First published in our Biotech Review of the year – issue 8.

The boundless potential of the CRISPR technology demonstrates that the industry can not only defend society against a dire pandemic, but also shape the very future of health. Indeed, the press release issued by the Royal Swedish Academy of Sciences when awarding the Nobel Prize pithily summarised the technology in its headline: ‘Genetic scissors: a tool for rewriting the code of life[1] ’, telling wording for the immense potential of Charpentier and Doudna’s discovery.

As often seen with ground-breaking technology, disputes have arisen concerning its intellectual property and last year saw a patent case relating to CRISPR-Cas9 before the Technical Board of Appeal of the European Patent Office (EPO)[2]. The Board’s decision in this case emphasises an important point for patent applicants: it remains vital to get the small formalities correct, no matter how significant the invention.

From lab to patent office

For quick context, as many readers will know, the CRISPR-Cas9 technique allows specific DNA sequences in virtually any genome to be located and edited or modified with relative ease. The specificity and accuracy of the technique has led to comparisons being drawn with the search function of modern word processers, and the potential applications range from medicine to agriculture to biofuels.

The case in question concerned an appeal against a decision in opposition proceedings brought by nine opponents to the patent. The Opposition Division had revoked the patent for lack of novelty over two pieces of prior art. This resulted from the finding that the patent was unable to make a valid claim to priority under Article 87(1) European Patent Convention (EPC) from certain US provisional applications. In its decision, the Opposition Division had applied the established case law in relation to the assessment of priority claims under Article 87(1). This is the so-called ‘all applicants’ requirement: all persons listed as applicants in a priority application must be listed as applicants for the subsequent application claiming priority (allowance being made for successors in title). The patent in this case had one applicant who was listed in the priority applications but who was missing from the later applications. The Opposition Division had thus held that the patent was not entitled to priority, leading to the finding of lack of novelty over two pieces of prior art published after the priority date.

Then the appeal

The appellants (the patent’s proprietors, The Broad Institute, MIT and Harvard) challenged the legitimacy of the ‘all applicants’ approach. The appeal drew a lot of attention not only because of the subject matter of the underlying invention, but also because the appellants were challenging the EPO’s rather formalistic approach to priority entitlement which had frustrated many patentees in the past, and is viewed by some as both unnecessary and readily utilised by third parties to invalidate otherwise good patents. In particular, the ‘all applicants’ approach is problematic for patents claiming priority to US priority applications (such as in this case) because of the requirement in the US to name the actual (and often numerous) inventors as applicants, even if their rights were assigned, for example, to their employer.

Inevitably, COVID-19 is driving significant growth and will figure prominently in the sector in the year ahead. Pfizer, for example, expects to produce 50m vaccine doses in 2020, and a further 1.3bn by 2021. The ventilator market grew by almost 200% in 2020, with the sector expected to be worth $7.72bn in 2020.

The appellants set out their case in the form of three questions, and the Board dealt with each in turn:

1.IIShould entitlement to priority be assessed by the EPO?

The appellants argued that the EPO should not assess priority entitlement as a matter of principle because the ‘all applicants’ approach results in issues of title raised by non-owners being used to destroy the underlying property right. The priority right should only be challenged by someone claiming to be the rightful owner. However, the Board disagreed. The EPC clearly sets out requirements for priority and the EPO is empowered and obliged to assess the validity of a priority right claim. There are many formal requirements under the EPC and the loss of a patent due to failure to fulfil such formalities is a feature of the EPC system. In the present case, the appellants had not complied with the well-established practice of the EPO. It was not for the Board to repair such errors.

2.  How is the expression ‘any person’ in Article 87(1) EPC to be interpreted?

In relation to this question, the appellants argued that ‘any person’ in Article 87(1) EPC must be interpreted to mean that anyone who duly filed the priority application (or his/her successor in title) can validly claim priority. Namely, if there are multiple applicants for the priority application, one, a plurality, or all, can validly claim priority. The ‘all applicants’ approach merely created additional obstacles for patentees. For the protection of third parties, the most important consideration for priority claims was not ‘identical applicants’, but that the same invention was being claimed.

For this question, the Board turned to the object and purpose of the 1883 Paris Convention for the Protection of Industrial Property (from which the requirements in Article 87(1) EPC derive), as well as to public policy considerations. The legal concept of priority in the Paris Convention allows applicants to be treated as if they had simultaneously filed the same patent application in a multiplicity of member states (something that was physically impractical if not impossible in 1883). It is this legal fiction of simultaneous filing that establishes the ‘all applicants’ requirement. If a group of persons decides together to carry out an act of filing, then they must act in unison for this purpose. The bar for overturning long established case law and practice should be a high one and the appellants were faced with over 100 years of consistent case law on this point. In light of the above considerations, the Board rejected the appellants’ argument and held that the ‘all applicants’ approach was the correct one.

3. Does national law (in this case US law) govern the determination of ‘any person’ who has ‘duly filed’ in Article 87(1) EPC?

With regards to this third question, the appellants had argued that the national law where the priority application was filed should be used to determine the meaning of ‘any person’. This is because the right arises at the time (and therefore in the country in which) the priority application was filed. In this case, the national law would be US law (under which the applicant’s status is tied to the degree of inventorship). Addressing this final point, the Board noted that the US is a signatory to the Paris Convention and therefore, in accordance with the US Constitution, the Paris Convention forms part of the ‘supreme Law of the Land’ in the US. Hence, it is the Paris Convention, rather than national law, that determines the meaning of ‘any person’.

Referral to the Enlarged Board of Appeal

The minutes of the final day of the hearing suggest that the Board quite seriously considered a reference to the Enlarged Board of Appeal. Ultimately, the Board’s view was that this was not necessary. The EPO had, without exception, adopted a consistent interpretation of Article 87(1) EPC since the inception of the European patent system and the Board thus felt able to answer the questions raised beyond doubt. The Board therefore disagreed with all three arguments put forward by the appellants and the appeal was dismissed.

There appears to be a growing global dispute between some of the key players of the CRISPR-Cas9 story, who are fighting for patent protection for this award-winning biotechnology. In this case the appellants’ efforts to change the EPO’s practices on priority were ultimately unsuccessful. The Board of Appeal made a clear statement that the ‘all applicants’ approach to priority entitlement is the correct one.

It is somewhat ironic that failure to comply with a century-old formality was capable of undermining a patent covering a biotechnology that may significantly impact the century to come. At least in the shorter term, 2021 and beyond will likely see more interesting disputes concerning patent protection arising from CRISPR-Cas9.

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[1] https://www.nobelprize.org/prizes/chemistry/2020/press-release/
[2] T 0844/18 (16 January 2020)