In biopharmaceuticals, an antibody patent is one of the most valuable patents in the field. A claimed monoclonal antibody (see Table 1) can be defined as:
- an antigen or an epitope on an antigen to which the antibody is directed;
- a hybridoma producing the antibody; or
- amino acid sequences constituting the antibody.
It is preferable if the antigen to be directed by the claimed antibody is a novel and inventive one. If it is novel and inventive, a monoclonal antibody patent can be defined directly by the antigen and a patent claim with the broadest scope can be granted. If it is not novel and inventive, although an antibody can still be claimed by a hybridoma
producing the antibody or amino acid sequences constituting the antibody, it will be unclear whether such a defined antibody can be considered to be inventive enough (see Table 2).
The biotech section of the Patent Examination Guidelines regarding patentability of a monoclonal antibody was mended in 2020 (see Table 3). The amendment entered into effect on 15 January 2021.
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