Will the EPO’s Enlarged Board of Appeal step into the CRISPR patent battle?

By  Jakob Wested, Timo Minssen & Esther van Zimmeren

Another version of this contribution has been published in Life Science Intellectual Property Review (LSIPR).

The Broad Institute is facing a formidable task in defending the revoked CRISPR patent claims in their pending appeal at the European Patent Office (EPO). Ultimately, some of the issues might still be referred to the Enlarged Board of Appeal. However, this might require a significant amount of legal and rhetorical agility.

“The Opposition Division’s interpretation of the EPC [European Patent Convention] is inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe.”

This was the rather strong reaction of the Broad Institute after the EPO’s Opposition Division’s (OD) decision to revoke one of their CRISPR patents. It could, however, also be argued that the case presents a simple failure of the patent applicants to comply with the long-standing European practice to apply an “all applicants” approach when claiming priority under article 87 of the European Patent Convention.

In a comment on the IPKat Blog, Rose Hughes stated that “[T]he Broad Institute and its co-proprietors have fallen foul of the trap opened up by the difference in the US and European requirements for a valid priority claim.”

Nonetheless, the BI very quickly announced its decision to appeal the OD decision before the Board of Appeal (BoA). In the following, we will consider whether some of the arguments raised by the BI against the decision of the OD may ultimately reach the Enlarged Board of Appeal (EBoA).

Background

In January 2018, the OD revoked one of the BI’s CRISPR patents due to the fact that Mr. Maraffini, one of the initial inventors and applicants in the US patent applications, was not mentioned as an applicant in the European patent application. This is an important requirement according to the so-called European “all applicants” approach.

As a result, the applicants could not claim priority on the basis of the US provisional patent (Art. 87 EPC) and the priority date had to be moved to a later date. As this required an assessment of additional priority rights, the OD came to the conclusion that the invention no longer fulfilled the criteria on novelty and inventiveness and, thus, the patent was revoked.

The BI and the other patent proprietors, the Massachusetts Institute of Technology and the President and Fellows of Harvard College (hereinafter we will only refer to the BI) attempted to convince the OD to take into consideration US patent law rules on the topic. These are less stringent, as they merely require one inventor in common between the priority application and the subsequent application (35 U.S.C. §119(e) and US Manual of Patent Examining Procedure (MPEP) section 1828).

Furthermore, the US provisional patent application had been divided into various European patent applications. The BI claimed that Mr. Maraffini was not included in the patent application concerned because he was not an inventor in relation to the subject matter for which protection was sought in that specific European divisional patent application.

It is worthwhile to note that disagreement existed regarding Mr. Marrafini’s inventorship and that it was settled in an arbitration proceeding between the BI and Rockefeller University just two days before the oral proceedings of the European opposition procedure. The outcome of the settlement was, however, not explicitly included in the opposition procedure due to the late submission (during the oral proceedings) (OD decision sec. 40 and 40.1). The OD ultimately decided to follow the long-standing European all applicants approach in relation to priority claims.

The all applicants approach

Article 87 EPC states the conditions under which an applicant for a European patent can claim priority from an earlier application. It mirrors Article 4(1) of the Paris Convention (PC). According to article 87(1) EPC, “any person who has duly filed a patent application in a state that is a party to the PC, or his successor in title, shall enjoy for the purpose of filing a subsequent European patent application in respect of the same invention, a right of priority during a period of twelve months from the date of filing of the first application.”

Claiming priority to the earlier application provides the subsequent application with the same effective filing date as the earlier application. This means that disclosures between the filing dates of the earlier and subsequent application cannot be cited against the novelty or inventiveness of the subsequent application. The all applicants approach entails that “any person” (cf. German: “Jedermann”; more restrictive: French: “Celui qui”) in article 87 EPC is interpreted as a requirement that all the applicants on the priority document or their successors in title, must also be the applicants of the subsequent patent application that claim priority.

The BI basically invokes three key arguments in the opposition procedure. Firstly, the EPO would not be competent to assess legal entitlement to the right of priority. This should be left to national courts. Secondly, “any person” in article 87 EPC should be interpreted differently. Thirdly, the meaning of “any person who has duly filed” should be interpreted according to the national law of the country of the priority application, in this case US law, rather than the EPC. It goes beyond the scope of the current contribution to discuss each of these arguments in detail. They raise important legal and governance questions regarding the competence of the EPO vis-à-vis national courts and questions of applicable law that would require a separate contribution.

In brief, the OD did not follow the argumentation of the BI. A deviation from the all applicants approach could, according to the OD, lead to a multiplication of proceedings with identical content, procedural inefficiencies and legal uncertainty and would have significant consequences for e.g. licensing agreements, infringement proceedings, the effect of settlements in infringement proceedings, etc.

This would run counter to the interests of patent offices and the public (OD decision sec. 66.9). Moreover, “the potential legal implications of the date of (first) priority in the assessment of patentability and validity of a patent application or a patent, [makes it] imperative that applicants and the public at large be provided with legal certainty and predictability with respect to the rules of law governing the subject of claiming priority (cf. T517/14 reasons 275)” (OD decision sec. 72).

The decision of the OD is firmly embedded in the EPO practice and case-law of the BoA, national case-law and European patent law doctrine. It is defended on the basis of important considerations about the functioning of the European patent system. As an administrative instance, the OD is bound by the interpretation of the BoA and the Examination Guidelines.

According to the OD, the case at hand did not present exceptional features that would justify a deviation from the case law and the guidelines (OD decision, sec. 66.10). However, the position is controversial as indicated by the expert opinions mentioned in OD decision sec. 66.6 and a critical analysis of the case-law. Interestingly, the OD also raises the question whether the priority right is actually the right instrument to address these issues (OD decision, sec. 66.10).

The fact that the OD adds these considerations seems to indicate that it acknowledges that the implications of the all applicants approach may call for a more substantive re-evaluation. Although, applying the all applicants approach in the current case might be in line with the case law and the guidelines, it does raise broader legal (applicable law), governance (powers of the EPO) and political (differences between the European patent and the US patent system) questions. The question of whether a case could be successfully referred to the EBoA might thus also depend on how “activist” or “political” the EPO, the BoA and the EBoA wish to be in this respect. A closer look at the rules and practice regarding the admissibility of such referrals to the EBoA may shed some light on whether such a referral is likely and how it may be addressed by the EBoA.

The admissibility of referrals to the EBoA

The main rationale for the creation of the EBoA was to ensure uniformity in the application of the EPC and to deal with points of law of fundamental importance (art. 112 EPC). Its jurisdiction is basically limited to deciding on points of law referred to it by the BoA and to giving opinions to points of law referred by the EPO President (art. 22, 112(1) (a) and (b) EPC). Only in very specific cases will parties to appeal proceedings that are adversely affected by the decision of the BoA be able to file a petition for review of the decision by the EBoA (art. 112a EPC). This institutional design was put in place to underline that the EBoA is not a “third instance forum” and that cases will only end up at the EBoA in exceptional cases (see Visser, The Annotated European Patent Convention, 25th edition [Part VI, art 112 (1)(a) EPC]).

The BoAs may refer a case to the EBoA on their own motion or they may decide to do so on the request of a party if a decision is required to settle a question of uniform application of the law or a point of law of fundamental importance (art. 112(1)(a) EPC). If the BoA rejects the request from a party, it shall give the reasons for doing so in its final decision. Decisions of the EBoA are binding on the BoA in respect of the appeal in question (art. 112(3) EPC). The President of the EPO may also refer a case to the EBoA if two BoAs have issued different decisions on the same point of law, i.e. when there seems to be a lack of uniform application of the law (art. 112(1)(b) EPC). The wording “two boards” is interpreted broadly. This means that the alleged lack of uniformity may originate from the practice of “two boards” from different divisions of the European Patent Organization, e.g. the examination divisions, the opposition divisions and the BoAs. However, as it was pointed out in G 3/08, EPO – Programs for computers, Enlarged Board of Appeal, 12 May 2010, the term “different decisions” is interpreted narrowly taking inter alia technological and legal developments into consideration when assessing whether there is a difference. At the same time, it should be stressed that referrals from the EPO President to the EBoA only lead to an “opinion” on the matter and not a decision that is binding the BoA in a particular case. It is thus up to a particular BoA to determine whether and to what extent it will take into account an opinion of the EBoA on a point of law within the context of the facts of the case. However, if a BoA would not take it into account or follow the opinion of the EBoA it will likely provide an extensive argumentation why it does not do so.

For the EBoA to accept a referal, the case must i.a. raise issues relating to the uniform application of the law and/or a point of law of fundamental importance. Moreover, the decision of the EBoA must be necessary for the BoA to reach a decision (see G 1/12, sec 6 – 14). A question regarding the uniform application of the law arises “where two boards have given diverging decisions or where a board intends to deviate from an interpretation or explanation of the EPC given by one or more boards in previous case law”. (G 1/12, sec. 10). A point of law of fundamental importance arises when “a board considers that the question cannot be answered directly and unambiguously by reference to the EPC […][or] its impact extends beyond the specific case at hand” (G 1/12, sec. 10). The necessity requirement is generally interpreted in the context of the internal functioning of the European Patent Organization, not in view of legal certainty of the public (cf. Visser, The Annotated European Patent Convention, 25th edition [Part VI, art 112 (1)(a) EPC]). If a BoA can answer an important point of law beyond doubt by reference to the EPC, the question cannot be referred to the EBA due to lack of necessity (Decision BoA, J 5/81, headnote 2).

Both the decision of the OD and the statements made by commentators indicate that the decision to revoke the patent based on the all applicants approach is well-founded in EPO practice. Furthermore, the OD held that the wording of the EPC may be construed to encompass this interpretation (OD decision sec. 64–67). From the above it follows that the BI would probably have to convince the BoA that this particular case involves exceptional circumstances that can provide grounds for a deviation from the all applicants approach. It is clear, however, that such a deviation from well-established practice would require an elaborated argumentation of the extraordinary circumstances and solid reasons for such a substantial change of course. The OD has already indicated that it does not find that such exceptional circumstances are present in the case at hand (OD Decision sec. 66.10, see also T 1388/10). Moreover, the uniformity criterion is understood as uniformity in the application of the EPC by the different boards and divisions. Deviation in EPO Practice from national jurisprudence is not considered as lack of uniformity (T 154/04). It would therefore be very surprising if the diverging US practice would be regarded as a lack of uniform application of the law.

If no lack of uniformity can be found, the only other option is that the case raise a point of law of fundamental importance. The argument that the all applicants approach is incongruent with the PC may provide the necessary leverage for an argument substantiating the fundamental importance of the issue, as it could potentially affect all patent applications claiming priority from US provisional patent application, and thus have an impact beyond the specific case at hand (G 1/12, sec. 11-12). However, the necessity criterion requires that the referring BoA must find that a ruling from the EBoA is necessary for it to reach a decision in order to determine a point of law of fundamental importance; in this case the interpretation of the PC and the EPC, questions regarding the competence of the EPO, the applicable law and the intersection between EPC and US patent law. In such circumstances, the BoA has previously shown some reluctance (OD Decision sec.60.1). Moreover, the key objective of the procedure in article 112 EPC is to ensure a uniform application of the EPC within the European Patent Organization, not to align the relation between the EPO and national patent systems (see Minssen & Gozzo, NIR, Vol. 76, No. 3 (2007) at 238-9 , Visser, The Annotated European Patent Convention, 25th edition [Part VI, art 112 (1)(a) EPC]). Nonetheless, it is clear that the case raises many complex and fundamental questions that are quite controversial and that create challenges for the global administration and management of patent portfolios.

Concluding remarks

The patent revoked by the OD (EP 2 771 468) is only the first of six of BI’s Europeans patents that have been opposed on the ground of lack of priority vis-à-vis their US provisional patent applications. The other patents are EP 2 896 697; EP 2 784 162; EP 2 921 557; EP 2 931 898 and EP 2 764 103. While it is still “too early” to foresee what will happen as the appeal is still pending, the outcome of the appeal is likely to have significant impact on the strength of the Broad’s CRISPR–patent portfolio. Thereby it adds yet another twist to the extraordinarily complex CRISPR patent landscape.

We believe however that referring the case to the EBoA will not be an easy task in view of the specific requirements and the raison d’être of article 112 EPC. Firstly, because the legal aspects of the decision appear to have a solid foundation in the practice of the EPO and the case-law. Secondly, the outcome of a case before the EBoA would risk disturbing the delicate balance in the international patent system. This could result in procedural inefficiencies and new practical challenges.

On the other hand, the issue of the right to priority under the EPC vis-à-vis international treaties is an essential question that has important implications for a large number of international patent families. To find and substantiate a point of law that is of fundamental importance and could justify a referral to the EBoA may thus not be impossible, but it will certainly require a significant amount of legal and rhetorical agility to convince the BoA and the EBoA to open this “pandora’s box”.

In the meantime, and as reported in a previous LSIPR issue, the Broad Institute has won another victory in the US. Last month, the US Court of Appeals for the First Circuit confirmed that a request for discovery for use in a foreign proceeding, in this case at the EPO, will be denied unless the relevance of that discovery can be demonstrated. Hence, any practitioner and academic would be well-advised to monitor the international developments carefully and stay tuned in the “evolving law of CRISPR”.

 

Timo Minssen is Professor of Law and Founding Director of CeBIL at the University of Copenhagen, Denmark. He is also the grant-holder & PI of CeBIL’s Collaborative Research Programme in Biomedical Innovation Law, which involves the Petrie-Flom Center as one of the core-partners. He can be contacted at: timo.minssen@jur.ku.dk .

Jakob Wested  is postdoc at the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen, Denmark. He can be contacted at: jakob.blak.wested@jur.ku.dk .

Esther van Zimmeren is Research Professor of IP law & Governance at the University of Antwerp, Belgium and a Permanent Visiting Professor at CeBIL. She can be contacted at: esther.vanzimmeren@uantwerpen.be .

Acknowledgments : CeBIL’s research is supported by a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme (grant agreement number NNF17SA027784).

 

Timo Minssen

Timo Minssen

Timo Minssen is Professor of Law at the University of Copenhagen (UCPH) and the Founder and Managing Director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL). His research concentrates on Intellectual Property-, Competition & Regulatory Law with a special focus on new technologies in the pharma, life science & biotech sectors including biologics and biosimilars. His studies comprise a plethora of legal issues emerging in the lifecycle of biotechnological and medical products and processes - from the regulation of research and incentives for innovation to technology transfer and commercialization.

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