[Guest post] Dramatic reversal in the CRISPR Broad Institute cases following G 1/22

In G 1/22 (and G 2/22), the Enlarged Board of Appeal (EBA) found that there is a strong rebuttable presumption that an applicant of a European patent application is entitled to claim priority. An interesting question following G 1/22 was the potential impact (if any) on the high-profile CRISPR dispute. The Broad Institute famously lost a highly commercially valuable CRISPR patent for invalid priority (T 844/18IPKat). However, with the dramatic shift in EPO's approach to priority represented by G 1/22, would the Broad now have a shot at maintaining a patent in this family? 

Earlier this month, oral proceedings were held in the consolidated appeal cases T 2360/19, T 2516/19 and T 2689/19 relating to the Broad Institute's European platform patents for CRISPR/Cas9 gene editing technology. The only issue discussed was the formal priority entitlement. Whilst we await the written decision from the Board of Appeal, a Katfriend present at oral proceedings has provided IPKat with the following exclusive report:

"The appeals in T 2360/19, T 2516/19 and T 2689/19 were lodged against opposition division (OD) decisions to either revoke or drastically narrow down patents on the CRISPR/Cas-9 technology held by the Broad Institute et al. Priority entitlement was an issue because neither the priority co-applicant and inventor Dr. Marraffini nor his successor-in-title, the Rockefeller University, was named as applicant on the subsequent PCT applications. In such a fact situation, a patent arising from the PCT application does normally not enjoy priority under Article 87(1) EPC, as was confirmed in the previous case T 844/18 by the same Board in a different composition for exactly the same fact situation (IPKat).  

The crucial question was whether decision G 1/22 (and G 2/22) that was handed down by the EBA in October 2023 would reverse the priority assessment of T 844/18. In its Headnote I, the EBA on the one hand confirmed the EPO’s competence to assess whether a party is entitled to claim priority under Article 87(1) EPC. However, on the other hand, the EBA also held:

'There is a rebuttable presumption under the autonomous law of the EPC that the applicant claiming priority in accordance with Articles 88(1) EPC and the corresponding Implementing Regulations is entitled to claim priority.' (Headnote I, second sentence)

In other words, by the “rebuttable presumption” approach, the burden of proof was shifted to the opponents. While before G 1/22, in case of non-identity of priority applicants and subsequent applicants, the patentees were obliged to demonstrate that they were entitled to claim the priority (e.g., in T 1201/14 even “beyond reasonable doubt”), it is now up to the opponents to “demonstrate that specific facts support serious doubts about the subsequent applicant’s entitlement to priority” (G 1/22, Reasons 110). 

Standing the case law on priority on its head

In the triple case at hand, the Opponents immediately realized the potential effect of the EBA decision and filed submissions pointing to evidence that, at the relevant PCT filing date, there was an inventorship dispute between Broad and Rockefeller, meaning that the latter did not agree with filing the PCT applications without them, which would imply that they did also not agree with claiming the priority for those PCT applications. In addition, the Opponents pointed to Rockefeller’s filing of a competing application with the USPTO for exactly the same subject-matter as one of the PCT applications, which was said to further support Rockefeller’s disagreement. Only after a later arbitration, a settlement was reached between these parties so that Rockefeller accepted not to be named on the PCT applications. The Opponents also argued that, in the cases at hand, if at all, only a weak presumption could apply since Broad could file the PCT applications with priority declarations complying with the formalities of Article 88 and Rules 52 and 53 EPC without the cooperation of the sidelined Rockefeller.

In the oral proceedings, the Patentees argued that the dispute between Broad and Rockefeller was only about inventorship and ownership, and not about priority entitlement. Rockefeller was even said to have had an interest in valid priority rights. Thus, there was an implied consent in claiming the priorities, a criterion that was also used by the EBA in G 1/22 in connection with the “rebuttable presumption”. 

The Opponents countered, inter alia, by referring to the basic principle of the law of evidence that, after having provided the prima facie case based on evidence that Rockefeller apparently disagreed with Broad’s priority claims, the burden of proof should have shifted to the Patentees to clearly demonstrate, beyond merely alleging a general implied consent, that Rockefeller indeed agreed with the priority claims. 

However, in the end, the Board agreed with Patentees and accepted validity of the claimed priorities. No reasoning was given in the oral proceedings. The Board also refused to refer questions of law to the EBA as had been suggested by two Opponents to clarify the conditions at which the “rebuttable presumption” applies. 

Analysis

As a first observation, the Board’s decision to accept the priorities can be regarded as an extreme interpretation of G 1/22. The body of evidence seemed quite clearly to be in the Opponents’ favour. In a preliminary opinion issued about one month ahead of the hearing, the Board even expressed its preparedness to accept validity of the priority claims based on the outcome of the arbitration as both a retroactive and implicit transfer of the priority rights. This approach might have been overcome by subsequent written submissions of the Opponents showing that, even under US law that was mentioned by the EBA as an example of valid retroactive transfers (G 1/22, Reasons 100), a retroactive transfer of rights is only acceptable as a confirmation of a preceding implicit transfer before the relevant date. Thus, Patentees must somehow have convinced the Board that there was a collaborative relationship between Board and Rockefeller before the PCT filing, enough to accept that the presumption of priority entitlement was not rebutted. It will be interesting to see how the Board will justify its decision in writing.

Although the EBA’s attempt to find in G 1/22 a pragmatic solution for the inflation of formal priority challenges in oppositions is appreciated, the Board seems to have overshot the mark in the three cases reported herein. This is so because the evidence on file proved that, at the relevant PCT filing date, the left-out priority applicant and his successor in title, the Rockefeller University, did not agree with filing the PCT application without naming them. In view of this, the question is now which evidence could ever lead to a valid rebuttal of the presumed priority entitlement. Hardly conceivable to find any. This, however, contrasts with the EBA’s conclusion that the EPO is competent to decide on priority entitlement. It will be interesting to see whether, in the near future, opponents will find a Board of Appeal who is more interested in finding a balanced approach that is in line with the established law of evidence principles and who might refer corresponding questions of law to the EBA to clarify how the EPO is supposed to exercise its competence to determine priority entitlement in accordance with Article 87(1) EPC". 

We now await the written decision from the Board of Appeal. 

Further reading


[Guest post] Dramatic reversal in the CRISPR Broad Institute cases following G 1/22 [Guest post] Dramatic reversal in the CRISPR Broad Institute cases following G 1/22 Reviewed by Rose Hughes on Friday, March 15, 2024 Rating: 5

4 comments:

  1. A few years ago, a company called AstraZeneca obtained an SPC extension based on the wrong, later, marketing authorisation date. They were not entitled to rely on this later date and using their illegitimate monopoly to block competition was found by the European Commission to be anti-competitive. >50 million EUR fine for a few weeks of abuse.

    Imagine the scenario where a pharmaceutical obtains many years of patent life based on a priority claim to which they are not entitled, even though upheld by the EPO during opposition proceedings. I wonder whether that would be deemed anti-competitive. Italy found a standard divisional application filing to be an abuse.

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  2. Wow, what an amazing reversal of fortunes. I don't think many people saw this coming, even after G1/22 came out. The Broad was very lucky that G1/22 went to the EBA when it did! It's completely saved their bacon on this issue.

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  3. In fact, G 1/22 explicitly states that ex post transfer of priority rights would be allowed under the EPC (see Reasons 100 and 114), in case that a presumption of entitlement exists on the date on which the priority is claimed. The rebuttal of the presumption must also relate to this date, and that later developments cannot affect the rebuttable presumption" (see Reasons 109).

    Based on this logic, the BoA concluded that, as being retroactive, an at least implicit transfer agreement by way of the settlement of the inventorship dispute would relate to this date, and confirmed the presumption on entitlement to exist on this date.

    OK. But does this mean that, if, based on disagreement, a party has already created facts, these facts can be undone by a later settlement that is then construed to imply that the earlier disagreement did not exist? Here is what happened:

    (i) Mr Marraffini has assigned his priority rights on inter alia P1 and P2 to Rockefeller University on that 12 Dec 2013 (i.e., one year after the earliest priority date) (assignment recorded at the USPTO under Reel 032309, Frame 0575).
    (ii) Rockefeller filed a non-provisional application that same day, as well as a PCT application PCT/US2013/074611 (published as WO2014093595), claiming the priority of inter alia P1 and P2.
    (iii) As recorded by a letter to the USPTO, Broad wasn’t happy with this step, claiming that Rockefeller’s submission was not authorized by Broad, and that Marraffini was not a legitimate inventor.

    As a result, the BoA envisaged that it would remit the case to the 1st instance for further negotiation.

    So, is it really true that the ex post transfer of priority rights, which the BoA deemed allowable, can be based on a presumption that the entitlement of such transfer existed already on 12 Dec 2013, i.e., the date on which the priority was claimed?

    Point taken, but considering the patent is eventually maintained - what does this all change, now, for those interested in using the technology, and asking themselves who to apply for a license?

    Well, not much. The licensing situation in the US remains unaffected by this decision, while in Europe, CVC still has the earlier priority date (25. May 2012 vs. 12. Dec 2012), and has claims that encompass the application in eukaryotes (see e.g., CVC’s EP280081B1, which was found, in 1st instance, to sufficiently enable claims related to the use in eukaryotes, because combinations with NLS (nuclear localization sequences) would be known from ZFN and TALEN, and a combination thereof with CRISPR would be in the routine of the skilled artisan. This case is in appeal though and oral hearings will take place in Oct 2024).

    So, the recent decision does not make it easier for those who what to use the technology - but probably not more difficult either.


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  4. The EPO has always been horrendous at handling these kinds of evidence correctly. Unless priority was claimed from a priority application filed at the EPO, they should have stayed out of the whole issue and left priority entitlement to be a matter of national law as those laws intersect with the PCT. This shambles of a decision is what you get when the EPO overreaches its core competencies.

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