About the author:
Sarah Gibbs is a senior associate and patent attorney at Appleyard Lees. Sarah helps clients protect their inventions in both the chemical and biochemical fields. As a result of working with a wide variety of clients in these sectors, she has experience and understanding of the challenges faced by different companies.
The Broad Institute of MIT and Harvard (‘Broad’) have won the latest round in the ongoing battle over patents relating to the gene editing technology, CRISPR.
We previously provided an update on the myriad of patent disputes in relation to CRISPR in both Europe and the U.S., primarily between Broad and the University of California/University of Vienna/Charpentier (CVC). In the latest development, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (UPSTO) have ruled that Broad owns the intellectual property for the use of the CRISPR technology in eukaryotes.
CRISPR gene editing is undoubtedly one of the biggest breakthroughs in biotech in recent years. Indeed, its huge potential means that the market for the technology is predicted to be in the order of billions, if not trillions, of U.S. dollars.
The use of CRISPR as a gene editing tool was first published in a 2012 paper authored by, among others, Jennifer Dounda of the University of California and Emmanuelle Charpentier, then of the University of Vienna (who went on to share the Nobel Prize in Chemistry in 2020 for their discoveries). Since then, a large number of patent applications in relation to CRISPR have been filed by numerous parties and the technology has been embroiled in patent battles ever since. To give some context, over six hundred applications are pending before the European Patent Office (EPO), forty European patents have been granted and over twenty of these have been opposed (often with multiple opponents). The situation is no less complicated in the U.S.
U.S. Interference Proceedings
Broad have several patents/applications directed to the use of CRISPR in eukaryotic cells. In a first interference action before the PTAB, the UPSTO considered whether the claims of these patents/applications were patentably distinct from the claims of a CVC application directed towards the use of CRISPR in all cells. In this case, the PTAB ruled in Broad’s favour concluding that there was no interference in fact. The decision was upheld by the Courts of Appeal of the Federal Circuit (CAFC).
However, this is not where it ended.
The USPTO issued a second interference action because CVC amended their claims in a series of continuation applications to be restricted to eukaryotic systems. Both Broad and CVC therefore had overlapping claims to the use of CRISPR in eukaryotic cells. It is in respect of this action that the latest ruling relates.
As already mentioned, the judges ruled in favour of Broad, concluding that they have priority over CVC with respect to a single RNA CRISPR-Cas9 system that functions in eukaryotic cells. In a further blow to CVC, the decision also found their claims to be unpatentable.
In the decision, the PTAB acknowledged that CVC developed the CRISPR system in 2012. However, they ultimately concluded that whilst CVC had hoped that the system would work in eukaryotes at that time, they “did not have a definitive and permanent idea of how to achieve that result as of that date”. Indeed, the PTAB cited the fact that CVC had encountered difficulty in getting the system to work in Zebrafish as evidence that there was reasonable doubt that the technique had a “reasonable expectation of success”.
What happens next?
Although CVC have lost the rights to the use of CRISPR in eukaryotes, the PTAB acknowledged that CVC’s patent rights to the broader invention were not at issue. Therefore, the situation as it currently stands in the U.S. is interesting in that Broad owns the rights to claims directed to the use of CRISPR in eukaryotic cells, whereas CVC retains broader claims to its use in any cells.
However, it is not the end of the story. Unsurprisingly, although CVC have said that they “respect” the decision, they have already indicated that they will appeal.
Also, there are interference proceedings brought by both Sigma and Toolgen that are still ongoing before the UPSTO. Each of these parties have applications to the use of CRISPR in eukaryotes that were filed just before those of Broad. The outcome of these cases will be interesting, especially as the present ruling simply stated that Broad’s “reduction to practice” – i.e., bringing the invention to fruition beyond mere conception – predates that of CVC, without indicating Broad’s earliest reduction to practice.
It is clear, therefore, that the challenges are far from over.
It is also worth noting that the licensing situation has also been complicated by the ruling. Editas Medicine, who license the technology from Broad, welcomed the decision. However, it is estimated that the ruling could result in a loss of millions, or even billions, of dollars to CVC in lost licensing revenue. Indeed, it would appear that biotech companies who currently license CRISPR from CVC must now try and negotiate a new deal with Broad. Whether they do this before or after the other interference proceedings are concluded is a question to be considered.
Broad currently have the upper hand in the U.S., with judges ruling in their favour in both the first and second interference actions (albeit with the caveat that the second decision can be appealed).
However, the reverse is true in Europe, where Broad’s patent to the use of CRISPR in eukaryotes has been revoked and CVC’s patent to the use in all cells has been maintained with only minor amendments at first instance.
In any case, it is clear that the challenges are not over and it is likely that there will be further twists in the tale before the situation is resolved.