"Methods for diagnosis or for treatment of diseases" refer to the processes of identifying, determining, or eliminating the cause or focus of diseases which are practiced directly on living human or animal bodies.

For humanity and ethical reasons, it is acknowledged that a doctor shall be given the freedom to choose any means in the course of diagnosis or treatment of diseases. Moreover, this kind of methods are not susceptible of industrial application because they are practiced directly on living human or animal bodies, and are not inventions-creations in the context of the Patent Law. Therefore, methods for diagnosis or for treatment of diseases shall not be granted patent rights.

However, instruments or apparatus for implementing these methods of diagnosis or treatment, or substances or materials for use in such methods are subject matters for which patent right may be granted.

 

Diagnostic Methods

Diagnostic methods refer to the processes of identifying, studying, and determining the cause or focus of diseases on living human or animal bodies.

 

Inventions Belonging to Diagnostic Methods

Where a method involving diagnosis of a disease complies with the following two requirements, it is a diagnostic method and cannot be granted a patent right:

(1) it is practiced on a living human or animal body; and

(2) its immediate purpose is to obtain the diagnostic result of a disease or health condition.

If an invention, as viewed from its description, is practiced on samples in vitro, but its immediate purpose is to obtain the diagnostic result of a disease or health condition for the same subject, it shall not be granted a patent right.

If a method claimed in a patent application includes diagnostic steps, or includes testing steps if no diagnostic steps, and the diagnostic result of a disease or health condition can be reached immediately based on the diagnostic or test information thus obtained according to the medical knowledge in the prior art and the disclosure of the application, then the method can be regarded as satisfying the above requirement (2).

The following are examples of diagnostic methods for which no patent right shall be granted:

method of measuring blood pressure, method of taking pulse, feet diagnostic method, X-ray diagnostic method, ultrasonic diagnostic method, gastrointestinal radiography diagnostic method, endoscopy diagnostic method, isotope tracing diagnostic method, infrared noninvasive diagnostic method, method of evaluating the risk of suffering diseases, method of predicting the therapeutic efficacy for diseases, and gene screening diagnostic method.

 

Inventions Not Belonging to Diagnostic Methods

The following are examples which do not belong to diagnostic methods:

(1) method of pathological anatomy practiced on a dead human or animal body;

(2) method the immediate purpose of which is only to obtain information from the living human or animal body as an intermediate result rather than to obtain the diagnostic result or health condition, or method of processing such information (e.g., physique and body parameters, physiological parameters, or other parameters); and

(3) method the immediate purpose of which is only to treat or test the body tissues, body fluids, or excrements that have been removed from the human or animal body in order to obtain information as an intermediate result rather than to obtain the diagnostic result or health condition, or method of processing such information.

As for the above items (2) and (3), it should be noted that only if the diagnostic result of a disease and health condition cannot be reached immediately based on the obtained information per se in accordance with the medical knowledge in the prior art and the disclosure of the application, can the information be regarded as an intermediate result.

 

Methods of Treatment for Diseases

Methods of treatment for diseases refer to the processes of intercepting, relieving, or eliminating the cause or focus of diseases so that the living human or animal bodies may recover or gain health or relieve pain.

Methods of treatment for diseases include the various methods which serve treatment purpose or which are of treatment nature. Prophylactic methods and methods of immunization are regarded as methods of treatment for diseases.

For a method both possibly serving treatment purpose and possibly serving non-treatment purpose, unless it is clearly stated that the method serves non-treatment purpose, it cannot be granted a patent right.

 

Inventions Belonging to Methods of Treatment for Diseases

The following are examples that belong to or shall be regarded as methods of treatment for diseases and thus shall not be granted patent rights:

(1) methods of treatment by surgery, methods of treatment by pharmaceutical therapy, or psychotherapeutics;

(2) methods of acupuncture, anesthesia, manipulation, massage, Gua Sha (scraping therapy), qigong, hypnosis, medicated bath, air bath, sunbath, forest bath, and nursing care for the purpose of treatment;

(3) methods of stimulating or irradiating a human or animal body by radiation of electricity, magnetism, sound, light, or heat etc. for the purpose of treatment;

(4) methods of coating, freezing, or diathermy etc. for the purpose of treatment;

(5) various immunization methods for prevention of diseases;

(6) methods auxiliary to a surgery treatment and/or pharmaceutical therapy, such as method of processing cells, tissues, or organs that will be returned to the same subject, method of hemodialysis, method of monitoring the depth of anesthesia, method of taking medicines, method of injecting medicines, or method of applying medicines externally;

(7) methods of fertilization, contraception, increasing the number of sperm, adosculation, or embryonic transfer etc. for the purpose of treatment;

(8) methods of cosmetic surgery, stretching limbs, losing weight, or increasing height for the purpose of treatment;

(9) methods of treating human or animal wounds, such as method of disinfecting or bandaging a wound; and

(10) other methods such as method of artificial respiration and method of oxygen supply for the purpose of treatment.

It shall be noted that although methods of treatment for diseases by using medicines are not patentable, medicines per se can be granted patent rights. For examination of patent applications concerning medical use of substances, Chapter 10, Sections 2.2 and 4.5.2 of this Part shall apply.

 

Inventions Not Belonging to Methods of Treatment for Diseases

The following methods are examples which do not belong to methods of treatment for diseases, and shall not be excluded from patentability under Article 25.1(3):

(1) methods of making artificial limbs or other prostheses, and methods of measurement in making such artificial limbs or prostheses. Take for example a method of making dental prosthesis, including the step of making tooth mould in the oral cavity of the patient and the step of making dental prosthesis outside the oral cavity. Although the ultimate aim is for treatment, the purpose of the method in itself is to make suitable dental prosthesis;

(2) methods of stockbreeding by treating animal bodies by a non-surgery means to change their growing trait, such as methods of applying certain electromagnetic stimulation to live lambs in order to accelerate their growth speed, improve the quality of mutton, or increase the output of wool;

(3) methods of butchering animals;

(4) methods of treating dead human or animal bodies, such as methods of anatomy, beautification, antisepsis, or making specimen;

(5) methods of purely cosmetic nature, i.e., methods of cosmetic nature which are not invasive to human body or do not produce wounds, including methods of deodorization, protection, decoration, or beautification for non-treatment purpose practiced partially on such directly visible parts as skin, hair, nail, and teeth externals;

(6) methods for making a human or animal not in a diseased state feel comfortable or pleased, or methods for supplying oxygen, negative oxygen ions, or moisture under a special condition such as for diving or for shielding from toxic gas;

(7) methods of killing bacteria, viruses, lice, or fleas on a human or animal body (on the skin or in the hair, excluding wounds and infected sites).

 

Methods of Surgery

Methods of surgery refer to the methods of traumatic or invasive treatment such as incision, resection, stitching, and tattooing practiced on living human or animal bodies with the aid of instruments. Such methods cannot be granted patent rights. However, a method of treatment such as incision, resection, stitching, and tattooing practiced on a dead human or animal body may be patentable in so far as it does not violate Article 5.1.

Methods of surgery are divided into one kind for the purpose of treatment and the other kind for the purpose of non-treatment.

A method of surgery for the purpose of treatment belongs to methods of treatment for diseases, for which no patent right shall be granted in accordance with Article 25.1(3).

For examination of methods of surgery for non-treatment purposes, Chapter 5, Section 3.2.4 of this Part shall apply.

 

2013-07-17