The updated EPO Guidelines for Examination will enter into force on 1 March 2024. A draft version of the Guidelines can be previewed here. The main updates this year reflect the recent decisions from the Enlarged Board of Appeal (EBA) in G2/21 (Evidence standard for inventive step/plausibility) and G 1/22 (Entitlement to priority). There are also updates on the sufficiency requirements for AI inventions, ways to define antibodies and acceleration of opposition proceedings in cases pending before the UPC.
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| Is the Broad CRISPR appeal coming back from the dead? |
The impact of G 2/21 on inventive step and free evaluation of evidence (E-IV-4.1, G-VII-5.2,11)
The decision of the EBA in G2/21 left plenty of scope for interpretation. The EBA concluded in G2/21 that a patentee "may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention" (Headnote II, G2/21). Recent Boards of Appeal decision have provided some clarity as to what it means for a technical effect to be "encompassed and embodied" (IPKat). The Guidelines have been updated to reflect the EBA's decision, but provide no further guidance on how it should be interpreted (G-VII-5.2,11). The decision in G2/21 on the principle of the free evaluation of evidence has also been included in an updated to E-IV-4.1.
Disclosure requirements for AI inventions (F-III-3, G-II-3.3.1)
Inventions relating to AI require supporting data and examples akin to the disclosure requirements for inventions in the biotech field (IPKat). This requirement has now been explicitly called out in the guidelines:
"Occasionally applications are filed in which there is a fundamental insufficiency in the invention in the sense that it cannot be carried out by a person skilled in the art [...] another example can be found in the field of artificial intelligence if the mathematical methods and the training datasets are disclosed in insufficient detail to reproduce the technical effect over the whole range claimed. Such a lack of detail may result in a disclosure that is more like an invitation to a research programme" (F-III-3)
and
"The technical effect that a machine learning algorithm achieves may be readily apparent or established by explanations, mathematical proof, experimental data or the like. While mere allegations are not enough, comprehensive proof is not required, either. If the technical effect is dependent on particular characteristics of the training dataset used, those characteristics that are required to reproduce the technical effect must be disclosed unless the skilled person can determine them without undue burden using common general knowledge. However, in general, there is no need to disclose the specific training dataset itself" (G-II-3.3.1)
ST.26 sequence listings and divisionals (A-IV-5)
The ST.26 standard for sequence listings came into force in July 2022 and applies to all new European applications filed after this date, including divisionals. Applicants are now therefore required to convert a ST.25 sequence listings filed for a parent case into the ST.26 format for any new divisionals. However, converting from ST.25 to ST.26 has the potential to add matter (as acknowledged by the WIPO itself). A solution to this problem is to add the ST.25 sequence listing to the end of the description of the divisional, and file the ST.26 after the initial filing date. However, applicants following this approach might incur high excess page fees if the sequence listing is very long. In response to pressure from epi, the EPO therefore agreed to waive the excess page fees for adding the ST.25 sequence listing to the description (IPKat). This provision has now been added to the Guidelines: "By way of exception, an additional fee is not due either for a parent application's ST.25 sequence listing filed in PDF format as part of a divisional application" (A-IV-5).
Designation of the inventor (A-III-7)
A-III-7 now states that the EPO will check whether the designated inventor is a natural person. This update follows the decision in J 8/20 (DABUS) that an AI cannot be designated as an inventor (IPKat).
Acceleration of opposition proceedings in cases of pending actions before the UPC (D-VIII-1.2)
The EPO recently announced new provisions for accelerating opposition in (IPKat). The Guidelines have been updated to reflect the latest notice:
"oppositions are to be given priority [...] if a party to the proceedings has submitted a reasoned request for accelerated processing in a case where an infringement action in respect of the European patent is pending before the Unified Patent Court or a national court of a contracting state, or if the EPO is informed by the Unified Patent Court, a national court or competent authority of a contracting state that infringement actions are pending" (D-VIII-1.2)
Antibodies (G-II-6.2)
At the EPO it is possible to claim a genus of antibodies according to their target antigen or epitope (IPKat). The Guidelines have been updated to further clarify the circumstances in which these types of claims are permitted, including the sufficiency requirements and the burden of proof with respect to prior art antibodies (G-II-6.2) (IPKat). The updates to the Guidelines on antibodies also reflect Boards of Appeal case law in this field (IPKat). Interestingly, however, specific guidance relating to the definition of antibodies according to their epitope has been removed.
Adaptation of the description
We are currently awaiting a referral on the legality of forcing applicants to amend the description in line with the allowed claims (IPKat). Controversy over description amendments began with a significant tightening to the requirement in the 2021 Guidelines (IPKat). This year, the Guidelines for opposition have been updated to explicitly state that adaptation of the description may also be required if the patent is amended during opposition:
"the description of the patent may be examined for compliance with the requirements of Art. 84 only when, and then only to the extent that, an amendment of the patent introduces non-compliance with Art. 84. In particular, inconsistencies between the description and the claims resulting from amendments during opposition proceedings and casting doubt on the subject-matter for which protection is sought must be avoided" (D-V-5)
Further reading
- 2019: Updates to the EPO Guidelines for Examination - the highlights
- 2021: Highlights from the new EPO guidelines for examination 2021: ViCo oral proceedings, description amendments and antibodies
- 2022: Changes in the draft 2022 EPO Guidelines for Examination on description amendments: Substantial changes or window-dressing?
- 2023: Highlights from the new EPO Guidelines for Examination 2023: Erroneous parts, UPC and sequence listings
Reviewed by Rose Hughes
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Tuesday, February 13, 2024
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Posts
I am a little confused by the statement that "the description of the patent may be examined for compliance with the requirements of Art. 84 only when, and then only to the extent that, an amendment of the patent introduces non-compliance with Art. 84".
ReplyDeleteArt 84 is a requirement of the claims. For an OD to conclude that an amended claim set meets the requirements of the EPC, it must first conclude that those claims comply with all relevant provisions of the EPC, including Art 84. This would seem to preclude revisiting Art 84 at a later stage.
Does this mean that we should view a pronouncement from an OD that an amended claim set meets the requirements of Art 84 EPC as representing only a provisional assessment, subject to later confirmation re: possible inconsistencies with the description? Is that even possible? Does the OD's pronouncement not terminate all deliberations on the matter?
@ Proof of the pudding alias Doubting Thomas,
DeleteIt would have been surprising that you would not have commented on the adaptation of the description.
You are really playing on words, and the situation is perfectly clear. Your position is against better knowledge and you know it.
It is only once the wording of the claims has been finalised, that the description can, and has to be, adapted to the claims.
In another blog, I have reminded you that if the applicant or the proprietor files AR which are allowable, but does not file an adapted description and is absent from the OP, then the application is refused or the patent is revoked. I have never been told off by a board for adopting this position as member of an ED or an OD.
If the applicant or the proprietor is present at the OP, it gets enough time to present an adapted description. In opposition it is important that the opponent is informed of the adaptation of the description. If the OD adapts the description without communicationg the adaptation to the opponent it commits a SPV. The opponent might not agree, and sometimes wants to see more adaptation. However, the last word stays with the OD. I do not remember seeing an opponent only filing an appeal if he is dissatisfied with the adaptation of the description.
An ED or an OD can only take a decision of grant or of maintenance in amended form with a complete set of documents. Such a decision is not possible if the description has not been adapted. This is standard practice. Nearly everyday boards remit to the first instance with the order to grant or maintain a patent with a defined set of claims and a description to be adapted.
Mr Thomas, with all due respect, you are missing the point that I was trying to make.
DeleteAccording to the EPO, Art 84 is the legal basis for their practice regarding adaptation of the description. If that is the case, then it is not legally correct for an OD to:
- pronounce that an amended claim set complies with the requirements of Art 84; and
- subsequently demand that the description be adapted to remove alleged inconsistencies with the claims.
This is because this practice treats the support requirement of Art 84 as if it were a requirement to be met by the description, whereas both the wording and the title of Art 84 make it abundantly clear that it is instead a requirement of the claims.
Perhaps this problem can be cured by ODs instead pronouncing that amended claims meet the clarity and conciseness requirements of Art 84 EPC, rather than of Art 84 in its entirety. Whilst this may be a nitpicking point, its purpose is to highlight the possibility that the EPO may not be looking at the requirements of Art 84 EPC through the right lens.
@ Proof of the pudding alias Doubting Thomas
DeleteWith all due respect, I am not missing anything you were trying to make.
Claims can well be clear and concise, whilst defining the matter for which protection is sought, but they are then not necessarily supported by the description.
As a member of an ED or OD, it would never have come to my mind to declare that an amended claim set complies with the requirements of Art 84 as a whole.
The examination of the compliance with the support requirement of Art 84 can only come after it has been decided that the claims are clear and concise, which is the first requirement under Art 84.
I would even go as far as to say that the order of the requirements in Art 84 is not a coincidence.
By doing as I did all along my active time and as you suggest, I think that this is the way to look ar Art 84 through the right glass.
Mr Thomas, are you really saying that no OD has ever considered Art 84 EPC in connection with an amended claim set and then announced their decison that "the claims ... comply with the requirements of Article 84 EPC"? My impression is that such prounouncements are commonplace.
DeleteI think that it is going a little too far to read some kind of significance (for the EPO's day-to-day practice) into the order that the three separate requirements are listed in the 2nd sentence of Art 84 EPC. However, it would be interesting if you could point to any objective evidence to support that conclusion.
In any event, the EPO interprets the "support" requirement of Art 84 to be two-way, namely as comprising a first requirement for the claims not to include any subject matter not described and a second requirement for the description not to include any subject matter not claimed. The first of these requirements must surely be considered by any OD that assesses compliance of the claims with Art 84. I therefore do not think that, at least under the EPO's interpretation, the separation of requirements is quite as clean as you suggest.
@ Proof of the pudding alias Doubting Thomas
DeleteI have been taught and practised all along my active time at the EPO that first the claims have to be clear and concise and as such allowable, whereby they should manifestly be novel, inventive and not comprise added matter.
Only then the question of the adaptation of the description comes into play. I have never confused adaptation of the description with clarity of the claims as such. I have also always accepted that adaptation of the description could wait until the wording of the claims has been ascertained.
.
You cannot discuss support of the claims without having first discussed their content. This is as objective as objective can be. Any other position would defy lthe most elementary ogic.
I have left active service now 12 years ago and a lot of things might have changed. I can even accept this, but you are really playing on words, and it is getting tiring to reply to this game.
Playing on words? No. Trying to make a serious point? Yes.
DeleteTo help you understand the point, take a look at paragraph 78 of the decision of the OD that was the subject of the appeal in T 673/22 (the topic of a post on your blog today). As you will see, Opponent 1 had the impression that objections to the description would be handled by the OD separately from objections to the claims.
Now how would the opponent have arrived at that impression? It did not come out of nowhere, and so must have been based upon the impressions that they formed from their prior dealings with the EPO.
And one more thing: even if an OD is very careful to pronounce that an amended claim set meets the clarity requirement of Art 84 EPC, there could still be a problem with the OD subsequently dealing with adaptation of the description. This is because, according to one line of case law of the Boards of Appeal, the legal basis for requiring adaptation of the description is the clarity provision of Art 84.
Like I say, whilst this may be nitpicking, it has a purpose. That is, it represents a plea for clear, consistent and logical reasoning from the EPO on the interpretation of Art 84 EPC. To date, that has (at least in my view) been sadly lacking in almost all EPO practice and case law on Art 84.
Very interesting how the parts on antibodies in the Guidelines are now tracking the case law very precisely, when in my experience certain opposition divisions are mostly ignoring them or coming to their own interpretations. It's not quite clear what the issue is here that the EPO is trying to solve, though it seems to be taking a sensible and fair approach. It's a shame the EPO cannot explain to us transparently why the Guidelines are focusing on this particular technology area and what the aims are they are trying to achieve
ReplyDeleteG 1/22-G 2/22 have certainly simplified the possibility of validly claiming the priority and in this respect it has to be welcomed.
ReplyDeleteThe problem with T 844/18 and the Broad Institute is slightly different. The discussion in T 844/18 turned around the absence of one of the inventors/applicants of the US provisional as applicant in the subsequent European application.
The main argument discussed at the time was not the fact of the Broad Institute was an applicant, but the absence of one of the original applicants of the original US provisional. The Broad Institute claimed that “any” applicant could be applicant in the subsequent European application. This is however not correct. The official language of the PUC is French and the plurality of “celui qui” is “ceux qui” and not merely “any” applicant, but “those who”. The English translation by WIPO is not binding.
It is thus doubtful that the situation will change for the divisional. With all three original applicants in the subsequent European application, then the presumption established by G 1/22-G 2/22 could apply. On the other hand application of Art 60 as claimed by the Broad institute at the time is now off in view of G 1/22-G 2/22.
I am thus of the opinion that the presumption established by G 1/22-G 2/22 is not applicable to the Broad Institute. In this particular case, absence of one of the original applicants, the presumption is clearly rebuttable.
I cannot agree with your opinion. The situation you describe was discussed by the enlarged board. Paragraphs 104, 105, 107 and 108 (at least) of the enlarged boards decision seem to contradict your view.
DeleteI respect your interpretation of § 104, 105, 107 and 108 of G 2/22, but this does not mean that I can agree with it.
DeleteThe absence of one of the inventors in the subsequent application, which was mentioned in the application from which priority is claimed, allows reasonable doubts whether the Broad Institute has validly claimed the priority.
I see there the beginning of a rebuttable presumption. I would not go as far as to claim that G 2/22 has solved the problem of whether “any” applicant is enough in the subsequent application. The problem stemming from an inadequate translation of “celui qui” has not been set aside by G 2/22.
Mr Thomas, might the following quote from paragraph 128 of G1/22 change your view?
Delete"An agreement (regardless of its form) can only be held against parties who were involved in the facts establishing the agreement. Co-applicants for the priority application who were not involved in the subsequent application may not be deemed to have consented to the reliance on the priority right by the other co-applicants for the priority application (a situation underlying e.g. T 844/18). The subsequent applicant(s) may however still be entitled to claim priority since the rebuttable presumption of entitlement does not depend on whether the involved applicants acted as co-applicants at any stage."
The Board of Appeal has recently issued its preliminary opinon applying G 1/22 to several of the Broad Institute's divisional patents that were found by the OD to have an invalid priority claim. In the Board's view, the rebuttable presumption does exist for this situation and notably, considers that none of the evidence filed by the opponents rebuts this presumption. In fact, they consider that a settlement agreement published many years after the priority and filing date to support the presumption that priority is valid.
DeleteThe Board's preliminary opnion can be seen here: https://register.epo.org/application?documentId=LS8SLZP2YRKZEG9&number=EP15154539&lng=en&npl=false
I think we can expect the opponents to have quite a bit to say in response to this preliminary opinion.
I do not think there is much room for reasonable doubt. The enlarged board were quite explicit that if the requirements of Article 88 are complied with, the presumption applies. I would further refer to the headnote of the decision:
DeleteThere is a rebuttable presumption under the autonomous law of the EPC that the applicant claiming priority in accordance with Article 88(1) EPC and the corresponding Implementing Regulations is entitled to claim priority.
II. The rebuttable presumption also applies in situations where the European patent application derives from a PCT application and/or where the priority applicant(s) are not identical with the subsequent applicant(s).
Paragraph 126 further confirms that the absence of one priority applicant is not sufficient proof to overturn the rebuttable presumption:
To put into question the implied agreement, evidence would be needed that an agreement on the use of the priority right has not been reached or is fundamentally flawed. For example, party B could act in bad faith to the detriment of party A who may then not be fully informed about the subsequent PCT application. A dispute between the parties at the relevant filing date was mentioned in an amicus curiae brief (efpia) as a further example (point 3.2). Factual indications putting into question the implied agreement have to be of a substantial nature and have to be presented by the party questioning the implied agreement.
@ Proof of the pudding and Anonymous of 16.02.24
DeleteI fully agree with Point 128 in G 1/22, that the subsequent applicant(s) may however still be entitled to claim priority since the rebuttable presumption of entitlement does not depend on whether the involved applicants acted as co-applicants at any stage.
I would however observe that, even if the Broad Institute might be prima facie considered as validly claiming priority, the fact that one of the inventors has been squeezed out from the subsequent application, allows to raise doubts about the validity of the priority claimed for this reason alone.
When looking at the complete case, we are clearly in the presence of a rebuttable presumption. There is ample room for reasonable doubt.
Regarding Guideline F-IV 4.3, first paragraph, the requirement for adaptation of the description is now worded as follows : « Any inconsistency between the description and the claims must be avoided if it casts doubt on the subject matter… » . The change is in the wording « if it casts doubt » (present tense) which replaces the former wording « if it could throw doubt » (hypothetical). This looks like a step in the right direction, making the wording of the EPO Guideline an inch closer to the PCT Guideline 5.29. This wording clarifies that the onus is on the ED to show that the inconsistency causes doubt. This will help applicants challenge the requirement when it is only justified by an ED’s reference to the Guideline, without specific reasoning.
ReplyDeleteConcerning the frequent case of description amendments entered by the ED at the 71(3) stage, applicants may challenge the amendments on the basis of Guideline C-V 1.1 which deals with the implementation of Rule 71(3). This Guideline states : « This text may include amendments and corrections made by the examining division on its own initiative which it can reasonably expect the applicant to accept. The applicant should be contacted by telephone or an official communication has to be written. »
This attitude is at loggerheads with the authoritative implementation of Rule 71(3) by EDs imposing amendments (i) the applicant is unlikely to accept (ii) without prior communication, which amounts to arm-twisting the applicant.
Dear Mr Hagel,
DeleteI can agree with you that the arm twisting of applicants in the communication under R71(3) is not acceptable, and cannot be considered as quality work delivered by EDs. This problem should be tackled by the EPO, even if it indirectly means a slight delay in granting patents. When the applicant disagrees with the amendments carried out by the ED, the grant procedure is anyway extended. So why not do it properly to start with?
As far as the provisions of the PCT are concerned, those have no influence on substantive law under which the EPO works and its interpretation in the Guidelines. The aim of the PCT is not to grant patents, but to ease the way in obtaining a patent. Designated and elected offices can divert from suggestions made in the PCT. Just look at the restauration of priority. The EPO has a much tougher stance than other offices. The same goes for added matter.