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Issues emerging from the guidelines on supplementary experimental data




Tina Tai and Guo Yu of China Patent Agent examine the difficulty of having supplementary experimental data considered by SIPO, comparing China’s approach with the stance taken by other jurisdictions

During the substantive examination and re-examination of a patent application as well as invalidation proceedings after the grant of a patent, submission of supplementary experimental data (i.e. post-filing experimental data) is often relied upon by the patent applicant or patentee, in particular where the invention concerns the fields of chemistry and pharmaceuticals. When fighting against the argument of lack of inventive step, the patent applicant or patentee often leverages supplementary experimental data to prove the advantageous effect of an invention and support the inventiveness of the invention.

This article focuses on the principles and standards of examination/adjudication with respect to supplementary experimental data adopted by the State Intellectual Property Office of China (SIPO) and courts at various levels in China. In addition, the article also includes some relevant provisions of Europe, the US, Japan and Korea and puts forward our suggestions on the basis of comparative research related to examination/adjudication of supplementary experimental data in China.

Current provisions

SIPO revised the Guidelines for Patent Examination (the guidelines). These came into effect on April 1 2017. They stipulate that: "Experimental data submitted after the date of filing, should be examined by the examiner. The technical effect proved by the supplementary experimental data should be one deducible by a person skilled in the art from the disclosure of the patent application as filed." This revision has replaced the statement that "any experimental data submitted after the date of filing shall not be taken into consideration" and provides that post-filing experimental data shall be considered by the examiner.

SIPO's current examination standards in practice

SIPO usually requests that the technical effect to be proved by supplementary experimental data be directed to the technical effect achieved by the invention as of the filing date. This must be an effect capable of being known by a person skilled in the art based on the original application documents and the prior art. Regarding the question of whether a person of ordinary skill in the art is capable of knowing the technical effect as of the filing date, SIPO generally judges it by whether there is explicit disclosure of the original experimental data in the original application documents. Only if the original application documents have explicitly disclosed the original experimental data of a technical effect can the comparative experimental data relative to the prior art submitted by the applicant or patentee in respect of the technical effect be taken into consideration. If there is no disclosure of the original experimental data of a technical effect in the description, SIPO generally will not allow supplementary experimental data to be used for proving the inventive step of an invention at the time of filing a patent application, even if there is an explicit reference to the relevant technical effect in the description accompanied by proof of the technical effect by experimental data or embodiments submitted after the filing date.

Comments from the Chinese courts

Regarding post-filing experimental data, the Chinese courts have set down some adjudication standards. For instance, Several Legal Issues to Note in IP Adjudication (2017) issued by the Beijing Higher People's Court (BHPC) states that the latest amendments of the guidelines as mentioned above "have changed the examination approach from a conservative, rigid one towards better balancing the maintenance of the first-to-file principle and the protection of the interest of the patentee". BHPC also provides its interpretation of the amendments:


In China, even if a technical effect has been explicitly disclosed in the original description or the effect can be deduced from it, if the experimental data for proving the effect is not disclosed in the original description, the effect will not be deemed as 'derivable from the disclosure of the patent application by a person skilled in the art’


"First, the technical effect to be proved by the supplementary experimental data must be explicitly stated in the original application documents, and the facts supported by the data must not go beyond the scope of the disclosure of the original application documents, i.e. such data may not be used for proving any new technical facts; second, the same criteria for admissibility of supplementary evidence applies, regardless of whether the supplementary experimental data is filed for overcoming insufficiency of disclosure in the description or proving the inventive step of a patent; third, notwithstanding the contents related to supplementary experimental data being part of the section on examination of chemistry inventions in the guidelines, the provisions are applicable to other technical fields as well; fourth, the experimental data is obtained based on the experimental conditions, facilities and experimental means as of the filing date."

The Supreme People's Court of China (SPC) also pointed out in a ruling (No. Xingtizi 8/2014) that:

"Regarding post-filing experimental evidence for proving the sufficiency of disclosure in the description, if it can be proved that a person skilled in the art, given his knowledge level and cognitive ability as of the filing date, may realise the invention based on the disclosure of the description of the experimental evidence, the experimental evidence should be taken into consideration and should not be rejected merely because it is submitted after the filing date. In considering the admissibility of experimental data, time factor and the subject should be rigorously examined. In terms of time factor, the experimental conditions and methods related to the experimental evidence should be directly derivable or easily conceivable by a person skilled in the art from the description as of the filing date or priority date. In terms of subject, consideration should be based on the knowledge level and cognitive ability of a person skilled in the art."

As seen from the above provisions and ruling, the Chinese courts seem to believe that SIPO (Patent Re-examination Board) has taken too conservative and rigid an approach in the examination of post-filing experimental data and deem that supplementary experimental data should be considered provided certain conditions have been satisfied.

SIPO and the courts' examination/adjudication practice

In order to have an accurate grasp of the current examination/adjudication standards of SIPO and the Chinese courts concerning post-filing experimental data, we have researched and analysed the re-examination decisions on pharmaceutical cases made by the Patent Re-examination Board (PRB) from early 2015 to the end of 2017 as well as relevant court rulings between 2014 and 2017.

From our research, we can identify four circumstances based on the disclosure and acceptance of supplementary experimental data:

The effect to be proved by the supplementary experimental data and relevant data is explicitly disclosed in the original description.

In this circumstance, post-filing experimental data is generally considered by SIPO (PRB), though the threshold on admissibility of such supplementary experimental data is in fact very strict.

The effect to be proved by the supplementary experimental data is explicitly disclosed in the original description, but no relevant data is disclosed therein.

In this circumstance, post-filing experimental data is generally not considered by SIPO (PRB) and the Chinese courts.

The effect to be proved by the supplementary experimental data is deducible from the original description, but no relevant data is disclosed therein.

In this circumstance, post-filing experimental data is generally not considered by SIPO (PRB) and the Chinese courts.

Neither the effect to be proved by supplementary experimental data nor relevant data are explicitly disclosed in the original description.

In this circumstance, post-filing experimental data is generally not considered by SIPO (PRB) and the Chinese courts.

It is known that:

Currently, post-filing experimental data for proving the technical effect of an invention is very unlikely to be considered in an examination by SIPO (PRB) and adjudication by the courts.

If no relevant experimental data is disclosed in the original application documents, SIPO (PRB) will generally not consider the supplementary experimental data regardless of whether the technical effect has been expressly recited in the original description.

Although the courts have set down some rules relating to the adjudication of supplementary experimental data, these rules are in practice highly consistent with the examination standards of SIPO (PRB). At the time of writing, we have found no rulings that have reversed the PRB's decisions and considered the supplementary experimental data submitted.

Relevant provisions in other countries

Some relevant provisions and rulings relating to the examination of post-filing experimental data in other countries and regions are as follows:

  • In the US, the Manual of Patent Examining Procedure (MPEP) stipulates that affidavits or declarations (including post-filing experimental evidence), when presented in a timely fashion, must be considered by the examiner in determining the issue of obviousness of claims for patentability.
  • For Europe, the Guidelines for Examination in the European Patent Office state that the effects proved by the supplementary experimental data should be taken into account if they are implied by or at least related to the technical problem initially suggested in the originally filed application.
  • In Japan, the Examination Guidelines for Patent and Utility Model stipulate that the examiner should consider the advantageous effects over the prior art argued and proved in the written opinion (such as supplementary experimental results) under the following circumstances: where the effects are stated in the description or where the effects, though not stated in the description, can be speculated by a person skilled in the art from the description or drawings.
  • In Korea, a ruling stated that the improved effect of an invention should still be considered in determining the inventiveness of an invention even if it is not explicitly described in the specification, provided that it can be inferred from the depiction therein by a person skilled in the art.

Comparison with relevant provisions of other countries

It is known from the preceding information that at least literally, there is not much difference in the provisions on examination of supplementary experimental data among patent offices of various jurisdictions and China. They all contain the stipulation that post-filing experimental data in support of a technical effect will be considered as long as the technical effect can be derived by a person skilled in the art based on the disclosure of the original application documents.

However, in examination/adjudication practice, the patent office in China, compared with its counterparts in the US, Europe, Japan and Korea, is less likely to consider supplementary experimental data. In particular, where the technical effect is explicitly disclosed in the original description but no relevant experimental data is disclosed therein, or where the technical effect is deducible from the disclosure of the original description but no relevant experimental data is disclosed therein, it is almost impossible that post-filing experimental data in support of the technical effect of the invention will be considered according to prevalent practice in China, while in contrast, post-filing experimental data, under similar circumstances, would be considered by patent offices in the US, Europe, Japan and Korea.

In our opinion, the reason for this phenomenon lies in the overly strict interpretation of SIPO and the Chinese courts on the provisions of the guidelines that "the technical effect to be proved by the supplementary experimental data should be derivable by a person skilled in the art from the disclosure of the patent application." SIPO and the Chinese courts' thinking might be that if relevant experimental data is not provided in the original description, the technical effect cannot be deemed as having been confirmed as of the filing date. Given that the effect has not been confirmed as of the filing date, from the perspective of the first-to-file principle the effect cannot be deemed as being derivable from the original application documents.

In other words, in China, even if a technical effect has been explicitly disclosed in the original description or the effect can be deduced from it, if the experimental data for proving the effect is not disclosed in the original description, the effect will not be deemed as "derivable from the disclosure of the patent application by a person skilled in the art". Accordingly, even if post-filing experimental data is submitted for proving the effect, it will not be taken into consideration.

Admittedly, the first-to-file principle and the disclosure-in-exchange-for-protection principle are the rudimentary principles of patent law. However, judging from current examination/adjudication standards of SIPO and the Chinese courts, the objective fact that the technical effect has been expressly recited in the original patent application documents or is deducible from the disclosure of the original application documents has obviously been overlooked. Original application documents are legal documents for expounding an invention and given that the objective fact has been included in the legal documents as of the filing date, supplementary experimental data for supporting such objective fact should certainly be taken into consideration.

In our view, such strict examination or adjudication will result in SIPO practising an examination standard different from its counterparts in the US, Europe, Japan and Korea with respect to post-filing experimental data, as well as creating too heavy and unreasonable a burden on patent applicants. Additionally, it may also affect the development of domestic and foreign pharma enterprises and the initiative of the enterprises in conducting research and development of new drugs, thus undermining the public's health choices.

In light of these problems, we hope that patent examination/adjudication in China will adopt a practice of considering post-filing experimental data for proving an effect, if the effect has been explicitly disclosed in the original description or is deducible from the disclosure despite the fact that there is no disclosure of relevant experimental data in the original description. We believe that, by adopting such a practice, China can make its examination standards consistent with those of other countries and regions, and additionally, inventions and creations can receive more extensive and stronger protection in China so as to ensure the advancement of science and technology in the country.

(This article was produced upon the request and under the sponsorship of Interpat. Interpat is a non-profit association of leading and senior IP counsels from research-based biopharmaceutical companies that promotes effective intellectual property protection throughout the world as a key incentive for sustainable innovation to advance global health.)

Tina Tai
  Ms Tai graduated from Peking University with a degree in applied chemistry in 1990 and a masters in polymer chemistry in 1993. She joined CPA in 1993 and qualified as a patent attorney in 1994. Ms Tai was admitted to practice law in 1999. She completed an LLM programme at the University of London from 2002 to 2003. She received further training at a famous company in Germany in 1997 and at other German and British law firms in 2001.

Ms Tai is skilled at drafting patent application documents in the polymer, pharmaceutical chemistry, organic chemistry and organic synthesis fields. She is experienced in preparing responses to office actions in substantive examination proceedings, cases of patent re-examination, invalidation, patent-related administrative litigation, infringement lawsuits and infringement analysis.

Ms Tai has represented many renowned domestic and foreign companies in a number of high-profile patent invalidation and patent infringement cases, such as the Viagra case and the Lipitor case for Pfizer, the Gemcitabine case for Eli Lilly and Company, and the Actemra case for F Hoffmann-La Roche.

Ms Tai participated in the research projects for the Third Amendment to Chinese Patent Law in 2005 and the Fourth Amendment to Chinese Patent Law in 2015. She has published dozens of academic articles in well known IP journals in China and abroad.

Ms Tai is a standing council member of the China Intellectual Property Society, a council member of the Chinese group of the International Association for the Protection of Intellectual Property (AIPPI) and a member of the All China Patent Agents Association and the Licensing Executives Society (LES) China.

Guo Yu
  Mr Guo received his degree in pharmacy and Japanese from Shenyang Pharmaceutical University in 1998, and his master’s degree in intellectual property from Tokyo University of Science in 2009. He joined Sanyou Intellectual Property Agency in 2000 and qualified as a patent attorney in the same year. Mr Guo joined CPA in 2002, and received further training with a law firm in Japan in 2005.

Mr Guo is skilled at drafting patent application documents in fields such as inorganic chemistry, organic chemistry, analytical chemistry, pharmaceutical chemistry, synthetic chemistry and biochemistry and experienced in preparing responses to office actions in substantive examination proceedings, handling re-examination and invalidation cases, and dealing with administrative litigation involving patents in the above fields.

Mr Guo is good at both oral and written Japanese. He knows patent laws and practices in both China and Japan well and is experienced in advising Chinese and Japanese enterprises on IP protection and strategy. He is a member of the All China Patent Agents Association.


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