Recently, the NTD Chemistry and Biotech Team with the leadership of Mr. Christopher Shaowei (Senior Partner), Ms. Heather Lin (Senior Partner) and Mr. Luke Zuo (Senior Partner) attended two hearings at the Beijing Higher People’s Court and the Civil Adjudication Tribunal No. 3 (IPR Division), in which two administrative judgments made by the Reexamination and Invalidation Department of the China National Intellectual Property Administration (CNIPA) were revoked. Wyeth’s 13 S. pneumoniae capsular polysaccharide conjugates patent was decided as valid in one judgment ((2019) Jing Xing Zhong No. 3211), and a patent was decided as valid in one judgment ((2020) SPC Zhi Xing Zhong No. 602).
By the 1970s, about 90 pneumoniae serotypes have been found, and the research has always been focused on developing an efficient vaccine to prevent and cure the Streptococcus pneumonia infection. The primary vaccine belonged to polysaccharide without carrier protein. Although the 14 and 23F polysaccharide vaccines were approved for clinical applications in 1977 and 1983, they did not take good effect. The main reason lied in the poor immunogens of polysaccharide which could not produce an immune response to protect the infants. The 13-valent vaccine involved in the two cases effectively elicits the antibody responses to all 13 S. pneumoniae serotypes and meanwhile keeps the immunogenicity of the 7 core serotypes. The vaccine（Prevenar13®） involved in the two patents were approved for markets in US (2009) and in China (2016). By 2018 and 2019, the global sales reached 5.802 billion dollars and 5.847 billion dollars.
The Reexamination and Invalidation Department of CNIPA cited the same one reference document in the two administrative judgments. A parent patent of 13-valent vaccine was invalidated, and a divisional patent application was also rejected.
The Reexamination and Invalidation Department combined the two technical solutions disclosed by the reference document, and the combined technical solution was regarded as the one closest to the prior art.
The IP court pointed out that the technical solution and the prior art of the invention shall be correctly understood and determined in the three steps of determining the inventiveness. The closest prior art is a technical solution that objective exists i.e., the person skilled in the art can determine the technical solution disclosed by the reference document as the closest technical art. If the reference document discloses two or multiple different technical solutions, the technical solutions shall not be reconstructed to form a new technical solution and determined as the closes prior art at the time of determining the inventiveness of the invention or utility model.
The Beijing Higher People’s Court pointed out that the closest prior art shall be a concrete technical solution. The whole contents disclosed by the reference document shall not be regarded as the closest prior art, so as to make confusions.
The chapter IV, Part II of the Guidelines for Patent Examination cited that there are three steps to determine the inventiveness, i.e., 1) Determining the closest prior art; 2) Determining the distinguishing features of the invention and the technical problem actually solved by the invention; 3) Determining whether or not the claimed invention is obvious to a person skilled in the art.
The judgments of the above two cases have shown that the Supreme People’s Court and Beijing Higher People’s Court gave clear explanation on the “prior art” i.e., the prior art refers to a concrete technical solution rather than the whole contents disclosed by the reference document. Because if the multiple technical solutions are combined, the contents of the reference document are extended in practice, and overlook the technical inspiration at the time of combining the technical solutions so as to underestimate the inventiveness of the patents.
Moreover, in one case, the Beijing IP Court gave a procedure for determining whether an invalidation decision is in accordance with the principle of examination upon request, as following: 1) confirming the complete written expression of the closest prior art in the Invalidation Decision; 2) confirming the complete written expression of the closest prior art claimed by the applicant of the invalidation; 3) comparing the above two expressions and picking out the difference; 4) with reference to the distinguishing technical features claimed by the applicant of the invalidation and the technical problem actually solved, determining that the difference of the two expressions is originated from the two technical solutions closest to the prior art, which belongs to substantive difference; 5) with reference to the other remarks in the request, determining that the above difference belongs to the other parallel technical solutions cited by the applicant. On such grounds, the Beijing IP Court decided that the Invalidation Decision issued by Reexamination and Invalidation Department of Patent Office were against the principle of examination upon request.
In conclusion, the above procedure provides a logical path for the parties involved to determine the validity of the Invalidation Decision in the patent administrative litigation, from which the legal professionals in IP field can learn.