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Any industrially applicable "invention" as defined in the laws, is patentable. The "invention" is defined by the Patent Law as "the highly advanced creation of technical ideas by which a law of nature is utilized". Therefore, a new technical idea, which utilizes a natural law, is patentable if it is industrially applicable. It may be a method or product. The method may be for producing a product, carrying out some operation or using some product. The product may be a mechanical, electrical or chemical product, or a combination thereof. It may be an apparatus, device or chemical composition or compound. Computer software and genetic engineering are also patentable if they meet the specific requirements according to the Examination Guidelines. Computer software per se can be protected even if it is not in a form of a storage medium. A business method can be patented in a form of a combination of software and hardware, if either the business method itself or the hardware is novel or unobvious from the state of the art.

The natural laws per se, mere discoveries, or non-technical ideas are not inventions, and accordingly, are unpatentable. Even if the subject matter is an invention as defined in the law, it is not patentable if it is not industrially applicable. For example, a therapeutic method for the treatment of a human body or a diagnostic method practiced on the human body is unpatentable. However, instruments or apparatus used for such purposes as well as pharmaceutical products are patentable. Mathematical discovery or algorithm per se is not patentable. Inventions liable to contravene public order, morality or public health cannot be patented either.

2. Patentability Requirements

1) Novelty

Section 29 par.1 of the Japanese Patent Law prescribes that "Any person who made an invention which is industrially applicable may obtain a patent therefor, except in the case of the following inventions:

i) inventions which were publicly known in Japan or elsewhere prior to the filing of the patent application;

ii) inventions which were publicly worked in Japan or elsewhere prior to the filing of the patent application;

iii) inventions which were described in a publication distributed in Japan or elsewhere prior to the filing of the patent application".

There is a six-month grace period for loss of novelty under certain conditions. However, since it is only applicable to the filing date in Japan, it is no use for foreign applicants who usually cannot file a Japanese application within six months from when the invention was made publicly known.

2) Inventive Step

Section 29 par.2 of the Japanese Patent Law prescribes that "Where an invention could easily have been made, prior to the filing of the patent application, by a person with ordinary skill in the art to which the invention pertains, on the basis of an invention or inventions referred to in any of the sub-paragraphs of paragraph (1), a patent shall not be granted for such an invention notwithstanding paragraph (1)".

This requirement is substantially equivalent to that of 35 USC 103. However, such prior application that was filed earlier than the subject application but was not published before the filing date of the application cannot be cited under this section. Such prior application can only be cited under Section 29bis. (See "4) Whole Content Approach) Practically, the rejection based on this section is most frequently issued by the Examiner.

3) Double patenting

Even an application which was not published before the filing of the subject application can be a bar to the grant of the subject application if it was filed prior to the subject application and claims a subject matter which is the same as that claimed in the subject application. In this case, the later filed application is rejected over the earlier application whether the applicants are the same or not. This rejection is practically issued only in case that the applicant of the subject application is the same as that of the earlier application, since if they are different the "whole content approach" type rejection can be issued, which is more convenient for the Examiner.

4) Whole Content Approach

Section 29bis of the Japanese Patent Law prescribes that even an application filed prior to the subject application, but not published before the filing of the subject application, which does not claim a subject matter which is the same as that claimed in the subject application, can be a bar to the grant of the application if it discloses the claimed invention somewhere in the disclosure, if neither the applicant nor the inventorship of the subject application is the same as that of the earlier filed application at the time of filing of the subject application. If either the applicant or the inventorship of the subject application is the same, the subject application cannot be rejected under this section.

Therefore, if you are aware of the existence of such an earlier application, you may make the applicant of one of the applications the same as that of the other. Then, after filing the application, the applicant can be changed to the initially intended one.

3. Filing Requirements

1) Formal Requirements for Filing Applications

The minimum requirements for the documents and information that must be submitted before the Patent Office to obtain the filing date are;

Petition with name of applicant (assignee),

Specification with claims,

Drawings, if any,

Priority claiming with name of country and priority date, if any, and

Attorney's name, if any (mandatory for foreign applicants).

The mailed documents are regarded as being submitted on the date of dispatch. Most applications are filed electronically. All the documents are required to be in the Japanese language. (It is possible to file applications in English. See 3. 4) "Filing in English")

The following documents and information may be supplemented later.

Abstract

Address of applicant

Name of representative (signatory) of applicant

Name and address of inventor

Application number of priority-claimed application

Power of attorney

(General power of attorney: Once a General power of attorney is filed, there is no need to file a further power of attorney.)

Certified copy of priority document

(Certified copy of the priority documents must be filed within 16 months from the priority date. If the priority is based on a European patent application, the certified copy need not be filed.)

The following documents or information are not usually necessary, but are required only in special cases.

Assignment

Certificate of Nationality (in the case of an individual)

Certificate of Corporation (in the case of a corporation)

The Assignment need not be notarized or legalized. The certificates need to be notarized, but need not be legalized.

2) Disclosure Requirements

The requirements for disclosure of a specification calling for a description of the object, constitution and advantages of the invention have been relaxed so as to require only a clear and sufficient disclosure of the invention by a revision effective as of July 1, 1995. Therefore, patent applications filed on or after July 1, 1995 are no longer subject to such requirements. This revision will avoid rejections of many U.S. based applications in which the advantages of the invention are not explicitly described.

The requirements for the statement of claims calling for paragraphs which set forth only the features indispensable for the constitution of the invention have been changed to require a clear and concise statement of all the matters which are regarded to be necessary to define the invention.

This revision will avoid unreasonable requirements by the Examiner, which require introduction of additional elements to the claims in view of the object or advantages of the invention as mentioned in the specification.

3) National Phase Entry of PCT Applications

In order to enter the national phase of a PCT application in Japan, a request for national phase entry must be filed within the term of 30 months from the priority date. A full Japanese translation of the PCT application must be filed together with the request, or, in the case where the request is filed within a period of 28 to 30 months from the filing date, may be filed within two months from the filing date of the request. There is no way to defer the filing of the request.

Since introduction of new matter is strictly prohibited, it is not recommended to file a translation of amendments of the specification at the time of entering the national phase. In view of such strict prohibition of introduction of new matter, it is not recommended to simply file amendments to make the form of the specification and claims conform to that of the counterpart application filed in another country. In other words, even when an amendment was filed in the international stage, it is not recommended to simply file a translation of such amendment at the time of entering the national phase in Japan.

4) Filing in English

A Japanese patent application can be filed initially in English. When an application was filed in English, a Japanese translation must be filed within two months from the filing date. If the translation is not timely filed, the application will be regarded as having been withdrawn.

In the case where the application was filed in English and the translation was filed later, the translation can be corrected at any time up until the end of the term for filing a response to a first Office Action and also in response to any Office Action. The Correction of errors in the translation is treated differently from the Amendment in such a way that a new matter (any matter which is not included in the first translation) can be introduced by the Correction, if such is disclosed in the English specification as filed. Even after the patent is granted, an error in translation can be corrected. After the grant of the patent, however, the correction is allowed only when the correction will not enlarge the scope of claims.

If the translation includes any matter, which is not included in the English specification as filed, the application will be rejected. Such a matter is regarded as a new matter and will be a reason for rejection, opposition and invalidation. It is, therefore, advisable to correct the English specification before filing if an error is found in the English specification.

Both the English application and the Japanese translation will be published for public inspection upon the lapse of 18 months from the priority date (filing date, if priority is not claimed) and the English application will be a basis of the whole content approach for rejecting later filed applications for any subject matter included in the disclosure. The Official fee for filing a patent application in English is JPY 24,000 instead of JPY 15,000 for a normal application. The Official fee for correcting translation is JPY 19,000.

5) Claim Drafting

There is no particular requirement or recommendation as to the format of claims in Japan. Any format of claim may be used in drafting claims in the Japanese patent application. Claims may be in the form of a combination claim, Jepson or continental type two-part claim or Markush type claim. Further, any number of independent claims or dependent claims can be filed.

Multi-dependent claims can also be filed, which is useful to decrease the number of dependent claims and thus save cost. The multi-dependent claims can depend from other multi-dependent claims, which is advisable to further reduce the number of claims and costs.

Means-plus-function claims can also be used. This type of claim is useful to broadly define an invention. There is no legislation or case law which has such a claim interpreted narrowly, as in the U.S.

From the practical viewpoint, it is advisable to draft as broad a scope of claims as possible regardless of the prior art or progress of the basic U.S. application, because the standard of examination in Japan is not always equal to that of the U.S., and accordingly, there is always a possibility that claims broader than those of U.S. claims be granted in Japan over the same prior art. Therefore, it is not advisable to voluntarily amend the Japanese claims to make them conform to the amended U.S. claims before the examination starts.

Fees do not change according to the type of claims. Only the number of claims affects the cost. The cost of filing an application is not affected by the number of claims. The fees that are calculated in terms of the number of claims are the examination fees and the patent annuities. The official fees for requesting examination increase by about 2.4% per claim and the annuities increase by about 8% per claim. Therefore, it is advisable to file a large number of claims initially and reduce it when filing a request for examination and further drop some claims during the prosecution or even after the patent is granted in view of not only the result of the examination but also the importance of claims from the viewpoint of business.

4. Prosecution

1) Steps and Procedures

1.1) Publication (Laying open)

All patent applications, except for those the publication of which is considered to be liable to contravene public order or morality, are laid open for public inspection after 18 months from the filing date or priority date whichever is earlier. It is possible, by filing a request, to have a patent application laid open earlier before the lapse of 18 months. After the publication, the applicant is able to send a warning letter to any possible infringer to establish a date to which the applicant will retroactively be entitled to demand compensation after the application is patented. The amount of the compensation is a reasonable royalty.

1.2) Request for Examination

The patent application is not examined until examination is requested. The request for examination can be filed at any time within three years from the filing date by not only the applicant of the application, but also anyone else. The government fee for filing a request for examination changes with the number of claims on file at the time of filing the request as follows. N is the number of claims. (Currency: Japanese Yen)

Request for examination ... \118,600 + \4,000N

-where the international search report has been established by an International Searching Authority other than the JPO (under the PCT) ... \106,000 + \3,600N

It is possible to reduce the number of claims by filing an amendment to save the examination fee at the time of or before filing the request for examination. Even after the examination is filed, it is possible to file an amendment to delete, increase or change claims. When the number of claims is increased by the amendment, an additional government fee must be paid. Even if the number of claims is reduced before the examination is started after filing the request for examination, there is no refund for the decreased number of claims. When the request for examination has been filed by a third party, the Patent Office notifies the applicant of the filing of the request and provides the applicant with an opportunity to file an amendment within three months (for foreign applicants) from receipt of such notice.

1.3) Amendment

Content:

The Japanese Patent Law was revised to be effective as of January 1, 1994 to speed up the examination of patent applications. It applies to all patent applications filed on or after January 1, 1994. The revision has introduced two new restrictions on amendments. The restrictions are so severe that a single careless amendment could result in irrevocable rejection of the application or invalidation of the patent.

The two new restrictions are as follows:

i) the introduction of "new matter" is absolutely prohibited, and

ii) the types of amendment that can be made in response to the Final Office Action are considerably limited.

The first of these restrictions makes it impossible for the applicant to add a new matter to the application after it has been filed. The "new matter" is strictly defined. Any matter to be added to the application must be directly readable from the original disclosure. Any matter which is not directly readable, but is only obvious or self-evident from the original disclosure cannot be added.

In the patent applications filed (or PCT applications having international filing date of) on or after January 1, 1994, claims can be freely amended within the disclosure of the original application, but the specification and drawings cannot be freely amended. The amendment of the specification and drawings is strictly limited not to introduce new matter, namely limited only to make changes which is directly readable from the original disclosure. It is not necessary to amend the specification to make it conform to the amended claims. Change of objects of the invention will sometimes be regarded as new matter and will be a reason for rejection.

It is important to note that even if the Examiner inadvertently allows an amendment including new matter, third parties can thereafter use the amendment as grounds for opposition or invalidation against the patent that issues therefrom. Accordingly, it is advisable to not even attempt to file an amendment which might introduce a new matter.

Therefore, a person who wants to attack a third party's application or patent may try to find new matter that was introduced by an amendment and can be used as the basis for an opposition or for an invalidation trial.

The second restriction makes it impossible to add an element or elements to the claims to narrow the scope of claims after the Final Office Action is issued. Only an amendment which further restricts an element or elements already recited in the claim is acceptable. The same restriction also applies when the applicant files an amendment at the time of filing an appeal against the decision of rejection. It is important to note that an amendment in violation of this restriction is not a reason for rejection. The Examiner simply dismisses such an amendment. Therefore, there is no risk in attempting to amend the claims to narrow them by addition of an element or elements thereto. The best way to get the Examiner to accept such an amendment at this stage may be to hold an interview with him or her. It will give the applicant an opportunity to persuade the Examiner that the amendment does not require him to conduct a further search and that the amended claims are patentable.

Time

In the patent applications filed (or PCT applications having international filing date of) on or after July 1, 1995, an amendment can be filed;

at any time until the end of the term for filing an amendment in response to the first Office Action where an Office Action is issued,

at any time until receipt of the Decision of Grant where no Office Action is issued,

in response to any Office Action, and

within 30 days from the date of filing an Appeal against the Decision of Rejection.

1.4) Submission of Prior Art

By Applicant:

There is no duty for the applicant to disclose or submit prior art information known to the applicant before the Patent Office. It is, however, advisable for the applicant to show and discuss the closest prior art in the specification or in an amendment to contend patentability of the claimed invention over the prior art in order to secure strength of the patent.

By a third party:

Anyone can submit prior art references or any kind of reasons for rejection for a published application to assist the Examiner. The person who submitted the reason for rejection cannot join the examination unlike the opponent in an opposition procedure or the appellant in an invalidation trial. The reason for rejection includes not only prior art references, but also insufficient disclosure, new matter violation in amendment, and new matter violation in translation (in applications filed in English and PCT applications).

1.5) Office Action and Response

If the Examiner finds any reason for rejection, he or she issues an Office Action. In response to the Office Action, the applicant can file a Response including an Argument and/or Amendments within three months (for foreign applicants) from the date of dispatch of the Office Action. A foreign applicant can easily obtain an extension of the term of three months by filing a request for extension at a cost of JPY2,100 (government fee).

There are various types of rejections as follows.

Lack of Novelty (Sec.29, par.1)

Obviousness (Sec.29, par.2 )

Whole Content Approach (Sec.29bis)

Double Patenting (Sec.39)

Insufficient Disclosure (Sec.36)

New Matter in Amendment (Sec.17bis, par.3)

New Matter in Translation (Sec.49, subpar.5)

Lack of Unity of Invention (Sec.37)

The typical effective way to overcome the most frequently issued obviousness type rejection is to clarify the differences in structure between the claimed invention and the cited prior art references, and explain the differences in the results obtained based on the structural differences. When the claimed invention is rejected over a combination of a plurality of prior art references, the common way to argue against such a rejection is to contend that there is no suggestion to combine them in the references in addition to the argument based on the difference in structure and results between the cited references and the corresponding element of the claimed invention. Particularly when the technical field to which the cited references pertain is far remote from that of the claimed invention, it is effective to contend the non-suggestion of combining the references.

In case that the "whole content approach" type rejection (Sec.29bis) is received, you do not have to argue against obviousness of the claimed invention from the cited prior art, but only have to argue against anticipation. If you can successfully clarify that the claims of the subject application are distinctly different (may be obvious) from the disclosure in the cited prior art or earlier application, you will be able to overcome the rejection under this section.

1.6) Divisional Application

Whenever an amendment can be filed, within 30 days from receipt of a Decision of Grant, or within four months from receipt of a Decision of Rejection, a divisional application or applications can be filed. Any number of divisional applications can be filed out of a parent patent application to claim inventions distinctly different from the invention claimed and rejected in the parent application. The "parent application" means, in case of PCT applications and applications filed in English, the original text of the PCT application or the English text initially filed, i.e. not the translation. (Therefore, it is possible to derive a whole original application from an incomplete parent application where the parent application is based on a PCT application or an English text application.)

The divisional application is entitled to have an effective filing date which is the same as that of its parent application. If any claim of a divisional application is regarded to define an invention which is substantially the same as that defined by a claim in its parent application, the divisional application is rejected over the parent application under Art.39, the provision prohibiting double patenting. Therefore, the claims of the divisional application must be distinctly different from any of the claims of its parent application. If three years have already lapsed from the filing date of a parent application when a divisional application is filed, caution must be used to file a request for examination within 30 days from the filing date of the divisional application. Otherwise, the divisional application will be deemed to have been withdrawn.

There is no Continuation application or Continuation-in-part application in Japan. A divisional application divided out of its parent application that was filed prior to April 1, 2007, however, can practically be used as a continuation application, if such a divisional application is directed to an invention which is substantially the same as the invention claimed in the rejected original application and the original application is amended to define an invention which is distinctly different from the invention claimed in the divisional application. In such a case, the original application may be amended to restrict claims to an easily allowable narrow scope so that the original application will soon be granted with the narrow scope by the Examiner without being sent to the Board of Appeals and the divisional application may be reexamined by the Examination Division with broad scope of claims. Alternatively, in such a case, the parent application may be withdrawn to avoid the double patenting rejection. However, if the parent application is the one that was filed on or after Aril 1, 2007, it is not practically possible to file a divisional application directed to claims that were rejected in the parent application. Such an application would be simply rejected and subject to the same restriction as that applied to an application which received a Final Office Action. That is, a further amendment is restricted to i) Deletion of a claim, ii) Narrowing down the scope of the claims to patentable claims, iii) Correction of errors, and iv) Clarification of an ambiguous descriptions which are pointed out in the Notice of Rejection.

1.7) Decision

After the response is filed, the Examiner reexamines the application in view of the argument and/or amendments, and makes a decision of grant if all the reasons for rejections have been cleared up or a decision of rejection if any of the reason for rejection has not been cleared up, or issues another Office Action if he or she finds a new reason for rejection.

In response to the Decision of Rejection, the applicant can file an Appeal before the Board of Appeals within four months (for foreign applicants) with or without an amendment.

1.8) Registration and Issuance of Patent

When a decision of grant is issued, the applicant is provided with a term (30 days even for foreigners) for paying a registration fee, which is the first three annuities. After the registration fee is paid, the patent is registered and the patentee is provided with the patent number. The registration date becomes the basis for calculating the subsequent annuity due. (Note that the patent term is calculated from the filing date.) Then, after the patent is registered, the patent is issued in a printed form. The date of the issuance of the printed patent becomes the basis for calculating the six-month opposition term.

2) Interviews

An interview with the Examiner is an effective way of advancing the application to allowance by persuading the Examiner of the patentability of the claimed invention. The interview with the Examiner is sometimes initiated by the Examiner and sometimes requested by the applicant. The interview may be face-to-face, but also may be by telephone and/or fax. The interview can be held at any time while the application is pending, but is recommended to be held after the examination has started and before the decision is made by the Examiner. It is possible to hold an interview with the Examiner even after the decision is made, if an appeal is filed against the decision along with an amendment so that the application with the amendment will be reexamined by the Examiner.

Hand-Change practice

It is a common practice in Japan that the applicant and the Examiner reach an agreement at an interview as to how to make amendments, the applicant send a draft of an amendment to the Examiner by fax at a later date, after confirmation thereof by the Examiner the applicant meets the Examiner to receive a formal Office Action by hand and show to the Examiner a formal Amendment prepared as agreed for his or her reconfirmation, and then submit the Amendment reconfirmed at the window of the Patent Office on that day. This is very common and is called hand-change (shukoh), which will considerably save time.

3) Accelerated Examination

The applicant of a patent application for an invention which is "being worked" or for an application having a foreign counterpart can request an accelerated examination of the patent application, if the examination has already been requested for the application. The conditions for the accelerated examination are that the claimed invention is actually being worked by the applicant or a licensee, or it is scheduled to be worked within two years by the applicant or a licensee, or the applicant has filed a corresponding patent application in a foreign country.

In order to have the examination of the application accelerated, the applicant must file an "Explanation of Circumstances Concerning Accelerated Examination". In the Explanation, the applicant must submit a prior art search result along with a statement comparing the claimed invention with the prior art, and the information as to the actual working or the foreign filing. A search report issued by a foreign patent office for the corresponding application can be used as the search result.

When the accelerated examination is carried out, the first Office Action will practically be issued in a few months according to practical experience although the Accelerated Examination Guideline issued by the Patent Office says that the examination shall be finalized within 36 months from the date of the request for the accelerated examination.

5. Appeal against Decision of Rejection

When the application is rejected, the applicant can file an appeal against the decision of rejection before the Patent Office within four months from the date of receipt of the Decision of Rejection. An amendment can be filed together with the Appeal. The amendment cannot be filed later, but must be filed along with the Appeal. If an amendment is filed together with the appeal, the application is sent back to the Examiner for reexamination. The Examiner may then withdraw his or her previous decision and issue a decision of grant, or maintain the decision. In the latter case or in the case where the appeal was filed without an amendment, the application is sent to the Board of Appeals where the case is examined by a Panel of three appeal judges. The judges may withhold the Examiner's decision or cancel it and issue a decision of grant.

Against a decision of appeal rejecting the application made by the Board of Appeals, the applicant can lodge a suit before the Tokyo High Court in an attempt to nullify the decision of appeal.

6. Opposition and Invalidation Trial

The post-grant opposition was abolished in 2004. That is, as of January 1, 2004, it became impossible to file an opposition against a patent.

After an application is patented, any interested party can file an invalidation trial against the patent at any time, even after the patent has expired.

7. Patent Term and Extension

The basic maximum patent term is 20 years from the filing date. When it was not possible to work the patented invention for two or more years because of the necessity of obtaining an approval or other disposition which is governed by provisions in laws intended to ensure safety in the working of the patented invention (i.e. due to delayed permission for the commercial marketing or use by the Drugs, Cosmetics and Medical Instruments Act or the Agricultural Chemical Control Act), an extension of the term by up to 5 years is granted by registering the extension of the term. The application for registration of the term extension must be filed within three months from the date of receipt of the permission.

The period of the term extension cannot exceed the period for which the working of the patented invention was not possible due to the delayed permission.

8. Claim Interpretation

The claim interpretation in Japan is basically conducted by the literal interpretation. When the meaning of an element recited in the claim is not clear, the content of the body of the specification is taken into consideration. Although the doctrine of equivalents is being frequently applied to claim interpretation in Japan recently, it is still important to be careful not to recite any unessential element in claims in order not to unduly limit the scope thereof.

A means-plus-function claim is interpreted broadly as the wording means as mentioned above. (See 3 5) Claim Drafting.)

File wrapper estoppel is applied to narrowly interpret claims in Japan.

9. Maintenance Fees

Initial three years' maintenance fees are to be paid as a registration fee to register a granted patent. The Registration Fee and the Government Maintenance fees increase with the number of claims as follows. N is the number of claims. (Currency: Japanese Yen)

For patent applications requested for examination on or after April 1, 2004

Registration Fee (initial 3 annuities).... 2,300 + 200 N

Maintenance Fees

(each year from 4th to 6th years)...... 7,000 + 500N

(each year from 7th to 9th years)...... 21,400 + 1,700 N

(each year from 10th to 25th years).. 61,600 + 4,800 N

10. Genetic Engineering

On February 27, 1997, the Japanese Patent Office published "Implementing Guidelines for Examination of Biological Inventions." The '97 Implementing Guidelines clarify that the invention in the field of genetic engineering can be claimed in a format, which is much more liberalized than before. For example, in contrast to the old guidelines which required a gene to be specified by base sequence, under the '97 Guidelines a gene may be specified by, for example, a combination of its function, physical and chemical properties, origin, preparation process and so forth. Of course, it may be specified by its base sequence. Further, a structural gene may be defined by specifying the amino acid sequence of a protein encoded by the gene. In this case, at least one example of the base sequence must be described in the specification.

Further, a gene may be broadly defined in a claim by use of an expression such as "deletion, substitution or addition" and "hybridization" along with the function of the gene. By use of such generic expressions, it is possible to obtain a claim having a broad scope of protection. It will be prudent to use such expressions rather than relying on the doctrine of equivalents, since the doctrine of equivalents would call for a great workload and a plenty of evidence.

A vector may be defined by specifying DNA base sequence, cleavage map, molecular weight, number of base pairs, sampling origin, preparation process, its function, properties and so forth. A recombinant vector may be described by specifying at least one of the gene and the vector, whereas it was required to specify a combination of the gene and the vector in the old guidelines. A transformant may be described by specifying at least one of the host and the transgene (or a recombinant vector), whereas it was required to specify a combination of the kind of the living being and the recombinant vector in the old guidelines.

A fused cell may be described by specifying the parent cell, function and properties of the fused cell, the process of preparing the fused cell and so forth.

A recombinant protein can be described by specifying amino acid sequence or base sequence of the structural gene encoding the amino acid sequence. It can also be described by specifying its function, physical and chemical properties, origin, preparation process and so forth.

A monoclonal antibody can be described by specifying antigen recognized by the monoclonal antibody, hybridoma producing the monoclonal antibody, cross reacting properties and so forth. The Guidelines also clarifies the "enablement requirement" in the specification of a patent application that the detailed description of the invention must be clear and complete enough to enable anyone skilled in the art to carry out the invention. In more detail, the enablement requirement for product inventions requires that the specification and the drawings shall be described in such a manner that the product can be made and can be used by anyone skilled in the art.

In the case of an invention of an article, the specification must be described in such a manner that anyone can make the article and the article is industrially usable. In the case of an invention of a method, the specification must be described in such a manner that the method is industrially usable. In the case of an invention of a process for making an article, the specification must be described in such a manner that the process or the article made by the process is industrially usable. A gene whose function is not known or clear, or a generically defined gene that is not defined by its function, is not regarded to be industrially usable.

In the case of an invention of a gene, vector, recombinant vector, transformant, fused cell, recombinant protein, monoclonal antibody and so forth, a process of preparing them must be described in the specification unless anyone skilled in the art is able to prepare them based on the common technical knowledge or other disclosure in the specification.

The Guidelines prescribe that a Sequence List shall be described at the end of the detailed description of the invention, and the Sequence List shall be submitted in a form of electronic data.