Pitfalls in patenting academic CAR-T cells therapy

ABSTRACT

Introduction

Emerging immunotherapies are pushing the boundaries of cancer treatment, with chimeric antigen receptor (CAR)-T cell therapy being one of the most advanced. Due to the increasingly crowded CAR-T cell field, patenting and protecting the intellectual property of these CAR-T cells implies a good knowledge of the legal landscape.

Areas covered

The present manuscript focuses on the challenges regarding the patenting process of CAR-T technology, beginning with a description of the main characteristics of CAR-T cells and their functionalities, continuing with the legal landscape applicable to patenting processes, and concluding by presenting the potential strategies to overcome the impediments that can appear when trying to patent CAR-T cells. It is meant to offer insights for those who are exploring possible patenting options in CAR-T cells territory. PubMed and Patenscope databases were used for patent and literature searching (2013–2023).

Expert opinion

There is no one-size-fits-all solution in this matter and the medical evolution of this therapy will certainly bring out even more challenges. Comprehensive knowledge of the intellectual property, exposure to potential litigation, growing competition, and the high price of therapy, are strikingly relevant in the broader landscape. Future endeavors would be to take steps toward the harmonization of the CAR-T patenting procedure.

KEYWORDS:

• Chimeric antigen receptor (CAR)-T cells
• CAR-T cells
• immunotherapy
• patents
• intellectual property

Article highlights

• There is a dire need for insights into the intellectual property for those who are exploring possible patenting options in CAR-T cells territory.

• Avoiding pitfalls in patenting CAR-T requires an overall understanding including the concept, history, claim drafting approach, current status in patenting, and case law, all integrated into a personalized strategy.

• Patenting efforts need to be directed toward a more creative approach due to the overcrowded field of CAR-T technology.

• The patenting trend in the matter of CAR-T cells is on the ascending path, with growing interest for applicability in different diseases, including solid tumors.

• Several strategies need to be taken into account as a checklist before filing a patent application

• There is no one-size-fits-all solution in this matter and the evolution of CAR-T cells therapy will certainly bring out even more challenges.

Declaration of interest

C Constantinescu is supported by an internal grant from the Iuliu Hatieganu University – School of Doctoral Studies. C Tomuleasa is also supported by a grant awarded by the Romanian National Ministry of Research, Innovation and Digitalization: PN-III-P4-ID-PCE-2020–1118 within PNCDI IV, Projects for Exploratory Medicine; Projects for Exploratory Medicine – PCE 225/2021; as well as by an international collaborative grant of the European Economic Space between Romania and Iceland 2021–2023: ‘Cooperation strategy for knowledge transfer, internationalization and curricula innovation in the field of research education at the 3rd level of study – AURORA.’ The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article from Pubmed at https://pubmed.ncbi.nlm.nih.gov and from WIPO at https://patentscope.wipo.int/search/en/search.jsf. Figures were generated using Servier Medical Art, provided by Servier, licensed under a Creative Commons Attribution 3.0 unported license.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author Contribution Statement

C Constantinescu helped with the concept and design, acquisition and interpretation of data, drafting the article, final approval. R Constantinescu helped with sharing legal background, drafting the article, revision, and final approval. JT Bergthorsson helped with consultation regarding CAR-T immunotherapies and drafting of the article. V Greiff helped with consultation regarding immunology and drafting of the article. A Tanase helped with acquisition of data and final approval. A Colita helped with drafting the article and information regarding hematology. C Tomuleasa helped drafting the article, final approval. All authors read and approved the final manuscript.

Additional information

Funding

This paper was not funded.