For starters, the definition
of “invention” according to Article 2(1) of the Patent Law and the requirement
of being “industrially applicable” of Article 29(1) of the Patent Law must be
satisfied to be considered patentable in
The following are examples
that do not satisfy the requirement of an “invention”
1)
A law of nature or a naturally occurring phenomenon.
2)
Those which do not require the use of a law of nature (abstract ideas such as a
mathematical algorithm; methods for writing a book or playing a game or
conducting business; mental processes, etc.)
3)
Those which violate laws of nature.
4)
Techniques or skills that can be achieved through training (martial arts,
fencing) and in which the result may be different depending on the person
performing the technique.
5)
Those deemed to be purely artistic in nature, such as paintings or sculptures.
The following are examples
that do not satisfy the requirement of being “industrially applicable”.
1)
Methods for treatment of the human body by surgery or therapy and diagnostic
methods practiced on the human body.
2)
Personal use inventions having no other industrial applications (i.e., method
of smoking, cooking recipes, how to wear a hat, etc.)
3)
Inventions that are impractical (i.e., a Dyson sphere encompassing a star to
harness all of its energy)
Software-related
Inventions
Software is
patentable, provided that it is related to it’s execution within a hardware
resource in order to achieve an objective.
A “program” for operating something that performs a process, and a
medium for storing the program are techniques by which software inventions are
described in claims.
The
claims must not simply describe an artificial arrangement and must be the
creation of a technical idea utilizing a law of nature. The claims must also
state that the information processing by means of software is
performed/realized as a computer system using hardware resources. The
description of the claims must specify whether the function specifies an
operational function (i.e., that performed by a human being) or a processing
function performed by the computer.
Business-related Inventions
If the method
requires human judgment, does not require a law of nature to function, or is
based on man-made rules, the method is generally not patentable. Again, if the method is associated with
hardware resources which execute the method (similar to as stated above), and a
law of nature may be used therein, the method becomes patentable. Such methods
tend to fall into the fields of communication and internet-based commerce.
Medical-related
Inventions
The case of
methods of
treating, operating upon, or diagnosing a human being is most commonly used to
reject a patent application, and by carefully wording the claims in order to
avoid direct mention of use of the invention on a human, or by the hand of a
skilled operator (physician), the industrially applicability requirement can be
satisfied. In
Products associated with
medical treatments and procedures are generally patentable.
The method for administering
a drug to a patient in itself is not patentable, however, the administration
period and amount of a drug for treatment is patentable.
The method for
treating a sample which has been obtained from a human and for analyzing the
data obtained from the samples do not fall under "methods for treatment of
the human body by surgery or therapy and diagnostic methods practiced on the
human body," unless it is deemed that the sample will be returned to the
human from which it was obtained, such as in dialysis. However, methods for
manufacturing a product (i.e., vaccines, genetically modified medicines, etc)
using materials obtained from a human do not fall under "methods for
treatment of the human body by surgery or therapy and diagnostic methods
practiced on the human body,", even if the manufactured medicine (product)
will be returned to the human from which it was obtained.
Often a second
medical use claim is drafted in order to specify that a known substance
(pharmaceutical composition) can be used in a new treatment application, i.e.,
“A use of substance (A) for the production of a pharmaceutical composition for
the treatment and prophylaxis of disease (X)”. If the method of treatment is,
for example, “The method for excising a tumor from a human using a scalpel”, it
is not patentable.
The
following is a general summary of medical-related inventions which are
patentable and which are not patentable in
|
Patentable |
Not patentable |
|
Medicine,
pharmaceutical compositions, etc |
Methods
for treatment of a human body with a pharmaceutical substance |
|
Medical
instruments or devices |
Methods
for contraception or delivery |
|
Methods
for treating samples removed from the human body (e.g. blood, or serum blood
products, tissue, or hair), and methods of obtaining data by analyzing the
above samples |
Methods
for surgical operations and drawing blood |
|
Cosmetic
methods for surgical operations even those having no therapeutic or
diagnostic purpose |
|
|
Methods
of giving or injecting medicine, or giving physical treatment to a patient to
cure a disease |
|
|
Operating
methods performed by a medical instrument, device, or apparatus lacking a
step or procedure for applying to the human body |
Methods
of transplanting an artificial internal organ or artificial limbs |
|
Methods
of preventing disease |
|
|
Methods
for manufacturing medicines (such as pharmaceutical drugs, vaccines,
genetically modified medicines) and for utilizing material obtained from
human parts in the treatment or prophylaxis of disease or conditions |
Methods
of treatment for the maintenance of physical health |
|
Preparatory
methods of treatment by therapy, auxiliary methods for improving treatment
results, or methods for nursing associated with treatment; |
|
|
Methods
of obtaining data by measurement of structures or functions of an organ in
the human body for detecting diseases or determining the physical condition
of the human body |
|
|
|
Operating
procedures on the human body by a medical instrument, or methods of
determining the condition of diseases on the basis of the data |
|
|
Methods
of measuring the shape or size of internal organs or the conditions of the
human body for detecting diseases or determining the physical condition of
the human body |