Loss of CRISPR Priority in Europe is a Warning to All Patent Applicants

On 17 January 2018, a panel of the European Patent Office (EPO) opposition division wholly revoked a patent co-owned by the Broad Institute (‘Broad’) relating to CRISPR/Cas9 ‘gene editing’ technology.  The European patent in question, number EP2771468, is entitled ‘Engineering of systems, methods and optimized guide compositions for sequence manipulation’, and is a European equivalent to US patent no. 8,906,616, which is one of the key Broad patents involved in the US patent interference dispute with the University of California (UC) – which is currently on appeal to the US Court of Appeals for the Federal Circuit.  As is usual with European opposition proceedings, the ruling was issued immediately at the hearing (which had originally been scheduled to continue for two further days).  A full written decision providing detailed reasons is likely to be a few weeks away.

Technically, the basis for revocation in the final decision is likely to be lack of novelty and/or inventive step of all claims of the Broad patent.  However, the underlying reason for Broad’s failure to defend its patent is a loss of priority.  In particular, the EPO panel determined that Broad was not entitled to claim priority from four of its earlier US provisional applications, including the earliest filing, US provisional application no. 61/736,527, which was filed on 12 December 2012.  This loss of priority was fatal to the patent, as a result of a number of publications – including Broad’s own – that occurred subsequently, but prior to the full application’s filing date of 12 December 2013.

While this decision is obviously pivotal in the ongoing disputes between Broad and UC over ownership of foundational patent rights relating to CRISPR/Cas9 technology, it also provides an object lesson and a timely reminder of essential requirements for valid priority claims for patent applicants around the world, in all fields of technology.  While the circumstances of Broad’s case are somewhat more complex than most patent filings, what has happened to it here is not at all specific to the particular invention at issue.  In a nutshell, the problem was that, at the time of filing international application no. PCT/US2013/074819 (from which the European patent is derived), the named applicants – Broad, MIT and Harvard – did not collectively own all of the rights necessary to claim priority from the earlier provisional applications.  More particularly, the provisional applications named a researcher from Rockefeller University as a co-inventor/applicant, yet neither the researcher nor Rockefeller was named as an applicant on the international application.  Nor had the named applicants received any assignment from Rockefeller of the right to claim priority in the international application.

In fairness to Broad, the US national law relating to ‘internal’ priority (i.e. claiming the benefit of a US provisional application in a subsequent non-provisional application) is less strict, and focusses on the substance of the invention actually claimed in the later application rather than on a distinct right of priority.  But this can hardly be an excuse for ignorance of the international position, especially when the stakes are so high.  Broad has issued a statement, arguing that the EPO decision is based on a technicality, and asserting that it is ‘inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe’.  I disagree.  Not only is this not the first time that the EPO has applied these rules in relation to priority claims, but it is not the only adjudicating body to have determined that they are, in fact, required by the international treaties in question.

Broad has vowed to appeal.  In the meantime – and in anticipation of the likelihood that any appeal will fail – all international applicants would be well-advised to ensure that they are clear on the ownership of the right to priority at the time of filing.  At the end of this article, I set out some guidelines for avoiding the troubles that Broad has encountered, not only at the EPO but at any international patent office.

Background – US Priority Claims

While there were four US provisional applications at issue before the EPO, it is sufficient to consider just one here, by way of example.  The earliest US provisional application (no. 61/736,527) names only inventors as applicants, as has traditionally been the practice in the US.  By surname only, those applicants were Zhang, Cong, Habib, Cox, Hsu, Lin, Ran, and Marraffini.  All but the last of these inventors were employees of, and had assigned their rights to, Broad, MIT, or Harvard.  Marraffini, however, was (and still is) a researcher at Rockefeller University.

US patent application serial no. 14/290,575 – which went on to become US patent no. 8,906,616 – and international application no. PCT/US2013/074819 were both filed naming only Zhang, Cong, Hsu, and Ran as inventors.  Broad contends that the provisional application disclosed multiple inventions, and that the subsequent applications disclosed and claimed only one of these inventions, for which only the four named inventors were responsible.  It appears that there was a long-running disagreement over this matter between Broad and Rockefeller, however Broad issued a media release 15 January 2018 (i.e. the day before the EPO opposition hearing was due to commence) announcing that the dispute had been resolved through binding arbitration, and that it was now agreed that Marraffini should not be named as an inventor. We can therefore take it that inventorship, and entitlement to ownership of the invention and the patents, is as Broad has asserted.

So Broad, MIT, and Harvard were the rightful owners of the invention, and of the right to obtain a patent, as at the date of filing the full US and PCT applications.  However, they were still not the only parties entitled to ownership of the four provisional applications at issue, including application no. 61/736,527.  Marraffini was named as an inventor on that application, and was therefore a legitimate joint applicant, even though it may have been as a result of contributions that were not ultimately claimed in the subsequent applications.  He, or a successor in title (i.e. Rockefeller), was therefore a joint holder of the right to claim priority from that application.

Where Do ‘Priority Rights’ Come From?

The ultimate origin of international priority rights is the Paris Convention for the Protection of Industrial Property, and in particular Article 4.A(1), which states:

Any person who has duly filed an application for a patent, or for the registration of a utility model, or of an industrial design, or of a trademark, in one of the countries of the Union, or his successor in title, shall enjoy, for the purpose of filing in the other countries, a right of priority during the periods hereinafter fixed

Although this refers only to a ‘person’, in the singular, and uses a masculine pronoun, the usual interpretation of such a provision is that a ‘person’ may be either a natural person of any gender, or an entity with legal personality (e.g. a corporation).  Where the applicant is, in fact, multiple persons, they are generally treated as each owning a share of an indivisible legal right.  Furthermore, it makes sense that Article 4.A(1) be interpreted on its plain terms, such that the right of priority must be held at the time of filing the application in which a claim to priority is made.  Otherwise, it would be possible for anybody to make claims to priority without the consent – or possibly even knowledge – of legitimate owners of the right to do so, and then seek retrospectively to secure the entitlement to do so at some future time, when circumstances are different.

To the extent that national laws and other international conventions reflect the terms of the Paris Convention, therefore, the EPO interpretation of the requirements for a valid claim to priority is entirely reasonable.  Article 87(1) of the European Patent Convention (EPC), which provides for the priority right in the case of European patent applications, also refers to ‘any person who has duly filed’ in a state party to the Paris Convention ‘an application for a patent…’.  It differs from Article 4.A(1) in requiring that the European patent application be ‘in respect of the same invention’ as the priority application.  However, this appears only to be an express statement of the requirement implicit in the Paris Convention that a right of priority can only exist in respect of an invention that is actually disclosed in the original application.  It does not address entitlement to ownership of the invention itself, and is concerned only with the applicant of the original application, and the entitlement to make a claim to the priority of that application.

Additionally, since Broad’s European patent application was based upon an international application, Article 8 of the Patent Cooperation Treaty (PCT) is also relevant.  Subparagraph 8(2)(a) provides, in particular, that claims to priority made in PCT applications are governed by Article 4 of the Paris Convention.  Subparagraph 8(2)(b), however, makes an exception for the case in which the country of filing of the priority application is the same as a country designated in the PCT application, in which case the claim to priority may be governed by the national laws of the country for purposes of that particular designation.  This means, for example, that the effect of a priority claim in the US national phase of a PCT application from an earlier US application is governed by US law.  It certainly does not mean that the European phase of the PCT application may be governed by US law – although I understand that this is part of Broad’s argument against the EPO’s decision.  I hope that we can all agree that this would be an absurd result, if true, effectively allowing applicants to bypass the terms of the Paris Convention and obtain a global benefit merely by virtue of claiming priority from an application filed in a country with more lenient laws in relation to ‘internal’ priority!

An Unsurprising Outcome

Broad should not, in fact, have been at all surprised by the decision.  The EPO Boards of Appeal have previously considered the right to claim priority, and there is therefore precedent for the interpretation applied by the opposition decision (see, for example, decision T 0577/11 (Entitlement to priority) of 14 April 2016).

The rules applied by the EPO are quite straightforward, although their application may sometimes – as in this case – seem harsh and unforgiving:

1. the right to claim priority from an earlier application is a separate and distinct right from ownership rights in any invention(s) that may be disclosed in the application and/or patent rights ultimately granted in respect of such invention(s);
2. the applicant(s) of a subsequent application must be in possession of the full right to claim priority at the time of filing that application; and
3. all applicants identified in a priority application must either be named on the subsequent application, or have assigned their share of the right to claim priority to one or more named applicants.

Furthermore – and contrary to the implication in Broad’s media statement that this is some sort of technicality unique to the EPO – in 2010 a judge in the England and Wales High Court reached essentially the same conclusion under UK law: Edwards Lifesciences AG v Cook Biotech Inc [2009] EWHC 1304.

Broad’s statement also appears to imply that the EPO’s interpretation somehow acts to thwart ‘treaties designed to harmonize the international patent process, including that of the United States and Europe’, by which I assume it is referring to the Paris Convention and the PCT.  However, considering that the Paris Convention dates back to 1883, and PCT Article 8 makes express reference to the 1967 ‘Stockholm’ version of the Convention, it is difficult to make sense of Broad’s argument.  The United States did not introduce provisional applications until 1995.  If Broad is correct then this change in US law unilaterally changed the effect of US priority claims throughout the world, which would be absurd!

Conclusion – Avoiding the Traps

Broad is entitled to appeal the decision of the EPO opposition division, though based on prior EPO Boards of Appeal decisions, related international rulings, and a plain-language interpretation of the relevant provisions in international treaties and national laws, its prospects of success appear slim, to say the least.

For everyone else, this unfortunate turn of events presents an opportunity to learn from Broad’s mistakes.  In that spirit, here are some handy guidelines that applicants may wish to consider when devising international filing strategies.

1. Always remember: the right to claim priority is distinct from ownership of rights in an invention.  While these conceptually separate rights will usually travel together, the time at which priority rights are transferred between parties may be critical!
2. There are all sorts of reasons why filing any application in joint names is less than ideal.  One alternative approach, for example, is to establish a single legal entity to which all of the rights are assigned, such as a joint venture company.  The collaborating parties can all hold shares in this entity, and any disputes over ownership can all be dealt with by allocation and division of the shares, out of reach of national and international patent laws and procedures.  Certainly, anyone considering joint ownership of any IP rights should seek legal advice specific to their circumstances.
3. When claiming international priority from an earlier application, whether in a PCT application, or in one or more separate national/regional applications, the applicant(s) for the new application must either be the same as the original application, or full successor(s) in title of the right to claim priority.  If there is to be any change to the applicant(s), for any reason whatsoever, it is imperative that the right to claim priority be transferred, via a written legal document, prior to filing the new application.
4. If it is not possible to perfect assignment of the right of priority prior to filing the new application, then it must name all of the applicants of the original application (or applications, in the case of multiple priority claims).  It is always possible to transfer ownership of the application after filing.  As Broad’s experience shows, it may not always be possible to retroactively correct a failure to secure full title to the priority right prior to filing.

This is not legal advice, of course, and it is probably not exhaustive!  Feel free to add any other suggestions or tips that you may have in the comments below.

Broad is not the first to fall foul of priority requirements.  Nor, sadly, do I expect that it will be the last.  However, unlike Broad I do not see this as a matter of some unreasonable ‘technicality’.  Legal ownership of rights matters, and there are very good reasons why people should not be permitted to exercise rights that they do not own!

Tags: CRISPR, Europe, International treaties, Paris Convention, Patent Cooperation Treaty, Priority claim