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18 January 2018Europe

Mixed views on Broad’s fate after EPO revokes CRISPR patent

Commentators have offered differing opinions on the impact of yesterday’s decision by the European Patent Office (EPO) to revoke a CRISPR/Cas9 patent owned by the Broad Institute of Harvard and MIT.

The EPO’s Opposition Division revoked European patent 2,771,468 in its entirety after finding that Broad could not claim two key priority dates.

Broad said it will appeal against the ruling and claimed it was based on a “technicality” that is inconsistent with international patent treaties, including the Paris Convention.

You can read yesterday’s report on the decision here.

Daniel Lim, senior associate at Allen & Overy, attended the hearing at the EPO. He has since told LSIPR that while some of Broad’s other opposed CRISPR patents will be vulnerable to revocation based on lack of priority, the institute does have other patents covering later, more specific inventions and different Cas proteins like Cpf1 which will be unaffected.

He said that, in the bigger picture, “this probably won’t change all that much”, although Broad will need to handle the “optics and PR aspect” of its first big public loss in a CRISPR patent fight.

“It will likely be at least two years before the appeals process is exhausted and Broad has lots of other granted and pending patents that they will get on with prosecuting to grant and licensing. All the various interested parties will keep researching and inventing and patenting,” he explained.

Ultimately, he added, the decision might knock some value off Broad’s fundamental CRISPR patent portfolio, pending appeal, and reduce the royalties that it derives from those.

“But they have a large portfolio and many more recent patents for new inventions,” he continued. “Having this patent invalidated in Europe (or even all of those affected patents) will not cause them to lose their position at the leading edge of CRISPR research and licensing overnight.”

In Europe, a patent applicant or its successor can enjoy a right of priority to an earlier application, with the later application being able to claim the earlier date.

But case law has indicated that where a later patent application is not filed by the same applicant, a transfer of priority must have occurred before the filing date of the later application.

In this case, the Opposition Division said Broad is not considered a successor because neither the inventor (Luciano Marraffini) nor his institution (Rockefeller University) of the earlier patent application—from which priority was claimed—were named as joint applicants on the later filed patent application (‘468).

In a statement released after the decision, Broad said it hopes the EPO’s Technical Board of Appeal will use this case as an opportunity to review and resolve international inconsistency in the application of priority—not just for CRISPR patents, “but for a wider range of European patents and applications that originated as US provisional applications”.

But Eric Rhodes, CEO of ERS Genomics—a company that provides access to CRISPR/Cas9 IP held by Emmanuelle Charpentier—disputed this claim.

In a statement, he said Broad failed to point out that the language pertaining to procedures in both the European Patent Convention and the Paris Convention is identical.

“Any such change, as expected by Broad, would require a change in the law itself,” Rhodes said. “The vast majority of the Broad Institute’s CRISPR patents in Europe are also affected by this same deficiency and we expect them to meet a similar fate.”

Timo Minssen, managing director and founder of the new Centre for Advanced Studies in Biomedical Innovation Law at the University of Copenhagen, told LSIPR that, considering the EPO’s position and the earlier case law on the question of priority, the chances of such an appeal succeeding are rather low, unless new facts emerge.

If this is the case, he says, it might be the first step towards Broad losing its more foundational IP protection directed to CRISPR and, in turn, imply that Broad may have to concentrate on other CRISPR applications and seek protection for these.

“It is clear that this would change the licensing landscape and open new market opportunities for more actors,” he said.

“While there are still hundreds if not thousands of gene-editing related claims and claim families out there, there would also be less broad protection available for the core technology. In simple terms, there would be more focus on narrower and different forms of protection for purpose-bound applications rather than broad patents.”

While stressing that the Opposition Division’s decision will not become final unless it is confirmed on appeal (potentially by the Enlarged Board of Appeal), Minssen pondered what would happen if the Broad wins the case on appeal.

If Broad would win the appeal in the absence of new facts, this would be a “game-changer” as it would change a central concept in patent law (of priority) and deviate from many years of consistent jurisprudence at the EPO and in Europe.

“The implications of such a decision would not only substantially affect biotechnology patents, but also many other areas of patenting. It would therefore not surprise me if the case would make it further up to the EPO’s Enlarged Board of Appeal, which sometimes accepts cases with a fundamental importance for European patent law.

“Therefore, it is clear that every patent practitioner and the life sciences community should monitor the next developments very carefully.”

Timo Minssen and Daniel Lim have both spoken on CRISPR at our Life Sciences Patent Network events - for more info on our upcoming Boston event,  click here.

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Biotechnology
30 January 2018   The University of Cambridge has partnered with the University of Copenhagen to address challenges in biomedical innovation law.

More on this story

Biotechnology
30 January 2018   The University of Cambridge has partnered with the University of Copenhagen to address challenges in biomedical innovation law.