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Discussion on Patentability of Diagnosis and Treatment Methods of Diseases


Fanhua Yin | June 3, 2020

1. Introduction of legal background

Article 25 of the Chinese Patent Law stipulates that no patent shall be granted for diagnosis and treatment methods of diseases.
It is well known that for humanitarian, social and ethical reasons, doctors should have the freedom to choose any methods and conditions in the process of diagnosis and treatment. In addition, due to individual differences of patients, different experiences of medical staff and different illnesses, different approaches should be taken and thus various results are achieved. Therefore,  diagnosis and treatment methods of diseases cannot be used in industry due to the lack of stability and repeatability.
In practice, how could we identify which technical solutions belong to diagnosis and treatment methods of diseases and avoid such non-patentable issues?

2. Common technical solutions involved

2.1 Diagnosis methods of diseases

Methods related to diagnosis of diseases should meet the following two conditions: one is to take living human or animals as the object; the other is to obtain the diagnosis result of the disease or health status as the direct purpose.

Let’s give an example of a method which includes either a diagnostic step or a testing step . As long as the said diagnosis or test method is known, the diagnosis of the disease or health status can be obtained directly according to the medical knowledge in the prior art and the technical solution disclosed in the patent. Then it is regarded as a diagnostic method. Common disease diagnostic methods also include disease risk assessment.

However, a method would be a patentable subject matter if both of the two requirements are met: 1) the essence of the technical solution is an improvement of the detection method and the solution itself only involves detection steps; 2) the results obtained after the implementation of the solution are independent of specific diseases. The common ones which do not belong to diagnostic methods of diseases are:

(1) Methods of pathological anatomy practiced on dead human bodies or animals;

(2) Methods of which the direct purpose is not to obtain the diagnosis result or health status, but merely to obtain information as an intermediate result from the living human or animal body, or methods of processing that information (physical, physiological or other parameters);

(3) Methods of which the direct purpose is not to obtain the diagnosis result or health status, but merely to process or test tissues, body fluids or excreta that have been separated from human or animal body in order to obtain information as an intermediate result, or methods of processing that information.

For (2) and (3) above, it should be noted that only if the obtained information itself does not directly lead to the diagnosis result of the disease or health status according to the medical knowledge in the prior art and the technical solution disclosed in the patent, then this information can be considered as an intermediate result.

2.2 Treatment methods of diseases

Treatment methods of diseases include a variety of methods for therapeutic purpose or with therapeutic properties. Disease prevention or immunization is regarded as a treatment method.
The common ones which do not belong to treatment methods of diseases are:
(1) Methods of manufacturing prosthetic limbs or prosthesis, and measure methods of manufacturing prosthetic limbs or prosthesis;
(2) Methods of livestock production in which animals are disposed non-surgically to change their growth characteristics;
(3) Methods of animal slaughtering;
(4) Methods of disposal of a dead human or animal body;
(5) Methods of purely cosmetic surgery;
(6) Methods of transporting oxygen, negative oxygen ions and moisture content in special circumstances such as diving and fire outbreak in order to make non-morbid human or animals feel comfortable and pleasant;
(7) Methods of killing bacteria, viruses, lice and fleas on the outside of human or animals (excluding wounds and infection sites).
The Guidelines for Patent Examination also stipulates that for a treatment method which may contain both therapeutic and non-therapeutic purposes, it should be clearly stated that the method is used for non-therapeutic purposes, otherwise a patent right cannot be granted.

3. Alternative drafting techniques

As practitioners in the patent field, especially patent attorneys, it is necessary to learn how to avoid drafting diagnosis and treatment methods of diseases as non-patentable subjects in claims.
(1) For claims related to diagnosis and treatment, we might try to draft  product claims. For example, although an implantable heart pump is to be implanted in a human body, the product itself can be protected.
(2) For treatment methods which contain both therapeutic and non-therapeutic purposes, if the non-therapeutic use of the method is clearly distinguishable from therapeutic use, we may exclude the therapeutic use. For example, we could add similar expression such as "non-therapeutic purpose" so that the method claim of non-therapeutic purpose can be patentable.
(3) For claims related to therapeutic use of drug, we may alternatively draft claims of methods for preparation of drug, which is known as the Swiss-type claim.

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