The CRISPR Patent Twist: Nobel Winners Seek Cancellation
As the debate continues, the future of CRISPR and its applications remains uncertain – highlighting the complexities involved in the patent law and the need for clarity in the intersection of science and intellectual property.
In a surprising turn, two 2020 Nobel Prize winners – Emmanuelle Charpentier and Jennifer Doudna– are asking to cancel two of their own CRISPR patents in Europe. This decision comes after a troubling ruling from a European technical appeals board, raising questions about the future of gene editing and intellectual property rights in the life sciences.
What is CRISPR?
CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats, is hailed as one of the greatest biotech discoveries of our time. It allows for precise DNA modifications, impacting fields like agriculture and medicine. The technology allows scientists to edit genes with remarkable accuracy, making it possible to develop gene therapies, create genetically modified organisms (GMOs), and address genetic diseases.
The excitement surrounding CRISPR has led to an intense battle for control over its commercial applications. At the centre of this struggle are Charpentier and Doudna, who were awarded the Nobel Prize in Chemistry in 2020 for their pioneering work on CRISPR-Cas9 technology, and Feng Zhang, a researcher at the Broad Institute of MIT and Harvard, who has also claimed to be a key inventor of the tool.
The Controversial Ruling
The European Patent Office (EPO) initially recognized the importance of Charpentier and Doudna’s work, granting them patents that were celebrated as groundbreaking. Their European patents were seen as a validation of their contributions and a counterbalance to the Broad Institute’s dominance in the US patent landscape.
In 2014, the Broad Institute secured a key US patent for CRISPR applications. Meanwhile, Charpentier and Doudna pointed to their European patents as vital assets in their ongoing fight. Recently, a European board ruled that Charpentier and Doudna’s earliest patent application lacked sufficient detail. The board claimed it did not adequately explain how to use CRISPR, thus failing to qualify as a valid invention.
In light of this ruling, Charpentier and Doudna’s legal team has proposed the cancellation of two specific European patents (EP2800811 granted in 2017, and EP3401400 granted in 2019). Their lawyers argued that the ruling was unjust and that withdrawing these patents is a necessary step to avoid a damaging precedent.
The Point of Contention
At the heart of the ruling is a technical detail regarding “protospacer adjacent motifs” (PAMs). PAMs are essential DNA sequences that determine where CRISPR can effectively target and cut DNA. The European board argued that Charpentier and Doudna’s initial application omitted this crucial information, leading to the verdict that their invention was not fully described.
The Nobel team contends that the need for PAMs was obvious and should not have impacted their patent’s validity. They have publicly disputed the board’s assessment, in a detailed response letter, aiming to clarify their position. They contend that the decision misinterprets common knowledge in the field and applies incorrect legal standards.
A Strategic Move
The decision to cancel the patents (EP2800811 and EP3401400) is seen as a strategic move. By pre-emptively cancelling these patents, Charpentier and Doudna hope to avoid the legal repercussions of a negative ruling. This tactic is described as a “scorched-earth” approach, indicating the lengths to which the Nobel laureates are willing to go to protect their intellectual legacy. This tactic, while drastic, seeks to protect their broader interests in the field.
Speaking to the media, Randi Jenkins, the chief intellectual-property attorney at the University of California, confirmed the plan but downplayed its significance. She emphasized that the team still holds other important patents in Europe.
The Impact
The cancellation affects a wide range of biotech firms that have secured licenses on CRISPR technology for the patents in question. Companies like Editas Medicine and Intellia Therapeutics, as well as Charpentier’s own ventures, rely on these patents for commercial operations.
ERS Genomics, a key player in CRISPR licensing, has sold access to over 150 organizations. Many of these companies may now face uncertainty regarding their rights to use CRISPR.
Licensing fees for CRISPR technology can be substantial too. Vertex Pharmaceuticals, for instance, paid $50 million for rights to sell a CRISPR-based treatment. Smaller companies, like StemSight in Finland, have also paid fees for licenses they believed were necessary for research. The uncertainty surrounding the validity of the patents these companies have licensed raises important questions about the financial viability of their research and development efforts.
What Next?
In a rapidly changing world, the need for clear guidelines and protections for innovators is paramount. This unexpected move by Charpentier and Doudna underscores the complexities involved in thepatent law in the fast-evolving field of biotechnology.
This situation also raises broader questions about the future of interdisciplinary research. The integration of biotechnology, neuroscience, and genetics has the potential to yield transformative advancements, but the legal frameworks governing these fields may struggle to keep pace.
As the debate continues, the future of CRISPR and its applications remains uncertain – highlighting the need for clarity in the intersection of science and intellectual property.
Acknowledgement:MIT Technology Reviewatwww.technologyreview.com/
