Patent Post-Filing Data Submission: A Look at Differences between Taiwan and China

Date: 12 August 2021

【Volume 54】The determination of technical effects is critical for deciding whether the corresponding technical means are inventive. In order to overcome obviousness, applicants often resort to post-filing data submission in hopes of proving that the claimed technical means produce unexpected results compared with prior art. Therefore, whether the data submitted after the date of filing is acceptable in different jurisdictions has a decisive sway over the determination on inventiveness.

A comparative analysis on the regulations in Taiwan and China are provided below, followed by our suggestions for those navigating the patent landscape in these jurisdictions. It is also worth noticing what the relaxed regulations set out in China’s new version Examination Guidelines since January 2021 may bring.

Taiwan: How the Taiwan IP Office views post-filing data submission

  1. The Examination Guidelines:

    According to the Taiwan Patent Examination Guidelines, it is acceptable to submit experimental data after the filing date as supplemental proof of inventiveness, provided that the effects to be proven by the experimental data have been disclosed in the specification or drawings as filed, or that the effects are directly and unambiguously derivable.

    The 2004 version of the Examination Guidelines stipulate that “If the applicant provides supplemental proof, determination may be made with reference to said supplemental proof. When determining whether the claimed invention is inventive, reference to the specification, drawings, and common knowledge at the time of filing may be made in order to understand the invention.”i

    The 2004 Guidelines further provide that “If the newly added effects are directly and unambiguously derivable from the technical content of the specification or drawings as filed by a person skilled in the art, supplemental information and amendments are allowed to prove the effects. However, if the specification as filed does not disclose experimental data on an effect, no new experimental data shall be introduced to prove said effect.”ii

    Though the Examination Guidelines have undergone several amendments since 2004, principles on the determination on post-filing data submission remain unchanged.

    What is noteworthy is that the Taiwan Intellectual Property Office (IPO) in fact adopts a relatively relaxed approach in practice, and usually accepts and examines the experimental data submitted before an approval decision is made. Nonetheless, in invalidity cases, the Taiwan IPO and courts judge more strictly and closely observes the regulations in the Examination Guidelines above.

  2. Recent Court Decisions:

    The Taiwan Intellectual Property Court has unified opinions regarding post-filing data submission, as evidenced by the two following cases introduced below.

    In the first example, JNC Co., Ltd. (“JNC”) challenges the validity of a patent owned by Merck Patent GmbH (“Merck Patent”)iii. During litigation, Merck Patent provided supplemental experimental data to prove its patent inventive. In the decision issued on 17 June 2020, the court pointed out that “It would be difficult for a person skilled in the art to confirm that the patent at issue produces effects such as low temperature stability and improved reliability with the disclosure of the specification. It is therefore difficult to say that the effects claimed in the supplemental proof are inevitably produced by the patent at issue. Evidence 3, the experimental data provided by Merck Patent during litigation, is obtained through experiments done by Merck Patent itself after the date of filing, and its authenticity is argued by JNC. As a result, these data are unable to prove that the patent at issue has clearly produced the claimed effects.”

    The court held the same reasoning and judgements for another case decided in June 2020, where the validity of a patent owned by DyStar Taiwan Ltd. is challenged by JEAN WAN INTERNATIONAL CO., LTD. iv

    The two cases above clearly demonstrate the court’s opinion that “The effects to be proven by the experimental data shall be disclosed in the specification or drawings as filed, or shall be directly and unambiguously derivable.”

China: CNIPA’s take on post-filing data submission

The China National Intellectual Property Administration (CNIPA) had been quite strict with the determination on post-filing data submission up until the positive changes made in 2021, which are summarized as follows:

  1. The 2010 version of China’s Examination Guidelines

    The Examination Guidelines in 2010 provide that “Whether the specification fully discloses the effects depends on the disclosure in the specification and claims as filed. Examples and experimental data submitted after the date of filing shall not be taken into consideration.”

    In practice, however, some examiners may allow the submission of experimental data compared with the closest prior art that prove the superior effects of the claimed invention, on condition that the data of the effects have been disclosed in the specification as filed. There are also quite a few examples where the court accepts such submission, including Warner-Lambert v. Jialin Pharmaceuticalv (2015) and AstraZeneca v. Salubrisvi (2018).

  2. The 2017 version of China’s Examination Guidelines

    In the 2017 “Decision on amending ‘Examination Guidelines’”, significant changes are proposed as such: “Whether the specification fully discloses the effects depends on the disclosure in the specification and claims as filed. Examples and experimental data submitted after the date of filing shall be examined. The technical effect proven by the supplemental experimental data shall be an effect which can be determined from the disclosure of the application by a person skilled in the art.”

    However, the CNIPA adopts a stricter policy in practice. The technical effects are considered to be derivable from the disclosure of the application only if the specification “clearly discloses the experimental data”. Those disclosing effects without clear experimental data will not be accepted. Among the decisions made on pharmaceutical-related patent invalidity cases from 2012 to 2019, 9 of them involve the patentee’s post-filing submission of supplemental experimental data, aiming to overcome the problem of obviousness or incomplete disclosure. Only one of these (Decision no. 37539) was accepted by the court as the data were disclosed in the priority application, while the rest were rejected (Decisions no. 20147, 22284, 33101, 33102, 33103, 33591, 36902, 39131).

  3. New changes made in the 2021 version of the Examination Guidelines

    The most recently amended “Examination Guidelines” effective since January 15, 2021 stipulate that “Supplemental experimental data submitted after the date of filing by the applicant in order to meet the requirements of Articles 22.3, 26.3, etc. shall be examined. The technical effect proven by the supplemental experimental data shall be an effect which can be determined from the disclosure of the application by a person skilled in the art.”

    Two Examples are further given in Chapter 3.5.2 of the Guidelines. Example 1 especially illustrates the situation where the specification discloses the preparation of a compound, its antihypertensive effect, and a method for determining the antihypertensive activity, but without experimental data. Under such circumstances, the technical effects proven by the supplemental experimental data regarding the antihypertensive effect “can be determined from the disclosure of the application”, and such data shall also be examined when evaluating inventiveness.

    Example 1 shows that the CNIPA has become more accepting of post-filing data submission. Though the specification may not disclose the relevant quantitative experimental data, if a person skilled in the art can determine the effect from the disclosure of the application, the applicant or patentee should be able to submit supplemental data.

Wisdom Suggested Strategies

The Taiwan IPO has been consistent on determining whether supplemental experimental data shall be accepted: if the specification discloses the corresponding effect, post-filing data submission is acceptable. Conversely, the CNIPA used to be quite strict. Even though the Examination Guidelines in 2017 allow post-filing data submission if the specification clearly discloses the corresponding effect, it is only on the condition that the specification as filed has already “clearly disclosed the experimental data”, otherwise it will be regarded as an assertive description. However, the newly amended 2021 version has adopted a more relaxed approach, and we shall wait and see how such new regulations will reflect in actual examination. Applicants should be more mindful of including the effects in their specifications so as to ensure the option of post-filing data submission. As for invalidity requestors, how to argue that the effect is not derivable from the disclosure of the application by a person skilled in the art and thus preventing supplemental data submission would be a question worth exploring.

 

[i]Page 2-3-21, Chapter 3, Part 2 of the 2004 Taiwan Patent Examination Guidelines

[ii]Page 2-6-8~9, Chapter 6, Part 2 of the 2004 Taiwan Patent Examination Guidelines

[iii]Taiwan Intellectual Property Court 2019 No. 77 Administrative Judgement

[iv]Taiwan Intellectual Property Court 2019 No. 78 Administrative Judgement

[v]China Supreme People’s Court 2014 No. 8 Administrative Judgement

[vi]Beijing High People’s Court 2018 No. 6345 Administrative Judgement

 

 

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