*AI-generated translation, for reference only.

[Keywords]

Administrative, Patent administrative case, Invalidation of invention patent, Confidentiality review, substantive content of technical solutions

[Case Facts]

Ri [Redacted] (USA) Diagnostics Co., Ltd. (hereinafter referred to as Ri USA) is the patentee of the invention patent with patent number 20131032****.8 and the title "An In Vitro Medical Diagnostic Device and System" (hereinafter referred to as "the patent"). On June 14, 2018, Guangzhou Wan [Redacted] Biotechnology Co., Ltd. (hereinafter referred to as Guangzhou Wan) filed a request for invalidation of the patent with China National Intellectual Property Administration, mainly arguing that the technical solution of the patent was the outcome of a certain scientific research project in Guangdong, and Ri USA failed to apply for confidentiality review and unilaterally applied for a patent in the United States for an invention completed in China, which violated the provisions of the Patent Law regarding confidentiality review; and that the patent was a patent applied for and granted in China by Ri USA with the same technical solution, but should not have been granted patent rights. On July 30, 2019, China National Intellectual Property Administration made the Invalidation Request Review Decision No. 41277 (hereinafter referred to as the challenged decision), maintaining the validity of the patent rights. Guangzhou Wan was dissatisfied and filed a lawsuit with Beijing Intellectual Property Court, requesting the revocation of the challenged decision and ordering China National Intellectual Property Administration to make a new review decision.

On December 28, 2021, Beijing Intellectual Property Court issued (2019) Jing 73 XC 13605, dismissing the lawsuit filed by Guangzhou Wan. Dissatisfied with the judgment, Guangzhou Wan appealed. On March 14, 2024, Supreme People's Court issued (2022) SPC IP Admin. Final 255, dismissing the appeal and upholding the original judgment.

[Judge's Opinion]

The main point of dispute in this case is whether the patent application for the involved technical solution violates the provisions of Article 20, Paragraph 1 and Paragraph 4 of the Patent Law of the People's Republic of China which was amended in 2008, that is, whether the substantive content of the involved technical solution was completed in China.

Paragraph 1 and Paragraph 4, Article 20 of the Patent Law revised in 2008 stipulate: "Any entity or individual who applies for a patent abroad for an invention or utility model completed in China shall, prior to doing so, report to the State Council's Patent Administration Department for a confidentiality review. The procedures, time limits, etc. of the confidentiality review shall be carried out in accordance with the regulations of the State Council." "For an invention or utility model that violates the first paragraph of this article and is applied for a patent abroad, if it is applied for a patent in China, no patent right shall be granted." The Article 8 of the Implementing Rules of the Patent Law (Amended in 2010) stipulates: "The invention or utility model referred to in Article 20 of the Patent Law as being completed in China means the substantive content of the technical solution being completed in China." The patent system is a quid pro quo system of exchanging protection for disclosure. In principle, the technical solution for which a patent is applied for must be disclosed. The legislative purpose of the above confidentiality review regulations is to avoid the disclosure of inventions or utility models involving national security or major national interests, which may damage national interests, due to the application for a patent. According to the above provisions, the legal standard for determining whether the patent applicant has the obligation to undergo a confidentiality review is whether the substantive content of the technical solution was completed in China.

 (1) Determination of the substantive content of the technical solution

To determine whether the patent application behavior violates the provisions of Paragraph 1 and Paragraph 4, Article 20 of the Patent Law (Amended in 2008), it is necessary to first determine the substantive content of the technical solution involved in the patent application.

First, regarding the review basis. To determine whether an already authorized patent should be declared invalid due to violating the provisions of Paragraph 1 and Paragraph 4, Article 20 of the Patent Law (Amended in 2008), the review should focus on whether the substantive content of the technical solution of the patent application filed abroad is completed in China. Therefore, in principle, the patent application text filed with foreign countries should be used as the review basis. If it can be confirmed that the technical solutions of the Chinese patent application and the foreign patent application are substantially the same, the patent application text of China can be used as the review basis.

Second, regarding the technical solution. As mentioned earlier, the establishment of the confidentiality review system is to prevent inventions and creations involving national security or major national interests from being declared invalid due to patenting. Therefore, the content of the confidentiality review should be the entire disclosure of the patent application, not limited to the claims..

Last, regarding the substantive content. The basis for granting patent protection to an invention or utility model lies in its contribution to technological innovation. Regarding the obligations of confidentiality review, the "substantive content of the technical solution" involved is the content of improvement made by the invention or utility model relative to the existing technology, which enables the invention or utility model to solve the technical problems it needs to solve and achieve the technical effects it needs to achieve. In the determination of "substantive content", the existing technology used as the comparison object can be the background technology recorded in the patent specification or the existing technology stated by the patentee or inventor as the starting point of the invention. The inventor is the person who makes creative contributions to the substantive features of the invention creation. If the existing technology stated by the inventor is closer to the technical solution required to be protected by the patent than the background technology in the specification, then the invention point stated by the inventor can be used as the main basis to determine the substantive content of the technical solution.

In this case, the background technology described in the specification of this patent is relatively general, and the first inventor of this patent testified as a witness in the first instance and compared it with the existing technology, stating three invention points of this patent. Compared with the description of the background technology in this patent specification, the existing technology relied upon by the inventor when stating the invention points is closer to the technical solution required to be protected by this patent. Therefore, the substantive content of this patent technical solution can be determined mainly based on the invention points stated by the inventor.

Regarding the additional technical features of the dependent claims of this patent from the main claims, whether they constitute the substantive content of the technical solution of this patent. Whether the additional technical features of the dependent claims can constitute the substantive content of the technical solution mainly depends on the contribution degree of this technical feature relative to the existing technology. The additional technical features of the dependent claims of this patent are further limitations on the functions and structures of related components. The evidence presented in the case cannot prove that they constitute new substantive content. Therefore, they are not recognized as the substantive content of this patent.

 (2) Regarding whether the substantive content of the technical solution was completed in China

The determination of the location where the substantive content of the technical solution was completed should be based on the available evidence, examining the formation process of the technical solution, the location where the inventor completed the substantive content of the technical solution, etc., and combined with the technological research and development rules in the relevant field, for a comprehensive judgment. In this case, first, from the formation process of the involved technical solution, according to the technical content recorded in the communication emails of the patent inventor, it can be seen that before the end of June 2010, the patent inventor had formed the technical conception of this patent and completed the relevant technical solution including the aforementioned three invention points. Without contrary evidence, it can be determined that the substantive content of this patent technical solution was completed before the end of June 2010. Second, from the location where the inventor completed the substantive content of the technical solution, based on the passport information of the three inventors of this patent and the formation process of the involved technical solution, it can be determined that the substantive content of the involved technical solution was not completed in China. Last, from the perspective of the technological research and development and industrialization rules in this field, for medical device-related invention creations, from determining the demand, forming the invention conception, completing the substantive content of the technical solution, to further improving and perfecting the technical solution, conducting clinical research and industrialization, it often takes many years. After certain industrialization research and testing, applying for a patent for a technical solution that has taken confidentiality measures and has a market prospect can objectively prolong the time for the technical solution to enter the public domain, which is also in line with the technological research and development and industrialization rules in the relevant field. Combining the project background and progress recorded in a certain scientific research project in Guangdong, it can be determined that the substantive content of this patent technical solution was completed when the project of this scientific research project was initiated. This project should be the industrialization process of the relevant technical solution. The evidence on record fails to prove of this technical solution was completed in China. The patent application behavior of the patent applicant from Rui Company in the United States did not violate the provisions of Paragraph 1 and Paragraph 4, Article 20 of the Patent Law (Amended in 2008).

[Judgment Digest]

When determining whether an already-authorized Chinese patent needs to be declared invalid due to violation of the provisions of the patent law regarding confidentiality review, it is necessary to examine whether the substantive content of the patent technology solution filed abroad before the Chinese patent application has been completed in China. The determination of the location where the substantive content of the technology solution is completed should be based on the evidence at hand, by reviewing the formation process of the technology solution, combined with the technological research and development rules in the relevant field, etc., for a comprehensive judgment.

[Corresponding Index]

Paragraph 1 and Paragraph 4, Article 19 of the Patent Law of the People's Republic of China (In this case, the provisions of Paragraph 1 and Paragraph 4, Article 20 of the Patent Law of the People's Republic of China that came into effect on October 1, 2009 were applied.)

Paragraph 1, Article 8 of the "Implementing Rules of the Patent Law of the People's Republic of China" (The version applicable in this case is Paragraph 1, Article 8 of the Implementing Rules of the Patent Law of the People's Republic of China that came into effect on February 1, 2010)

First Instance: Beijing Intellectual Property Court, (2019) Jing 73 XC 13605 (December 28, 2021)

Second Instance: (2022) SPC IP Admin. Final 255 (March 14, 2024)