National Cancer Institute Lxprhcm8 Ti Unsplash

Formulating an international strategy for filing patent applications in the immunotherapy space

The present article is our final in our antibodies series, where we have explored some considerations for support and enablement, inventive step, and the various types of claim formats that are typically used when seeking patent protection for antibody inventions.

Bringing together all the considerations discussed across our article series, it is clear that Europe and the US are guided by different tests and case laws. Thus, the journey of navigating through prosecution for a single patent application filed in both jurisdictions is very different. To minimize the overall costs of prosecuting an antibody patent application in these countries, it is best practice to apply strategies that are jurisdiction-specific, rather than to mirror one strategy to another jurisdiction.

Noticeably, the EPO is actively cracking down on overly-broad patent applications in the immunotherapy space that attempt to obtain patent protection beyond what the applicant should be entitled to. This is both good and bad news for potential patent applicants in this space, as it means that antibody inventions that are genuinely novel and inventive should be entitled to appropriate patent protection. However, it also means that the scope of any protection can in some cases, be quite narrow. 

We recommend that to fulfill the support and enablement requirements, as well as to assist with demonstrating inventiveness of the antibody invention, Applicants should include as much detail as possible in their applications early on. Specifically, it is advised that the patent application should include details that describe the relationship between structure and function and for this to be supported by a number of specific working examples, with emphasis on the unexpected technical effects that are achieved, and/or highlighting the difficulties in the method for preparing the antibody or conducting the method, if these processes are not routine to try in the art. The inclusion of these details is especially important given that some countries do not permit the addition of further material after filing.

Typically, the broader the claim scope sought after, the greater the amount of data will be required to support the claim, which is true for whether the application is filed in the US, Australia or in Europe.

Having a well-formulated strategy in place prior to filing an antibody patent application is crucial in minimizing downstream costs whilst giving the application the best possible chances to proceed through to acceptance and grant. If you have any questions in relation to patenting in the immunotherapy space, please do not hesitate to contact our Life Sciences team.