Patricia Granahan, an IP attorney at Wolf Greenfield, told BioPharma-Reporter.com that while several institutes have laid claim to CRISPR-Cas technology with patent submissions, recent Supreme Court cases have opened the door to challenges from rivals.
Multiple organisations have filed PCT (international) patents related to uses of CRISPR-Cas, the method of cutting and modifying genomes using a short sequence of RNA (Cas-9) to guide endonuclease. The system can both “knock-in” and “knock-out” genes, creating wider possibilities than other gene-editing methods such as zinc-finger nuclease.
A team at the Broad Institute and MIT, led by Feng Zhang, filed a claim in January this year as inventors of the CRISPR-Cas-9 system for modifying genetic expression.
Other organisations, including Sangamo Biosciences, the University of California, the University of Vienna, Georgia Tech Research Corporation, Vilnius University, and Fred Hutchinson Cancer Research Center, have filed patents since 2012 for methods of using CRISPR, such as to target specific diseases.
But Granahan told us two Supreme Court decisions – Mayo Collaborative Services v. Prometheus Laboratories in 2012, and Alice Corporation v. CLS Bank International in June this year, provide a precedent for the patents to be contested.
Both cases come down to the principle that no one may patent natural objects or laws – in Mayo, a diagnostic test based on the natural relationship between metabolites in the blood and the effects of a drug, and in Alice, a computer-based technical algorithm that amounted to an abstract idea.
Companies have realised they must make their patent claims much more narrow, said Granahan. “As long as what you’re claiming doesn’t occur in nature you don’t have a problem with Mayo and Alice.” She said organisations are likely to use CRISPR in future to produce compounds that differ slightly from nature – with greater bioactivity or a longer life, to claim protection.
CRISPR-Cas gene editing relies on two components that occur separately in nature: clustered regularly interspaced short palindromic repeats (CRISPRs) of short DNA sequences, and the Cas9 protein, an RNA-guided enzyme which can make double strand cuts in DNA.
The two parts “occur in nature individually and are now joined together in one unit,” which is why CRISPR-Cas patents have so far been accepted, said Granahan. “But they might not stay patented.”
Licensing vs litigation
As long as patents are “alive” – that is, within 20 years of their filing date – they can be contested. “People are likely to try to challenge these CRISPR patents,” Granahan said. “Many companies have looked at it and thought ‘wow, this is a technique I’d love to have access to.’
“Because there are so many players in the field, the major players may get together and say they won’t assert their patents against you if you don’t assert against me.” This consortium would license out the technology to paying partners, she said.
Another possibility is that some organisations could try to block access to others via litigation.
At the moment, “We don’t know if CRISPR will be long-term or flash-in-the-pan. People are already trying to find ways to make it more specific, more efficient – it may well develop considerably over the next few years.” The debate over whether CRISPR patents will hold up, and who ultimately can own the technology, will be decided in the coming months and years, said Granahan.