The most obvious characteristic of antibody, a functional protein, is that it can combine with an antigen. In the laboratory in early years, specific antigens were often injected into experimental animals to produce antibodies, and the antibodies produced in the animals would not be only one single type. The same individual animal may produce multiple antibodies against the antigen, which is called polyclonal antibody. Then it is possible to obtain antibodies with better specificity through screening, or further use hybridoma technique to produce cell lines capable of producing monoclonal antibodies.

In this kind of patent data, the clear information at first is usually the design of an antigen. Therefore, in the early antibody-related patents, the description of the antigen is the priority in the specification. As for the antibody, it may not be sequenced because it has not achieved the stage of monoclonal antibody.

In recent years, litigation cases have appeared frequently, with discussion on the extent to which the specification of antibody-related patents must be disclosed to meet the patent requirements. All in all, with the development of relevant techniques, the current antibody-related patents need to disclose more information before they succeed in being approved. This year, Chapter G-II 5.6 was added to the examination criteria by European Patent Office, which clearly regulates the disclosure of antibody-related patents. Antibody drugs are currently a hot-spot research and development filed, and Europe is also a key area in the layout of drug patents. Therefore, the specification in this section must also be the emphasis of relevant patents in the future.

From Tai E International Patent & Law Office

September 2021