Interpretation of G 2/21: Inventive step may be supported solely by post-published data (T 0116/18)

The minutes of oral proceedings have been published from the referring Board of Appeal case behind G 2/21 (T 0116/18). The minutes are brief but confirm the Board of Appeal's decision to acknowledge the inventive step of the claimed invention and to dismiss the appeal. The inventive step of the claimed invention was acknowledged based on the post-published data submitted by the Patentee. The minutes therefore support an interpretation of G 2/21 that permits inventive step to be based on a purported technical effect that is neither explicitly mentioned nor supported by data in the application as filed. 

G 2/21 case catch-up: The evidence standard for inventive step (it's not about plausibility)

At issue in the case referred to the Enlarged Board of Appeal (EBA) in G 2/21 were product claims to a new combination of known insecticides (EP 2484209). The application included data demonstrating the inventive, synergistic effect of the insecticide combo against two species of moth (T 0116/18).

At opposition, the Opponent submitted data showing that the insecticide combo did not in fact have a synergistic effect against one of the exemplified moth species (P. xylostella) at certain weight ratios. The Opponent argued that the purported technical effect of the claimed invention could thus not be supported. In response, the Patentee filed their own new data showing the efficacy of the insecticide combo against a third species of moth (C. suppressalis). The Patentee argued that the technical effect of the invention was the narrower effect of the insecticide combo against C. suppressalis. Importantly, the application as filed mentioned C. suppressalis but did not provide any efficacy data against this particular moth species for compounds falling under the scope of the claims.

Both the Patentee and the Opponent in T 0116/18 therefore wished to rely on post-published data for their inventive step argument. The Opponent wished to rely on post-published negative data, showing that a purported technical effect was not achieved. In response, the Patentee wished to rely on post-published data supporting an alternative inventive step argument for the claimed subject matter. 

How many moths needed for an invention? 

In its interlocutory decision, the Board of Appeal sought clarity from the EBA on whether post-published evidence may be taken into account for inventive step. Importantly, the Board of Appeal also came to interlocutory conclusions on inventive step for when the post-published was either ignored or taken into account. The Board of Appeal concluded that:

  • If the data in the application as filed and the Opponent's post-published data were taken into account, inventive step (synergy against P. xylostellacould not be acknowledged (r. 12.4.9)

  • If the data in the application as filed, and both the Opponent's and Patentee's post-published data were taken into account, inventive step (synergy against C. suppressallis) could be acknowledged (r. 12.5.1). 

The decision of the EBA in G 2/21

In G 2/21, the EBA decided that:

"A patent applicant or proprietor 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, emphasis added)

The EBA did not give an opinion on how the principle that a technical effect is "encompassed and embodied" by the application as filed should be applied to the facts of the case in G 2/21. Crucial to the understanding of G 2/21 is thus how the Board of Appeal would implement the decision.

Minutes from Oral proceedings in T 0116/18

The EBA remitted the case in G 2/21 back to the Board of Appeal for a decision on inventive step. It was therefore left to the Board of Appeal to apply the "abstract principles" of G 2/21 to the facts of the case in question. As mentioned above, the Board of Appeal in T 0116/18 had already reached its own conclusions regarding inventive step for the different scenarios in which the Patentee's and/or Opponent's post-published data could be considered. According to the minutes of oral proceedings, the Board of Appeal found that these conclusions could not be revisited in view of the binding effect of the interlocutory decision. Further additional data from the Opponent, relating to C. suppressalliscould therefore not be taken into account (page 3, last paragraph). 

The minutes of oral proceedings do not record the details of the subsequent discussion over the interpretation of G 2/21. The minutes merely record the Board of Appeal's conclusion that the Patentee could "rely on the synergism against C. suppressallis" shown in their post-published evidence for technical effect. On this basis, the Board of Appeal found the claims inventive and dismissed the appeal. 

EPO and UK divergence on "plausibility"

The UK courts have also recently interpreted G 2/21In Sandoz v BMS ([2023] EWCA Civ 472). Lord Justice Arnold interpreted G 2/21 as supporting an ab initio plausibility standard for both sufficiency and inventive step (i.e. that an invention and its technical effect must be rendered plausible in the application as filed in view of common general knowledge). However, the UK is increasingly out of step with the EPO on "plausibility". Most importantly, the UK continues to treat "plausibility" as almost a legal test in and of itself (IPKat), and consequently fails to make a distinction between the evidence standard for inventive step and sufficiency (IPKat). By contrast, the interlocutory decision in T 0116/18 confirmed the very well-established EPO case law that the sufficiency (Article 83 EPC) of a technical effect is not at issue, if the technical effect is not a claimed feature of the invention (G 1/03, r 2.5.2). In G 2/21the EBA also dismissed "plausibility" as a catch-word for the evidence standard for a purported technical effect (G 2/21, r. 58), finding that it is not a legal test having basis in the EPC.

Final thoughts

We now await publication of the written decision from the Board of Appeal which will hopefully provide more guidance on how G 2/21 should be interpreted. However, we can already draw a few conclusions from the minutes:

First, by accepting the Patentee's post-hoc inventive step argument, it appears the Board of Appeal was comfortable finding inventive step based on a purported technical effect for which there was no direct data provided in the application as filed. This is a potentially important development in the case law, with implications across technical fields (IPKat). Technical effect in T 0116/18 was acknowledged with respect to a moth species, C. suppressalis, which was only mentioned in the context of data relating to insecticides that did not fall under the scope of the claim (Example 4). Therefore, it appears from the Board of Appeal decision in T 0116/18 that a purported technical effect does not need to be mentioned in the application as filed in order for it to be considered "encompassed and embodied" by technical teaching of the application as filed (G 2/21). Instead, a purported technical effect may be solely supported by post-published data. 

Second, the minutes of oral proceedings from T 0116/18 also confirm the apparent divergence of the UK and the EPO on the evidence standard for inventive step. It is difficult to align the interpretation of G 2/21 by Lord Justice Arnold in Sandoz v BMS with the Board of Appeal decision in T 0116/18 reported in the minutes of oral proceedings. As previously discussed, this discrepancy has at its heart the failure of the UK courts to distinguish between the evidence standard for inventive step and sufficiency (see Sandoz v BMS, para. 50 "subsequent data cannot be a substitute for sufficient disclosure in the specification") (IPKat)

These issues and more will be discussed at CIPA Congress in Cambridge on 3 October. PatKat will be joining Ian Jones (GJE), James St.Ville KC (8 New Square) and Sarah J. Rodriguez (Finnegan), in a panel discussion on "plausibility" in all its guises, chaired by Greg Corcoran (ASML).

Further reading

Interpretation of G 2/21: Inventive step may be supported solely by post-published data (T 0116/18) Interpretation of G 2/21: Inventive step may be supported solely by post-published data (T 0116/18) Reviewed by Rose Hughes on Sunday, September 10, 2023 Rating: 5

9 comments:

  1. Wow! This decision is perhaps more important than the G decision. So one can show the synergistic effect necessary for inventive step by post-filing data only. The specification does not need to 'show' it (i.e. have the data), at least for an insecticidal composition situation. This is not a medical use (therapy) situation where achievement of the therapeutic effect is a technical feature of the claim (and so must be disclosed in the specification), and so it will be interesting to see whether Divisions and Boards dealing with therapy inventions will decide on a different set of rules for the plausibility requirement. [The written decision will be fascinating]

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    1. Indeed. Bring on the written decision. I suppose the squeeze on the Board is how to do justice between the parties (fair protection versus legal certainty), given the constraints on the Technical Boards which the highly prescriptive (and unassailable) problem-solution approach to patentability imposes. At the EPO that is, even if not elsewhere.

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  2. One wonders why the present board has ever bothered to refer a question to the EBA.
    The apparent result could have been achieved without this bother.
    This is the more so since the decision of the EBA is not helping the matter whatsoever, beside the fact that the word plausibility is not to be used and the lateness of submission is not necessarily determining for its acceptance.
    In case of diverging submissions from the parties in matters of experimental data, case law says that the benefit of the doubt goes to the proprietor.
    Such a consideration would at least be understandable, even if one cannot be entirely convinced by it. The position of the board is to simply accept any submission if it has the merits needed by the boards to come to a decision, whatever it might be.

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    1. Anonymous of Thursday, 14 September 2023 at 00:43:00 GMT+1, I think the Board could have come to a decision without the referral to the EB, but I think everyone who uses the EPO has benefitted from the G decision. That decision explicitly did not come up with a specific structured test for the use of post-filing data, and that is useful for everyone to know (i.e. there is no specific test along the lines, x, y, z, etc). That means the use of the post-filing evidence will have to be decided on in the specific situation according to the facts of the case, without the Board having the ability to completely ignore or completely accept the post-filing data. In practical terms from what I have seen EPO Divisions are now (after the G decision) much more accepting of post-filing data in support of the technical effect being achieved. I think anything that makes the system less strict is good at this time when every other test is becoming stricter.

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    2. The point about "every other test" of patentability getting ever "stricter" is, I think, a good one.

      One imagines that the chorus of criticism in recent years, over the manifold consequences of strict adherence to i) the almighty "Gold Standard" and ii) the unassailable and brutally prescriptive problem-solution approach, has not gone entirely unnoticed by the members of the EBA.

      Contemplating the imposition on the captive Applicant of yet another turn of those two particular thumbscrews was perhaps giving the individual board members uneasy feelings in their respective guts.

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    3. Anonymous of Thursday, 14 September 2023 at 00:43:00 GMT+1Saturday 16 September 2023 at 16:31:00 GMT+1

      Dear Santa,

      I can agree with you that the G decision has clarified that post-published evidence cannot be dismissed merely for the reason that it is post-published. I do however beg to think that this result was achieved before the G decision, and that in this respect, the situation has not changed.

      By not giving clear replies to the questions raised, and accepting that its considerations can be seen as abstract, the EBA has not been helpful whatsoever.

      I would rather claim that in the absence of clear cut rules, we risk in the end to be faced with arbitrary decisions of the boards. When one sees how dealings at the boards has become a procedural lottery, it does not bode well when it comes to the topic of post-published evidence. If it is not admitted in first instance, it has barely a chance to be admitted before the boards.

      Examining or opposition divisions might accepting post published evidence more willingly, but the problems created by post-published evidence have not been solved in the slightest. We are actually back to square one.

      I would rather the guess that since the term plausibility has now been banned by the EBA, other terms like credibility, foreseeability, expectation and the like will come up. Overall gain: nope.

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    4. Thank you Anonymous of Thursday, 14 September 2023 at 00:43:00 GMT+1, but I disagree with your point about the term 'plausibility' now being banned since showing of achievement of technical effect in the specification is still going to be an important requirement in many situations, especially for therapy inventions. I think in the chemical/pharma/biotech field you often end up the situation where the distinction over the prior art is the showing of the achievement of the technical effect (essentially due to 'reasonable expectation of success' introducing the idea that resolving of the doubt of whether it works can be an important part of the technical contribution). That entire understanding of what inventions (and contributions) can be hasn't gone away merely due to this decision based on showing synergy for an insecticidal composition - so let's see what happens next.
      I also disagree with your procedural lottery point, though of course I see the danger you are pointing out. I think Boards are actually quite good at what they do, and can be trusted to judge inventive step properly in the absence of clear cut rules.
      I also personally believe that even where a Board does not admit post-published evidence it still reads it, and receives some comfort that any decision they make in favour of the applicant/patentee is sensible.

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    5. Anonymous of Thursday, 14 September 2023 at 00:43:00 GMT+1Thursday 21 September 2023 at 16:59:00 GMT+1

      Dear Santa,

      Whilst I can agree with you that “in the chemical/pharma/biotech field you often end up the situation where the distinction over the prior art is the showing of the achievement of the technical effect. The technical effect is the treatment of some illness, group of patients, dosage regimen etc.

      In such a situation, the technical effect is claimed as it is the therapeutic indication, and this leads me to G 1/03 and T 2001/12 (just look at the catchword). In a nutshell, G 1/03 and T 2001/12 made clear that if an effect is not claimed, then the objection should be Art 56. If an effect is claimed, then the objection is not lack of IS, but lack of sufficiency. This is why in T 488/16 (Dasatinib 1) sufficiency was not given, while in T 950/13 (Dasatinib 2) sufficiency was given. In T 847/14, the effect was claimed, hence lack of sufficiency. In T 1469/16, the effect was not claimed, hence lack of inventive step. I thus never understood why in G 2/21 the EBA limited itself to IS. There is a clear interplay between Art 83, 84 and 56.

      As far as the procedural lottery is concerned, I invite you to look at different situations: combination of claims, deletion of claims, and OP by ViCo or not, late admission of experimental data by an OD.

      In case of combination of claims some boards admit them, e.g. T 418/17, T 2855/18 or T 1174/18 and some boards do not admit them, e.g. T 3027/18, T 2248/17 or T 1991/12.

      In case of deletion of claims, some boards consider that they do not represent an amendment to a proprietor’s case, e.g. T 1480/16, T 2243/18, T 1792/19, T 1151/18, T 1857/19, or T 2201/19. Some boards consider that deletion of claims represent an amendment, but admitted them, e.g. T 2091/18, T 1597/16, T 1439/16, T 1224/15,
      T 908/18, T 682/16 or T 168/16. Some boards considered them as an amendment and they were not admitted even if they could be considered as not being detrimental to procedural economy, e.g. T 1259/17, T 482/19 or T 317/20.

      As far as OP are concerned, some boards find that G 1/21 gives limits to the discretion of the boards not to hold in-person OP, e.g. T 2341/16, T 2303/19 or T 996/20. Other boards refuse to hold in-person OP T 2526/19, T 1158/20 or T 758/20. In the latter the board even went as far as to claim that G1/21 could be ignored.

      In case of experimental data, those are not admitted even filed within the time limit under R 116(1), e.g. T 2051/09, T 1310/10, T 1223/10, T 1130/13. In T 1605/16 the OD admitted experimental data but since the other party had not requested postponement, its right to be hear had not been violated. In T 518/17 experimental data filed by the other party when entering appeal were admitted by the board.

      I am thus still of the opinion, that as far as procedure is concerned, there is a lottery effect at the boards. The RPBA20/21 have given great discretion to the boards in procedural matters and this discretion is not applied uniformly. This has also to be seen with respect of R 6/20, in which the EBA reiterated its position that it would not review discretionary decisions of the boards.

      When you find that any decision they make in favour of the applicant/patentee is sensible. This stance might be acceptable for the patentee but not to opponent. However, it is perfectly acceptable that in case of contradictory assertions by the parties, whereby the Office is not in a position to decide, then the benefit of the doubt goes to the proprietor, cf. T 72/04, T 808/05 or T 1598/15.

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    6. Thank you Anonymous of Thursday, 14 September 2023 at 00:43:00 GMT+1 for that illuminating reply. I do not disagree with the point you are making on the lottery effect for procedural issues. However my comment was really only about inventive step being decided correctly. I believe Boards do a good job in recognising the contribution and judging by a consistent standard what is inventive and what is not.
      In terms of the procedural issues you talk of, I would say that in practical terms EP attorneys know what they must do in terms of defending their client's best interests, i.e. how to argue admissibility, or whether it is or is not amendment of the case, etc. However I also agree that the inconsistencies you mention are very frustrating. Thank you for such a detailed and long reply

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