The Supreme Court heard the first administrative dispute over the patent of a genetically modified drug, providing guidance for the practice of patent examination!

Recently, the Intellectual Property Court of the Supreme People's Court of ChinaA case of administrative dispute over the rejection of an application for a patent for invention was heard and conducted.The court upheld the first instance judgment and asked the State Intellectual Property Office of China to make a new review decision. The case is the first domestic patent application review dispute for biological gene technology drugs, and it is also the court2019The "closing work" of the "concentrated sentencing week" in 2002 has aroused widespread concern in the industry, and a number of TV stations have carried out relevant news reports.

It is understood that the patent application involved is named“binding molecule”The invention patent application belongs to the field of monoclonal antibody gene technology. The applicant for the patent is Erasmus University Rotterdam Medical Center in the Netherlands,The main content involves the technology of using immunized animals to develop human heavy chain antibodies, that is, the method of producing macromolecular drugs using transgenic technology. Heavy chain antibodies are widely used in the treatment of tumors and immune diseases. The innovation of the patent is to insert human gene fragments into the genes of test mice to form transgenic mice, immunize mice with antigens, and finally produce heavy chain antibodies. Monoclonal antibody drugs are currently the fastest growing therapeutic biological macromolecular drugs, which have significant efficacy in anti-tumor, autoimmune diseases and other aspects, and have huge market potential. The technical scheme of the patent application in this case is simply a kind of natural use of human beings.VGene fragments, a method for producing miniaturized antibodies in mice by transgenic technology.

After the inventor filed a patent application with the State Intellectual Property Office of China, the Patent Office conducted a substantive examination of it and concluded that its claims were not creative, and that there were already camelized non-human mammals in the prior art.VA technical scheme for producing antibodies by heterologous expression of gene fragments. When antibody miniaturization and low immunogenicity have been the direction of research and exploration by ordinary technicians in the art, it is easy for ordinary technicians in this field to think of using "naturally occurring from humans."Vgene fragment "substitution" non-human mammal camelizedVGene fragments "produce antibodies, and therefore decided to reject the patent application. If the applicant is not satisfied, he shall file an application for review with the State Intellectual Property Office of China, and the State Intellectual Property Office of China shall maintain the original rejection decision after the review. If the applicant refuses to accept it, he will file an administrative lawsuit. The Beijing Intellectual Property Court ruled to revoke the review decision of the State Intellectual Property Office of China. The State Intellectual Property Office of China appealed against the original judgment to the Intellectual Property Court of the Supreme People's Court of China.

The Court's intellectual property court held that it is difficult for ordinary people to think of a new thing before it is invented, but once it is invented, seeing it afterwards may feel that it is very easy to invent it. It is equally possible to make the mistake of "hindsight" when judging the creativity of a patent application. The State Intellectual Property Office was influenced by "hindsight" when judging whether the patent application in this case was creative.

The applicant has carried out patent layout in dozens of regions around the world and has been authorized in the United States, Europe, Japan, South Korea, Canada, Australia and other regions, with broad market prospects.