The foundation of the patent system is based on inventors disclosing their invention fully to the public in exchange for the exclusive rights to the claimed invention, irrespective of the technical field.
As with all patent applications, life sciences inventions need to be supported by experimental data and other technical information. However, the first-to-file patent system, the need to meet inventor requirements regarding publication of results, and the cost and complexity of clinical trials frequently means that the difference between the technology to be patented (e.g., a new cell therapy for a particular disease) and the data that can be produced in support (e.g., illustrating efficacy in a suitable in vitro disease model) is often greater than in other fields. It is therefore important to ensure that patent attorneys and their clients are aware of the challenges and co-operate effectively to overcome these.
We conclude this report by emphasizing the key points that are relevant for all life sciences inventions.
The scope of the claimed invention must be supported by the description and the examples presented in the application. If the scope is too broad, then the prosecution is lengthier and more costly and can lead to a rejection; if the scope is too narrow, then competitors may find strategies to work around it.
The reporting of the scientific data must be in accordance with both current knowledge and practices in the art, and with required standards (e.g., ST.26 sequence listings)
(1)Romero, L. and J.M. Vela (2014). Alternative models in drug discovery and development part II: in vivo nonmammalian and exploratory/experimental human models. In: In Vivo Models for Drug Discovery. Wiley, 59–90. doi:10.1002/9783527679348.ch03. and treaties (e.g., Budapest Treaty,(2)G 0003/19 (Pepper (follow-up to Tomatoes II and Broccoli II)) of 14.5.2020. European Patent Office; 2020. Available at: https://www.epo.org/law-practice/case-law-appeals/recent/g190003ex1.html (accessed May 26, 2025). TRIPS agreement,(3)Summary of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (1977). World Intellectual Property Organization. Available at: https://www.wipo.int/treaties/en/registration/budapest/summary_budapest.html (accessed May 26, 2025). Biotechnology Directive,(4)Choudhary, L. and A. Kumar (2022). Stem cell patenting: moral and legal dilemma. Journal of Intellectual Property Rights, 27, 42–51. Available at: http://nopr.niscpr.res.in/handle/123456789/59278 (accessed May 26, 2025). etc.).Knowledge of prior art documents is essential when preparing the patent application, as it can be used to show how the invention is better than the current state of the art and to avoid overlap in scope.
Understanding the specific requirements of different jurisdictions of interest, and how these may impact upon protection, is important.
Clear, complete and timely communication between patent attorneys and researchers or inventors is essential.