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Oct 07,2019

Discussion on Supplementary Experimental Data in China's Patent Practice

Total word count:13098

In China's patent practice, submitting experimental data after the filing date (also known as post-filing data) in support of patentability of inventions, has long been debated in the patent community. Opinions divide in this regard, yet it is worth noting that post-filing data provided by the applicant or patentee may serve as useful evidence, when such invention is challenged for substantive defects, such as, lack of inventiveness (Article 22.3 of the Patent Law), lack of claim support (Article 26.4) and lack of sufficient disclosure (Article 26.3). In accordance with the stipulations of Patent Law and Guidelines for Examination, post-filing data purported for demonstrating the patentability of the claimed inventions shall not be prohibited. This article focuses on discussing the role of post-filing data in support of inventiveness. Some relevant patent cases are also introduced for detailed analysis.

 

I. Legal basis for filing supplementary data

 

Further to the definition of inventiveness set forth by Article 22.3 of the Patent Law , the Guidelines for Examination specifies that: if the invention produces an unexpected technical effect as compared with the prior art, the examiner may determine that the invention involves an inventive step without the need to question whether its technical solution has prominent substantive features. Therefore, technical effect is essential in evaluation of the inventiveness of an invention.

 

Technical effects of the claimed invention need to be demonstrated by embodiments, examples and/or data. Experimental data plays an important role in proving that the claimed invention has achieved some better or unexpected technical effects, especially in the fields of chemical, pharmaceutical, biotech and the like. In the event that comparative data in support of the better effects is not included in the original description, it necessitates the filing of supplementary data as useful evidence if inventiveness is questioned by the examiner or challenged by a third party.

 

 

 

II. Requirements for filing supplementary data

 

Applicant or patentee preparing for post-filing data needs to pay attention to: 1) the timing of submission, 2) the formalities, and 3) the data content.

 

1. Timing of data submission

 

In theory, the applicant or patentee has the opportunity to file experimental data, if needed, during various stages such as substantive examination, reexamination, invalidation or even legal proceedings. However, there would be different considerations in these different stages.

 

At the stages of substantive examination or reexamination, the experimental data is more likely to be accepted because of: (1) lower requirements for the formality of evidence; for example, it is not required for extraterritorial evidence to be notarized and legalized or translated by a designated translation agency, and (2) no cross-examination of a third party.

 

At the stages of invalidation or legal proceedings, if a third party gets involved, things will become more complicated. Not only the requirements for the formality of evidence are stricter, but also the authenticity and relevancy of the evidence may frequently be questioned. Data submitted by one party is usually objected by the counterparty. The alleged grounds for such objection can be the following: the data provide by an interested party (any individual or organisation having a stake) is not reliable, or some deficiencies exist, such as experimental conditions, methods, apparatus used, comparison standards and the like. In that event, the unilaterally submitted data stands a lower chance of being admitted, if no other supporting evidence has been provided. Of course, the Patent Reexamination Board (PRB) or the Court may require, if necessary, the data be verified by a neutral organization mutually agreed by the concerned parties. However, such a procedure is undoubtedly time-consuming and costly.

 

In particular, in administrative litigations, the court ascertains, inter alia, the legitimacy of the Reexamination Decision or Invalidation Decision made by the PRB in respect of procedure and application of law. Therefore, post-filing data in support of the factual issue, if filed at this stage, would be strictly examined on both procedure and substantive contents. In this connection, the Beijing Higher People's Court in its Administrative Judgment of Final Instance No. 3046 specifies: “For the administrative litigation case, what should be determined is the legality of the concrete administrative act. In principle, the court's judgment shall be based on the evidence on which the administrative action at issue was made, i.e., the evidence submitted during the pre-grant proceedings by the object of the administrative action”. In this litigation case, the court explicitly questioned the timing of supplementary data presented by the patentee though not directly rejected them. In the end, these data was found inadequate in support of inventiveness of the claimed invention.

 

In the post-grant proceedings including administrative litigation, though it is still possible to submit new evidence, it is increasingly difficult to have the evidence accepted. Therefore, in order to lower the risk of rejection, it would be advisable to file the supplementary data in support of the inventiveness as far as possible at the substantive examination or reexamination stage before the grant of the patent.

 

2. Formality of data

 

In general, there are no mandatory requirements for the formality of the data in the Patent Law or the Guidelines for Examination, except under the following situations:

 

1)      If the data is formed outside the territory of China mainland, at the post-granting procedures, such as invalidation or administrative litigation, it is required that these data be notarized by the notary in the foreign jurisdiction and verified by the Chinese Embassy or Consulate to that nation.

 

2)      If the data is presented in foreign language, at the stage of substantive examination or reexamination, it is usually required to be translated into Chinese, and at the stage of invalidation or administrative litigation, it must be translated by a designated translation agency with an official seal affixed.

 

3)      If the data is presented in the form of witness testimony, at the stages of invalidation or administrative litigation, the witness may be required to appear in count for a cross-examination.

 

3. Content of data

 

In most cases, for the sake of straightforwardness, post-filing data is presented in a form of comparative results toward the closest prior art cited by the examiner .The applicant or patentee is strongly advised to follow the below principles in the preparation of supplementary data:

 

(1)    The comparative data should be directed to the technical effects which were described and for which the corresponding experiment data was given in the original specification to some extend; otherwise, they are most unlikely to be accepted;

(2)    The comparison should be made between the claimed invention and the closest prior art; and

(3)    The data should correspond to the scope of the technical solutions as claimed.

 

The above principles will be further discussed in the following two cases.

 

[Case 1]

Case 1 relates to a patent application claiming a group of compounds with formula (I) (not illustrated herein) having insecticidal activities. The examiner's objection during the granting procedure focused on whether the experimental data shown by its representative compound I-1-a-2 could support the technical benefits and thus make it inventive. In the original description of the patent, Example C showed that compound I-1-a-2 had an activity of “≥ 90” against Phaedon cochleariae at an application rate of “1000 ppm” after “a desired test time”. Reference document 1 (D1) cited by the examiner disclosed a similar compound I-1-a-4 having insecticidal activity.

 

As regards the data in the original description, the different result of insecticidal activities could not be well reflected between compound I-1-a-2 of the Invention and I-1-a-4 of D1 due to the very high application rate in the tests. In order to make clear comparison of such activities, the applicant submitted, during prosecution, supplementary data, which was generated at a lower application rate of 10 ppm as follows:

 


 

From the above table, it was clear that the data derived from the Invention had demonstrated much better insecticidal activity. The panel in the reexamination procedure finally accepted such data and opined that: though the supplementary data was generated at an application rate of 10 ppm, different from 1000 ppm as described in the original description, the purpose of lowering its application rate was for distinguishing the insecticidal activity of the Invention from that of D1 without introducing any new content for comparison. Meanwhile, as the mortality rate was tested at the same timeframe (7 days) and toward the same pest, such comparative data should be accepted for evaluation. The panel thus concluded that claimed compounds are inventive over D1, and the application has been granted after further examination.

 

[Case 2]

Case 2 relates to a patent application claiming a group of pharmaceutical compounds specifically illustrated as compound 14b and its pharmaceutically acceptable salts:


 

In order to prove better pharmaceutical effects of the above compound as compared with the cited prior art, the applicant submitted test results of activities of compound 15b (a hydrochloride of compound 14b) as a receptor to dopamine D2S, serotonin-5HT1A and serotonin-5HT2A, respectively. Due to change of experimental conditions, the test results of IC50 and Ki values varied from those recited in the original description. For example, the three Ki values corresponded to less than 1/2, more than two-fold, and less than 1/20 of those values in the original description. In this respect, the court gave its opinion in Administrative Judgment of First Instance No. 2414 that: “As the direction of changes and amplitude of the Ki values are inconsistent with those in the original description, it would be difficult to deem such supplementary data convincible”. The court's decision is not in favor of the applicant.

 

Therefore, it can be seen from the above two cases that some examiners may accept the post-filing data collected with modified experimental conditions for the purpose of comparison of the technical effects between the claimed invention and the prior art, to the extent that such modification does not result in some inconsistency with those disclosed in the original description.

 

Another issue in relation to the acceptance of supplementary data focuses on the basis for such submission. If there were no examples or the examples only provided a qualitative result in the original description, there might be no basis for submitting supplementary data to prove the benefits of the claimed invention. This principle is specified in the Administrative Judgment of Final Instance No. 2470 (2017): “If the applicant or patentee wishes to prove the inventiveness of his/its invention over the prior art by filing comparative experimental data, there is a premise that the data should be directed at the technical effects clearly described in the original specification. The so-called ‘technical effects clearly described' is to be construed as the technical effects which are clear, specific, verifiable and, generally, supported by objective data, but not those general, assertive or declarative. The description should enable those skilled in the art to clearly know the advantageous technical effects. In this particular case, the description of the patent in issue only describes the technical effects as ‘being not only extremely potent but also having a high selectivity for β2 adrenergic receptors'. Such technical effect is general and assertive, not specific. Under the circumstances, the supplementary data shall not be accepted, otherwise it will run counter to the system of first-to-file for an invention”.

 

The Administrative Judgment of Final Instance No. 00309 (2015) of the Beijing Higher People's Court also specifies that: “Regarding the technical effect of the invention, the original description only describes that ‘the compound of formula I is used to inhibit the undesired action of TNFα' and that ‘these compounds can also be used in veterinary treatment of mammal other than human in need of tissue or inhibition of TNFα production', without giving any experimental data of activities. After reading the description, those skilled in the art can only recognize that the compounds of the patent application have a general TNFα inhibition effect, without being convinced of their activities above normal level or any other unexpected technical effect. The applicant alleges that according to counter evidence 5 [a technical document describing the relevant data], the specific inventive compound (of formula I) lenalidomide has a TNFα inhibition activity about 2000 times that of thalidomide and EM-12 and thus has unexpected technical effect. However, the indicated effect and usage are neither implied in the original specification nor directly deduced from the prior art”.

 

What is also worth mentioning in relation to the acceptance of supplementary data is that the closest prior art cited by the examiner, is generally required as the comparative object. For example, for a compound claim, the compounds used as a comparative example shall be the most similar compound in the closest prior art. Having said that, other types of comparative examples would not be completely ruled out, but these examples may need more detailed analysis or explanation so as to convince the examiner to accept it for evaluation of the inventiveness of the claimed invention.

 

III. Conclusion

 

This article focuses on China's patent practice in filing supplementary data for the support of patentability of the claimed invention, especially inventiveness. The Guidelines for Examination, which was amended in April 2017, insinuates that standard might be relaxed for the applicant to file supplementary data in the issue of insufficient disclosure, though the judgment for acceptance of such data still depends on the corresponding content in the original disclosure. In the recent practice of patent prosecution, it has been noted that the examiner tends to focus more on the issue of inventiveness of the claimed invention than on other substantive issues such as claim support or sufficient disclosure, especially if the examiner intends to reject the patent application.

 

In a nutshell, to obtain better patent protection in China, it would be highly recommended that some experimental data in relation to the technical results achieved by the claimed invention, if available at the time of filing, could be included in the original application. In the event of being challenged on the patentability of the claimed invention, the applicant or patentee may provide supplementary data as evidence to demonstrate advantageous technical effects as compared to the prior art, to increase the chance of success. For the timing of submission, it would be better that supplementary data could be filed during the substantive examination or reexamination stage as far as possible before the grant of the patent.

 

 

Contributors: Ms. Jing HOU & Ms. Xiaoling DUAN