Intellectual property landscape around prime editing
Intellectual Property Landscape Around Prime Editing
Prime editing, a revolutionary genome editing technology, has been at the forefront of significant intellectual property developments and patent disputes. This technology, which allows for precise DNA edits without the need for double-strand breaks, was developed by Dr. David Liu and his team at the Broad Institute and Harvard University. The intellectual property landscape surrounding prime editing is complex, involving multiple patents, licensing agreements, and ongoing legal challenges.
Patents and Licensing
Dr. David Liu's team has secured several patents for prime editing. These patents cover the fundamental technology of prime editing, including the use of a nucleic acid programmable DNA binding protein (napDNAbp) combined with a reverse transcriptase, guided by a modified guide RNA (PEgRNA)[3][5][7]. The prime editing technology is described as a "search-and-replace" method for genome editing, which is more precise and versatile compared to earlier CRISPR systems[8].
Prime Medicine, a company co-founded by Liu, has been proactive in securing and expanding its patent portfolio. It was awarded a U.S. patent for prime editing in September 2022, which is set to expire in 2040[12]. This patent covers methods of using prime editors and is a critical asset for the company. Prime Medicine has also in-licensed all improvements to prime editing from Dr. Liu’s lab, reinforcing its position as a leader in this field[2].
Patent Disputes and Challenges
The prime editing field has not been free from disputes. Other companies and research institutions have developed technologies that overlap with prime editing, leading to potential patent infringement issues. For instance, Tessera Therapeutics and Tome Biosciences have developed technologies that bear similarities to prime editing. Tessera's technology uses a non-viral method involving mobile genetic elements, while Tome's PASTE technology also employs components similar to those used in prime editing[1][4].
These similarities have raised concerns about potential legal challenges. For example, the PASTE patent, which was awarded to Tome Therapeutics, has been scrutinized for its conceptual and technological overlap with prime editing[2]. Such overlaps could lead to complex legal battles over intellectual property rights, reminiscent of the disputes seen with earlier CRISPR technologies[11].
Licensing and Commercialization
The commercialization of prime editing technologies is heavily dependent on licensing agreements. Prime Medicine has established itself as a key player by securing licenses for foundational patents and by planning to continue investing in prime editing technology[2]. However, the landscape is complicated by the fact that other companies developing similar technologies may also need to navigate these patents to bring their products to market.
For instance, companies like Tessera may face challenges if their technologies are deemed too similar to prime editing, potentially requiring them to obtain licenses from Prime Medicine or engage in legal battles[1][4]. This scenario underscores the importance of clear and strategic patent licensing in the biotechnology field, where innovation is rapid and overlapping technologies are common.
Conclusion
The intellectual property landscape around prime editing is characterized by a robust patent portfolio held by Prime Medicine and ongoing challenges related to patent overlaps with other emerging technologies. As the field continues to evolve, it is likely that we will see further developments in patent filings, licensing agreements, and potentially contentious legal disputes. These factors will play a crucial role in shaping the future of prime editing and its applications in medical research and therapy.
Citations:
[1] https://www.nature.com/articles/s41587-024-02208-0
[2] https://www.genengnews.com/news/paste-dont-cut-genome-editing-tool-looks-beyond-crispr-and-prime/
[3] https://patents.justia.com/inventor/david-r-liu
[4] https://www.oligotherapeutics.org/innovation-versatile-gene-editing-technologies-and-patent-battles/
[5] https://patents.google.com/patent/WO2020191248A1/en
[6] https://www.frontiersin.org/articles/10.3389/fpos.2021.745898/full
[7] https://patents.google.com/patent/WO2020191153A2/en
[8] https://www.cell.com/trends/biotechnology/fulltext/S0167-7799%2823%2900085-9
[9] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9978821/
[10] https://www.nature.com/articles/s41434-021-00263-9
[11] https://www.biopharmadive.com/news/crispr-patent-biotech-uc-broad-intellia/619684/
[12] https://www.liebertpub.com/doi/pdf/10.1089/genbio.2023.29088.aph