Inventions in the chemical and pharmaceutical field differ from mechanical inventions due to their unpredictability and the need for the invention to be confirmed by experiments. The admissibility of post-filing experimental data during the Chinese patent examination process has been a much debated issue for chemical and pharmaceutical patent applicants for many years.
Following diplomatic talks between Washington and China, China affirmed on 5 December 2013 that “the Chinese Patent Examination Guidelines permit patent applicants to file additional data after filing their patent applications, and that the Guidelines are subject to Article 84 of the Law on Legislation, to ensure that pharmaceutical inventions receive patent protection”. At around the same time, the Patents Affairs Department of SIPO also held a briefing to address the problem of Examiners applying a different standard of examination for sufficiency of disclosure, from that required by SIPO. In practice, there have still been inconsistent approaches by individual Examiners, with many refusing to consider post-filing experimental data at all.
In an effort to ensure a more consistent approach draft revisions to the Patent Examination Guidelines, published for public consultation on 27 October 2016, included a key change to enable the submission of post-filing experimental data during examination of chemical/pharmaceutical type patent applications for supporting the sufficiency of disclosure. The revisions were approved on 28 February 2017 and the Amended Guidelines will become operational as of 1 April 2017.
This small but significant amendment will be welcomed by patent applicants in the chemical/pharmaceutical field in China, particularly those originating from international jurisdictions such as the United States, with a more liberal approach to allowing the inclusion of post-filing data during examination.
Sufficiency of Disclosure
Generally, in China the determination of sufficiency of the disclosure, is performed based upon the contents of the specification as originally filed. Article 26(3) of the Chinese Patent Law specifies the requirement for sufficiency of the disclosure: “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”.
For chemical inventions, what is considered “sufficiently clear and complete” is outlined in Chapter 10 of the Examination Guidelines. In particular, working examples are discussed under “Section 3. Sufficient Disclosure of Chemical Invention”. The relevant section, together with the changes to be made in the Amended Guidelines, is shown in the marked up text below.
3.4 Regarding Examples
Chemistry is an experimental science, and a number of inventions in this field need to be verified by experimentation, therefore, the description generally shall include working examples, in case of an invention of a product, for instance, those which specifically show how to make the product and how to use it.
The number of embodiments needed in the description depends on the extent to which the technical features are generalized in the claim…...
3.5 Regarding the Submission of Supplementary Experimental Data
Whether or not the description is sufficiently disclosed is judged on the basis of the disclosure contained in the initial description and claims any examples and experimental data submitted after the date of filing shall not be taken into consideration.
The Examiner shall examine supplementary experimental data submitted after the date of filing. The technical effect to be demonstrated by the supplementary experimental data should be (an effect) that can be arrived at by a person skilled in the art from the contents disclosed in the patent application.
The deletion of the existing limitation that “data submitted after the date of filing shall not be taken into consideration”, should reverse the current stringent approach taken by some Chinese Examiners who reject any post-filing data evidence submitted during the examination process.
The Amended Guidelines aim to make clear to Chinese Examiners that post-filing experimental data demonstrating a technical effect, should not be rejected just because it is post-filing data, but may be considered as long as the technical effect can be understood by a person skilled in the art from the application as originally filed.
However, it is important to note that the admissibility of the post-filing experimental data is not guaranteed and needs to be determined by the Examiner on a case by case basis. In particular, the applicant must still satisfy the Examiner that the technical effect is capable of being derived from the original disclosure.
It is important to note that the revisions are limited to the examination of the requirement of sufficiency of disclosure (Article 26(3)). Unfortunately, the Amended Guidelines did not take the opportunity to clarify the position concerning the use of post-filing experimental data in addressing a lack of support objection (Article 26(4)). Article 26(4) of the Chinese Patent Law requires that claims must be supported by the description. This means that the technical solution defined in the claims must be one that a person skilled in the art can arrive at directly or by generalization from the contents sufficiently disclosed in the description, and shall not go beyond the scope of the contents disclosed in the description.
China is known to have a relatively strict approach to determination of appropriate support in specifications in the field of chemical and pharmaceutical type inventions, especially when compared to the approach taken in other jurisdictions, such as US and Europe.
In practice, when responding to a lack of support objection raised during prosecution in China, it can be a useful strategy to submit evidence (including post-filing experimental data) to provide as much scientific rationale as possible to aid the Examiner’s understanding, or to show that the Examiner’s concern as to a potential lack of support is unfounded. However, the extent to which such evidence will be accepted, currently varies from Examiner to Examiner.
The submission of post-filing experimental data to prove inventiveness of the claimed technical solution over the prior art, has generally been possible, although the data must be directed to the technical effect disclosed in the original application.
Once in force, the Amended Guidelines clearly indicate that post-filing data can be submitted to address sufficiency objections raised by Chinese Examiners. The position regarding post-filing data in relation to support and inventiveness objections is less clear. The AIPLA (American Intellectual Property Law Association), amongst others, has encouraged further amendments to the Guidelines to allow consideration of post-filing data for assessing compliance with all relevant articles of the Patent Law and, in different technical fields, not just chemical/pharmaceutical inventions. It remains to be seen whether SIPO will be persuaded by this and how the Amended Guidelines will be implemented in practice.
However, the amendment will not provide a panacea to cure the deficiencies of a poorly drafted specification. Applicants must still ensure that the invention is sufficiently disclosed, i.e. identifying, describing the preparation, and the use and/or technical effect of the chemical/pharmaceutical invention. The applicant must also ensure that all available experimental data which would be useful to support the technical effect of the invention is disclosed in the description. Accordingly, as many representative examples and data supportive of the claimed scope as possible, should be included. Post-filing experimental data cannot be used to rectify insufficient disclosure at the time of filing.
Furthermore, in view of the increased importance of post-filing data in potentially addressing objections, inventors should be encouraged to keep accurate, dated records and laboratory notes, even after a patent application has been filed.