This week saw the latest instalment in the now infamous multijurisdictional CRISPR patent war between two heavyweight academic institutions, the Broad Institute[1] and the University of California[2] - a win at the Court of Appeal for the Federal Circuit (CAFC) for the Broad institute. With the possibility of a further appeal to the Supreme Court seemingly unlikely, this particular battle seems to be over, but the war rages on in Europe.
Background
The University of California (UC) and the Broad Institute (Broad) are two of the biggest players in the CRISPR space. The revolutionary gene editing technology consistently attracts mainstream media attention because of its therapeutic potential and massive investments in companies such as Editas Medicine and Intellia Therapeutics seeking to bring CRISPR-based medicine to market.
UC has a pending application to a broad CRISPR method, and Broad has later-filed patents limited to CRISPR in eukaryotic cells e.g. human cells. Under the applicable US law in this case (now superseded), where two parties claim “patentably indistinct” subject matter, the patent can only be awarded to the first inventor. On this basis, UC initiated interference proceedings in an attempt to strip Broad of its patents.
In February 2017, the patent review board (PTAB) found in favour of Broad holding that there was no interference-in-fact. Broad’s claims were deemed patentably distinct because, given the differences between eukaryotic and prokaryotic systems, the skilled person would not have had a reasonable expectation of success in applying the CRISPR system in eukaryotes. UC appealed the decision, arguing that the PTAB “(1) improperly adopted a rigid test for obviousness that required the prior art contain specific instructions, and (2) erred in dismissing evidence of simultaneous invention as irrelevant”.
The Appeal
The CAFC noted at the outset that the appeal “turns in its entirety on the substantial evidence standard” i.e. was the PTAB’s finding of no reasonable expectation of success supported by “substantial evidence”?
In short, the CAFC’s answer was, “yes”. The substantial evidence included expert testimony on the physiological differences between eukaryotic cells and prokaryotic cells, prior art failures and notably, various contemporaneous statements made by UC inventors expressing doubts and frustrations in getting CRISPR to work in eukaryotic cells. Unfortunately for UC, words such as “profound discovery” and (upon hearing the news of Broad’s success), “I hope you’re sitting down”, seem to have been just too emotive to ignore.
UC did its best to offer its own substantial evidence to the CAFC that the skilled person would indeed have a reasonable expectation that CRISPR would work in eukaryotic cells. They pointed to prior art techniques that had been used for adapting prokaryotic systems for use in eukaryotic cells, and showed that obstacles adopting other prokaryotic systems had been overcome. UC also noted that six research groups independently applied CRISPR in eukaryotic cells within months of its disclosures, but this all fell on deaf ears.
What must have been intensely frustrating for UC, is that the CAFC acknowledged that there was indeed evidence that supported UC’s position, but firmly stated that its role as an appellate court is not to reweigh evidence, stating: “It is not our role to ask whether substantial evidence supports fact findings not made by the Board”. Rather, the CAFC’s role was purely to assess whether the findings the PTAB did make were supported by substantial evidence. Having decided that they were, the PTAB’s decision was upheld.
What next?
Overall, the CAFC’s decision is probably as expected. However, it is important to note (and indeed the CAFC made a point of stating this in its judgement) that this was not a ruling on the validity of either set of claims. With that in mind, while this particular chapter in the saga has come to an end, it’s hard to imagine that further litigation doesn’t lie on the horizon. It’s also worth remembering that Broad has not been getting everything its own way. Earlier this year, one of Broad’s foundational European CRISPR patents[3] was revoked in opposition proceedings. That decision has now been appealed, but due to a fundamental priority issue, many commentators feel that the Broad will be lucky to overturn the decision. There is certainly plenty more to look forward to in the coming months.
Read the full decision here. For more information or advice, please contact Jamie Atkins or your usual contact at Kilburn & Strode.
[1] Together with MIT and Harvard