In the development of novel and innovative antibody-based assets, it is crucial to co-develop patent strategies to maintain intellectual property (IP) rights. As IP offices (ie. USPTO, EPO) place immense scrutiny on antibody-related patent applications during the prosecution process, preparation of all the requirements prior to patent filing is key to a successful application. Though the requirements may vary depending on the country or region where the patent application is filed, the general requirements include:
- Novelty – The antibody must be new and not previously disclosed or made available to the public prior to patent filing.
- Inventive step/Non-obviousness – The antibody must not be obvious to those skilled in the art and must have a technical effect.
- Sufficiency – The patent application must include a written description, which allows replication of the invention.
To satisfy the general requirements listed above, it is particularly helpful for antibody patent applications to include a description of the antibody’s biophysical properties, such as primary structure, as well as associated benefits that may include binding affinity, specificity, epitope targets, and production and purification information. In this regard, next generation protein sequencing (NGPS) and proteomics can provide valuable data to strengthen patent applications for antibody-based assets. De novo protein sequencing, surface plasmon resonance (SPR), and hydrogen-deuterium exchange-mass spectrometry (HDX-MS) are established methods for the characterization of the antibody’s primary structure, binding affinity/specificity, and antigenic epitopes, respectively.