Patentability – Medical Methods

 According to Article 25(3) of the Chinese Patent Law, no patent right can be granted for “methods for the diagnosis or for the treatment of diseases”.

  It is only methods that are excluded; instruments or devices for implementing a method of diagnosis or treatment and substances or materials used in diagnosis or treatment of diseases are all patentable.

Method of Diagnosis

The Examiner’s Guidelines further limits the exclusion on methods of diagnosis by stating that a method of diagnosis is only unpatentable if:-

(1) It takes a live human or animal body as the object on which diagnosis is carried out;

(2) Its immediate purpose is to obtain the diagnosis of a disease;

(3) It covers the entire process of diagnosis.

  Thus, methods to treat or test tissue, body fluids or a discharge that has already been extracted from a human body or animal body are patentable, as are methods of pathologic anatomy employed on a dead human or animal, because in both cases the object on which diagnosis is carried out is not a live human or animal.

  In principle requirements (2) and (3) should enable a method which is an intermediate step in obtaining a diagnostic result to be patented. For example a method for obtaining treatment information (e.g. shape, physiological or other parameters), rather than a final diagnostic result..

  However the Guidelines states that even if the claim and/or description does not satisfy all of conditions (1) to (3), it may still be excluded if the Examiner considers that it relates to the above in substance. For example if a claim refers to measurement of a physiological parameter and the Examiner knows that that parameter can be used to directly diagnose a disease on the basis of medical knowledge, then the application shall be rejected. Therefore it seems that a method for obtaining intermediate treatment information, such as physiological parameters, can only be patented if neither the description nor claims define all of the steps for making a clinical diagnosis and it is not known from medical knowledge in the prior art how to use said parameter to arrive at a diagnosis.

Method of treatment

The Examiner’s Guidelines defines a “method of treatment” means as a “process of stopping, relieving or eliminating the cause or focus of diseases in order to restore the health of a live human or animal or alleviate its sufferings”. It is understood to include methods of surgery, birth control, embryonic transfer, plastic surgery, weight reduction and vaccinations as well as more conventional methods of treatment. 

If a method contains both a purpose of treatment and a purpose of non-treatment (e.g. a superficial cosmetic purpose), the application will only be granted if the claims clearly indicate that the method is used for a "non-treatment purpose". 

The exclusion applies to methods only so a patent right may be granted to a medicine per se, but not its method of application. 

If a substance is known, but its use as a pharmaceutical or for a particular method of treatment is not known, then a method of preparation of a pharmaceutical may be claimed, e.g. "the application of compound X for preparation of a pharmaceutical for the treatment of disease Y".