Salomon’s patent dilemma and the first CRISPR therapy

In the story from the Bible King Solomon ruled between two women who both claimed to be the mother of a child. In the CRISPR saga the contention is between biotech companies over foundational patents, and the next crucial episode will unveil the consequences for the first CRISPR therapy, Casgevy.

The problem is that the US patent on editing human cells with CRISPR isn’t owned by Vertex Pharmaceuticals and CRISPR Therapeutics, the companies that received regulatory approval for Casgevy in the United States. The US patent “is owned by the Broad Institute of MIT and Harvard, probably America’s largest gene research center, and exclusively licensed to a Vertex competitor, Editas Medicine, which has its own sickle-cell treatment in testing”, writes Antonio Regalado in the MIT Technology Review.

Please consider that Casgevy has a U.S. list price of $2.2 million so we can update Regalado’s calculations. There are about 20,000 people with severe sickle-cell in the US who might benefit. It’s a total potential market of around $40 billion and a patent holder could potentially demand 10% of the take, or more. “That means Editas will want Vertex to pay. And if it doesn’t, Broad and Editas could go to the courts to claim patent infringement, demand royalties and damages, or even try to get an injunction to stop the treatment from being sold”.

The worst case scenario seems unlikely as suing would delay saving patients and would seriously tarnish the reputation of Broad and Editas. However, to frame the risks of exclusively licensing a key technology like CRISPR to a single company or two, we suggest rereading a 2022 editorial in Nature Biotechnology entitled “Licensing for profit and for good”.

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