“US Patent Office Upholds Harvard and MIT’s CRISPR-Cas9 Genome Editing Patents”

In a landmark decision on Monday, the US Patent Office’s appeal board upheld a set of patents covering CRISPR-Cas9 genome editing in plants and animals held by Harvard University and the Massachusetts Institute of Technology (MIT). This ruling comes as a significant victory for the Broad Institute, a collaborative entity between the two universities, and a setback for the University of California, Berkeley, the University of Vienna, and Emmanuelle Charpentier (CVC).

CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, refers to a set of DNA sequences. Cas9, on the other hand, is an enzyme that can cut these DNA sequences. The research on CRISPR sequences dates back to 1993, but it was the foundational work on CRISPR-Cas9 gene editing in 2011 by Emmanuelle Charpentier and Jennifer Doudna that earned them the 2020 Nobel Prize for Chemistry.

The first CRISPR-Cas9 patent application was filed in May 2012 by Charpentier, Doudna, Martin Jinek of UC Berkeley, and Krzystof Chylinski of the University of Vienna. However, in December of the same year, researchers from the Broad Institute filed their own patent application. The Broad Institute was the first to be awarded a CRISPR patent in April 2014, based on work dating back to February 2011.

The Broad Institute’s patents were challenged in 2015 when CVC sought an interference proceeding to determine which group should be recognized as the inventor of the technology. CVC argued that details its researchers disclosed should invalidate subsequent Broad patent applications.

The USPTO initiated its interference proceeding in 2016, and in 2017 found that the Broad Institute’s claims did not interfere with those made by CVC researchers. This decision was upheld by the US Court of Appeals in 2018, which affirmed that Broad Institute’s patents were separately patentable and didn’t overlap with what CVC claimed.

A second interference proceeding was initiated by the USPTO in 2019, covering 10 CVC CRISPR patents and 13 Broad Institute patents and one Broad patent application. This proceeding concluded on Monday with the USPTO’s Patent, Trial and Appeal Board (PTAB) siding with the Broad Institute and against CVC.

In a statement, the Broad Institute said, “This decision once again confirmed Broad’s patents were properly issued. As the PTAB and US federal courts have repeatedly established, the claims of Broad’s patents to methods for use in eukaryotic cells, such as for genome editing, are patentably distinct and not reasonably expected from results of biochemical ‘test tube’ experiments.”

The University of California, Berkeley, expressed disappointment with the ruling, which doesn’t affect more than 40 other CRISPR-related patents in the US, as well as patents in other countries. “The University of California is disappointed by the PTAB’s decision and believes the PTAB made a number of errors,” the university said in a statement. “CVC is considering various options to challenge this decision.”

The Broad Institute patents at issue are also currently being challenged by biotech firms Toolgen and Sigma-Aldrich. This ongoing patent war underscores the high stakes and intense competition in the field of genome editing, a technology that holds immense potential for medical and agricultural advancements.