit against the Opposition/Trial Decision in the Intellectual Property High Court. When the Decision made by the Intellectual Property High Court is dissatisfied, a further appeal to the Supreme Court may be permitted.

2-2. Requirements for Patent Application

(a) A patent application can be filed without claiming priority in the Japan Patent Office (JPO) in the Japanese language (Article 36, Patent Act) or in the English language (Article 36-2, Patent Act). However, when the patent application in the English language is filed, a Japanese translation thereof must be filed within one year and two months (14 months) from the filing date in Japan.

(b) Japanese Patent Application Claiming Priority Under Paris Convention. A Japanese patent application claiming priority under the Paris Convention

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can also be filed in the Japanese language or in the English language. When the application in the English language is filed, a Japanese translation thereof must be filed within one year and two month (14 months) from the priority date. Further, a priority document must be filed within one year and four months (16 months) from the priority date (the filing date of the basic application of the claimed priority). However, submission of the priority document may be omitted when the first application was filed in the country (US, EP, KR) whose Patent Office and the JPO can electronically exchange the priority document. The priority document may be submitted via Digital Access Service (DAS) of WIPO if the patent office that received the priority application participates in DAS.

(c) Enter the Japanese National Phase of PCT application (filing of a national form and a Japanese translation) When Japan is designated in a PCT application, a national form describing bibliographic items and a Japanese translation of the specification, claims, drawings and Abstract must be filed within 30 months from the priority date. However, when the national form is filed during a period of 28 – 30 months from the priority date, the Japanese translation of the specification, claims, drawings and Abstract can be filed within two months from the filing date of the national form (Article 184-4, Patent Act).

2-3. Laying-Open of Unexamined Patent Application

When a patent application was filed in the JPO, the content of the application is laid-open to the public after the lapse of one year six months (18 months) from the priority date. However, in the case of a PCT application which has entered the Japanese national phase, the content thereof (a Japanese translation thereof) is published in a National Publication of the Translated Version of PCT application, promptly upon expiration of the term of filing the national form, that is, upon expiration of 30 months from the priority date. It should be noted that by the laying-open of the application the applicant has the right to claim the compensation against a person who has commercially worked the invention (Article 65, Patent Act).

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2-4. Request for Examination of Application

For prosecution of a Japanese patent application, it is required to file a request for examination of the application within three (3) years from the filing date in Japan (Article 48, Patent Act). However, in the case of a PCT application entered the Japanese national phase, the request for examination must be filed within three (3) years from the International Filing Date (Article 48-3, Patent Act). Official Fee for requesting examination is as follows.(a) Non-Convention or Convention Japanese application.

\118,000 + (\4,000 x the number of claims)(b) PCT application entered the Japanese national phase

(When the International Search was already made by a Patent Office other than the JPO) \106,000 + (\3,600 x the number of claims)

It should be noted that when the applicant decides to abandon the application, and if it is after requesting examination of the application but before starting of the examination thereof by the Examiner, the applicant can file a request for refund of a 50% of the examination fee.

2-4-1. Accelerated Examination

A patent application, which satisfies a predetermined condition, such as, a working-related application or a foreign country filed-related application, can be subjected to an accelerated examination by filing a written explanation of circumstances concerning accelerated examination. A Japanese patent application having a corresponding foreign application is the foreign country filed-related application, and, therefore, it can be an object of the accelerated examination. As one of the requirements for the accelerated examination, the applicant must describe an explanation of comparison of the invention of the application with related prior arts, in the written explanation of circumstances concerning accelerated examination. In the case of a PCT application entered the Japanese national phase, it is sufficient to describe an explanation of comparison of the invention of the application with each of the related prior art documents listed in the

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International Search Report. Further, in requesting the accelerated examination, it is possible to amend claims and describe an explanation of comparison of the invention of the amended claims with the related prior art references. Accelerated examination can be requested after filing the request for examination but should be requested before receiving a first office action.

2-4-2. Patent Prosecution Highway

This is a kind of accelerated examination. A Japanese application having a corresponding application in a foreign country such as US, EP CN, KR, CA, AU, RU, GB, DE and SG, the Patent Prosecution Highway can be requested by amending the Japanese claims to be conformable to the claims allowed in the foreign country. Patent Prosecution Highway can also be applied based on the claims which have been acknowledged as patentable in the International Search Report. The documents required for the Patent Prosecution Highway are: the document describing comparison between the Japanese claims and the claimed allowed in the foreign country (for example, explaining that the Japanese claims are corresponding with the claims allowed in the foreign country), a copy of the Office Actions (including a Notice of Allowance), and copies of cited documents (for patent documents, only a list of patent publication numbers is sufficient). Further, due to the difference of patent practice between Japan and the foreign country, it is possible to change the category of the subject matter of invention by an amendment. Example: US allowed claims: A method (process) of treating diabetes ↓ Corresponding Japanese claims: A pharmaceutical agent for treating diabetes

Patent Prosecution Highway can be requested after filing the request for examination but should be requested before receiving a first office action.

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2-5. Amendments of Application (Article 17-2, Patent Act)

2-5-1. Timing and the Scope for making amendments

(a) Before receipt of a first Notice of Reason for Rejection The specification, claims and/or drawings can be amended within the scope of the disclosure of the originally filed application. Introduction of new matter is not permitted.

(b) After receipt of the first Notice of Reason for Rejection(i) When a f irst Notice of Reason for Rejection is received (Art icle

17-2, Paragraph 1, Item 1, Patent Act). The timing for making amendments is during a period of time limit specified by the Notice of Reason for Rejection (generally, 3 months from the mailing date of the Notice of Reason for Rejection, and a further 3-month extension can be requested). It should be noted that amendments of claims are limited to amend claims within the scope of satisfying the requirements of unity of invention with the examined invention. (Article 17-2, Paragraph 4, Patent Act). For example, assuming that the Examiner states the following reason for rejection: Claim 1: A (lack of novelty) ? examined. Claim 2: A + B (having novelty but lack of inventive step) ? examined. Claim 3: A + C (lack of requirements for the unity of invention with Claim 2) - not examined. In this case, amendments of deleting Claims 1 and 2, and maintaining Claims to be examined, can not be permitted.

(ii) When the Final Notice of Reason for Rejection is received. The timing for making amendments is during a period of time limit specified by the Final Notice of Reason for Rejection (generally, 3 months from the mailing date of the Notice of Reason for Rejection, and a further 3-month extension can be requested). Amendments of claims are, as in the case of the above-mentioned

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( i ) , l imi ted to amend c la ims wi th in the scope of sat is fy ing the requirements of unity of invention with the examined invention, and, further, the amendment of claims shall be limited to the followings: ‧ the deletion of claim or claims; ‧ the restriction of claim or claims; ‧ the correction of errors; or ‧ the clarification of ambiguous description.

(iii) When a Notice of Decision of Rejection is received. The applicant can file a demand for appeal against the Decision of Rejection (Article 17-2, Paragraph 4, Patent Act). The timing for making amendments is at the same time with filing of the demand for appeal. The time limit is generally four (4) months for a foreigner residing abroad from the mailing date of the Notice of the Decision of Rejection, and this time limit is inextensible. Amendments of claims are limited to the items as listed in (ii) above.

2-6. Claim dependency

Under the Japanese Patent Practice, the form of multiple dependent claims is permitted, and, further, the form of multiple dependent claims of multiple dependent claims is also permitted.

2-7. Having a Personal Interview with the Examiner - Regarding the Notice of Reason for Rejection of the application, the applicant may ask the Examiner to have a personal interview in the Patent Office or a telephonic interview with the examiner. - Generally, it is preferable to ask the Examiner for having such interview more than two weeks before the due date for filing a response. - Object of having such interview includes: making a technical explanation of the invention to the Examiner; presenting the applicant's proposed amendments and obtaining the Examiner's opinion, and the like. By having such interview with the Examiner, the Examiner's real opinion in issuing the Notice of Reason for Rejection, or unclear points in the Notice of

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Reason for rejection, can be formed, thereby to avoid receiving a further Notice of Reason for Rejection or the Decision of Rejection of the application. Having the interview with the Examiner is very effective means to properly responding to the Notice of Reason for Rejection.

2-8. Presentation of Information by a Third Person (Article 13-2, Regulations under the Patent Act).

Any third party can present information to the Patent Office with respect to a patent application that is laid-open to the public. Whether the information is considered in examination depends on Examiner.

2-8-1. Timing of Presentation of Information

Presentation of Information can be made any time after laying-open of a patent application. Even after granting a patent on the application presentation of information can be made. Any third person can make presentation of information, without any limitation, and it is not required to divulge the name of a person making presentation of information.

2-8-2. The Information that Can Be Presented.

To effect reasons for rejection of the application, or to effect reasons for invalidating a patent. For example: - amendments have been made to introduce new matter, or the amendments do not comply with the requirements of Article 17-2, Item 3, Patent Act); - the invention is an invention which can not be protected under the Patent Act, or the invention is not industrially applicable (not complying with the requirements of Article 29, Main Paragraph (Paragraph 1), Patent Act); - effecting lack of novelty of the invention (Article 29, Paragraph 1, Patent Act); - effecting lack of inventive step of the invention (Article 29, Paragraph 2, Patent Act); - effecting observation of prior art effect (Article 29-2, Patent Act); - effecting existence of prior application (inhibition of double patenting) (Article

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39, Paragraphs 1 to 4, Patent Act); - effecting objection to the application as not meeting the enablement requirements (Article 36, Paragraph 4, Item 1, Patent Act); - effecting objection to the application as not meeting the support requirements for claim (Article 36, Paragraph 6, Items 1-3, Patent Act); and - effecting objection to the application in which the features disclosed are beyond the disclosure made in the original foreign language application file (introduction of new matter to the disclosure of the original foreign language application file) (Article 36-2, Paragraph 2, Patent Act).

2-9. Division of Patent Application

2-9-1. Timing for Filing a Divisional Application

(a) Division of a patent application can be made within the scope of claims and/or drawings, in the time limit allowable for filing amendments of the specification and claims as stated in Paragraph 2-5-1 above (Timing for making amendments of specification) (Article 44, Paragraph 1, Item 1, Patent Act). Note that in the case where a demand for appeal against the Decision of Rejection of the application is filed, the division of the patent application can be made only concurrently with the filing of the demand for appeal (Article 17-2, Paragraph 1, Item 4, and Article 44, Paragraph 1, Item 1, Patent Act).

(b) Within 30 days from the mailing date of the Notice of Grating a Patent (Article 44, Paragraph 1, Item 2, Patent Act). Division of the application is permitted within 30 days from the mailing date of the Notice of Granting a Patent. However, even within the period of 30 days from the mailing date of the Notice of Granting a Patent, if the required patent registration were paid and a patent were registered, division of the application could not be made, because the application would no longer be pending in the Patent Office. It should be noted that this timing of dividing the application within 30 days from the mailing date of the Notice of Granting a Patent can be applied only to the applications filed on or after April 1, 2007.

(c) Within three (3) months from the mailing date of the Notice of Decision of the application (Article 44, Paragraph 1, Item 3, Patent Act).

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The application may be divided within three (3) month from the mailing date of the Notice of Decision of Rejection, without filing a demand for appeal against the Decision of Rejection. However, this timing of dividing the application within three (3) months (four months for a foreign applicant) from the mailing date of the Notice of Decision of Rejection can be applied only to the applications filed on or after April 1, 2007. For the applications filed on or before March 31, 2007, division of the application can be made only with the filing of a demand for appeal against the Decision of Rejection of the application.

It should be noted that the division of application can not be made after receipt of the Notice of Appeal Decision to Granting a Patent, or the Notice of Appeal Decision to Reject the Application, after filing the demand for appeal against the Decision of Rejection of the application.

2-9-2. Requirements for Divisional Application

(a) The entire invention described in the parent application should not be divided. That is, it is required to divide part of the invention described in the parent application.

(b) The invention of a divisional application should not be identical with the invention described in the parent application. The divisional application for the invention identical with the invention described in the parent application provides a basis for causing double patenting (not meeting the requirements of Article 39, Paragraph 2, Patent Act). In this case, it is required to submit, at the time of filing the divisional application, a written statement explaining that the divisional application does not cause double patenting.

(c) Division of the application must be made within the scope of the disclosure of the originally filed application. New matter to the invention described in the parent application cannot be added to the invention in the divisional application. When new matter is introduced in the divisional application, the retroactive filing date cannot be permitted. In order to confirm that no new matter is added, it is required to submit, at the time of filing the divisional application, a written statement identifying the description changed from the description of the parent application

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and stating that the changed description is within the scope of the disclosure of the parent application.

(d) The divisional application should be made within the scope of disclosure of the parent specification immediately before the division, in the case of the divisional application which is made within 30 days from the mailing date of the Notice of Granting a Patent or within three (3) months from the mailing date of the Notice of Decision of Rejection of the application.

2-10. Demanding Appeal against the Decision of Rejection of the application.

2-10-1. Summary

The applicant who has received the Notice of Decision of Rejection and the applicant is dissatisfied with the Decision of Rejection of the application, the applicant can file a demand for appeal against the Decision of Rejection within three (3) months (four (4) months for a foreigner applicant) from the mailing date of the Notice of Decision of Rejection (Article 121, Paragraph 1, and Article 4, Patent Act). Further, an amendment amending claims, specification and/or drawings can be filed concurrently with the filing of the demand for appeal against the Decision of Rejection of the application (Article 17-2, Paragraph 1, Item 4, Patent Act).

2-10-2. Grounds for Demanding Appeal against the Decision of Rejection of the application.

A written demand for appeal must describe the substantial grounds for demanding appeal (Article 131, Patent Act). However, when the demand for appeal is filed without describing the grounds for demanding appeal (Appeal Brief), late filing of the grounds for supplementing the demand for appeal is permitted. In this case, generally, an Invitation for Correct (or supplementing the grounds for demanding appeal) is served on the applicant in about a month from the date of filing the demand for appeal. Then, in response to the Invitation for Correct, the applicant should file, within 30 days from the mailing date of the Invitation for Correct, a document describing the substantial grounds for demanding appeal.

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2-10-3. Flow of Appeal Proceedings

When amendments of claims, specification and/or drawings are made concurrently with the demand for appeal, the amended application shall be turned over to the Examiner, who had final decided to reject the application, for re-consideration of the amended application (Article 162, Patent Act). When the Examiner finds that the amendments have overcome the reason for rejection and no new reason for rejection is found, the Examiner decides to grant a patent. On the other hand, when the Examiner finds that the amendments have not overcome the reason for rejection, the Examiner forwards the application to a designated Appeal Board consisting of three or five designated Appeal Examiners, for re-examination of the application by the Appeal Board (Article 136, Patent Act). When an Appeal is flied without amendments, the application shall be forwarded directly to the designated Appeal Board for re-examination, without turning over the application to the primary Examiner for re-consideration. After conclusion of re-examination by the Appeal Board (Article 156, Patent Act), an Appeal Decision shall be made (Article 157, Patent Act). When the original Decision of Rejection shall be maintained, the Appeal Decision that “the Demand for Appeal is not approved” , is issued, and when the original Decision of Rejection shall not be maintained, the Appeal Decision that “the Demand for Appeal is approved” (Appeal Decision to Grant a Patent) is issued.

2-11. Suit against Appeal Decision

When the Demandant (the Applicant) is dissatisfied with the Appeal Decision, the Demandant (the Applicant) can file a lawsuit in the IP High Court to seek a Court Decision to reverse the Patent Office Appeal Decision. The lawsuit must be initiated within 30 days (120 days for a foreign applicant) from the mailing date of the Notice of Appeal Decision or the Certified Copy of Decision (Article 178, Paragraph 3, Patent Act).

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2-12. Topics of Different Technical Fields

2-12-1. Medicinal Inventions

- A second medicinal use invention is protected in the form of “a medicine for curing or treating . . . .” , or “a pharmaceutical agent for curing or treating . . . . “ - In Japan, a method of treating a human, or performing medical activities on a human, cannot be patented. - In order to obtain a patent on a medicinal invention, the specification of the initially filed application should contain a data showing pharmacological effects of the claimed medicine. When the data showing pharmacological effects of the claimed medicine is submitted in response to the Notice of Reason for Rejection, generally such late filing of the data is not accepted.

2-12-2. Genetic Engineering-Related Inventions

Describing a sequence of a gene or a polypeptide, the following forms of description are accepted. (Example 1) A protein having ○○ activities, comprising an amino acid sequence having substitution, deletion, insertion or addition of one or several amino acids in an amino acid sequence of Sequence ID NO: Y. (Example 2) A protein having ○○ activities, comprising an amino acid sequence having 90% or more of identity with a amino acid sequence of Sequence ID NO: Y. (Example 3) A protein having ○○ activities, encoded by a base sequence which hybridizes with the nucleotide sequence of the Sequence ID NO: Y, under stringent conditions.

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3. Post-Grant Procedures

3-1. Opposition Procedure

3-1-1. Details of Opposition

Any person may file an Opposition to a patent (Article 113, Main Paragraph, Patent Act). That is, an Opposition may be filed by the name of an attorney or a straw man instead of a true opponent's name in order to hide a true opponent's name, although anonymous filing is not permitted.

3-1-2. Periods for Filing Opposition

An Opposition to a patent can be filed only within six(6) months from the publication date of the Patent Gazette.

3-1-3. Grounds for Filing Opposition

Article 113, Patent Act exhaustively specify matters constituting grounds for Opposition to a patent.(a) The patent has been granted on a patent application with an amendment which

introduced new matter.(b) The patent has been granted contrary to the provisions of enjoyment of rights

by foreigners (Article 25, Patent Act); the requirements of novelty of the invention (Article 29, Paragraph 1, Patent Act); the requirements of inventive step of the invention (Article 29, Paragraph 2, Patent Act); the provisions of prior art effect (Article 29-2, Patent Act); the provisions of public order and morality (Article 32, Patent Act); or the provisions of first-to-file rule (Article 39, paragraphs 1 to 4).

(c) The patent has been granted in violation of a treaty.(d) The patent has been granted on a patent application not complying with the

requirements of enablement, support and clarity (Article 36, Paragraph 4, Item 1, or Paragraph 6, Items 1, 2 and 3, Patent Act).

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(e) The matters stated in the description, scope of claims or drawings attached to the foreign language written application are not within the scope of matters stated in foreign language documents.

3-1-4. Procedures of Opposition

Opposition proceedings are conducted by a collegial body consisting of three or five trial Examiners (Art.114, Para.1), and all procedures for the proceedings shall be in writing (Art.118, Para.1). In opposition proceedings, the Examiners may ex officio enter grounds not submitted by the patentee or the opponent (Art.120bis, Para. 1). No claim other than claims opposed by the opponent shall be examined ex officio in opposition proceedings (Art.120bis, Para. 2). In a case where the trial Examiner-in-chief makes a decision to revoke the patent, an opportunity to submit arguments within a reasonable period of time shall be given to the patentee and other participants if any. The patentee may file a request for corrections of the specification, claims, and/or the drawings attached to the Application for Patent, only within the period for filing the patentee's arguments. The requirem