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Survival Rule of Supplementary Experimental Data in Invalidation in Chemistry Field

12

MAY

2020

In China, according to the provisions of the current Patent Examination Guidelines for supplementary experimental data, it is stated that “experimental data submitted after the application date shall be examined by the examiner, and the technical effects demonstrated by the supplementary experimental data can be obtained from the content of the patent applications by those skilled in the art. "Subsequently, the Supreme Court issued on April 28, 2020 on Several Issues Concerning the Trial of Administrative Cases Concerning Patent Authorization (1) (Public Comment Draft) also provides a judicial interpretation of the above-mentioned new provision, namely Article 12, "Drug patent applicants and patentees submit experimental data after the application date to further prove that the technical content related to the specific technical effect in the specification is sufficient, and the technical effect based on the description, drawings and common knowledge on the application date can be confirmed by those skilled in the art, it should be examined by the people's court. The drug patent applicant and patentee submit experimental data after the application date to prove that patent application or patent has a different technical effect over the citations, and the technical effect based on the description, drawings and common knowledge on the application date can be confirmed by those skilled in the art, it should be examined by the people's court.” and Article 13,“ If the parties submit experimental data, proof of the source and formation process of experimental data, including experimental materials and sources, experimental steps, conditions, environment or parameters, as well as the personnel and institutions that complete the experiment to affect its authenticity, relevance and proving power may be requested by the people’s court. If the authenticity is disputed, the people’s court may entrust an institution with corresponding qualifications or a third party recognized by the parties to test or verify the experimental data. "

In practice, the author notes that although supplementary experimental data opens a wider path for patent applicants to argue for inventive step in the substantive examination, and the acceptance of the data by the examiner is relatively more relaxed, in the invalidation, supplementary experimental data both face with a more stringent cross-examination link, and like a double-edged sword, both for invalidation requesters and for patentees, the use of more than one can achieve real thorns. Therefore, in this article, the author will discuss how to provide real and effective supplementary experimental data in the invalidation.

  1. How to treat the authenticity and legitimacy of supplementary experimental data

When submitting supplementary experimental data at the invalidation, the first level is the cross-examination. In practice, the author believes that there is still a large difference between the examination stage and the invalidation stage of the cross-examination standards for supplementing experimental data. In the examination stage, the examiner's consideration of the authenticity of the experimental data is more biased to the rationality of the data and the relevance of the patent, especially for the extra-territorial evidence, which does not require cumbersome notarization and certification procedures, nor does it need to be cross-examine with the provider, however these links are indispensable in the invalidation stage.

In the invalidation case 4W105771, the patentee attached a counter-evidence when submitting an response to the invalidation request, that is, a supplement to the statement of the provider of the experimental data, and the provider who issued the statement attended the oral hearing as a witness to make statements and accept inquiries about his business experience and relevant content in the counter-evidence. Its authenticity was confirmed by the panel.

In the invalidation case 4W105692, the requester provided supplementary experimental data issued by the third-party testing agency as evidence. The evidence was complete and sealed with the official seal, and the report reviewer attended the oral hearing as a witness to explain operation process in detail. Its authenticity was confirmed by the panel.

In the invalidation case 4W107036, the experimental data in the counter-evidence provided by the patentee was submitted when he responded to the Office Action at the substantive examination for the patent, and was accompanied by a personal statement consistent with its experimental data at the invalidation stage. The panel believes that the experimental data is recorded in the examination document of this patent, which can be queried through the website of CNIPA. Its authenticity and openness were confirmed by the panel.

However, in the case of invalidation request 4W108026, the supplementary experimental data provided by the patentee is provided unilaterally. There is no original test record, and no experimental personnel attended the oral hearing. They also refused to carry out technical evaluation on the experimental effect of this patent and related evidence. Therefore, the authenticity of the supplementary experimental data cannot be confirmed by the panel.

  1. The technical effect proved by the supplementary experimental data cannot be new

The technical effect proved by the supplementary experimental data is intrinsically related to the fact of disclosure on the application date, which is also the essential requirement of the Chinese patent system's pre-application system and exchanging protection for disclosure. Any new content submitted after the application date will not be accepted. The author believes that the specific meaning of "the technical effect proved by the supplementary experimental data can be obtained from the content disclosed in the patent application to those skilled in the art " is not only limited to whether the relevant technical effect is recorded in the application document, but it is also required that the specific embodiments or examples that can prove the technical effect are indeed recorded in the content of the patent application.

In the invalidation case 4W105771, the panel believes that the supplyment experimental data is to prove that the compound of claim 1 of this patent has good metabolic stability, but high metabolic stability is only mentioned in the background technology section in this patent application document, but the article does not give any experimental data related to metabolic stability, and those skilled in the art cannot expect that the compound has good metabolic stability according to the prior art, so the patentee should not be allowed to use experimental data by post-submission to prove the technical effect of metabolic stability that has not been confirmed in the original patent application documents.

In the invalidation case 4W105696, the panel believes that the specification does not disclose specific experimental data or results. On the premise that those skilled in the art cannot anticipate the synergistic effect, the lack of experimental data and results-based experimental conclusions cannot enable those skilled in the art to confirm the synergistic effect of the drug, and the experimental data supplemented by the patentee was later than the application date, thus it did not belong to the content recorded and disclosed in the original application document of the patent, nor the prior art content of this patent. Supplementary experimental data cannot be accepted.

However, In the invalidation case of 4W107030, when determining whether the above supplementary experimental data can be accepted in this case, the most important factor is still how the technical effect is disclosed in the specification. It is not difficult to see that when the panel studied the content of the above-mentioned patent application, the main content of the specification was to study the conversion problem between Form A and Form B of the pharmaceutical composition, and through various processes and conditional description to speculate the possibility of producing the above technical effects. On this basis, as those skilled in the art can understand that the supplementary experimental data can be regarded as the verification of the technical effect described in detail in the specification. That is to say, those skilled in the art can deduce the comparison of the data obtained from the supplementary experimental data based on the content disclosed in the patent application involved. This is like a step-by-step operation in the mathematical calculation process. The supplementary experimental data is just to make the calculation step more complete and easy to understand, but its presence or absence does not affect the final result. Therefore, supplementary experimental data can be accepted.

  1. Supplementary experimental data can prove that this application or this patent has a different technical effect than the citations

As mentioned by the author in the opening chapter, applicants are not able to exhaustively retrieve all the relevant technologies that may be relevant when writing application documents. Even after the grant of patent rights, they will still face the closest search for the existing technology by the invalidation requester. When faced with unknown existing technology at any stage, supplementing experimental data is a good tool for the verification of technical effects. Similarly, if the invalidation requester can make good use of this blade, it will also give the patentee a fatal blow.

In the invalidation case 4W106919, the panel believes that the involved patent examples record that DIPAS (the present patent compound), which is also of formula A, is more stable than DEAS (prior art compound) and is a preferred precursor for preparing silicon oxide thin films with low etch rates. The patentee submitted the counter-evidence as supplementary experimental data. From the stability test and storage period study of the counter-evidence, it can be seen that the stability of DIPAS is better than that of DNPAS (di-n-propylaminosilane) and DNBAS (di-n-butylaminosilane), and also longer than that of DNPAS and DNBAS. The above data shows the excellent stability of DIPAS. That is, the patent chooses diisopropylaminosilane as a silane precursor and has achieved excellent technical effects. Therefore, the inventive step of the patents involved is recognized.

In the invalidation case 4W108480, the panel believes that the patent specification involved records that at 90% relative humidity, the B-type crystal has about 0.2% hygroscopicity. It can be seen from this that the effect of crystal B having low hygroscopicity has been described in the original specification. Although the specific patent methods and conditions are not detailed in the patent specification of the case involved, the hygroscopicity of the detection substance is a conventional technical means in the art. Those skilled in the art can determine the appropriate conditions and methods to measure and confirm the hygroscopicity of the substance according to the specific circumstances and needs. The conditions used in the supplementary experimental data are consistent with the "relative humidity 90%" described in the specification. The measured water absorption of the crystal B is less than 0.5%, and it is also consistent with the result described in the specification 0.2%, which is not a new technical effect. Those skilled in the art can understand that as long as the supplementary experimental data complies with the rules of parallel testing when conducting comparative tests, using the same conventional test methods and conditions in the field, the comparison results obtained are logical and the results can be used to explain the difference in hygroscopicity between Form B and varenicline hydrochloride. Therefore, the content of the supplementary experimental data is considered in the process of inventive evaluation.

The invalidation case 4W105692 just illustrates how the invalidation requester can hold the edge of supplementing experimental data. The invalid requester submitted a US patent application as the closest prior art when requesting the invalidation of the patent in question, and then submitted supplementary experimental data, that is, the performance calculation of the refrigerant composition in claim 1 vs. the closest prior art submitted by a third-party testing agency. In this calculation, the difference between the two in each value is very small, which shows that these differences cannot bring unexpected technical effects to the patent in question. The panel believes that the difference between the composition of the closest to the prior art and the patent in question is only a slight difference in the content of the components. The patent in question does not record any unexpected technical effects, and the different technical effects claimed by the patentee is not recorded in the patent specification involved, so the panel does not recognize the inventive step of the claim

Conclusion

The author believes that the examiner's judgment on the authenticity, legality and relevance of supplementary experimental data when reviewing supplementary experimental data is from the perspective of those skilled in the art, starting from the substantial description of the patent involved, understanding and clearly the true meanings of the supplementary experimental data to give a conclusion. In summary, the most advantageous preparation method for supplementing the authenticity and legality of the experimental data is prepared by a third party who has no interest in the parties, and the third party can also complete the cross-examination of the oral hearing. Second, the supplementary experimental data that used to prove the technical effect of the patent in question cannot be new content. Maybe the technical effect does not necessarily need to be completely consistent with the content disclosed in the patent application in question, but it must also be obtained from it. Furthermore, whether the content recorded in the supplementary experimental data can be used for judging that the patent in question is inventive requires those skilled in the art to understand and analyze based on the content of the patent disclosure and common general knowledge.

About the Firm

Ge Cheng & Co Ltd.
Address Level 19, Tower E3, The Towers, Oriental Plaza, No 1 East Chang An Avenue, Beijing 100073, China.
Tel 86-10-8518 8598
Fax 86-10-8518 3600
Email davidcheng@gechengip.com , info@gechengip.com
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