In China, a method for treating or diagnosing a disease cannot be granted for a patent right.  Generally speaking, we suggest amending this kind of claims into Swiss-type claims, namely pharmaceutical use claims.

For example, “A method for treating disease A in a subject by administrating Compound B” may be amended into “Use of compound B in manufacturing a medicament for treating disease A”.

However, please note that, Part II, Chapter 10, Section 5 prescribes as follows:

As for a medical-use invention relating to a chemical product, the following aspects shall be taken into consideration when the examination of novelty is carried out: 
……
(4) whether or not the features relating to use, such as the subject, mode, route, usage amount, interval of administration can define the procedure of manufacture of a pharmaceutical. The distinguishing features merely present in the course of administration do not enable the use to possess novelty.

As for the administration features such as mode, route, usage amount, interval of administration

If the original method claim further recites the feature, such as “said Compound A is for administration in an individual dose of 100 mg to 600 mg”, which is apparently the administrating feature of the medicament and is not related to manufacturing medicament in the subject matter of the amended claim, and thus will be deemed as having no definition on the pharmaceutical use claims.  In view of this, we may try to further amend this feature into “said medicament comprises an individual dose of 100 mg to 600 mg”, which is related to manufacturing medicament.  

Nevertheless, please note that, even if this amended feature is not disclosed in the prior art, and the Examiner will accept the novelty of the amended claims, he/she may further opine such dose selection during manufacturing a medicament is a common selection in the art by limited experiments, and thus is obvious for the skilled in the art.  Therefore, we may need to further prove such dose selection can bring about unexpected technical effects, and then the technical solutions claimed in the subject application have inventiveness relative to the prior art.

As for the subject of administration

Likewise, if the claimed subject is only different from the one in the prior art in terms of the age, the physiological indicator, which may not make the use, namely, the disease to be treated or diagnosed different, then the differences in subject do not enable the use to possess novelty.

Take Invalidation Decision under No 568709 as an example, the allowed claim 1 recites “Use of degarelix in manufacturing a medicament for use in the treatment of metastatic stage prostate cancer, the treatment includes administration at an initial dose of degarelix of 160 to 320 mg, and at a maintenance dose of degarelix of 60 to 160 mg, once every 20 to 36 days thereafter, and wherein the subject has a baseline serum alkaline phosphatase level of about 150 IU/L or greater prior to treatment.”  

Firstly, the administration features “administration at an initial dose of degarelix of 160 to 320 mg, and at a maintenance dose of degarelix of 60 to 160 mg, once every 20 to 36 days thereafter” are not related to manufacturing medicament in the subject matter of this claim, and thus is deemed as having no definition on this claim. 

As for the feature relating to the physiological indicator of the subject “the subject has a baseline serum alkaline phosphatase level of about 150 IU/L or greater prior to treatment” defined in the claim, the Reexamination Panel first examines whether the physiological indicator are generally recognized in the art as a basis for determining disease classification and staging, thereby measuring whether the claimed pharmaceutical use essentially defines a new disease classification and staging.  However, this claimed physiological indicator is insufficient to distinguish a new disease classification and staging from the one in prior art.  Further, since this physiological indicator does have a certain connection to the disease progression, the Panel examines whether changes in the physiological indicator demonstrate a better therapeutic effect on the disease progression, but also there are no such evidences to prove this physiological indicator make the claimed technical solution have unexpected technical effects.  

In summary, the disease defined by the physiological indicator cannot be distinguished from the one in the prior art, and the therapeutic effect brought by the change on physiological indicator can be expected by those skilled in the art, this case is finally invalidated.