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

Release time:

2020-01-21 19:52

Recently, the Intellectual Property Court of the Supreme People's Court of China heard a case of rejection of an invention patent application for review of an administrative dispute and issued a public judgment. The court upheld the first-instance judgment and requested the State Intellectual Property Office of China to make a new review decision. This case is the first domestic patent application review dispute for biogenetic technology drugs, and it is also the "closing work" of the court's 2019 "Centralized Sentencing Week". It has attracted widespread attention in the industry, and many TV stations have carried out related news. report.
南京华讯知识产权顾问有限公司
It is understood that the patent application involved in the case is an invention patent application named "binding molecule", which belongs to the field of monoclonal antibody gene technology. The applicant of the patent is the Rotterdam Medical Center of Erasmus University 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 solution of the patent application in this case is simply a method for producing miniaturized antibodies in mice through transgenic technology using natural V gene fragments of human beings.
After the inventor filed a patent application with the State Intellectual Property Office of China, the Patent Office conducted a substantive examination on it and considered that its claims were not creative. In the prior art, there have been technical solutions for heterologous expression and production of antibodies using camelized V gene fragments of non-human mammals. When the miniaturization and low immunogenicity of antibodies have been the direction of research and exploration by those of ordinary skill in the art, it is easy for those of ordinary skill in the art to think of using "naturally occurring V gene fragments derived from human" instead of "camelized V gene fragments of non-human mammals" to produce antibodies, and thus 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.
南京华讯知识产权顾问有限公司
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.

First case, patent application, gene, China, State Intellectual Property Office, technology, antibody, fragment, invention, review