(1) Simple discoveries of laws of nature, and natural phenomena;

(2) Ideas that violate laws of nature (perpetual motion machines, etc.);

(3) Ideas that do not use laws of nature (pure algorithms, methods of conducting business, methods of playing games, etc.),

(4) Techniques that can be attained by personal skill (how to throw a knuckleball, etc.); and

(5) Artistic works.

(1) Methods of medical treatment, or operating on or diagnosing a human being;

(2) Inventions for pure personal use such as methods of smoking, method of tying knots, new cooking recipes, etc.; and

(3) Inventions that are highly impractical such as a protective net covering the entire earth with a plastic film, a device capable of changing the orbit of the earth, etc.

Most cases in this category do not require any consideration as they would be readily rejected by common sense. However, there may be some cases which require careful consideration and may have practical significance.

Some information for specific inventions is provided below.

(A) Medical Inventions: Medical treatment of a human being is not patentable as it is not considered to be "industrially applicable", but products associated with medial treatment are generally patentable. Such products include drugs, surgical tools, implants, and diagnostic tools.

A medical use of a known compound is patentable. A second medical use of a known compound is also patentable.

On the other hand, administering a drug to a human being is an act of medical treatment, and is therefore unpatentable. Claiming this category is permissible in some countries. Therefore, when an application with such a claim is translated and filed in Japan, the claim is often rewritten into a pharmaceutical composition claim. A Swiss-type claim is also permissible, which is typically in the format of "Use of substance X in the manufacture of a pharmaceutical drug for the treatment of disease or condition Y."

(B) Software Inventions: Software by itself is not patentable, but is patentable when it is used in association with hardware resources to achieve a useful purpose. Most computer process inventions fall under this category. Such an invention can be claimed as a "program" for operating a computer that executes a certain method or process, or a "medium" storing such a program.

(C) Business Method Inventions: A method of conducting business is not patentable to the extent that it is based on man-made rules or requires human judgment because it does not make use of laws of nature. However, there have been a large number of "business method” patent applications, and many of them have been granted. For such an application to be granted, the method is required to be associated with hardware resources such as computers similar to software inventions, and incorporated with a concept that makes use of laws of nature. Typical business method patents are directed to methods of conducting business based on a novel mode of transaction via the Internet or other modes of communication.

(1) An applicant may amend the specification, or drawings within one year and three months of the application (or priority) date.

(2) An applicant may amend the specification, or drawings after one year and three months of the application (or priority) date and before receiving a copy of the decision to publish the examined application in the following cases:

1. where an applicant makes a request for examination and amendment is made at the same time of applicant’s request for examination;
2. where an applicant receives a notification under Art.48quinquies (48-5)(2)(request for examination by a person other than an applicant) and amendment is made within three months of the receipt of the notification;
3. where an applicant receives a notification under Art.50 and amendment is made within the time limit designated by Art.50 which governs procedures regarding notification of reasons for rejection;
4. where the applicant demands an appeal under Art.121(1) (appeal against an examiner’s rejection), amendment may be made at the same time as filing the applicant’s demand of an appeal against an examiner’s decision of rejection under Art.121 (1).

(3) An applicant may amend the specification, or drawings after publication of an examined application in the following cases:

1. where an applicant receives a notification under Art.50 and an amendment is made within the time limit designated by Art.50 which governs procedures regarding notification of reasons for rejection;
2. where an opposition to the examined application is filed and an amendment is made within the time limit designated by notification of opposition to the examined application in accordance with Art.57; and
3. where the applicant demands an appeal under Art.121(1) and amendment is made at the same time as filing the applicant’s demand of an appeal against an examiner’s decision of rejection under Art.121(1).

(1) Before publication of examined application

An amendment can be made as long as the gist of the specification is not changed. An amendment to enlarge, reduce or change the scope of claims within the scope of the features disclosed in the specification or drawings originally attached to the request, is regard as not changing the gist of the specification.

(2) After publication of examined application

1. An amendment can be made to matters covered by reasons for rejection in accordance with Art.50, opposition to an examined application in accordance with Art.57 or an examiner’s decision of rejection under Art.121(1), however the amendment shall be directed to the following:

1. the restriction of a claim or claims;
2. the correction of errors in the description;
3. the clarification of ambiguous description.

2. Art.126(2) shall apply mutatis mutandis to matters governed by the preceding subsection (i) (The correction of the specification or drawings may not be such as to substantially enlarge or modify a claim or claims.).

(1) An applicant may amend the specification, or drawings within one year and three months of the application (or priority) date.

(2) An applicant may amend the specification, or drawings after one year and three months of the application (or priority) date and before receiving a copy of the decision to publish the examined application in the following cases:

1. where an applicant makes a request for examination and amendment is made at the same time of applicant’s request for examination;
2. where an applicant receives a notification under Art.48quinquies(48-5)(2) (request for examination by a person other than an applicant) and amendment is made within three months of the receipt of the notification;
3. where an applicant receives a first notification under Art.50 and amendment is made within the time limit designated by the notification of reasons for rejection in accordance with Art.50 (reasons for rejection);
4. where an applicant receives a notification of rejection and amendment is made within the time limit designated in accordance with Art.50 with respect to the final notification of reasons for rejection;
5. where an applicant demands an appeal under Art.121(1) (appeal against an examiner’s rejection) and amendment is made at the same time as filing the applicant’s demand of an appeal against an examiner’s decision of rejection under Art. 121 (1) .

(3) An applicant may amend the specification, or drawings after publication of an examined application in the following cases:

1. where an applicant receives a notification under Art.50 and an amendment is made within the time limit designated by the notification of reasons for rejection in accordance with Art.50;
2. where an opposition to the examined application is filed and an amendment is made within the time limit designated in the notification of opposition to an examined application in accordance with Art.57;
3. where an applicant demands an appeal under Art.121(1) and amendment is at the same time as filing the applicant’s demand of an appeal against an examiner’s decision of rejection under Art.121(1).

(1) Before publication of examined application

1. An amendment shall remain within the scope of the features disclosed in the specification or drawings originally attached to the request. See QUESTIONS AND ANSWERS REGARDING JAPANESE PATENT PRACTICE Q78 and A 78
2. Subject to the preceding subsection, in the case of subsections 1(2)(iv) and (v), the amendment shall be limited to the following:

1. the cancellation of a claim or claims referred to in Art.36(5);
2. the restriction of a claim or claims (only if the restriction of all or some matters necessary to define the invention claimed in a claim or claims under Art.36(5), the industrial applicability and the problem to be solved of the invention as claimed in the amended claim or claims are the same as those of the invention as claimed in a claim or claims prior to the amendment);
3. the correction of errors in the description;
4. the clarification of ambiguous description.

3. Art.126(3) shall apply mutatis mutandis to matters covered by the preceding subsection (ii) (b) (amended claims must be one which could have been patented independently at the time of filing of the patent application.).

(2) After publication of examined application

1. An amendment shall remain within the scope of the features disclosed in the specification or drawings originally attached to the request.
2. An amendment can be made about the matters raised by reasons in accordance with Art.50, opposition to examined application in accordance with Art.57 or examiner’s decision of rejection under Art.121(1), however the amendment shall be directed to the following:

1. the restriction of a claim or claims;
2. the correction of errors in the description;
3. the clarification of ambiguous description.

3. Art.126(2) shall apply mutatis mutandis to matters governed by the preceding subsection (ii) (The correction of the specification or drawings may not be such as to substantially enlarge or modify a claim or claims.).

(1) An applicant may, before the transmittal of the copy of an examiner’s decision that a patent is to be granted, amend the description, patent claim(s) or drawing(s) attached to the request.

(2) After the receipt of a notification under Art.50, amendment may be made only in the following cases:

1. where an applicant receives a first notification under Art.50 and amendment is made within the time limit designated by the notification of reasons for rejection in accordance with Art.50;
2. where an applicant receives a notification of rejection and amendment is made within the time limit designated in accordance with Art.50 with respect to the final notification of reasons for rejection;
3. where an applicant demands an appeal under Art.121(1) and amendment is made at the same time as filing the applicant’s demand of an appeal against an examiner’s decision of rejection under Art.121(1) .

(1) An amendment shall remain within the scope of the features disclosed in the specification or drawings originally attached to the request.

(2) Subject to the preceding subsection, in the case of subsections 1(2)(ii) and (iii), the amendment shall be limited to the following:

1. the cancellation of a claim or claims;
2. the restriction of a claim or claims (only if the restriction of all or some matters necessary to define the invention claimed in a claim or claims under Art.36(5), the industrial applicability and the problem to be solved of the invention as claimed in the amended claim or claims are the same as those of the invention as claimed in a claim or claims prior to the amendment);
3. the correction of errors in the description;
4. the clarification of ambiguous description.

(3) Art.126(4) shall apply mutatis mutandis to matters governed by the preceding subsection (2)(ii) (amended claims must be one which could have been patented independently at the time of filing of the patent application.).

(1) An applicant may, before the transmittal of the copy of an examiner’s decision that a patent is to be granted, amend the description, patent claim(s) or drawing(s) attached to the request.

(2) After the receipt of a notification under Art.50, amendment may be made only in the following cases:

1. where an applicant receives a first notification under Art.50 and amendment is made within the time limit designated by the notification of reasons for rejection in accordance with Art.50;
2. where, after receipt of a notification of reasons for rejection, an applicant has received a notification under Art.48septies (48-7) and amendment is made within the time limit designated in accordance with that Art.;
3. where an applicant receives a notification of rejection and amendment is made within the time limit designated in accordance with Art.50 with respect to the final notification of reasons for rejection;
4. where the applicant demands an appeal under Art.121(1) and amendment is made at the same time as filing the applicant’s demand of an appeal against an examiner’s decision of rejection under Art.121 (1).

(1) An amendment shall remain within the scope of the features disclosed in the specification or drawings originally attached to the request.

(2) Subject to the preceding subsection, in the case of subsections 1(2)(iii) and (iv) the amendment shall be limited to the following:

1. the cancellation of a claim or claims;
2. the restriction of a claim or claims (only if the restriction of all or some matters necessary to define the invention claimed in a claim or claims under Art.36(5), the industrial applicability and the problem to be solved of the invention as claimed in the amended claim or claims are the same as those of the invention as claimed in a claim or claims prior to the amendment);
3. the correction of errors in the description;
4. the clarification of ambiguous description.

(3) Art.126(4) shall apply mutatis mutandis to matters governed by the preceding subsection (2)(ii) (amended claims must be one which could have been patented independently at the time of filing of the patent application.).

(1) An applicant may, before the transmittal of the copy of an examiner’s decision that a patent is to be granted, amend the description, patent claim(s) or drawing(s) attached to the request.

(2) After the receipt of a notification under Art.50, amendment may be made only in the following cases:

1. where an applicant receives a first notification under Art.50 and amendment is made within the time limit designated by the notification of reasons for rejection in accordance with Art.50;
2. where, after receipt of a notification of reasons for rejection, an applicant has received a notification under Art.48septies (48-7) and amendment is made within the time limit designated in accordance with that Art.;
3. where an applicant receives a notification of rejection and amendment is made within the time limit designated in accordance with Art. 50 with respect to the final notification of reasons for rejection;
4. where an applicant demands an appeal under Art.121(1) and amendment is made at the same time as filing the applicant’s demand of an appeal against an examiner’s decision of rejection under Art.121 (1) .

(1) An amendment shall remain within the scope of the features disclosed in the specification or drawings originally attached to the request.

(2) Invention(s) specified by amended claims shall satisfy the requirement of unity of invention under Art.37 with respect to invention(s ) specified by the claim(s) prior to the amendment. See QUESTIONS AND ANSWERS REGARDING JAPANESE PATENT PRACTICE Q79 and A 79

(3) Subject to the preceding subsection, in the case of subsections 1(2)(iii) and (iv) the amendment shall be limited to the following:

1. the cancellation of a claim or claims;
2. the restriction of a claim or claims (only if the restriction of all or some matters necessary to define the invention claimed in a claim or claims under Art.36(5), the industrial applicability and the problem to be solved of the invention as claimed in the amended claim or claims are the same as those of the invention as claimed in a claim or claims prior to the amendment);
3. the correction of errors in the description;
4. the clarification of ambiguous description.

(4) Art.126(5) shall apply mutatis mutandis to matters governed by the preceding subsection (3)(ii) (amended claims must be one which could have been patented independently at the time of filing of the patent application.).

(1) Statutory subject

The Japan Patent Law, Art.2 defines an "invention" as being "a creation of technical idea utilizing laws of nature". Therefore, inventions in which a law of nature is not utilized (e.g. business method per se, computer programming language itself, gaming rules) are non-statutory inventions. Patent applications claiming non-statutory inventions would be rejected under Art.29(1) main paragraph of the Japan Patent Law. "Utilizing a law of nature" is not required for statutory subjects for US or EP patent system. In the US patent system, a new and useful process, machine, manufacture, or composition of matter is required for statutory subject matter, and in the EP patent system, a technical contribution to the state of the art in the technical field is deemed to be required for statutory subject matter.

(2) Categories of software-related inventions

In Japan, a software-related invention can be expressed in a sequence of processes or operations connected in time series, as an invention of a process, and can be expressed by a combination of multiple interrelated functions, as an invention of a product.

A software-related invention can also be expressed by a program claim as well as a computer-readable storage medium claim. Specifically, "a program" which specifies multiple functions performed by a computer can be defined as "an invention of a product", as follows.

[Example 1] "A program which makes a computer execute procedure A, procedure B, procedure C, …"

[Example 2] "A program which makes a computer operate as means A, means B, means C, …"

(3) Business method invention

Regarding a business method invention, if the business method invention can be expressed as "information processing by software" that is concretely realized by using hardware resources, the business method invention would be deemed to be "a creation of technical ideas utilizing a law of nature" (statutory subject matter).

(For applications filed on or before March 31, 2012)
JPO has adopted 6 month grace periods for specific situations. The specific situations include those (1) where a person having a right to obtain patent made experiments in public, made a publication, or made a presentation in writing at a conference designated by the JPO, and (2) where an invention is unintentionally disclosed to the public. In these situations, if a patent application is filed in Japan within 6 months from the public disclosure with certain evidence, novelty and inventive step will not be negated by the public disclosure. Please note that the application should be filed in JAPAN within 6 months from the first disclosure to the public.
(For applications filed on or after April 1, 2012)
JPO has adopted 6 month grace periods for specific situations. The specific situations include those (1) where an invention has become publicly known "as a result of an act of the person having the right to obtain a patent"(except for patent, utility model, design and trade mark applications published anywhere in the world), and (2) where an invention is unintentionally disclosed to the public. In these situations, if a patent application is filed in Japan within 6 months from the public disclosure with certain evidence, novelty and inventive step will not be negated by the public disclosure. Please note that the application should be filed in JAPAN within 6 months from the first disclosure to the public.

The JPO generally states that in a specification for medical use cases (pharmaceutical composition cases), pharmacological data (or a description equivalent to the data), effective dosage and an administration method must be described at the time of its filing. U.S. originating JP patent applications sometimes do not have any pharmacological data in the original U.S. specifications. In such cases, use claims (pharmaceutical composition claims) cannot be allowed due to insufficient disclosure. The JPO does not accept addition of data at a later stage (e.g., when responding to an Office Action). Thus, it is recommended that at least one datum (e.g., IC50 data) be added to the specification before filing the application with JPO.

For second medical use cases, disclosure of data in the original application is critical. If no data is disclosed in the original application, there is no way to revive the application. Thus, we usually ask for actual data to be included in a patent application for filing in Japan. Usually, one in vitro datum (e.g., IC50 data) for one compound is sufficient for this purpose.

For combined use cases, the situation is the same. Actual data are generally required in the original application. In this case, if the inventive step can be found in a synergistic effect from a combination of two active ingredients, data showing such a synergistic effect are required in the original application.

In Japan, a method-of-treatment claims are NOT acceptable. However, a second medical use claim can be claimed in a variety of claim formats as shown below.

(1) A pharmaceutical composition for the treatment of Disease X, comprising Compound Y.

(2) An anti-disease X agent comprising Compound Y.

(3) Use of Compound Y in the manufacture of a medicament for the treatment of Disease X (Swiss type claim).

As shown above, Swiss-type claims are permissible in Japan. However, actually Swiss type claims are not necessary in Japan since the other claim formats such as composition claim can sufficiently cover the second medical use invention. It is believed that the composition claim format can provide more broad patent coverage than the Swiss-type claim format.

1. Basics

2. Filing of a Japanese Translation

3. Amendment for the Purpose of Correction of Mistranslation

4. Correction after Grant

1. With respect to multiple dependent form of claims, a multiple dependent claim can serve as a basis for other multiple dependent claims.

For example:

The multiple dependent claim 4 serves as a basis for another multiple dependent claim 7.

In Japan no additional official fee is charged for multiple dependent claims (ex. claims 4 and 7 of the above-mentioned case).

Claim dependency in a different category is generally permissible subject to clarity.

Example:

Claims 1 and 2 are permissible, however claim 3 is not permissible. Claim 3 depends from claims of a different category, therefore claim 3 is not clear in spite of the additional similar technical feature.

A description of "any one of proceeding claims" is not permissible. Specific numbers of the claims are described (ex. according to any one of claims 1, 2 and 3).

It is recommended that claim dependency be reconsidered when a patent application or a request for examination is filed with the JPO.

2. An official fee for a request for examination and annuity depends upon the number of claims. It is recommended that the number of the dependent claims be reduced at the time of filing a request for examination.

A patent term extension is possible for up to five years if the invention could not be worked due to the necessity of obtaining an approval or other disposition prescribed by Cabinet Order. Such approval includes an approval provided under legal regulations designed for ensuring product safety. Typical examples include marketing approval for drugs.

An applicant applying for registration of patent term extension is limited to the patentee (the Patent Law, Art.67-3(i). However, where a patent is owned jointly, each of the joint owners may not, except jointly with the other owners, apply for registration of patent term extension (Art.67-2(iv)). In addition, it is required that the patentee, exclusive licensee or registered non-exclusive licensee under the patent obtain marketing approval.

The application for registration of patent term extension must be filed within a 3 month period from the date of marketing approval. When an application for registration of patent term extension is filed, the patent term shall be deemed extended until the decision of refusal becomes final and conclusive, or registration of extension is made (Art.67-2(v)).

A new Invalidation Trial System was introduced on January 1, 2004. At the same time, the Post-Grant Opposition System was abolished. The invalidation trial is conducted by the Board of Appeals and Trials of the JPO.
Anyone can file a demand for an invalidation trial at anytime even after the expiration of the patent (Art.123). The grounds for invalidity are similar to those for rejecting a patent application during examination (Art.123(1)). A demandee (patentee) can file a trial for correction to remove the grounds for invalidity under limited conditions (Art.126).

An invalidation trial case is usually handled by a three member panel of trial examiners. In practice, the invalidation trial is conducted by documentary proceedings. Usually an oral hearing is held once during the trial proceedings. A patent right that has been declared invalid is deemed to have not existed from the issue of the patent (Art.125).

In an infringement lawsuit at a district court, it is common for a defendant to submit invalidity-defense arguments to the court. However, it is also common to simultaneously file a demand for invalidation trial at the JPO. In the infringement lawsuit, the court can judge whether the patent is invalid (Art.104-3). However, a court decision can bind only parties involved in the case. The JPO has exclusive jurisdiction to invalidate a patent in an invalidation trial. It is possible that contradictory decisions may be rendered by the district court and the JPO on the validity issue. However, if appealed, the IP High Court reviews the district court decision and the JPO decision.

A party dissatisfied with the trial decision may seek review at the IP High Court by filing a lawsuit against the trial decision with the IP High Court (Art.178(1)).

In the case of a demand for an appeal against an examiner's decision of rejection, if an amendment is made to a description, claims or drawings within 30 days from the date of the demand, an examiner who examined the patent application, reexamines the patent application (Art.162). This is a kind of pre-appeal procedure. It is noted that if an amendment is not made, appeal examination (by a collegial body of appeal examiners) will begin without the pre-appeal procedures.

In the reconsideration, if the examiner considers that the rejection(s) have been overcome by the amendment, the examiner annuls the examiner's decision of rejection and issues a decision to grant a patent (Art.164(1)). Except for this situation, the examiner reports to the Director-General of the Patent Office the result of the examination without rendering a decision on the demand for the said appeal (Art.164(3)).

As a general rule, questioning is directed to all appeal cases having reports prepared as described above. The written questioning is sent to the appellant, and the appellant is given an opportunity to submit a written reply. After submission of the written reply, appeal examination by a collegial body of appeal examiners is initiated.

A party dissatisfied with a decision rendered by the Board of Appeal or Trial may seek review at the IP High Court by filing a lawsuit against the Board decision with the IP High Court (Art.178(1)). The Board decisions are inclusive of an appeal decision of rejection, an invalidation trial decision and the like.

A party in the case may file a lawsuit with the IP High Court within 30 days from the date on which a certified copy of the board decision has been received (Art.178(3)). If a party in the case is a foreign resident, the above-mentioned period is 120 days (Art.178(5)).

A party in the case dissatisfied with an IP High Court's decision may file a lawsuit against this decision with the Supreme Court under the limited reasons (Civil Procedure Law, Art.312).

In Japan the IP high court was established on April 1, 2005. This court received approximately 350 lawsuits against appeal or trail decision related to the Patent application/Patent from April 1, 2007 to March 31, 2008. The recent average trial period is approximately nine months.

Under the requirement for Prior Art Document Disclosure (Art.36(4)(ii)), if an applicant has knowledge of at least one prior art document relevant to the claimed invention at the time of filing of the patent application, the applicant is required to disclose the title of the prior art document in the patent specification. However, there is no need to submit a copy of the prior art document to the Japan Patent Office.

If an applicant does not have any knowledge of prior art document relevant to the claimed invention at the time of filing, it is advisable for the applicant to state that effect together with a reason in the patent specification. If the applicant fails to make a statement to that effect in the patent specification, the Examiner may issue a Notice about the requirement to the applicant (Art. 48-7). When the applicant receives the Notice, the applicant has to submit a written opinion or file an amendment to add the title of the prior art document in the patent specification within a designated time period (60 days) of response.

Finally, failure to comply with the requirement for Prior Art Document Disclosure is a reason for rejection (Art.49(v)), but such a failure is not a ground for invalidity (Art.123) because such a failure is not a substantial defect to the patentability of the invention.