Guest post by Tracy Che
China patent agent at Beijing ZBSD Patent & Trademark Agent Ltd.
Patent eligibility of the diagnosis or treatment of diseases in China
Generally, methods for the diagnosis or treatment of diseases are not patent eligible in China, as stipulated in item (3) Article 25.1 Patent Law of PRC.
For humane and ethical reasons, doctors in China are given freedom to choose any means in the course of diagnosing or treating diseases. Since these methods are practiced directly on living humans or animal bodies, they are not inventions-creations according to China patent law. Therefore, methods for the diagnosis or treatment of diseases shall not be granted patent rights.
That being said, there are strategies for making related products and process patent eligible in China.
Methods for diagnosing diseases
A method for diagnosing a disease cannot be granted a patent if it includes the following two requirements:
(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 (see section 184.108.40.206 Chapter 1 Part II in Guidelines for Patent Examination).
Let’s look at some claim examples.
“1: A method of detecting X marker…”.
Analysis: If the X marker specifically diagnoses Y disease, then the immediate purpose of the method is to obtain a diagnostic result. Therefore, claim 1 is not patent eligible.
Innovations in biomedicine often relate to the discovery of new substances (such as disease markers), and the discovery of new uses of known substances. In the case of such innovations, the claim can be amended to a Swiss-type claim:
“Use of X (such as a compound, a composition, a primer or a probe for Z gene, and a marker for Y disease) in the preparation of a … reagent (such as a detection kit (or diagnosis kit) for diagnosing an Y disease, or a medicament (or pharmaceutical composition) for treating an Y disease)”.
This Swiss-type claim limits the subject of preparation of the above-mentioned reagent, that is, by the manufacturer. Since a doctor does not need to prepare such a reagent in person, it is not limited by the Swiss-type claim. Therefore, this Swiss-type claim is patent eligible in China.
If the claim is worded such that a doctor will be restricted by such a claim, however, then the claim would not be patent eligible: “X is used to diagnose (or treat) Y disease”, or “Use of X as the medication for treating Y disease”.
One suggestion is to amend the claim to a Swiss-type claim. In most cases, the detection can be carried out in vitro. Here, we can amend claim 1 to:
“1. Use of X in the preparation of a kit for detecting Y disease …”.
“1. A method for diagnosing Z disease by measuring x-markers and y-markers…”.
Suggestion: In addition to the Swiss-type amendments, the claim can be amended into a product claim as follows:
“1. A device comprising modules for performing the steps of: comparing a measured concentration of each marker with the respective threshold value, combining the comparison results to form a combination of comparison results, ……wherein the marker comprises an x marker and y marker, the device also includes data for a predetermined threshold of the marker.”
Section 4.3 Chapter 1 Part II in Guidelines for Patent Examination specifies that 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 rights may be granted.
The apparatus of the above amended claim is essentially a device (or system) comprising software modules. According to the claim, the manufacturer or supplier of the device (or system) will be restricted from production or sales, rather than the doctors themselves. The amended claim is patent eligible.
“1: Use of a primer or a probe for detecting of SNP genetic marker for assessing the risk of suffering Y disease….”.
Analysis: Original claim 1 above equates to a method of assessing the risk of suffering Y disease with the primer or the probe.
With respect to the SNP genetic marker . . . , the risk of suffering Y disease is assessed to be highest for a AA genotype, followed by a BB genotype and a CC genotype in this order.
Therefore, original claim 1 qualifies as a method for evaluating the risk of suffering diseases. As such, it is not patent eligible.
Suggestion: amend claim 1 as follows (Swiss-type claim):
“1. Use of a primer or a probe for detecting of genetic marker in the preparation of a kit for assessing the risk of suffering Y disease, wherein said genetic marker is a SNP genetic marker rsXXXX which is…”.
“1: A method of detecting the content of alcohol in blood…”.
Analysis: The immediate purpose of the method is to detect the content of alcohol in blood only, and not to confirm the presence of alcoholism. That is, the immediate purpose of the method is not to obtain a diagnostic result. Therefore, the above claim is patent eligible.
Methods for treating diseases
Methods for treating diseases relate 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. Treatments of diseases include various methods that serve a purpose or have a nature of treatment. Prophylactic methods and methods of immunization are regarded as methods of treatment for diseases (see section 4.3.2 Chapter 1 Part II in Guidelines for Patent Examination).
“1. A method for the control of abnormal cell growth in mammals…”.
Analysis: Whether the bone properties (Case 5) or abnormal cell growth (Case 6) is directly related to some diseases. In most cases, abnormal cell growth or decease of the bone properties will lead to some disease. Therefore, it would be hard to argue patent eligibility.
Suggestion: The first option is a Swiss-type claim amendment. The second option is an exclusionary amendment.
1） Swiss-type claim amendment: case 5 can be amended to “Use of compound A in the preparation of an improver of bone properties….”.
2）Exclusionary amendment: if there are some disclosures and/or some examples in the description like “abnormal cell growth or decease of the bone properties will not lead to some disease”, the applicant can try to use an exclusionary amendment (cases 5 and 6). For example, the feature of “the method is one that serves a non-treatment purpose” can be incorporated into the claim.
In conclusion, methods for the diagnosis or treatment of disease are not patent eligible in China. However, strategic language to cover related products and methods could move claims from the realm of diagnosis/treatment into patent eligible subject matter.