Date:13 January 2023

【Volume 100】

It is a critical issue in patent examination practice whether a prior art considered to be not operable due to its mistakes, typographical errors or contradictions in its disclosure can be used as probative evidence which proves a disputed patent to be not novel or to be obvious. Generally, there are two levels of results in practice: (1) the first one is to simply exclude the legal validity of the erroneous part to be a disclosed prior art; and then (2) the second one is based on the first one, to further deem the corrected content as the disclosure of the prior art. The judgement principles regarding this issue in regulations and examination practice in each jurisdiction are different. Recently, related cases are F. Hoffmann-La Roche AG v. Celltrion Healthcare Taiwan in Taiwan and the (2021) Zui Gao Fa Zhi Xing Zhong No. 83 Judgment of Supreme People's Court in China. Also, U.S. judiciary has established the principle that “information with obvious error cannot be used as support of argument that the disputed claims have been disclosed” in the In re Yale case in 1970. Recently, the US Court of Appeals for the Federal Circuit (CAFC) further illustrated the concept of “obvious error” in LG Electronics Inc. v. ImmerVision, Inc. On the other hand, the most specific and clear guidance provided in the Guidelines for Examination in the European Patent Office indicates different results corresponding to different situations of error in the prior art in judgment. In this 4-part series, the related regulation and specific cases of Taiwan, China, US and Europe will be compared and analyzed.

Part I. Taiwan

1. Patent Examination Guidelines in Taiwan

   There is no judgment principle for errors in the citation in the current Patent Examination Guidelines in Taiwan. However, the section “2.2.2 Citation”, Chapter 3 Patentability, Part II mentions that:

   “The disclosure of a citation must be such that a person ordinarily skilled in the art can reproduce and use the claimed invention. For example, where a claimed invention is a compound, if a citation only discloses the existence of the compound or simply provides the name or chemical formula of the compound without indicating how to prepare and use the compound, and a person ordinarily skilled in the art can by no means deduce the preparation or isolation of the compound in light of the teachings of the citation or common general knowledge on the publication date of the citation, the compound as claimed cannot be rejected for lacking novelty based on the citation.”

   In other words, if there is an error in a citation which may render it unable to be carried out and utilized, it shall not be allowed to conclude that the citation has disclosed the claimed invention .

2. Court Judgment: F. Hoffmann-La Roche AG v. Celltrion Healthcare Taiwan ((2021) Min Zhuan Shang Zi No. 31 Judgment of Intellectual Property and Commercial Court)¹

   In a recent judgment of Intellectual Property and Commercial Court (IP Court) in Taiwan, the courts of the first and second instance both considered that there is typographical error in the citation and therefore denied the validity of the erroneous content as disclosure. Then, they further deemed the corrected content as the technical disclosure of the citation.

   Case facts

   F. Hoffmann-La Roche AG claimed that because there is no regulation about correction of mistakes and typographical errors in the disclosure of citation in Patent Examination Guidelines in Taiwan, the judgment of patentability of the disputed patent should be based on the disclosure of the citation in the form, i.e., “an IV dose of 100 mg Rituximab”.

   However, in the first instance ((2020) Min Zhuan Su Zi No. 79 Judgment), the IP Court considered that there were skipped numbers and typographical errors in the description about the references in Celltrion Exhibit 9. Also, the description of “administration dose of 100 mg” in Celltrion Exhibit 9 was a typographical error. Therefore, the description “administration dose of 100 mg” should be corrected to 1000 mg according to Reference 3 (Celltrion Exhibit 11) listed in Celltrion Exhibit 9. Thus, the court considered that the disputed patent was obvious because the administration dose after correction would be the same as the technical means of the disputed patent. F. Hoffmann-La Roche AG disagreed and appealed for the second instance.

   The second instance court opinion

   The court of the second instance agreed with arguments of the judgment of the first instance. The court considered that the reference cited in Celltrion Exhibit 9 was, of course, the prior art explicitly described in Celltrion Exhibit 9 and belonged to a part of the disclosure of Celltrion Exhibit 9.

   The judgment of the second instance stated that:

   There should be only three cited references throughout Celltrion Exhibit 9. However, there were five numbers in the bibliography of references. Also, the only content of Number 2 was a blank line and the only content of Number 4 was one word, “Abstract.”, which were obvious mistakes in the bibliography of references. A person ordinarily skilled in the art would appreciate that there were skipped numbers and typographical errors in the bibliography of references and therefore would analyze and compare substantially the content cited in the context of Celltrion Exhibit 9 and those references when understanding the technical disclosure of Celltrion Exhibit 9 as a whole and reasonably deduce the correct correspondence.

   Besides, Celltrion Exhibit 9 disclosed that part of the subjects received the second or third course of Rituximab treatment with two 100 mg intravenous (IV) doses given two weeks apart, which was different from the administration “dose” of retreatment claimed in the disputed patent (two 1000 mg IV doses of rituximab given 14 days apart). However, according to the content of Celltrion Exhibit 9, the first course of Rituximab treatment included a low dosage group with two 500 mg IV doses given 14 days apart, or a high dosage group with two 1000 mg IV doses given 14 days apart. If the second or third course of Rituximab treatment was two 100 mg IV doses given 14 days apart based on Celltrion Exhibit 9, a person ordinarily skilled in the art could easily notice that the dose of retreatment is 1/5 or 1/10 of the first course of treatment, which was apparently not able to achieve the purpose of retreatment, which was to maintain the efficacy of the first treatment. This should be a typographical error.

   Celltrion Exhibit 9 had already illustrated that the details of Rituximab retreatment cite Celltrion Exhibit 11, which disclosed the follow-up course of treatment included two 1000 mg IV doses of Rituximab given two weeks apart. Therefore, a person ordinarily skilled in the art would appreciate that a dose of 100 mg of follow-up treatment disclosed in Celltrion Exhibit 9 should be 1000 mg in typographical error based on the dose of follow-up treatment disclosed in Celltrion Exhibit 11. It should be interpreted as two 1000 mg IV doses given two weeks apart.

3. Conclusion

   Disclosure which cannot be reproduced and used does not constitute probative prior art. This concept is broadly adopted in Europe and US practice.

   Correspondingly, Patent Examination Guidelines in Taiwan and the judgment of F. Hoffmann-La Roche AG v. Celltrion Healthcare Taiwan also introduce a similar concept.

   Patent Examination Guidelines in Taiwan only mentions the conclusion that the legal validity of the erroneous part to be a disclosed prior art is excluded (result (1) in the first paragraph herein). However, in the judgment of F. Hoffmann-La Roche AG v. Celltrion Healthcare Taiwan, it is concluded that a person ordinarily skilled in the art would easily notice errors, including not only an easily noticeable typographical error in the form, but also the errors found by judging substantially based on scientific reasonability and technical facts with reference to the references cited in the prior art. This judgment concluded by further deeming the corrected content as the disclosure of the prior art (result (2) in the first paragraph herein).

   In the next part, the regulations and case examples in China will be introduced in detail.