Post-filing data is important for the Applicant to get a patent right, especially for the Applicant in the biological and chemical field. However, you may find the examination standard for the post-filing data is very strict in China.  

The sixth amendments to the Guidelines for Patent Examination already have taken effect on January 15, 2021, making a new clarification for the examination of the post-filing data.

In combination with this new clarification, the changes for the examination of the post-filing data during these recent years are summarized as follows:

Before April 1, 2017, the post-filing data only can be used to prove the technical effect directly recorded in the original application. 

After April 1, 2017, according to the third amendment to Guidelines for Patent Examination, the Examiner should make an examination on the post-filing data, and the technical effect proved by the post-filing data should be obtainable by the skilled in the art from the contents disclosed by the patent application. This means that even if the effect is not clearly recorded in the original application, the un-recorded properties can be intrinsically, inherently produced from the disclosure such as other use, properties recorded in the original application, then the claimed technical solution has the inventiveness.  That is to say, the Applicant can provide arguments or other evidences to prove that there are the intrinsic, inherent relationship between the technical effects proved in the post-filing data and the contents in our patent, such as principle, other properties, or uses. 

However, during the particular examination, the Examiners are more inclined to accept the post-filing data for proving the inventiveness of the claimed technical solutions relative to the prior art, rather than that for proving sufficient disclosure.

Therefore, the sixth amendments to the Guidelines for Patent Examination, further indicates that, the post-filing data can be submitted by the Applicant for meeting the requirements for inventiveness and sufficient disclosure etc.    

Moreover, the newly amended Guidelines for Patent Examination provide the following two examples in terms of post-filing data of drug patent.

Example 1

A claim seeks to protect Compound A. The specification records the preparation examples of Compound A, the effect of lowering blood pressure and the experimental method for measuring the activity of lowering the blood pressure, but the experimental result data are not recorded. In order to prove that the specification is fully disclosed, the Applicant supplemented the effect data of Compound A for lowering the blood pressure. For those skilled in the art, according to the original application documents, the effect of Compound A for lowering the blood pressure has been disclosed, and the technical effect to be proved by the post-filing data can be obtained from the disclosure of the patent application documents. It should be noted that the post-filing data should also be examined when commenting the inventiveness.

Example 2

A claim seeks to protect the compound of general formula I, the specification records the general formula I and its preparation method, as well as the preparation examples of several specific compounds A, B, etc. in the general formula I, and also records the anti-tumor effect of general formula I and the experimental method and experimental result data for determining antitumor activity, wherein the experimental result data records the IC50 value of the example compound on tumor cells is in the range of 10-100 nM. In order to prove the inventiveness of the claims, the Applicant submitted the comparative experimental data, which showed that the IC50 value of compound A was 15nM, while the compound of Reference 1 was 87nM. For those skilled in the art, according to the recordation of the original application documents, compound A and its anti-tumor effects have been disclosed, and the technical effects to be proved by the post-filing data can be obtained from the disclosure of the patent application documents. It should be noted that, at this time, the Examiner needs to further analyze whether the technical solution sought to be protected by this claim meets the requirements of inventiveness in conjunction with the post-filing data.

As can be seen, the examination standard for post-filing data is more flexible than before, which is benefit for the Applicant.