Nobel Prize Winners Seek to Have CRISPR Patents Canceled

MIT Technology Review has reported that the team that earned the Nobel Prize in chemistry for developing CRISPR is asking to cancel two of their own European patents.

The patents being voluntarily disavowed are EP2800811, granted in 2017, and EP3401400, granted in 2019.

As the National Human Genome Research Institute explains,

CRISPR (short for “clustered regularly interspaced short palindromic repeats”) is a technology that research scientists use to selectively modify the DNA of living organisms. CRISPR was adapted for use in the laboratory from naturally occurring genome editing systems found in bacteria.

CRISPR has been called the biggest biotech discovery of the century.

The Royal Swedish Academy of Sciences awarded the Nobel Prize in Chemistry in 2020 to Emmanuelle Charpentier (Max Planck Unit for the Science of Pathogens, Berlin, Germany) and Jennifer A. Doudna (University of California, Berkeley, USA) for their development of a method for genome editing.

As the Academy explained,

Emmanuelle Charpentier and Jennifer A. Doudna have discovered one of gene technology’s sharpest tools: the CRISPR/Cas9 genetic scissors. Using these, researchers can change the DNA of animals, plants, and microorganisms with extremely high precision. This technology has had a revolutionary impact on the life sciences, is contributing to new cancer therapies, and may make the dream of curing inherited diseases come true.

CRISPR technology was used to fight the COVID-19 pandemic. As the New York Times reported in May of 2020,

A team of scientists has developed an experimental prototype for a fairly quick, cheap test to diagnose the coronavirus that gives results as simply as a pregnancy test does.

The test is based on a gene-editing technology known as Crispr, and the researchers estimated that the materials for each test would cost about $6.

CRISPR technology was also used to develop COVID-19 vaccines.

Patents were sought for the Nobel-winning work. The patent holders are the University of California, the University of Vienna, and Emmanuelle Charpentier.

Hundreds of other patents have also been filed for inventions related to CRISPR gene-editing technology and applications.

However, as TestBiotech explains,

The European patents granted on CRISPR/Cas gene scissors technology have been the subject of legal dispute for more than ten years. In the USA, the patents held by Doudna and Charpentier, which are now awaiting a decision in Europe, have already been revoked for technical reasons. Despite opposition, the European Patent Office (EPO) upheld patents EP2800811 and EP3401400, but they are now under review. Appeals were filed against these decisions, and public hearings and final decision-making were scheduled for October 2024. Meanwhile, these hearings are canceled.

Testbiotech, a German nonprofit, filed an opposition against one of the EU CRISPR patents because of ethical concerns. As a result, the European Patent Office (EPO) ruled in a 2022 decision that the human germline would be excluded from patent claims.

As the MIT Technology Review explains,

The request to withdraw the pair of European patents, by lawyers for Nobelists Emmanuelle Charpentier and Jennifer Doudna, comes after a damaging August opinion from a European technical appeals board, which ruled that the duo’s earliest patent filing didn’t explain CRISPR well enough for other scientists to use it and doesn’t count as a proper invention.

The Nobel laureates’ lawyers say the decision is so wrong and unfair that they have no choice but to preemptively cancel their patents, a scorched-earth tactic whose aim is to prevent the unfavorable legal finding from being recorded as the reason.

In August, as the Review reports,

… a technical body decided that Berkeley had omitted a key detail from its earliest patent application, making it so that “the skilled person could not carry out the claimed method,” according to the finding. That is, it said, the invention wasn’t fully described or enabled.

The omission relates to a feature of DNA molecules called “protospacer adjacent motifs,” or PAMs. These features, a bit like runway landing lights, determine at what general locations in a genome the CRISPR gene scissors can land and make cuts and where they can’t.

In the 76-page reply letter sent by lawyers for the Nobelists, they argue there wasn’t really any need to mention these sites, which they say were so obvious that “even undergraduate students” would have known they were needed.

Another CRISPR-related dispute is between Charpentier and Doudna, the Nobel Prize winner, and Feng Zhang, a researcher at the Broad Institute of MIT and Harvard, who claimed to have invented the CRISPR tool first on his own.

The Review states that “There’s no doubt that Charpentier and Doudna were first to publish, in a 2012 paper, how CRISPR can function as a “programmable” means of editing DNA.”

As the Review notes,

Back in 2014, the Broad Institute carried out a coup de main when it managed to win, and later defend, the controlling US patent on CRISPR’s main uses. But the Nobel pair could, and often did, point to their European patents as bright points in their fight.

As the Review explains,

The cancellation of the European patents will affect a broad network of biotech companies that have bought and sold rights as they seek to achieve either commercial exclusivity to new medical treatments or what’s called “freedom to operate”—the right to pursue gene-slicing research unmolested by doubts over who really owns the technique.

These companies include Editas Medicine, allied with the Broad Institute; Caribou Biosciences and Intellia Therapeutics in the US, both cofounded by Doudna; and Charpentier’s companies, CRISPR Therapeutics and ERS Genomics.

ERS Genomics, based in Dublin, calls itself “the CRISPR licensing company” and claims to have sold nonexclusive access to its “foundational patents” to more than 150 companies, universities, and organizations.

The patent licensing fee for small startups starts at $15,000 per year.

In the US, the Broad Institute has also been licensing the US CRISPR patent rights. Vertex Pharmaceuticals won approval to sell the first CRISPR-based treatment for sickle cell disease and agreed to pay $50 million for the patent license.