---- Discussion about experimental data after filing date

   

Wanqing CHEN 

The latest revision of Chinese Guidelines for Patent Examination (2010) has been implemented since April 1, 2017, in which provisions of experimental data submitted after filing date were amended regarding to the sufficient disclosure of an invention in a description in the field of chemistry.

 

It recited in Section 3.4 (2), Chapter 10, Part II, “Whether or not the description is sufficiently disclosed is judged on the basis of the disclosure contained in the initial description and claims, any embodiment and experimental data submitted after the date of filing shall not be taken into consideration”. Now, the content regarding the embodiment and experimental data was deleted, and Section 3.5 was added: “Any supplementary experimental data submitted after the date of filing shall be examined. The technical effect to be demonstrated by the supplementary experimental data shall be an effect that can be obtained by a person skilled in the art on the basis of the disclosure contained in the patent application.”

 

Does this mean that it is possible to submit experimental data after the date of filing to overcome the drawback of insufficient disclosure of a description? How to understand “the technical effect can be obtained by a person skilled in the art on the basis of the disclosure contained in the patent application”?

 

Actually, as early as 2015, the Supreme People's Court (SPC) for the first time pointed out in a trail judgment ((2014) Xing Ti Zi No.8) that it is not appropriate to refuse to take experimental data into consideration only on the grounds of “submitted after the filing date”. Although the judgment was made two years earlier than the enforcement of the amendment of the Guidelines, it is very important for understanding the new provision due to its deep analysis with respect to additionally filed experimental data.

 

The judgement states: "the Court believes that, for the experimental evidence submitted after the date of filing for demonstration of the sufficient disclosure of description, if on the basis of the knowledge level and cognitive ability of a person skilled in the art before the date of filing, it can demonstrate that the invention can be achieved according to the disclosure of the description, the experimental evidence should be taken into consideration and should not be refused just because it is submitted after the date of filing”.

 

The SPC indicated such experimental data belong to experimental evidence. Therefore, based on the principle of “the burden of proof lies upon him who affirms”, it is the obligation and also the right of a party to submit an evidence to support his opinion. Examination on experimental evidence should focus on the authenticity, legitimacy, relevance and probative force of the evidence. In this regard, the wording in the original provision in the Guidelines is not appropriate.

 

Second, what kind of experimental data can be adopted to demonstrate the sufficient disclosure of a description? The judgment states: "if on the basis of the knowledge level and cognitive ability of a person skilled in the art before the date of filing it can demonstrate that the invention can be achieved according to the disclosure of the description, the experimental evidence should be taken into consideration”. In other words, the probative force of such evidence does not lie in supplementing contents that is not (sufficiently) disclosed in the description, but rather in demonstrating, in way of clarification and explanation, that the description per se meets the requirements of sufficient disclosure.

 

For the problem that whether or not inventions are sufficiently disclosed by the descriptions, on one hand, the principle “disclosure for protection” needs to be followed, which is the basis of patent system. That is, the patentee obtains a certain period of exclusive rights while he or it needs to sufficiently disclose his or its invention to promote scientific and technological progress thereby benefits the whole society. This is also the origin and legislative principle of Article 26 (3) of the Chinese Patent Law: “the description shall set forth the invention or utility model in a manner sufficiently clear and complete so as to enable a person skilled in the relevant field of technology to carry it out”.

 

On the other hand, the principle "first-to-file" also need to be followed. That is, for the same invention, the patent right shall be granted to the person who first files a patent application. It is not allowable that filing a patent application when the invention is not completed so as to occupy an earlier filing date and gradually complete the application document later. Therefore, the description should have sufficiently described the invention on the date of filing.

 

In the judgement, the SPC further pointed out: “When examining on experimental evidence, the time point and the subject should be stringently examined. First, in terms of the time point, discussions should be made on the basis of the knowledge and ability before the filing date (priority date) to judge whether the experimental conditions and methods involved in the experimental evidence could be directly obtained or readily conceived for a person skilled in the art by reading the description. Second, in terms of the subject, discussions should be made from an eye of a person skilled in the art with the common knowledge level and common cognitive ability.”

 

Since the description should have sufficiently described the invention on the date of filing, if the description (and claims) has a defect that is inconformity with the Chinese Patent Law. it is not allowable for an applicant to introduce any “new contents” beyond the scope contained the initial application document to overcome the defect, no matter in way of amending the initial description (or claims) (Article 33 of the Patent Law and Rule 43 (1) of the Implementing regulations of the Patent Law) or submitting evidence for reference.

 

It is noted that the latest revision of the Guidelines only provides the principle regarding to the examination of "technical effect to be demonstrated", while the above judgement made by the SPC examined and provided guiding to the whole evidence including experimental conditions, methods and so on. The author agrees that the supplementary experimental data should be fully examined on both experimental contents and contents to be demonstrated (such as technical effect).

 

A deep understanding of the amendments to the Guidelines will be discussed through reference to the case involved in the above judgement ((2014) Xing Ti Zi No. 8).

 

This case relates to a patent invalidation requested by Beijing Jialin Pharmaceutical Company, LTD. (hereinafter referred to as Jialin) for the patent No. 96195564.3 owned by Warnier Lambert Company, LLC. (hereinafter referred to as Warnier Lambert). The patent claims a crystalline Form-I hemicalcium hydrate containing 1-8 mole(s) of water (3-mole preferred). However, in the only preparation example disclosed in the description, it was not determined whether the obtained crystal contains any crystal water, let alone the moles of the crystal water. In addition, the product was prepared by being seeded with a slurry of crystalline Form-I atorvastatin, but the way to obtain the seed crystal was not disclosed. In other words, the description of the patent did not complete the confirmation of the claimed crystalline hydrate, nor did it sufficiently disclose its preparation method. Therefore, it was difficult to convince a person skilled in the art that the crystalline Form-I atorvastatin hemicalcium hydrates could be prepared in a controlled manner. As a result, the patent was declared invalid due to insufficient disclosure of the invention under Article 26 (3).

 

During the second trail, Werner Lambert submitted a third-party experimental report to demonstrate that the embodiment in the description could inevitably prepare and obtain the hydrate containing 3 moles of crystal water. However, the heating duration and cooling conditions adopted in the preparation method in the evidence were queried during the trail. Jialin believed that the evidence was not obtained through a repetitive experiment based on that disclosed in the patent description. For example, method A of Example 1 of the patent recites, "the mixture is then heated to 51-57°C for at least 10 minutes and then cooled to 15-40°C ". However, for Experiment 1 in the submitted experimental report, the corresponding heating duration was "17 hours". For Experiment 2, the method was "stirred overnight" at 52-57°C, and the duration for cooling the mixture to ambient temperature in both Experiments was "10 hours".

 

Jialin argued that the heating duration described in the description was not in the same level as that adopted in the experimental report. In addition, since the cooling method was not specified in the description, based on the general understanding of a person skilled in the art, the cooling method should be such as standstill cooling or natural cooling. However, the 10-hour cooling duration in the supplementary experimental report obviously indicated a controlled cooling.

 

Warner Lambert argued that the scale in the experimental report was about 125 mL, i.e., a laboratory scale, while it is an industrial scale in the embodiment of the description with a volume of over 1300 L. Therefore, a person skilled in the art would have recognized that the temperature would drop very slowly during the cooling of the Example system, and the reaction system would be maintained above 40℃ for quite a long time. In addition, Warner Lambert indicated that, according the teachings of textbooks in the field, in the crystallization process, in order to obtain crystals with good particle size, a controlled cooling is preferred rather than a natural cooling. The company also provided the corresponding evidence.

 

Both parties in this case introduced the concept of "a person skilled in the art". However, Jialin focused on the understanding of the contents in the description; while Warner Lambert emphasized the common knowledge in the art.

 

The SPC, on the one hand, affirmed that the common knowledge evidenced by Warner Lambert was indeed the common knowledge that a person skilled in the art should know. On the other hand, it pointed out that for the specific crystalline Form-I atorvastatin hemicalcium hydrate, the specific heating duration and the specific cooling speed in the controlled cooling could not be readily conceivable to a person skilled in the art based on the description in combination with the knowledge existed before the priority date of the patent.

 

Regarding to the provision that the description should disclose the invention or utility model in a complete way, Section 2.1.2, Chapter 2, Part II of the Guidelines recites: "all the relevant contents that a person skilled in the art cannot obtain directly and uniquely from the prior art shall be described in the description". In turn, obviously, the supplementary experimental evidence cannot include any contents that neither are described in the description nor can be obtained "directly and uniquely " from the prior art.

 

Although the SPC used the wording "readily conceivable to a person skilled in the art” in the judgement, it was consistent with the criteria prescribed in the Guidelines.

 

The examination of supplementary experimental evidence should not be confused with the examination of an inventive step. The examination of an inventive step is, based on the contents of relevant prior art prior to the filing date (or the priority date), judging whether the invention can be easily obtained (obviousness), which is used to evaluate the contribution of the invention to the prior art. The examination of the supplementary experimental evidence submitted after the filing date is for preventing any unjust enrichment based on the principles of “disclosure for protection” and "first-to-file”. Both the examinations are made from the perspective of a person skilled in the art while the judgement criteria are obviously different. Since patent legislation aims to promote scientific and technological development and social progress, the examination on unjust enrichment should be stringent.

 

In this case, in terms of evidence, the experimental method in the evidence included contents that a person skilled in the art could not obtained from the disclosure of the description so that the evidence was not adopted. In addition, the SPC further pointed out that even if the experimental evidence could demonstrate that the hydrate containing 3 moles of crystal water could be prepared and obtained with the method disclosed in the description, it could not change the fact that the description of the patent failed to complete the confirmation of the product. In this sense, the evidence still cannot be adopted.

 

From the above discussion, it can be seen that the amendment to the supplementary experimental data in the Guidelines does not mean any change of examination criteria, but just the improvement of the description of the original provision. The experimental data submitted after the filing date should be fully examined on specific experimental contents and contents to be demonstrated, but not be limited to the technical effect that the data intend to demonstrate. In addition, the contents that "can be obtained by a person skilled in the art from the contents disclosed in the patent application” should include: the contents recorded in the application documents as well as the contents can be directly and uniquely obtained by a skilled person on the basis of the contents recorded in the application documents in combination with the prior art.

 

This could be a guiding case to experimental data submitted after filing date, whatever it is used for overcoming the defect of insufficient disclosure or for overcoming other defects such as lack of inventive step.