Guidebook. for Japanese Intellectual Property System 2 nd Edition

Transcription

1 Guidebook for Japanese Intellectual Property System 2 nd Edition

2 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, 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, 2012 Yoshiyuki KAWAGUCHI, Ph.D., Patent Attorney 2

3 2nd Edition Revision of the Patent Act of Japan, signed into law in 2014, will take effect on April 1, The Revision includes major changes such as reintroduction of the post-grant Opposition system. To conform to the Revision, we have now prepared the 2 nd 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, 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 2015 Akira HIRAKAWA, Patent Attorney 3

4 Table of Contents Ⅰ Patent 1. Patentability 1-1. Industrially Applicable Invention (Article 29, Paragraph 1, Patent Act) An Invention which is industrially applicable Inventions which cannot be industrially applicable (Medical Acts) Patentability of computer software-related inventions Patentability of Business Method Inventions Novelty (Article 29, Paragraph 1, Patent Act) Publicly Known Invention Publicly Worked Inventions Invention Described in a Distributed Publication Exception to Lack of Novelty of Invention (Article 30, Patent Act) Method of determining novelty Selection Invention Use Invention Inventive Step (Article 29, Paragraph 2, Patent Act) Criterion for Determining Inventive Step Motivation Advantageous Effects 25 4

5 Obstructive Factors (Teach away) Prior Application Effect (Article 29-2, Patent Act) Description Requirements Enablement Requirements (Article 36, Paragraph 4, Item 1, Patent Act) Support Requirements (Article 36, Paragraph 6, Item 1, Patent Act) Clarity Requirements (Article 36, Paragraph 6, Item 2, Patent Act) Prior Application (Double Patenting) (Article 39, Paragraph 1, Patent Act) Determination of "the earliest date" Determination of subject matter a prior application and a later filed application Determination of identicalness of the subject matter Right to obtain a patent Transfer of, and granting a license under, the right to obtain a patent The right to obtain a patent for a joint invention Procedures: from filing a patent application to obtaining a Patent Right 2-1. Flow Chart Requirements for Patent Application Laying-Open of Unexamined Patent Application 38 5

6 2-4. Request for Examination of Application Accelerated Examination Patent Prosecution Highway Amendments of Application (Article 17-2, Patent Act) Timing and the Scope for making amendments Claim dependency Having a Personal Interview with the Examiner Presentation of Information by a Third Person (Article 13-2, Regulations under the Patent Act) Timing of Presentation of Information The Information that Can Be Presented Division of Patent Application Timing for Filing a Divisional Application Requirements for Divisional Application Demanding Appeal against the Decision of Rejection of the application Summary Grounds for Demanding Appeal against the Decision of Rejection of the application Flow of Appeal Proceedings Suit against Appeal Decision Topics of Different Technical Fields Medicinal Inventions Genetic Engineering-Related Inventions 48 6

7 3. Post-Grant Procedures 3-1. Opposition Procedure Details of Opposition Periods for Filing Opposition Grounds for Filing Opposition Procedures of Opposition Effects of a decision of opposition Lawsuit against trial decision Trial for Patent Invalidation Grounds for Patent Invalidation Person who can request for a trial for patent invalidation Term for requesting for a trial for patent invalidation Effects of a trial decision of invalidation Lawsuit against trial decision Request for correction of the description, claims and/or drawings during a trial for patent invalidation Requirements for request for correction Term for filing a request for correction (Article 134-2, Paragraph 1, Patent Act) Effects when the correction is approved Trial for Correction Extension of the Duration of Patent Right (Article 67, Paragraph 2, Patent Act) What is the system of extension of the duration of patent right? Procedures for obtaining the extension of the duration of patent right (Article 67-2, Article , Patent Act) Requirements for obtaining the extension of the duration of patent right Trial for invalidation of registration of extension of the duration of patent right (Article 125-2, Patent Act) 58 7

8 4. Patent Right 4-1. Patent Right Effects of patent right Limits of patent right Technical scope of patented invention Indirect Infringement Licenses Exclusive License Non-Exclusive License Non-exclusive license based on prior use Enforcement Demand for injunction and disposal of infringing products Claim for damages, etc Presumption of Amount of Damage Presumption of Negligence Right to claim compensation (Article 65, Patent Act) Jointly owned patent rights 65 8

9 Ⅱ Utility Model 1. Requirements of Application for Utility Model Registration 1-1. Japanese National Phase Utility Model Application of a PCT application (filing a National Form and a Japanese translation) Utility Model Registration Correction of the Scope of Claims Report of Utility Model Technical Opinion Responsibility of holder of Utility Model Right Patent Applications based on Utility Model Registration (Conversion of Application) 70 9

10 Ⅲ Trademark 1. The procedures for obtaining a trademark right Points to remember Examination 75 10

11 Ⅰ Patent 1. Patentability 1-1. Industrially Applicable Invention (Article 29, Paragraph 1, Patent Act) 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. 11

12 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 12Patent Ⅰ

13 industrially applicable invention 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 13Patent Ⅰ

14 by the data structure recorded thereon. (b) "A program" which specifies a multiple of functions can be defined as "an invention of a product." performed by a computer - 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 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 14Patent Ⅰ

15 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) 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 15Patent Ⅰ

16 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 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." 16Patent Ⅰ

17 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.) 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 17Patent Ⅰ

18 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." Exception to Lack of Novelty of Invention (Article 30, Patent Act) In Japan, even when an invention has lost novelty, the Japanese Patent Act 18Patent Ⅰ

19 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 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: 19Patent Ⅰ

20 (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 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 20Patent Ⅰ

21 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." 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. 21Patent Ⅰ

22 "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) 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. 22Patent Ⅰ

23 "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 belowmentioned "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 wellknown 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 23Patent Ⅰ

24 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 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 24Patent Ⅰ

25 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.) 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. 25Patent Ⅰ

26 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. 26Patent Ⅰ

27 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 wellknown 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 27Patent Ⅰ

28 specification does not make any effect on enforcement of the patent right 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 28Patent Ⅰ

29 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 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 29Patent Ⅰ

30 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." 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 30Patent Ⅰ

31 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 Prior Application (Double Patenting) (Article 39, Paragraph 1, Patent Act) Like most of the other countries, the Japanese Patent Act employs the first-tofile system. Article 39, Paragraph 1 Patent Act, provides as follows. 31Patent Ⅰ

32 "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." 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 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 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. 32Patent Ⅰ

33 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 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). 33Patent Ⅰ

34 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 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. 34Patent Ⅰ

35 2. Procedures: from filing a patent application to obtaining a Patent Right 2-1. Flow Chart Procedures for Obtaining a Patent Right 1 Application 2 Formality Examination 4 Request for Examination 6 Substantive Examination 9 Decision to Grant a Patent 13 (Patent Fee payment) Registration 14 Publication of Patent Gazette [18 months after filing] 3 Publication of Unexamined Application No Request for Examination 5 Deemed Withdrawal 7 Notification of Reasons for Refusal 8 Written Argument / Amendment 10 Decision of Refusal 11 Appeal against Decision of Refusal 12 Appeal Examination Appeal Decision to Grant a Patent Appeal Decision of Refusal 15 Opposition 16 Trial for Invalidation Decision of Revocation Decision of Invalidation 17 Intellectual Property High Court Supreme Court 35Patent Ⅰ

36 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 laidopen 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 36Patent Ⅰ

37 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 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 37Patent Ⅰ

38 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 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) 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). 38Patent Ⅰ

39 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 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 39Patent Ⅰ

40 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 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. 40Patent Ⅰ

41 2-5. Amendments of Application (Article 17-2, Patent Act) 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 first Notice of Reason for Rejection is received (Article 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 41Patent Ⅰ

42 (i), limited to amend claims within the scope of satisfying 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 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 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 42Patent Ⅰ

43 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 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 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 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); 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 - effecting observation of prior art effect (Article 29-2, Patent Act); - effecting existence of prior application (inhibition of double patenting) (Article 43Patent Ⅰ

44 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) Division of Patent Application 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 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, (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). 44Patent Ⅰ

45 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, 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 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 45Patent Ⅰ

46 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 Demanding Appeal against the Decision of Rejection of the application 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) 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. 46Patent Ⅰ

47 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 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). 47Patent Ⅰ

48 2-12. Topics of Different Technical Fields 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 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. 48Patent Ⅰ

49 3. Post-Grant Procedures 3-1. Opposition Procedure 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 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 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). 49Patent Ⅰ

50 (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 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 requirements of correction are the same as those in Invalidation Trial explained later. In a case where a request for correction of the patent is filed by the patentee, an opportunity to submit arguments within a reasonable period of time shall be given to the opponent Effects of a decision of opposition In a case where a decision to revoke the patent has become conclusive, the patent right shall be deemed not to have existed. In other words, with the revocation decision the patent right shall lapse retroactively. In a case where the opposition to the patent is found groundless, a decision to maintain the patent shall be made. Such a decision cannot be appealed to IP High Court. Instead, patent invalidation trial, which is separate from opposition proceedings, may be filed. 50Patent Ⅰ

51 Lawsuit against trial decision In a case where the patent is revoked by the opposition procedure, the patentee can file a lawsuit against the IP High Court to seek a court decision to reverse the opposition decision to revoke the patent, basically within 30 days from the date on which a Certified Copy of the Opposition Decision was served Trial for Patent Invalidation When a patent falls under any of the below-mentioned grounds for patent invalidation, a request for a trial for patent invalidation can be filed (Article 123, Paragraph 1, Body, Patent Act) Grounds for Patent Invalidation (a) The patent has been granted on a patent application with an amendment which introduced new matter (Article 123, Paragraph 1, Item 1, Patent Act). (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); the provisions of joint applications (Article 38, Patent Act); or the provisions of first-to-file rule (Article 39, paragraphs 1 to 4). (Article 123, Paragraph 1, Item 2, Patent Act.) (c) The patent has been granted in violation of a treaty (Article 123, Paragraph 1, Item 3, Patent Act). (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). (Article 123, Paragraph 1, Item 4, Patent Act.) (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 51Patent Ⅰ

52 stated in foreign language documents. (Article 123, Paragraph 1, Item 5, Patent Act.) (f) The patent has been granted on a misappropriated application filed by a person who is not the inventor and has not succeeded to the right to obtain a patent for the invention. (Article 123, Paragraph 1, Item 6.) (g) After the grant of the patent, the patentee has become unable to hold a patent right under Article 25, Patent Act, or the patent has become in violation of a treaty. (Article 123, Paragraph 1, Item 7.) (h) When the correction of the specification, claims or the drawings of the patent has been obtained in violation of the provisions of purposes of correction (Proviso to Article 126, Patent Act), or requirements for correction (Article 126, Paragraphs 5 to 7, Patent Act) in the trial for correction, or contrary to the purpose of correction in the request for correction (Proviso to Article 134-2, Paragraph 1, and Artiecle 120-5, Paragraph 2, Patent Act). (Article 123, Paragraph 1, Item 8, Patent Act.) Person who can request for a trial for patent invalidation Only an interested party can file a request for a trial for patent invalidation (Article 123, Paragraph 2, Patent Act) Term for requesting for a trial for patent invalidation A request for a trial for patent invalidation can be filed even after the lapse of the patent right (Article 123, Paragraph 3, Patent Act) Effects of a trial decision of invalidation When a trial decision to the effect that a patent is to be invalidated has become final and binding, the patent right shall be deemed never to have existed (Article 125, Patent Act). However, when the patent falls under the above (g) of the grounds for patent invalidation and when a trial decision to the effect that the patent is to be invalidated has become final and binding, the patent shall be deemed not to 52Patent Ⅰ

53 have existed from the time the above (g) of the grounds for patent invalidation first become applicable to the patent (Proviso to Article 125, Patent Act) Lawsuit against trial decision When a party in the case or an intervenor is dissatisfied with the trial decision made in the trial for patent invalidation, a lawsuit can be filed against the IP High Court to seek a court decision to reverse trial decision, basically within 30 days from the date on which a Certified Copy of the Trial Decision was served (Article 178, Paragraphs 1, 2 and 3, Paten Act) Request for correction of the description, claims and/or drawings during a trial for patent invalidation The demandee in a trial for patent invalidation can file a request for a correction of the description, scope of claims and/or drawings (Article 134-2, Paragraph 1, Paten Act) Requirements for request for correction (a) The correction shall be limited to the following purposes: (i) restriction of the scope of claims; (ii) correction of errors in the description or of incorrect translations; and (iii) clarification of an ambiguous statement. (iv) amendment of a dependent claim quoting one of preceding claims may be rewritten in the form of an independent claim without quoting the preceding claim. (b) The correction should remain within the scope of the matters disclosed in the originally filed application, and should not add any new matter (Article 126, Paragraph 5, Patent Act, applied mutatis mutandis). (c) The correction should not substantially enlarge or alter the scope of claims (Article 126, Paragraph 6, Patent Act, applied mutatis mutandis). (d) In the case where the correction is for the purpose of the above (a)(i) or (ii) of claims which have not been subjected to the trial for patent invalidation, the 53Patent Ⅰ

54 invention recited in the claims after the correction should meet patentability requirements independently (Article 126, Paragraph 7, Patent Act, applied mutatis mutandis by reading Paragraph 7 differently) Term for filing a request for correction (Article 134-2, Paragraph 1, Patent Act) (a) During a time limit for submitting a written answer in the trial for patent invalidation (Article 134, Paragraphs 1 and 2, Patent Act). (b) During a time limit designated, when a judgment to reverse the trial decision has become final and binding in the lawsuit seeking the judgment to reverse the trial decision against the trial decision of dismissal with request for the trial for patent invalidation, and at the time of re-opening of the invalidation proceedings, if such motion is made by the demandee of the trial for patent invalidation (Article 134-3, Patent Act). (c) During a time limit designated in the Ex Officio proceedings in the trial for patent invalidation to give the party in the case an opportunity for presented opinion or arguments (Article 153, Paragraph 2, Patent Act). (d) During a time limit designated in a notice informing, in advance, the party in the case a summary of a trial decision to be made. (Article 164-2, Paragraph 2, Patent Act) Effects when the correction is approved When the correction of the description, claims and/or drawings has been approved, the filing of the patent application, the laying open of the application, the examiner's decision or the trial decision to the effect that the patent is to be granted, or the registration of establishment of the patent right, shall be deemed to have been made on the basis of the corrected description, the claims or drawings (Article 128, Patent Act, applied mutatis mutandis) Trial for Correction The patentee can file a request for a trial for correction with regard to of correction of the description, scope of claims and/or drawings (Article 126, 54Patent Ⅰ

55 Paragraphs, 1, 5, 6, 7, Patent Act). The trial for correction may be requested after granting a patent, and even after the lapse of the patent right (Article 126, Paragraph 8, Patent Act). However, the request for the trial for correction of the description, claims and/or drawings may not be filed during a period of time from the time when a trial for patent invalidation has become pending before the Patent Office to the time when a trial decision of the invalidation proceedings has become final and binding. (Article 126, Paragraph 2, Patent Act). The correction in the trial for correction should also meet the requirements for correction described in above (note: the requirement (d) is applied to all claims). (Article 126, Proviso to Paragraph 1, and Paragraphs 5-7, Patent Act.) When the trial decision that the description, scope of claims and/or drawings are to be corrected has become final and binding, the filing of the patent application, the laying open of the application, the examiner's decision or the trial decision to the effect that the patent is to be granted, or the registration of establishment of the patent right, shall be deemed to have been made on the basis of the corrected description, the claims or drawings (Article 128, Patent Act) Extension of the Duration of Patent Right (Article 67, Paragraph 2, Patent Act) What is the system of extension of the duration of patent right? For inventions in a certain field, such as, medicines and chemicals, a considerable length of time is required for performing required examinations and trials in order to obtain the Government Approval under the provisions of Laws for the purpose of ensuring safety. Hence, due to requiring such considerable length of time, the applicant/inventor(s) cannot enjoy the benefits provided by the granted patent right (that is, cannot work the invention), during a full period of duration of patent right, because the medicinal or chemical product cannot be put into market without receiving the Government Approval. That is, because of obtaining an approval or other disposition which is governed by provisions in laws intended to ensure safety (the disposition provided by the Cabinet Order as specified in Article 67, Paragraph 2, Patent Act, hereinafter will be called the disposition provided by 55Patent Ⅰ

56 the Cabinet Order"), and when the patented invention could not have been worked, the duration of patent right of such inventions relating to medical compounds, medical use, and agriculturals, can be extended for a period not exceeding five years. The following dispositions are designated by the Cabinet Order: the registration of agricultural chemicals under the Agricultural Chemicals Regulation Law and the approval and certification of drug products, in vitro diagnostics and regenerative medicine products under the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics Procedures for obtaining the extension of the duration of patent right (Article 67-2, Article , Patent Act) The patentee who desires to apply for registration of an extension of the duration of a patent right should file an application for registration of the extension of the patent right at the prescribed timing by taking prescribed procedures. An application to register a patent term extension must be filed within three months of the date of the disposition designated by the Cabinet Order under Article 67(2). However, such an application may not be filed after the expiration of the original term of the patent right. If an application to register a patent term extension cannot be filed within three months after the date of the disposition for any reason not attributable to the applicant, the applicant must file the application within 14 days after the reason ceases to exist (or within nine months after the date of the disposition, whichever period expires earlier). When a disposition designated by the Cabinet Order is unlikely to be obtained by six months prior to the expiration of the term of a patent right, the applicant must submit a document providing the following information on or before that day: (i) the name and domicile or residence of the person filing the application; (ii) the patent number; and (iii) the disposition designated by the Cabinet Order under Article 67(2). 56Patent Ⅰ

57 Requirements for obtaining the extension of the duration of patent right (1) The patented invention should have obtained the disposition provided by the Cabinet Order prior to working it. When a product (or a product and use thereof) of the patented invention, which has obtained the disposition provided by the Cabinet Order is recited in the scope of claims, it is recognized that the patented invention needed to obtain said disposition prior to working it. In the case where one patent right need to have a plurality of disposition provided by the Cabinet Order, and when the patented invention has become possible to be worked only after obtaining the second and subsequent dispositions, such portion of the patented invention is recognized that such portion needed to obtain the disposition provided by the Cabinet Order. (2) The patentee, its exclusive licensee or the registered non-exclusive licensee under the patent has obtained the disposition provided by the Cabinet Order for the patented invention. The disposition provided by the Cabinet Order may be obtained by either the patentee, its exclusive licensee or the registered non-exclusive licensee. (3) A period for obtaining the extension of the duration of patent right should not exceed the period of time, during which the patented invention was unable to be worked. "The period of time, during which the patented invention was unable to be worked" means a period of time from filing an application for obtaining the disposition provided by the Cabinet Order plus a period of time required for performing the tests or trials to satisfy the prescribed conditions, after the date of registration of establishing the patent right. (4) An application for obtaining the extension of the duration of patent right should be filed by patentee. When the patent right, for which the extension of the duration is desired, is jointly owned, an application for obtaining the extension of the duration of patent right should be filed jointly by the joint owners. When the application for obtaining the extension of the duration of patent right is filed, JPO examines the application and the patent term is extended if JPO judges that the patent satisfies the requirements of the extension. 57Patent Ⅰ

58 Trial for invalidation of registration of extension of the duration of patent right (Article 125-2, Patent Act) When registration of extension of the duration of patent right does not satisfy any of the above-mentioned requirements, a third person may demand a trial for invalidation of registration of extension of the duration of patent right. When the trial decision to invalidate the registration of extension of the duration of patent right has become final and conclusive, the extension of the duration through the registration of the extension shall be deemed never to have existed. However, in the case where the trial decision of invalidation of the extension has become final and conclusive by the reason that the period of time for which the extension of duration was requested exceeded the period of time during which the patented invention was unable to be worked, the period of time which has exceeded the period of time during which the patented invention was unable to be worked, is invalidated. 58Patent Ⅰ

59 4. Patent Right 4-1. Patent Right Effects of patent right A patentee shall have an exclusive right to commercially work the patented invention (Article 68, Patent Act). Hence, the patentee can enforce the patent right, such as, requesting an injunction based on the patent right, against a third party who has worked the patented invention as his/her business (not limited to the act of profit-making) without due authorization by the patentee and without legitimate reason. However, the patentee cannot exercise the patent right when the patent right is recognized as the one that should be invalidated by a trial for patent invalidation (Article 104-3, Patent Act). The term "working" of an invention means the following acts. (a) In the cases of an invention of a product, acts of manufacturing, using, assigning, exporting, importing or offering for assignment, etc. (b) In the case of an invention of a process (method), acts of using the process (method). (c) In the case of an invention of a process (method) of manufacturing a product, acts of using, assigning, exporting, importing or offering for assignment, etc. of the product manufactured by the process (method), in addition to the acts of using the product Limits of patent right The effects of the patent right shall not be effective in any of the following cases (Article 69, Patent Act). (a) The effects of the patent right shall not be effective against the working of the patented invention for the purpose of experiment or research. (b) The effects of the patent right shall not be effective against vessels or aircraft merely passing through Japan or machines, instruments, equipment or other 59Patent Ⅰ

60 accessories used therein. (c) The effects of the patent right shall not be effective against products existing in Japan prior to the filing of the patent application. (d) The effects of the patent right shall not be effective against acts of preparing medicines according to a prescription prepared by a physician or a dentist or to medicines prepared by the prescription Technical scope of patented invention The technical scope of a patented invention shall be determined based on the statements in the scope of claims (Article 70, Patent Act). Here, the meaning of each term used in the scope of claims shall be interpreted in consideration of the statements in the description and drawings. Further, in determining the technical scope of a patented invention statements in the abstract shall not be taken into consideration. Moreover, in determining the technical scope of a patented invention, a prosecution history of the application of the granted patent shall be taken into consideration (estoppel) Indirect Infringement Although not directly infringing a patented invention,performing certain preliminary or assisting acts which have a high probability to cause a direct infringement, is deemed as an indirect infringement act (Article 101, Patent Act). Acts deemed to constitute indirect infringement are listed below. (a) Where a patent has been granted for an invention of a product, acts of producing, assigning, etc., importing or offering for assignment, etc., any product to be used exclusively for the production of the product as a business. (b) Where a patent has been granted for an invention of a product, acts of producing, assigning, etc., importing or offering for assignment etc., any product to be used for the production of the product and indispensable for solving the problem by the invention as a business, knowing that the invention is a patented invention and the product is used for the working of the invention. 60Patent Ⅰ

61 (c) Where a patent has been granted for an invention of a product, acts of possessing the product for the purpose of assigning, etc., or exporting it as a business. (d) Where a patent has been granted for an invention of a process (method), acts of producing, assigning, etc., importing or offering for assignment, etc., any product to be used exclusively for the use of the process (method) as a business. (e) Where a patent has been granted for an invention of a process (method), acts of producing, assigning, etc., importing or offering for assignment etc., any product to be used for the use of the process (method) and indispensable for solving of the problem by the invention, knowing that the invention is a patented invention and the product is used for the working of the invention as a business. (f) Where a patent has been granted for an invention of a process (method) of producing a product, acts of possessing the product produced by the process (method) for the purpose of assigning, etc., or exporting it as a business Licenses Exclusive License An exclusive license shall have an exclusive right to work the patented invention as a business to the extent permitted and established by the contract granting the license (Article 77, Paten Act). Where an exclusive license is granted on the patent right and its establishment is recorded in the Patent Office, even the patentee cannot work the patented invention within the scope where the licensee has an exclusive right to work the patented invention. Regarding the exclusive license, the following points should be noted. - In the case where a pledge is established for his/her share of the exclusive license, or granting a non-exclusive license to a third party on his/her exclusive license, obtaining the consent of the patentee is required. - In the case where the patentee abandons the patent right, or initiates a demand for correction or a trail for correction, the patentee must obtain the consent of the exclusive licensee. 61Patent Ⅰ

62 - An exclusive license may be transferred, when the business of working the relevant invention is transferred together, where the consent of the patentee is obtained, or where the transfer occurs as a result of general succession including inheritance Non-Exclusive License A non-exclusive license shall have a right to work the patented invention as a business to the extent permitted and established by the contract granting the license (Article 78, Patent Act). A non-exclusive license shall have effect on any person who subsequently acquires the patentee or the exclusive licensee, or the exclusive license on the patent right without registration of the non-exclusive license (Article 99, Patent Act). Regarding the non-exclusive license, the following point should be noted. A non-exclusive license may be transferred, when the business of working the relevant invention is transferred together, where the consent of the patentee is obtained, or where the transfer occurs as a result of general succession including inheritance Non-exclusive license based on prior use A non-exclusive license based on prior use is a statutory non-exclusive license that is granted on a person who, without knowledge of the content of an invention claimed in a patent application and has been working the invention or preparing for the working of the invention in Japan at the time of the filing of the patent application (Article 79, Patent Act). The non-exclusive license based on prior use is a license granted in view of the fairness and preventing the existing facilities from devastation. Regarding the non-exclusive license, the following points should be noted. - A person who is working the invention must be working in good faith. The working of the invention or preparing for working of the invention must be performed within the state of Japan. The term "preparing" has the meaning that the 62Patent Ⅰ

63 person has the intention of working the invention immediately, and his/her intention is presented to the extent of recognizing it objectively. - A non-exclusive license based on prior use allows a person to work a patented invention of the patent application as a business within the scope of the invention which had been worked or prepared for working it and for the purpose of business. - Payment for compensation is not required. - A non-exclusive license based on prior use may be transferred, when the business of working the relevant invention is transferred together, where the consent of the patentee is obtained, or where the transfer occurs as a result of general succession including inheritance Enforcement Demand for injunction and disposal of infringing products A patentee or exclusive licensee may demand a person who infringes or is likely to infringe the patent right or exclusive license to stop or prevent such infringement, based on a right to demand an injunction (Article 100, Paragraph 1, Patent Act). Further, the patentee or exclusive licensee may demand disposal of infringing products and removal of facilities used for the act of infringement (Article 100, Paragraph 2, Patent Act). The demand for disposal of infringing products must be made concurrently with the demand for injunction Claim for damages, etc. A patentee or an exclusive licensee may claim damages against a person who has infringed its patent right or exclusive license, intentionally or negligently (an infringer), for the damage caused by such infringement (Article 709, Civil Code). A statutory period for claiming damages is within three (3) years from the time when a patentee or an exclusive licensee became aware of an infringement of its patent right or exclusive license. However, even after the lapse of the statutory period of three (3) years, a patentee or an exclusive licensee may demand compensation for unfair profits 63Patent Ⅰ

64 gained by a person (a beneficiary) who obtained such unfair profits by a patented invention without any legal cause thereby to cause damage to the patentee or the exclusive licensee (Article 703, and Article 704, Civil Code). A patentee or an exclusive licensee may demand compensation for unfair profits gained by the infringer within 10 years Presumption of Amount of Damage Generally, the burden of proof for an amount of damages is on the person who claims damages. However, in the case of the infringement of a patent right, in many a case it is extremely difficult to prove an exact amount of damages. Therefore, the Japanese Patent Act provides methods of presumption of amount of damage (Article 102, Patent Act). For example, Article 102, Paragraph 1, Patent Act, provides a method of presumption of amount of damage by the following calculation: Amount of damage = (the amount of profit per unit of articles which would have been sold by the patentee or the exclusive licensee if there had been no infringement) x (the quantity of articles assigned by the infringer). Further, Article 102, Paragraph 2, Patent Act, provides that the amount of profits earned by the infringer shall be presumed to be the amount of damage sustained by the patentee or exclusive licensee. Still further, Article 102, Paragraph 3, Paten Act, provides that the amount of the license fee that the patentee or exclusive licensee would have been entitled to receive for the working of the patented invention as the amount of damage. A patentee or an exclusive licensee can request a court to order an infringer to produce documents, for example, documents indicating quantity of articles assigned by the infringer or the amount of profit earned by the infringer by the act of infringement, necessary for calculating the damage (Article 105, Paten Act) Presumption of Negligence Since a patented invention is laid-open to public after granting a patent, negligence of an infringer is presumed (Article 103, Patent Act). The person 64Patent Ⅰ

65 to whom a patentee or an exclusive licensee may claim damages is limited to a person who has infringed its patent right or exclusive license intentionally or negligently (Article 709, Civil Code). However, due to the presence of the abovementioned provision of Presumption of Negligence of the Patent Act, the patentee or the exclusive licensee is no longer required to prove that its patent right or the exclusive licensee has been infringed by the infringer intentionally or negligently Right to claim compensation (Article 65, Patent Act) A patent application is laid-open to public after a lapse of one year and six months from the date of the filing (Article 64, Patent Act), whereupon it becomes possible for a third person to access the laid-open application. However, a patent right of the invention of the laid-open application will not exist until a patent is granted and registered in the Patent Office. Because of this, the applicant has a right to claim compensation for damages caused by a third person who worked the invention during a period of time from the laying open of his/her patent application until a patent is granted and registered in the Patent Office. This is the right to claim compensation After the laying open of a patent application, where the applicant has given warning with documents stating the contents of the invention claimed in the patent application, the applicant may claim compensation against a person who has worked the invention as a business after the warning and prior to the registration establishing a patent right Jointly owned patent rights Since a patented invention is an intangible property, all the joint owners of a patent right thereof may work the patented invention simultaneously. Then, when a patent right is owned jointly by a plurality of owner, due to the capital strength and technical power of one of the joint owners, a property value of a share of the other of the joint owners may possibly fluctuates. Hence, the Japanese Patent Act provides special provisions regarding jointly owned patent rights (Article 73, Patent Act). That is, the following points should be noted regarding the jointly owned patent 65Patent Ⅰ

66 rights. - No joint owner may assign or establish a rights of pledge on said joint's owner's own share without the consent of all the other joint owners. However, in the case of an assignment by the general succession including inheritance, obtaining such consent of all the other joint owners is not required. - No joint owner may grant an exclusive license or a non-exclusive license, or recordal of establishing such a license in the Patent Office with regard to the patent right to any third party without the consent of all the other joint owners. - Joint owner may abandon his/her right to its share, without obtaining the consent of the other joint owners. - Unless otherwise agreed upon by contract, each of the joint owners of the patent right may work the patented invention without the consent of the other joint owners. - No joint owner can file an application for the registration of extension of the duration of a patent right unless jointly with all the other joint owners. 66Patent Ⅰ

67 Ⅱ Utility Model System of Applying and Registering Utility Model 1. Requirements of Application for Utility Model Registration Different from the Patent Act, the Utility Model Act protects "devices" relating to the shape or structure of an article or combination articles, and thereby to contribute to the development of industry. Therefore, ideas relating to methods and programs are not protected by the Utility Model Act. A protected range by the Utility Model Act is narrower than a protected range by the Patent Act. As above-mentioned, since the Utility Model Act protects the devices, drawing(s) illustrating the devices are one of essential documents for filing an application for a Utility Model Registration. Still further, different from the patent application, filing of a utility model registration application in the English language cannot be accepted. The utility model application should be in only the Japanese language. Moreover, even a Convention Utility Model Application claiming a priority under Paris Convention, the 67

68 Japanese application must be filed in the Japanese language Japanese National Phase Utility Model Application of a PCT application (filing a National Form and a Japanese translation) As in the case of the Japanese National Phase Patent Application, a request with the national form describing the bibliographic items together with a Japanese translation of the specification, claim(s), drawing(s) and Abstract must be filed within 30 months from the priority date. However, when the national form is filed within months from the priority date, the Japanese translation of the specification, claim(s), drawing(s) and Abstract can be filed within two (2) months from the date of filing the national form (Article 48-4, Utility Model Act). 2. Utility Model Registration The Utility Model Act adapts a non-examination system. Hence, a substantive examination to an application for a utility model registration is not performed (there is no system for requesting a substantive examination). However, when the application fails to meet several registration requirements, amendments to the description, scope of claims and drawing(s) attached to the application is ordered (Article 6-2, Utility Model Act). Then an applicant of the application can file amendments by a designated time limit. Note that filing a voluntary amendment is permitted within a month from the date of filing the application for a utility model registration (Article 2-2, Paragraph 1, Utility Model Act). The term of the utility model right is 10 years from the date of filing. Note that there is no publication system of an application for a utility model registration, however a registration of a utility model is published after registration of establishment of a utility model right. 68Utility Model Ⅱ

69 3. Correction of the Scope of Claims After registration of the establishment of the utility model right, the holder of the utility model right may correct the description, scope of claims, or drawings to the application only once, except for the following cases: (i) where two months have lapsed from the date when the first Report of Utility Model Technical Opinion was served; and (ii) where the time limit initially designated under Article 39(1) for a trial for invalidation of utility model registration has expired (Article 14-2(1), Utility Model Act). The above-mentioned limitation of opportunity for correction is decided in consideration of providing the holder of the utility model right with an appropriate opportunity to correct the contents of the utility model right and reducing a load of monitoring of the third party. Further, the purpose of correction is limited to (i) restriction of the scope of claims, (ii) correction of errors, (iii) clarification of an ambiguous statement and (iv) reformulation of a dependent claim into an independent claim (Article 14-2(2)). 4. Report of Utility Model Technical Opinion As stated above, the Utility Model System employs the non-substantive examination system. Hence, the holder of the utility model right may not exercise his/her utility model right against an infringer, unless he/she has given warning in the Report of Utility Model Technical Opinion regarding the registered utility model (Article 29-2, Utility Model Act). The Report of Utility Model Technical Opinion is a document including an opinion made by Japanese Patent Office with respect to a validity of the utility model registration, and it is made to provide the holder of the utility model right and third parties with an objective judgment material regarding a validity of his/her utility 69Utility Model Ⅱ

70 model right. Any parson can file a petition requesting a technical opinion to obtain the Report of Utility Model Technical Opinion from the JPO (Article 12, Utility Model Act). 5. Responsibility of holder of Utility Model Right In a case where a trial decision to the effect the utility holder registration is to be invalidated has become final and binding after the holder of utility model right against, or gave warning thereof to, an infringer, the holder shall be held liable to compensate damage sustained by the infringer as a result of the exercise of his/her right or the warning provided (Article 29-3, Utility Model Act). However, if the holder exercised his/her right or gave warning thereof based on the Report of Utility Model Technical Opinion having an evaluation that the utility model registration is valid, the holder can quit of the liability. 6. Patent Applications based on Utility Model Registration (Conversion of Application) A holder of utility model right can file a patent application based on his/her own utility model registration, except for several exceptions (e.g., where 3 years have lapsed from the date of filing an application of the utility model registration) (Article 46-2, Patent Act). In a case where the patent application based on the utility model registration is filed, the registered utility model right has to be waived, and the converted patent application shall be examined according to conditions for patentability under Patent Act, in response to filing a request for examination. 70Utility Model Ⅱ

71 Ⅲ 71

72 1. The procedures for obtaining a trademark right < Applications in Japan > < Applications under the Madrid Protocol > 1 Application Payment of official fee 1 Application for international registration International registration Japan Patent Office Examination Approve Refuse Decision of granting registration Statement of Grant of Protection(document) Notification of payment(document) Approve Office Action 2 Argument/Amendment Appoint a Japanese attorney Refuse Applications in Japan Application under the Madrid Protocol 3 -a Payment of official fee 3 -b Payment of the second part of individual fee Decision of Refusal 4 Registration, issue of Certificate of Trademark Registration Publication Opposition Within 2 months Within 3 months Appeal against the Decision of Refusal Applications under the Madrid Protocol Applicant/local representative Japanese patent attorney The International Bureau Japan Patent Office 72Trademark Ⅲ

73 2. Points to remember 1 Applications in Japan The information and document required for a trademark application include the following: The name and the domicile or residence of the applicant for the trademark registration A trademark for which registration is sought (electric file in JPEG format is needed in the case where the trademark included a logo or device, electric file in BMP and/ or GIF formats are allowable in case of the logo or device in black and white) The designated goods or services ( a multi-class application is possible) The information of basic application and a priority certificate in case a Trademark Application is under the Paris Convention, claiming a priority right. When claiming a priority from the filing date of a first trademark application, the applicant must file a trademark application in Japan within 6 months from the filing date of the basic application. Procedures A priority document has to be filed within 3 months from the filing date in Japan. Power of Attorney Form, signed by the applicant is required. 2 If the applicant receives an Office Action from the Japanese Patent Office, a response to the Office Action should be submitted within 3 months from the mailing date of the Office Action. The one-month extension of time is available only once with payment of the extension fee. 3 -a The registration fee must be paid within 30 days from the mailing date of a Notice of Decision to grant registration. The registration fee may be paid either for a full 10-yesr term of protection, or a half 5-year term protection. 73Trademark Ⅲ

74 1 Under the Madrid Protocol 2 If the applicant desires to submit an argument and/or an amendment to respond to the Office Action, the applicant must appoint a Japanese attorney(s), and concurrently with filing an argument and/or an amendment in the Japanese Patent Office, a Power of Attorney signed by the applicant must be filed. Note that the signed Power of Attorney must be the original. A photo copy of the Power of Attorney cannot be accepted by the Japanese Patent Office. The information and document required for submitting an argument and/or an amendment includes the following: International registration number A signed Power of Attorney (see the above) 3 -b If no reason for refusal is not found in the application, a certified copy of decision of granting registration, a certified copy of Statement of Grant of Protection and a notification of payment of required registrations fees are transmitted from the Japan Patent Office to the applicant. The second part of the individual fee is payable within the prescribed period indicated in the notification, which is transmitted from the International Bureau. The applicant or the applicant's representative pays the second part of the individual fee to the International Bureau. The appointed Japanese attorney cannot pay the individual fee. The amount of the individual fee and account information of the International Bureau are indicated in the cover letter transmitting the notification of payment. Where the second part of the individual fee is not paid within the prescribed time limit, the international registration in the International Register shall be cancelled with respect to Japan. 4 The Japan Patent Office issues the Certificate of trademark registration for both the application in Japan and application under the Madrid Protocol. 74Trademark Ⅲ

75 3. Examination An application for trademark registration is examined by an examiner of Japanese Patent Office. The examiner mainly judges the distinctiveness of a trademark and the similarity of the trademark to prior registered trademark(s). *Some typical cited grounds for rejections (i) A trademark which is identical or similar to prior registered trademark(s) if the trademark is used in connection with the designated goods or designated services relating to the prior registered trademark(s) or goods or services similar thereto. Such trademark is not registered because the trademark is likely to cause confusion in connection with the goods and services pertaining to the prior trademark. Although Japan has adopted the Nice International Classification System, goods and/ or services are categorized into some groups unique to Japan and independently of the International Classification System. In Japan each group has a certain code. Specifically, goods or services categorized into the same group are presumed to be similar. (ii) Indefiniteness of the designated goods or services If the designated goods or services are not complying with as the goods or services according to the Examination Guidelines, the applicant receives an Office Action because of indefiniteness of the designated goods or services. 75Trademark Ⅲ

76 Index A Accelerated Examination 39 Amendments 41 Appeal 46 B Business Method Inventions 14 C Claim dependency 42 Clarity Requirements 30 Computer Software-related Inventions 13 Correction 53,54 D Description Requirements 27 Divisional Application 44 Double Patenting 31 E Enablement Requirements 28 Enforcement 63 Exception to Lack of Novelty of Invention (grace period) 18 Extension of the Duration of Patent Right 55 G Genetic Engineering-Related Inventions 48 I Indirect Infringement 60 Inventive Step 22 Interview with the Examiner 42 J Joint invention 34 Jointly owned patent rights 65

77 L Licenses 61 M Medical Acts 12 Medicinal Inventions 48 N Novelty 15 P Patent Prosecution Highway (PPH) 40 Patent Right 55 PCT 32 Priority 32 R Request for Examination 39 S Selection Invention 20 Support Requirements 29 T Technical scope of patented invention 60 Trademark 72 Trial for Patent Invalidation 51 U Use Invention 21 Utility Model 68

78 About IP Firm SHUWA Our firm, IP Firm SHUWA(Sera, Toyama, Matsukura & Kawaguchi / Kohhara & Fujita), is a major intellectual property firm known as "Shuwa" in Japan. We boast having over forty patent attorneys with more than seventy technical and clerical staff, which ranks us in the top 1% of all patent firms in size in Japan. Our highly skilled patent attorneys and technology experts provide reliable services in every field of intellectual property, i.e. patents, designs, trademarks, and copyrights. We have been offering services for nearly thirty years since its foundation along with new members. We guarantee long years of good relations with our clients and we are confident in providing you with the most satisfactory services to obtain and protect your intellectual property right.