Elliot ZHOU, Partner of Foundin IP

 

 

Over the years, we have heard many complaints from patent applicants about the CNIPA’s attitude against life science and chemistry patent applications, as the CNIPA examiners seemed to be reluctant to grant a patent with good scope in these areas. Sometimes, Chinese patent examiners seemed to be willing to grant a patent only when there was a good experimental data described in the specification. If the experimental data described in the specification was only for one or two compounds, the CNIPA examiners would probably like to grant a claim only for the specific one or two compounds. If there was no experimental data in the specification at all, the CNIPA would probably reject the patent application.

 

Some of the applicants are trying to overcome the office actions by submitting post-filing data, typically confirmatory experimental data to overcome the insufficiency of disclosure rejection, or comparative data to overcome the obviousness rejection. But not all the examiners are willing to accept the post-filing data, especially if there were no good argumentations presented by patent attorneys on how the effects demonstrated in the post-filing data are derivable from the patent application as filed. 

 

Nevertheless, based on our experience, the CNIPA has greatly improved the chances of accepting the post-filing data since 2020, largely because

(i) The Patent Examination Guideline of China was amended in 2021, where two examples were given by the new guideline on what kind of “post-filing data” should be accepted, and

(ii) The Supreme People’s Court (SPC) of China issued a Judgement in 2019 on the CNIPA’s invalidity decision against AstraZeneca’s Patent No. CN200610002509.5. This Judgement clearly illustrated the “positive criterion” for accepting the post-filing data and “negative criterion” for rejecting the post-filing data.

 

==Regarding the Amendment of the Patent Examination Guideline==

Part 2, Chapter 10, Section 3.5.1 of the Patent Examination Guideline (2023) set forth that the technical effect to be demonstrated in the post-filing data must be derivable from the patent application as published in the viewpoint of those skilled in the art.

 

Section 3.5.2 further gives two examples on what kind of post-filing data is considered as being derivable and thus should be accepted by the CNIPA. Particularly, Example 1 under Section 3.5.2 showed that even if there were no experimental data at all in the patent application as published, the CNIPA may still accept the post-filing data given that the specification has provided sufficient description that makes a skilled artisan believe that the effect of the compounds shown in the post-filing data is derivable from the patent application. 

 

Specifically, the Example 1 of the patent examination guideline is reproduced below.

“[Example 1] The claim intends to protect a compound A. Although the specification described an example of preparing the compound A, and described an experiment of how to test the reduction of the blood pressure, it failed to describe any experimental result. To prove that there is a sufficient disclosure, the applicant submitted a post-filing data which demonstrated that the compound A has a blood-pressure reducing effect. To those skilled in the art, the blood pressure reducing effect of the compound A can be understood based on the patent application, so the effect to be demonstrated in the post-filing data shall be considered as being derivable from the patent application as published.”

 

This example is a revolutionary change when you compare with the old examination guideline. It opened a window that even if the specification does not contain any experimental data or just contains prophetic examples, the CNIPA may still accept the post-filing data as long as the applicant can provide sufficient argumentations on the derivability of such data. For example, there must be at least sufficient disclosures in the patent application on how the compound was made, used and tested. 

 

Indeed, in our daily work, we have used this Example 1 to push the Examiner to accept the post-filing data in a number of patent prosecution cases we represented in the pharmaceutical and chemistry areas, and the success rate to eventually convince the examiners is very high.

 

==Regarding the SPC’s judgement on AstraZeneca’s Patent==

During the invalidity proceeding against AstraZeneca’s Chinese Patent No. CN200610002509.5, AstraZeneca submitted two pieces of post-filing data (E2 and E5), trying to demonstrate that the compound as claimed has a higher metabolic stability and better bioavailability over the prior art. However, both of the re-examination panel of the CNIPA and the Court of first instance refused to accept these post-filing data by holding that the data are not derivable from the patent application as published. Specifically, the patent application contained only one description stating that “(the compound) also has a surprisingly high metabolic stability and bioavailability”, but there is no data at all in the detailed description to support this statement.

 

When this case was eventually appealed to the Supreme People’s Court (SPC), the SPC took a different standpoint. The SPC elucidated with details in the Judgement on what kind of post-filing data could be accepted (positive criterion) and what kind of post-filing data shall not be accepted (negative criterion).

 

If the post-filing data were to be accepted, the “positive criterion” is that the original patent application must explicitly or implicitly disclosed the matter to be proven by the post-filing data. Basically, if the matter to be proven has been described in the specification, then the post-filing data which serves to prove such a matter would not violate the first-to-file principle. The SPC further clarified that one can’t refuse the post-filing data by simply saying that the original patent application merely described the matter to be proven but fails to describe the relevant experimental data.

 

If the post-filing data were to be refused, the “negative criterion” is that the applicant can’t use the post-filing data to remedy the deficiencies that were inherently present in the original patent application. In other words, the post-filing data is supposed to be used to prove the truthfulness of the matter that has been explicitly or implicitly disclosed in the original patent application. The post-filing data would function as a supplementary proof only, and would not act as a proof to independently prove something that was not disclosed in the original patent application.

 

The SPC’s judgement again emphasized that the preliminary data present in the original patent application is not a must for the submission of post-filing data. This judgement reversed the old opinions taken by many CNIPA examiners and IP practitioners where at least a preliminary data is required to be present in the original patent application. In the AstraZeneca case, even though the specification only described that “(the compound) also has a surprisingly high metabolic stability and bioavailability” without any experimental data, the SPC considered that this statement alone could serve as a sufficient disclosure for AstraZeneca to submit post-filing data to prove the matter that the compound is indeed associated with a high metabolic stability and better bioavailability.

 

==Summary==

Based on what we experienced, the CNIPA are indeed more and more flexible in accepting the post-filing data these years. However, more burden is given to the patent attorneys, because they need to prepare and submit very good argumentations on how the effects demonstrated in the post-filing data are derivable from the patent application as published. If such “derivability argumentations” are not well-drafted or even missing, the examiners/panels may easily reject the post-filing data.

 

Thus, if the applicants wish to submit a data to overcome the obviousness issue or support issue, we strongly suggest the patent attorneys to quote Example 1 or Example 2 under Section 3.5.2 of the patent examination guideline, or quote the SPC’s Judgement on AstraZeneca case, whenever applicable, because this kind of “derivability argumentations” will greatly increase the chance of success for the CNIPA examiners to accept the post-filing data. We have been successfully using this kind of argumentations to increase the success rate for our clients.

 

If you have any questions related to this topic or any questions on the Chinese patent practice, please feel free to contact Mr. Elliot ZHOU at patent@foundin.cn.