EPO revokes CRISPR patent – a clear cut case of invalid priority?

On 17 January 2018, The EPO revoked one of the Broad Institute’s patents relating to a fundamental aspect of CRISPR technology. The opposition board upheld the EPO's preliminary opinion that the claims were invalid in view of an invalid priority claim. The EPO’s decision is not surprising, given the long-standing approach of the EPO to the primary issue in question, namely that the right to claim priority from an earlier application is afforded to the applicant of the earlier application, or his successor in title, and to no other party.

A decision to uphold the patent would have represented a fundamental change in how the EPO understands priority rights, and it is a sign of the importance of this technology that The Broad considers this a battle worth fighting.

Background

CRISPR-cas9 gene editing technology (CRISPR) provides a cheap, efficient and easy way to precisely modify genetic information. CRISPR has long been the subject of highly contentious patent battles in the US between the Broad Institute and the University of California (UC­), Berkeley. These battles continue to rage, and are likely to represent one of the last contentious cases of the pre-AIA first-to-invent system. A number of CRISPR patents have now been granted in Europe, opening up a new front in the CRISPR patent wars.

The patent

The patent in question EP 2771468 derives from a PCT application on 12 December 2013, claiming priority from 12 US provisional applications, the earliest of which was filed on 12 December 2012. The patent was granted on 11 February 2015 to three co-proprietors, The Broad Institute, MIT and Harvard College, with the following claim 1:

1. A non-naturally occurring or engineered composition comprising:
a Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPRCas) system chimeric RNA (chiRNA) polynucleotide sequence, wherein the polynucleotide sequence comprises
(a) a guide sequence of between 10 - 30 nucleotides in length, capable of hybridizing to a target sequence in a eukaryotic cell,
(b) a tracr mate sequence, an
(c) a tracrRNA sequence
wherein (a), (b) and (c) are arranged in a 5’ to 3’ orientation,
wherein when transcribed, the tracr mate sequence hybridizes to the tracrRNA sequence and the guide sequence directs sequence-specific binding of a CRISPR complex to the target sequence,
wherein the CRISPR complex comprises a Type II Cas9 protein complexed with (1) the guide sequence that is hybridized to the target sequence, and (2) the tracr mate sequence that is hybridized to the tracrRNA sequence, wherein the tracrRNA sequence is 50 or more nucleotides in length.
Opposition proceedings

During the post grant opposition period, nine notices of opposition were submitted, by parties including CRISPR Therapeutics AG and Novozymes. The opponents requested revocation of the patent in its entirety on a number of grounds, including that the patent was not entitled to claim priority from at least two of the priority documents, including the earliest of the provisional applications US 2012/61736527.

A note on priority: requirements in Europe vs US

Article 87 EPC provides the conditions under which an applicant for an EP patent can claim priority from an earlier application, and mirrors Article 4(1) of the Paris Convention. According to Art. 87(1) EPC, any person who has filed a patent in a state a party to the Paris Convention, or his successor in title, shall enjoy such a priority right to the same invention for a subsequent 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.

 It is a long-established principle of EP case law that, for a valid priority claim under Art. 87 EPC, the applicant of the subsequent application claiming priority, who is not the person who filed the earlier application, must be that persons successor in title when the subsequent application is filed. In practice, this means that an assignment from the applicant of an earlier application to his successor after the filing date of the subsequent application, is not sufficient for a valid priority claim under the EPC (T 577/11.3).

So what if an earlier application has more than one applicant? According to current EP case law, in the situation where an earlier application has joint applicants, the right to claim priority from the application is considered to belong simultaneously and jointly to the two applicants (who thus constitute a single legal entity). In practice, this means that the earlier application can only serve as a basis for claiming priority for the filing of a subsequent application that designates all applicants of the earlier application (T 788/05).

It is also possible to assign the right to claim priority from an application separately to the assignment of the application itself. Such an assignment must also take place before the filing of the subsequent application and the requirements for demonstrating such an assignment are stringent, as recently confirmed by the EPO technical Board of Appeal (T 1201/14, IPKat post).

The US has less stringent priority requirements. In the US, in order to result in a valid priority claim, an earlier and subsequent applicant claiming priority must have at least one joint inventor in common (MPEP § 213.02). Consequently, when a US provisional application is filed in the name of the inventors, with assignment from the inventor to the owner after the filing date, there is no requirement in the US for the assignment to occur before the filing of a subsequent PCT application claiming priority from the provisional.

Overturning EPO case law on priority -
a mountain to climb?
An invalid priority claim for the CRISPR patent?

The Broad Institute and its co-proprietors have fallen foul of the trap opened up by the difference in the US and Europen requirements for a valid priority claim. In their grounds of opposition, the opponents all argued that the EP 2771468 priority claims to the US provisionals US and 2012/61736527 and US 2013/61748427 (P1 and P2 in the opposition proceedings) were invalid, on the grounds that one or more of the applicants of P1 and P2, or their successors in title, were not listed as applicants for the PCT application from which EP 2771468 was derived.

As matter of objective fact, it appears that the opponents observation is correct. The priority documents listed Luciano Marraffini of Rockefeller University as an applicant. Marraffini does not appear as an applicant on the PCT application forming the basis of EP 2771468, and no evidence was submitted to proceedings that Marraffini had assigned his rights to The Broad Institute before the filing date of the PCT application.

In response, the proprietors argued that the EPO case law is not in line with the principles of the right to claim priority under Article 87 EPC and the Paris Convention.

Luciano Marraffini
A key aspect of the proprietors' arguments in response to the objection was that the right to claim priority under Article 87 EPC should be interpreted according to national law. In their written reply to the notice of opposition, The Broad argued that each of P1 and P2 disclosed more than 1 invention (as is common in US provisional applications). Under US law, they observed that it is a requirement for all the inventors that contributed to the subject matter of the invention(s) disclosed anywhere in a provisional application (whether the description, drawings or claims) are named as applicants. They further observed that to be named as an inventor on a patent application, one has to be the inventor or have derived the right from the inventor, and that under US law an inventor can only assign rights to inventions, and the right to claim priority from such inventions, to which she/he has contributed.

Therefore, it was argued, only the inventor-applicants with the right to claim priority from the subject matter of P1 and P2 to which the subsequent PCT application was directed, were listed on the PCT application. Marraffini, the Broad argued, did not have the right to the invention to which the PCT application was directed and therefore was not listed as an applicant for the PCT application.

To complicate matters further, whilst opposition proceedings were progressing before the EPO, The Broad Institute and the Rockefeller University were locked in a patent dispute over whether Luciano Marraffini should be included as an inventor on the patent. This issue was settled following arbitration on January 15th 2018 (i.e. two days before proceedings) and it was agreed that Luciano Marraffini of the Rockefeller would not be named on the patent. A press release to this fact was submitted during oral proceedings itself (although this was rejected by the Opposition Division for having been filed late).

To support their position, the Broad submitted declarations from such eminent figures as Lord Hoffman.

The Decision

In oral proceedings, the EPO upheld its preliminary opinion that the priority claim was invalid, and that disclosures between the filing date of the US provisionals and the filing date of the PCT application were citeable against the claims. In their preliminary opinion, the EPO emphasized that “in both the EPC and the Paris Convention systems the decisive fact for a valid claim of priority is the status of the applicant, rather than the substantial entitlement to the subject matter of the first application” (EPO's own emphasis).

Those of us not lucky enough to attend the public proceedings await publication of the decision. However, it seems the priority issue was dealt with even more swiftly than expected, given that the scheduled four days of argument were completed in a day and a half.

Appeal

It is testament to the value of the CRISPR technology, that The Broad has already filed a notice of appeal against the decision. A hint as to the grounds under which they will appeal may be found in the Broad’s press release. They appear to accept that the EPO’s decision was in line with the EPO’s own “formal requirements”, but argue that these requirements are inconsistent with the principles of priority provided by the Paris Convention and Article 84 EPC. The Broad Institute proclaims themselves confident that “the EPO will, on appeal, harmonize the EPO procedures to be consistent with international treaties and compatible with the fundamental principles of the Paris Convention”.

This Kat admires The Broad’s optimism!

Author: Rose Hughes
EPO revokes CRISPR patent – a clear cut case of invalid priority? EPO revokes CRISPR patent – a clear cut case of invalid priority? Reviewed by Rose Hughes on Monday, January 22, 2018 Rating: 5

21 comments:

The Convention watchdog said...

The reason for the "early" end of the oral proceedings was not that the priority question was not sufficiently discussed. On the contrary, the discussion covered all aspects brought forward by the parties and based on numerous legal expert opinions. Rather, a discussion on novelty and inventive step did not take place as expected, since the proprietor submitted new claim requests which the Opposition Division did not admit into the proceedings. As to the substance of the priority question, one may mention that the problem is not so much the general difference between US and EP law, but the difference between US law on internal priorities and the law of the Paris Convention on priorities.

Look at things said...

It is interesting to note that the question of assignment of priority in procedures before the EPO has become rather acute in recent times.

At least two recent decisions dealt with the topic: T 577/11, T 1201/14 (which was commented on this blog).

To simply say that the EPO should either accept that when two parties who consent that the priority right was correctly transferred, or when the identity of the invention is not at stake, the EPO should turn a blind eye to the problem of priority assignment is too easy as rights of third parties might be touched.

To say as well that such a decision should, in analogy to Art 60, be decided by a national court is not satisfactory either.

One possibility would be a referral to the Enlarged Board. So, wait and see!

Mr Blobby-Obvious said...

Article 112(1)EPC. "In order to ensure uniform application of the law, or if a point of law of fundamental importance arises"...

Where are the conflicting decisions? I know of none. How is a point of law of fundamental importance to be defined? By reference to the commercial value of the patent at stake? Based on the arrogance and volume of whining by the disaffected party? The noisy people are already on the lobbying train, taking the issue all the way to the top, wherever they seem to believe that is. "Lord Hoffman supports us", they rant. "Who cares!", I say.

The UK Supreme Court has already twisted the law to compensate for incompetent patent drafting, and now some deluded people believe the Boards of Appeal will do the same at the EPO to compensate for blatant ignorance of international patent laws. Hire someone competent at the start and these problems will not arise. I may have had a little sympathy if these patents were drafted many moons ago, but they were drafted so recently at a time when the decisions were making loud, noisy waves.

Look at things said...

@ Mr Blobby-Obvious

There are no diverging decisions, but in spite of this, the point might be considered as “a point of law of fundamental importance”, as it can have deleterious effects. The number of cases at stake might however not warrant a referral.

There is a very simply way to obviate such assignment problems. In case of doubt or should the time for priority assignment be too short to be finalised before the subsequent filing: file the priority claiming application with the same applicants/inventors as the original filing, and assign the application to the new owner afterwards.

I do not see any reason not to proceed so, and all the recent decisions, in which the patent fell because of a document published in the priority interval, would not exist.

Lord Neuberger’s decision was certainly not a decision which improved or clarified the situation, and one can indeed considered that it boils down to compensate for shoddy drafting. I would see the Altavis vs.Elli Lilly decision more as a way of compensation for the old “Improver” decision. I would therefore consider that this precise decision was not an “improvement”. It seems best to leave their Lordships alone, and let them rest in peace. One Lord does not (or better should not) make the law, exactly as one swallow doesn't make it spring.

Max Drei said...

What a splendid rant from Blobby, in response to a provocative comment from LaT.

Americans are inclined to think that it's only a matter of time before the rest of the world comes round to their way of thinking. And who can say they're wrong. No wonder they advocate so zealously.

As to Paris priority failures because of formal slip ups in the timeous assignment of the right of priority, despite LaT's point that 3rds can be burned, I have misgivings about 3rd parties butting in on "family" matters. Like in England where only the aggrieved deprived owner can dispute ownership of a patent, I think only those deprived of a Paris priority right should be able to dispute the misappropriation of it by somebody else.

Bit like Ethicon vs USSC at the Federal Circuit, I might suggest.

CASE passed... said...

The Broad Institute proclaims themselves confident that “the EPO will, on appeal, harmonize the EPO procedures to be consistent with international treaties and compatible with the fundamental principles of the Paris Convention”.

The EPO may follow the PCT rules and articles, but the PCT has so many "if national laws allow", "if not contravening national law", that it is obvious that the national law stands above the PCT.
And the EPO has not signed other international treaties, and will therefore not be bound by them, EVEN IF every single member state has signed and ratified that treaty.
As many articles about the EPO confirm, the EPOrg and the EPOff have little interest in international treaties, international standards, or complying with generally acknowledged principles of law, if there is no clear indication within the EPC to do so.

I see this statement and the filing of the appeal as a try to keep at least something of the cake, and a try to tell imvestors that not everything is lost, and that they please do not sell the shares yet.

Mr Blobby-Obvious said...

Lucky this wasn't a US IPR decision. My ears wouldn't have survived the sonic whine from the "IT'S NOT FAAAIIIIIIRRRRRRRR!!!!" brigade. Aeroplanes would have fallen from the sky and satellites knocked out of their orbits, and all because the spoiled brats are throwing their toys out of their prams.


It is NOT a point of law of fundamental importance. All points of law can have deleterious effects, but luckily I, and many others, have studied my subject. Foresight is a wonderful thing!

Anonymous said...

I am one who thinks that when both parties agree that the right of priority was validly transfered there should be no room for the EPO to challange that. Different countries have different rules on how a transfer of rights can be made and the EPO should not try to create their own standard that e.g. two parties in Japan have to observe when they file an EP patent application, potentially months after they have transfered the right of priority in a valid contract (eg orally) according to Japanese law.

Look at things said...

@ Anonymous 08:46, 23.01.2018

I beg to disagree on this point.

Do imagine the case of an opponent raising a novelty objection on the basis of a document published in the priority interval, while at the same time claiming that the priority has not been validly transferred.

In such a situation the EPO has no choice than to establish whether the priority has been correctly transferred, especially before filing the subsequent application claiming priority. It cannot be left to the first and the second applicant to bring forward a declaration stating that they have agreed on the transfer of priority. Such a decision cannot be left at the whim of parties. And hence the EPO has to dig into the matter and cannot shift the ball to another court. Oral transfer? A bit too easy.

What would otherwise be the legal basis for saying that the novelty objection raised by the opponent is moot? Just because two parties claim a valid transfer of priority? Let's remain serious.

Anonymous said...

@Look at things:

Well, it is established and codified that there is priority and that it can be transfered. So the two applicants have a legal basis. On the other hand, I do not see any provision in the EPC that would prevent a transfer of priority by an oral contract or presecribe a specific form for that matter. It is a legal principle that contracts can be made in any form if there are no specific provision in the law that require a specific form. Even further, I think that it is illegal when the EPO in light of no formal requirements in the EPC now generartes arbitrary formal requirements for priority transfer. Notarized? Hand written? Text form? Depending on the mood of a particular BoA, every contract could be declared not satisfactory by the EPO while it is perfectly legal and binding from a national perspective. I can buy out Elon Musk from Tesla if we both agree by an oral contract. Why should there be a special requirement for priorities, in particular as the EPC does not prescribe any specific form? I would also like to draw your attention to T796/12 where national law was used to decide whether an appeal can be filed by an opponent, who is no longer on the national company register and therefore "defunct". It was found that this is admissible, as the national law and jurisprudence assume that the no longer registered company is still a (somewhat limited) legal person. Point being: If national law decides whether a legal person is a legal person, it should also decide the validity of a civil contract.

Anonymous said...

There does appear to be some validity to Broad's submissions. Essentially, it appears that Broad are arguing what could be called a reverse partial priority. That is, the PCT application claims priority to only part of priority documents P1 and P2 and the proper applicants for the relevant parts of P1 and P2 were also the applicants for the PCT application. The applicant who is not an applicant for the PCT application was not entitled to the relevant parts of P1 and P2 and so shouldn't be an applicant for the PCT application and shouldn't be required to assign a right to priority for an invention he has no entitlement to.

There could well be basis for this in the EPC. In particular, Article 87 EPC refers to an application "for the same invention". Broad are arguing that P1 and P2 contained several inventions and the PCT application only covered some of those inventions. If P1 and P2 do contain several inventions then, according to US law, different applicants can be entitled to different inventions. In that case it is at least arguable that, if the PCT application does not claim all of the inventions in P1 and P2, then only the applicants of P1 and P2 that are entitled to the relevant inventions of the PCT application need be applicants of the PCT application.

I believe that this should be the correct interpretation. Otherwise we end up in the situation where a joint applicant that has no entitlement to an invention is required to assign a right to priority in the invention he has no rights in in order that a subsequent application has a valid priority claim. Of course, this goes against the current case law but an appeal to the Enlarged Board could well overturn this and I believe that such a decision wouldn't be against the EPC.

Anonymous said...

Casual Observer:

Unless I am missing something, is not the submitted Notice of Appeal deficient on the basis the address of the appellant has not been provided?

Mr Blobby-Obvious said...

Has sufficient information been provided to identify the appellant? Residence = GaGa Land?

Oral contracts are wholly binding on the EPO if they are binding in the country were made. Back-dated agreements are fine in my book also, provided you can file the evidence at the EPO on the day the contract is deemed to have entered into force. At the time of filing the priority-claiming application, full priority rights will be in the possession of the applicant. Fair?

Mr Blobby-Obvious said...

" Otherwise we end up in the situation where a joint applicant that has no entitlement to an invention is required to assign a right to priority in the invention he has no rights in in order that a subsequent application has a valid priority claim."

No we don't. The joint applicant may have no right in the invention, but they do have rights in the priority right, which exists outside of the USA.

This is little different than the UK-US position on invention ownership, whereby a UK employee inventor has rights in the US patent even though the UK Patents Act states all rights belong to the employer. Written assignment from the inventor to the employer then being standard practice to record the change of ownership. The UK Patents Act is not limited to rights in UK inventions, as supported by "all other purposes of S.39:

"...shall, as between him and his employer, be taken to belong to his employer for the purposes of this Act and all other purposes"

On the partial priority argument, this does not stand, because the priority right under Article 87 EPC resides with "Any person..who has duly filed an application..." The 'person' means the joint applicants, and the issue of partial rights in the invention is not relevant. The wording is identical to that used in the Paris Convention.

It is great that attorneys look to find ways to solve these issues on behalf of their clients, but didn't someone once say that hindsight was a wonderful thing, but foresight is better? No? ok.

The Convention watchdog said...

The discussion seems to shift away from the facts of the case decided by the Opposition Division. Even the proprietor does not allege that there was a consent by all the co-applicants of the provisional to file the internatial application claiming priority from the provisional. As to the form of transfer it seems to be meanwhile uncontested EP practice that it is governed by national law, i.e. in the case of a US provisional US civil law.

Glad to be out of the madhouse said...

What I find quite impressive in these Oral Proceedings is that the Broad was reportedly represented by 15 patent attorneys and lawyers from 9 different (and mostly expensive) firms. Those are quite a few billable hours...

And 64 auxiliary requests? Seriously?!

Finally I cannot fathom what went through the mind of the person(s) who thought it a good idea to disclose the settlement between the Broad and Rockefeller University only after the first day of oral proceedings, and then to try to introduce it into the proceedings the next day. I'm sure the OD was very impressed...

Glad to be out of the madhouse said...

I must also say that I love how US practitioners often think that everybody but them misunderstands the Paris Convention. That often gets a few laughs in proceedings before the EPO...

Anonymous said...

@Glad tp be out of the madhouse: yes, I noticed as well the huge number of representatives from various expensive firms. It appears though that they are representing the opponents. Broad is represented by a firm I do not know (I am not in the biotech sector though). The EPO file has now more than 42000 pages. That they claim priority from 11(!) prior applications is also somewhat unsual. What we maybe can learn from this: when the complexity becomes too high, the risks also increase. Keeep it as small and simple as possible.

MaxDrei said...

More thoughts. Deep inside the USA, it is not just First to File and the importance of the Paris Convention that is less than fully understood.

Investors in the USA suppose that litigation is a lottery but that their man will win provided that i) his pocket is deep enough and ii) the jury does not come to the idea that he is a Bad Guy. Quality at the patent drafting stage is seen as a secondary matter, less "sophisticated" than litigation, less valuable.

Further, Americans always suppose that nothing is decided till everything is decided, namely at trial (ie Oral Proceedings).

Yet further, Americans always suppose that once a patent issues, its validity is, in practice, unassailable.

As to the pace of the proceedings on this European patent thus far, note that the B1 issued just 9 months after EPO national phase entry.

More haste, less speed?

THE US anon said...

MaxDrei's thoughts about "deep in the USA" are - not surprisingly - way off from reality here.

ex-examiner said...

In my experience there is more than an element of truth in Max Drei's view. When I was a UK patent examiner in the 1980's I often found that patent applications from large US electronics companies had to be abandoned or severely limited in scope because they had published details of their new inventions in such things as the International Solid State Conference Proceedings. I used to become aware of these via reports in the American electronics journals that we used to get circulated, and around 50% of my citations comprised such non-patent literature. They would probably have a better chance of getting away with it today: I understand that when the UKIPO moved to Wales, the non-patent literature files that examiners had carefully built up were binned, and most of the better US electronics journals have folded anyway.

Likewise the presumed validity issue. When, in industrial practice, I was involved in a cross-licence activity, the US firm argued that one of its key patents had high validity because it had been subject of post-grant amendment. They presumably thought that the UK procedure was equivalent to the US "re-examination" procedure. I knew from personal experience that, in the UK, the examiner merely ensured that the amended claims were of narrower scope than the original claims, and we were able to dispel their belief by supplying an extract from the UK Patents Practice Manual that explicitly discussed the procedure.

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