Key points
- For those readers who are in a hurry and are not specifically interested in the principle of the free evaluation of evidence, below the link is a condensed version of the decision with only the parts about "plausibility" and with the (extensive and important) citations of earlier case law and national law omitted, i.e. only the reasoning of the Enlarged Board.
- The relevant headnote 2 of the decision is 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."
- I note that the term "plausibility" is not used in the headnote.
- This headnote requires some interpretation. The preliminary opinion contained a statement that is almost verbatim the same as the headnote (see my analysis of that statement here), though the remarks in the preliminary opinion about "significant doubts" did not make it to the final decision.
Summary of Facts and Submissions
Referred points of law
I. By interlocutory
decision T 116/18 of 11 October 2021 (hereinafter: the referring decision),
Technical Board of Appeal 3.3.02 (hereinafter: the referring board) referred
the following questions of law to the Enlarged Board of Appeal (hereinafter:
the Enlarged Board) for decision under Article 112(1)(a) EPC in combination
with
Article 22 RPBA 2020:
If for acknowledgement of inventive step the patent proprietor
relies on a technical effect and has submitted evidence, such as experimental
data, to prove such an effect, this evidence not having been public before the
filing date of the patent in suit and having been filed after that date
(post-published evidence):
1.
Should an exception to the principle of free evaluation of
evidence (see e.g. G 3/97, Reasons 5, and G 1/12, Reasons 31) be accepted in
that post-published evidence must be disregarded on the ground that the proof
of the effect rests exclusively on the
post-published evidence?
2.
If the answer is yes (the post-published evidence must be
disregarded if the proof of the effect rests exclusively on this evidence), can
the post-published evidence be taken into consideration if, based on the
information in the patent application in suit or the common general knowledge,
the skilled person at the filing date of the patent application in suit would
have considered the effect plausible (ab initio plausibility)?
3.
If the answer to the first question is yes (the post-published
evidence must be disregarded if the proof of the effect rests exclusively on
this evidence), can the post-published evidence be taken into consideration if,
based on the information in the patent application in suit or the common
general knowledge, the skilled person at the filing date of the patent
application in suit would have seen no reason to consider the effect
implausible (ab initio implausibility)?
Reasons
Scope
and Focus of the referral
Preliminary considerations
21 The referring decision points out in the introductory part of the referred questions that three questions of law arise in the context of examining inventive step of a claimed subject-matter.
22 In accordance with Article 52(1) EPC, patents shall be granted
for any inventions, in all fields of technology, provided that they are new,
involve an inventive step and are susceptible of industrial application.
23 According to the established
jurisprudence of the boards of appeal, the assessment of inventive step is to
be made at the effective date of the patent on the basis of the information in
the patent together with the common general knowledge then available to the
skilled person (see T 609/02, T 1329/04, T 1545/08; see also Case Law of the
Boards of Appeal [hereinafter: CLB], 10th edition, 2022, I.D.4.3.3, and the
decisions therein).
24 The boards of appeal and the administrative departments of the
EPO regularly apply the "problem and solution approach" in the course
of deciding whether or not a claimed subject-matter involves an inventive step
and fulfils the requirements of Article 56 EPC. This approach consists
essentially of the following methodologic steps (see CLB, 10th edition, I.D.2,
and the decisions therein):
(a) identifying the "closest prior
art";
(b) comparing the subject-matter of the claim at
issue with the disclosure of the closest prior art and identifying the
difference(s) between both;
(c) determining the technical effect(s) or result(s) achieved by and
linked to these difference(s);
(d) defining the technical problem to be solved
as the object of the invention to achieve these effect(s) or result(s); and
(e) examining whether or not a skilled person, having regard to the state of the art within the meaning of Article 54(2) EPC, would have suggested the claimed technical features in order to obtain the results achieved by the claimed invention.
25 The technical problem must be derived from effects directly and
causally related to the technical features of the claimed invention. An effect
could not be validly used in the formulation of the technical problem if the
effect required additional information not at the disposal of the skilled
person even after taking into account the content of the application in
question (see CLB, 10th edition, I.D.4.1, and the decisions therein).
26 Step (c), which is the most relevant in
the context of the present referral, requires that, in order to determine the objective
technical problem, the technical results and effects achieved by the claimed
invention as compared with the closest prior art must be assessed. According to
the established case law of the boards of appeal (see CLB, 10th edition,
I.D.4.2, and the decisions therein) it rests with the patent applicant or
proprietor to properly demonstrate that the purported advantages of the claimed
invention have successfully been achieved.
Intermediate conclusion
55 The Enlarged Board concludes from these considerations that the
principle of free evaluation of evidence qualifies as a universally applicable
principle in assessing any means of evidence by a board of appeal.
56 Hence, evidence submitted by a patent
applicant or proprietor to prove a technical effect relied upon for
acknowledgement of inventive step of the claimed subject-matter may not be
disregarded solely on the ground that such evidence, on which the effect rests,
had not been public before the filing date of the patent in suit and was filed
after that date.
57 This, however, does not immediately lead
to the answering of referred question 1 in the negative, without needing to
turn to referred questions 2 and 3 because they are dependent on an affirmative
answer to referred question 1. Notwithstanding the specific drafting of the
referred questions, the Enlarged Board accepts that the gist of the matter
underlying the present referral extends
beyond the literal wording of question 1.
58 The Enlarged Board considers the
conceptional notion inherent in the term "plausibility", which is
often used as a generic catchword, as not being a distinct condition of
patentability and patent validity, but a criterion for the reliance on a
purported technical effect. In this sense, it is not a specific exception to
the principle of free evaluation of evidence but rather an assertion of fact
and something that a patent applicant or proprietor must demonstrate in order
to validly rely on an asserted but contested technical effect. It appears to
the Enlarged Board that the parties, the President of the EPO and the majority
of third parties have a similar understanding.
59 As suggested by the parties and the President of the EPO, the
Enlarged Board acknowledges a need to provide guidance on the application of
the principle of free evaluation of evidence in respect of such post-published
evidence for the reliance on a purported but contested technical effect.
Jurisprudence regarding the reliance on a technical effect
for inventive step
General considerations
60 Before entering into a discussion of the case law of the boards of appeal, the Enlarged Board takes note of the decision in T 578/06, point 13 of the Reasons, where the board of appeal stated that the EPC required no experimental proof for patentability and considered that the disclosure of experimental data or results in the application as filed and/or post-published evidence was not always required to establish that the claimed subject-matter solved the objective technical problem. The board of appeal, while referring to T 893/02 and T 1329/04, emphasised in point 15 of the Reasons that this case law considered the establishment of a plausible reliance on a purported technical effect "only relevant when examining inventive step if the case in hand allows the substantiation of doubts about the suitability of the claimed invention to solve the technical problem addressed and when it is thus far from straightforward that the claimed invention solves the formulated problem. This is all the more clear from decisions where an inventive step was in fact denied because the formulated problem was not considered to have been solved."
61 In a number of decisions, the boards of appeal excluded from consideration post-published evidence because the content of the evidence was not available to the skilled person at the relevant date (T 1791/11: as the sole basis for establishing that the application solved the problem it purported to solve; T 125/12: to support an effect that was non-plausible from the application as filed; T 1285/13: the assessment of inventive step was to be made at the effective date of the patent on the basis of the information in the patent together with the common general knowledge then available to the skilled person, post-published evidence filed to support the argument that the claimed subject-matter solved the problem to be solved was taken into account if it was already credible from the disclosure in the patent that the problem is indeed solved; T 2348/13: post-published articles D42 and D43 did not illustrate common general knowledge; T 488/16: As the post-published documents were the first disclosure showing that the purported technical problem had actually been solved, these documents were therefore not taken into consideration in the assessment of inventive step; T 1099/19: The claimed technical effect was not made plausible at the effective date of the patent, and the post-published documents were not taken into account as they were the first disclosure going beyond speculation).
62 There are also decisions by which the
competent board of appeal considered post-published evidence submitted in the context
of assessing a claimed technical effect, albeit without a different outcome on
the issue of inventive step (T 179/16, T 978/16, T 1499/16, T 229/17, T 334/18, T 1306/18).
63 In T
108/09 post-published evidence was taken into account because the board of
appeal found that this evidence had not been the only source of information
regarding the claimed technical effect so that the data contained therein could
be used in the evaluation of whether or not the problem underlying the
invention in suit was plausibly solved.
Analysis of the case law
64 The Enlarged Board is aware of the case
law cited by the referring board as examples for different approaches to the
acceptance of a patent applicant's or patent proprietor's reliance on an
asserted technical effect (see points VI.(6) to (8) above and points 13.4 to
13.6 of the Reasons for the referring decision). As the volume of decisions on
the relevance of post-published evidence, such as experimental data, to prove
an alleged technical effect for acknowledgement of inventive step in the
context of
Article 56 EPC is too big to discuss in detail, the Enlarged Board
focusses on a selection of in particular more recent jurisprudence, which the
development of the earlier case law appears to culminate in.
65 In T 31/18, point 2.5.2 of the Reasons, which was categorised by the referring board as type III case law (see point 13.6 of the Reasons for the referring decision, also referring to T 2371/13, point 6.1.2 of the Reasons), the board of appeal held that the technical effect relied upon for inventive step according to the problem-solution approach must either be explicitly mentioned in the application as filed or at least be derivable therefrom, but not necessarily originally supported by experimental evidence. It could not be expected from a patent applicant to include an extensive amount of experimental evidence corresponding to all technical features which could possibly be claimed in the application as filed and which could possibly constitute a future distinguishing feature over the closest prior art, since said closest prior art and its technical disclosure may not be known to the applicant at the filing date of the application.
Decisions referred to as type I case law
66 Decision T 1329/04 is mentioned by the referring board as a key
example for the conceptional notion underlying referred question 2 (type I, see
point 13.4 of the Reasons for the referring decision). The board of appeal in T
1329/04 did not take into consideration post-published evidence and ultimately
denied an inventive step of the claimed subject-matter because the application
as originally filed lacked enough evidence to make it at least plausible that a
solution had been found to the purportedly solved problem. The relevant
reasoning is to be found in points 10 and 11 of the Reasons (emphasis added):
…
67 According
to T 235/13, T 787/14, T 488/16, T 2200/17,
T 377/18, T 391/18 and T 1442/18, post-published evidence can be taken
into account in support of a technical effect that was considered by the
competent board of appeal plausible already from the application as originally
filed. The following passages from the aforementioned decisions appear decisive
for the particular board of appeal for its findings:
T 235/13, point 2.6 of the Reasons:
T 787/14, points 19 to 21 and 23 of the
Reasons (emphasis added):
T 488/16, points 4.5, 4.9 and 4.19 of the
Reasons (emphasis added):
T 2200/17, point 9.6 of the Reasons:
T 377/18, point 3.3.1 of the Reasons:
T 391/18, points 83 and 8.4 of the Reasons:
T 1442/18, point 7.1 of the Reasons:
68 There are also decisions in which
post-published evidence was not taken into account because that evidence was
regarded as the sole basis for establishing that the technical problem was
indeed solved. Post-published evidence filed to support the argument that the
claimed subject-matter solved the problem to be solved could only be taken into
account if this was already credible from the disclosure in the patent:
T 415/11, points 51 and 54 of the
Reasons:
T 1791/11, points 3.2.6 and 3.2.7 of the
Reasons (emphasis added):
T 1322/17, point 4.4.7 of the Reasons:
Decisions referred to as type II case law
69 Examples of decisions taking post-published evidence into consideration only if the skilled person at the filing date of the patent application in suit would have seen no reason to consider the effect implausible, as underlying referred question 3 (type II, see point 13.4 of the Reasons for the referring decision) are T 536/07, T 1642/07, T 1677/11, T 919/15, T 2097/15, T 184/16 and T 2015/20.
T 536/07, points 9 and 11 of the Reasons:
T 1642/07,
points 18, 21 and 22 of the Reasons (emphasis added):
T 1677/11, point 9.5 of the Reasons
(emphasis added):
T 919/15, point 5.6 of the Reasons:
T 2097/15, points 2.2 and 2.2.2 of the
Reasons:
T 184/16, points 2.5 to 2.9 of the
Reasons:
T 2015/20, points 2.6, 2.7 and 5 of the
Reasons (emphasis added):
Intermediate conclusion
70 The Enlarged Board takes note of the
classification done by the referring board in respect of the case law of the
boards of appeal concerning the relevance of post-published evidence to prove
an asserted technical effect for acknowledgement of inventive step (see points
13.4 to 13.6 of the Reasons for the referring decision).
71 However, when analysing the case law in
more detail and irrespective of the conceptual terminologies for what questions
2 and 3 refer to as two distinct plausibility approaches, the Enlarged Board
understands from the case law of the boards of appeal as common ground that the
core issue rests with the question of what the skilled person, with the common
general knowledge in mind, understands at the filing date from the application
as originally filed as the technical teaching of the claimed invention.
72 Applying this understanding to the aforementioned decisions, not in reviewing them but in an attempt to test the Enlarged Board's understanding, the Enlarged Board is satisfied that the outcome in each particular case would not have been different from the actual finding of the respective board of appeal. Irrespective of the use of the terminological notion of plausibility, the cited decisions appear to show that the particular board of appeal focussed on the question whether or not the technical effect relied upon by the patent applicant or proprietor was derivable for the person skilled in the art from the technical teaching of the application documents.
Considerations concerning the jurisprudence regarding
sufficiency of disclosure
73 As noted in points 11 and 12 above, the
referred questions do not require an answer to the issue of sufficiency of
disclosure and Article 83 EPC. However, as the terminological notion of
plausibility relied upon by the referring board in questions 2 and 3 of the referral
and the reasons for it is mainly to be found in the case law of the boards of
appeal with regard to the patentability requirement of sufficiency of
disclosure, the Enlarged Board accepts the appropriateness of a comparative
analysis and comparative considerations in this regard.
74 While the issues of sufficiency of disclosure (Article 83 EPC) and inventive step (Article 56 EPC) and their assessment are clearly to be treated separately and on their own, as correctly pointed out by the referring board in point 13.3.1 of the Reasons of the referring decision, the Enlarged Board is aware of the case law in particular concerning second medical use claims where the notion of "plausibility" has been used. For such claims, the issue of reliance on post-published evidence for a purported technical effect arises in particular in the context of sufficiency of disclosure.
Indeed, a technical effect, which in the case of for example a second
medical use claim is usually a therapeutic effect, is a feature of the claim,
so that the issue of whether it has been shown that this effect is achieved is
a question of sufficiency of disclosure under Article 83 EPC.
Hence, because the subject-matter of second medical use claims is commonly
limited to a known therapeutic agent for use in a new therapeutic application,
it is necessary that the patent at the date of its filing renders it credible
that the known therapeutic agent, i.e. the product, is suitable for the claimed
therapeutic application. The Enlarged Board explained the legal and historical
background to the patentability of further medical uses in its decision G 2/08.
75 In decision T 609/02 (points 5 to 9 of the Reasons, emphasis
added), cited by the referring board and in some decisions discussed in the
context of inventive step, the board of appeal reasoned its finding on lack of
sufficiency of disclosure:
76 Other examples for decisions in line with T 609/02 can be found
in the following cases:
T 1599/06,
points 6, 7.1, 7.2 and 8 of the Reasons (emphasis added):
T 754/11, point 25 of the Reasons (emphasis added):
T 760/12,
point 3.3, 3.10 and 3.15 of the Reasons (emphasis added):
T 895/13, points 15 to 18 of the Reasons (emphasis added):
T 1045/13,
points 3.2 and 3.3 of the Reasons (emphasis added):
T 2059/13,
points 4.5.3 and 4.6 of the Reasons (emphasis added):
T 887/14, points 3.6.11 to 3.6.13 of the Reasons:
T 321/15,
points 3.2.5 and 3.3 of the Reasons (emphasis added):
T 1680/17, point 3 of the Reasons (emphasis added):
T 1571/19,
points 1.2 and 1.16 of the Reasons (emphasis added):
Intermediate conclusion
77 The reasoned findings of the boards of
appeal in the decisions referred to above make clear that the scope of reliance
on post published evidence is much narrower under sufficiency of disclosure
(Article 83 EPC) compared to the situation under inventive step (Article 56
EPC). In order to meet the requirement that the disclosure of the invention be
sufficiently clear and complete for it to be carried out by the person skilled
in the art, the proof of a claimed therapeutic effect has to be provided in the
application as filed, in particular if, in the absence of experimental data in
the application as filed, it would not be credible to the skilled person that
the therapeutic effect is achieved. A lack in this respect cannot be remedied
by post-published evidence.
National legal framework and jurisprudence with regard to
the reliance on a technical effect for inventive step
78 While according to the AIPPI 2019 Study on plausibility none of the statutory framework of the EPC Contracting States referred to in the following contain an explicit patentability requirement for what the referring decision in questions 2 and 3 refers to as plausibility concepts (see group reports for Switzerland, Germany, France, United Kingdom (England and Wales) and The Netherlands), the Enlarged Board is aware of the respective national jurisprudence and literature. In the following, the different approaches concerning the reliance on an asserted technical effect for inventive step and the relevance of post-published evidence have been identified by way of examples.
Switzerland
Germany
France
The Netherlands
United Kingdom (England and Wales)
Intermediate conclusion
86 Like the EPC, none of the legal systems of the EPC Contracting States provide for an explicit patentability requirement for what the referring decision discusses and addresses with what is referred to in questions 2 and 3 under the term "plausibility".
87 Notwithstanding the fact that the
aforementioned decisions were taken on the decisive facts of the case in hand
and the particular submissions made by the parties to those proceedings, the
Enlarged Board recognises a certain degree of common ground that the courts of
the EPC Contracting States, when confronted with the examination of an asserted
technical effect in the assessment of inventive step and with the question
whether a patent proprietor may rely on post-published evidence to confirm that
technical effect, ponder on the technical teaching of the claimed
subject-matter that the person skilled in the art, with the common general knowledge
in mind, understands from the patent application.
Concluding considerations
88 As already mentioned in points 55 to 59 above, the proceedings
under the EPC are governed by the principle of free evaluation of evidence
which is also known in various EPC Contracting States with a civil law system.
89 The principle of free evaluation of evidence depicts a
universally applicable principle of both procedural and substantive law in
assessing any means of evidence submitted by a party in proceedings under the
EPC, be it an administrative department of the EPO or a board of appeal as the
competent judicial body reviewing decisions of such administrative departments
pursuant to Article 106(1) EPC.
90 As the principle of free evaluation of evidence is enshrined in the right of each party to proceedings under EPC to give evidence in appropriate form pursuant to Articles 113(1) and 117(1) EPC, it may not be used to disregard evidence per se insofar as it is submitted and relied upon by a party in support of an inference which is challenged as to its plausibility and is decisive for the final decision.
91 Hence, evidence submitted by a patent applicant or proprietor
to prove a purported technical effect relied upon for acknowledgement of
inventive step of the claimed subject-matter may not be disregarded solely on
the ground that such evidence, on which the effect rests, had not been public
before the filing date of the patent in suit and was filed after that date.
92 The term "plausibility" that is
found in the case law of the boards of appeal and relied upon by the referring
board in questions 2 and 3 of the referral and the reasons for it, does not
amount to a distinctive legal concept or a specific patent law requirement
under the EPC, in particular under Article 56 and 83 EPC. It rather describes a
generic catchword seized in the jurisprudence of the boards of appeal, by some
national courts and by users of the European patent system.
93 The relevant standard for the reliance on a purported technical
effect when assessing whether or not the claimed subject-matter involves an
inventive step concerns the question of what the skilled person, with the
common general knowledge in mind, would understand at the filing date from the
application as originally filed as the technical teaching of the claimed
invention. The technical effect relied upon, even at a later stage, needs to be
encompassed by that technical teaching and to embody the same invention,
because such an effect does not change the nature of the claimed invention.
94 Hence, 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 consider said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.
95 The Enlarged Board is aware of the abstractness of some of the
aforementioned criteria. However, apart from the fact that the Enlarged Board,
in its function assigned to it under Article 112(1) EPC, is not called to
decide on a specific case, it is the pertinent circumstances of each case which
provide the basis on which a board of appeal or other deciding body is required
to judge, and the actual outcome may well to some extent be influenced by the
technical field of the claimed invention. Irrespective of the actual
circumstances of a particular case, the guiding principles set out above should
allow the competent board of appeal or other deciding body to take a decision
on whether or not post-published evidence may or may not be relied upon in
support of an asserted technical effect when assessing whether or not the
claimed subject-matter involves an inventive step.
Order
For these
reasons it is decided that the questions of law referred to the Enlarged Board
of Appeal are answered as follows:
1.
Evidence submitted by a patent applicant or
proprietor to prove a technical effect relied upon for acknowledgement of
inventive step of the claimed subject-matter may not be disregarded solely on
the ground that such evidence, on which the effect rests, had not been public
before the filing date of the patent in suit and was filed after that date.
2.
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.
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