G 2/21 - The preliminary opinion (and Ariad and Toolgen)

Key points

• The Enlarged Board has issued a preliminary opinion in referral G 2/21. This opinion is of course non-binding. It was naturally discussed on numerous weblogs already (e.g. here).
• The Enlarged Board, in the preliminary opinion: "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. The technical effect relied upon [for inventive step],  even at a later stage, needs to be encompassed by that technical teaching and to embody the same invention." (r.15)
• As a comment, the Board here seems to  formulate the requirement that a technical effect, which is invoked by the patentee (or applicant) in the assessment of inventive step according to the problem-solution approach, needs to be "encompassed by [the] technical teaching [of the application as filed]", wherein said technical teaching is "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" 
• This rule appears to be an elaboration of the established line of case law that "as a matter of principle, any effect provided by the invention may be used as a basis for reformulating the technical problem, as long as that effect is derivable from the application as filed (T 452/05, ...) (CLBA I.D.4.4.2); see also T 13/84: "A reformulation of the problem which then may become necessary is not precluded [...] if the problem could be deduced by the person skilled in the art from the application as filed when considered in the light of the [closest prior art]." The Enlarged Board seems to rephrase and refine "derivable"  and "could be deduced"  in terms of the technical teaching of the application.
• The technical effect invoked by the patentee (i.e. "relied upon") also needs to "embody the same invention", according to the above-cited part of the preliminary opinion.  I understand this requirement to refer to the invention as the skilled person understands it from the application as filed (i.e. not necessarily the same invention as claimed in the application as filed). The phrase "the same invention" is (probably) not used here in the sense of "the same subject matter" (as it was in G2/98) since G 2/21 is about inventive step and not about Article 123(2).
  
• see CLBA I.D.4.4.2: "In relation to new effects it was not permissible to change the nature of the invention".
• These requirements are tied to the application as filed and the skilled person's common general knowledge at the filing date.
• To cite Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010): “the test [for possession/written description] requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.”
• These requirements are probably to be applied in addition to, and distinct from, the requirement of T939/92 r.2.6 that a technical effect must be credibly achieved over (substantially) the entire claim.
• The Enlarged Board: "It is then on the basis of the application documents and this technical teaching that a purported technical effect relied upon for inventive step is to be assessed as to whether the skilled person, having the common general knowledge in mind, would have had any significant reason to doubt it."
• " In the absence of any such doubts, the reliance on post-published evidence, such as experimental data, for the purported technical effect would seem to serve as a potential source for a deciding body to conclude whether or not it is convinced of said technical effect when deciding on the inventiveness of the claimed subject-matter." 
• The Enlarged Board here seems to confirm the main rule that post-published evidence can be used to show that the effect is actually achieved (over the entire claim), cf. T939/92. 
• The Enlarged Board: " However, whether such [post-published] evidence could also successfully be relied upon in the event that the skilled person, on the basis of the application as originally filed together with the common general knowledge, had significant doubts in respect of the purported technical effect, appears questionable." 
• The Enlarged Board here possibly conveys that post-published evidence is, as a general rule, not suitable to show what the skilled person would consider as the technical teaching of the patent application "on the basis of the application as originally filed together with the common general knowledge" (i.e. as of the filing date). This observation seems as such independent of the existence, or not, of significant doubts.
• To give a noteworthy example of possible suitable post-published evidence was recently given in one of the CRISPR-Cas interference cases: 
  "the [PTAB] considered the opinion of the peer reviewers of the eLife manuscript, that: "This excellent paper [note, this paper was published a day after filing provisional patent application P3] demonstrates the capability of a method based on the bacterial CRISPR-Cas system to introduce targeted, mutagenic double-strand breaks into human chromosomal DNA. (...)" The Board concludes that "[t]hus, the reviewers, persons of ordinary skill in the art at the time CVC P3 was filed, considered the gels depicted in Figures 38B and 36E [of the manuscript, but also included in the patent application] to contribute to evidence of a CRISPR-Cas9 system that successfully cleaved DNA within eukaryotic cells, noting 'the paper demonstrates' this and the study 'show[s]' it.  ... the Board emphasizes that the possession test requires "an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art" (emphasis in opinion) [citing Ariad, see above]. The similarity of the disclosure in P3 and the eLife publication, and the publication reviewer's assessment of the science disclosed therein, was sufficient to convince the Board that the CVC inventors possessed the invention and were entitled to priority benefit to the P3 provisional application. " (source: PatentDocs 23.10.2022) (I'm not entirely sure if contemporaneous non-published documents such as peer review comments are post-published evidence in the sense of G2/21).
• Perhaps it can be said that a technical effect is not a part of the technical teaching of the application as filed, even if it is explicitly (or verbatim) stated in the application as filed, if the skilled person would have had significant doubts about that technical effect on the filing date and on the basis of (only) the application as filed and his/her common general knowledge at that date. This technical effect can then not be invoked under the PSA.
• The burden to show the significant doubts will be on the opponent but the initial burden to show the required technical teaching will be on the patentee, it seems to me.
• An example would be a patent application stating that 'the inventive compound are effective against [long list of all kinds of diseases]'. The application in such a case states verbatim that the compound works, but that may be no technical teaching in the sense of the preliminary opinion. 
• The Enlarged Board seems to indicate that the above-discussed rules, as stated in the preliminary opinion,  are not rules pertaining to the admissibility of the evidence. The Enlarged Board, as a preliminary remark, observes that "the principle of free evaluation of evidence [under Article 117 EPC] does not appear to allow disregarding evidence per se insofar as it is submitted and relied upon by a party in support of an inference which is challenged and is decisive for the final decision" (without prejudice to the discretionary power to hold late-filed evidence inadmissible, it may be added). 

EPO 

https://register.epo.org/application?documentId=L95QJ8WQRL3OUXE&number=EP12002626&lng=en&npl=false 

Text of the preliminary opinion below the jump.

Introduction

[...]

Admissibility of the referral

7 The Enlarged Board is satisfied that the referral meets the

requirements of Article 112(1) (a) EPC.

8 The referring board has set out in detail why an answer to the

referred questions is indispensable for its decision on the

appeal before it, because, in its view, the final decision on

the appeal hinges on whether evidence published after the

filing date of the patent in suit (post-published evidence)

and submitted by the patent proprietor to prove a technical

effect can be taken into account or must be disregarded. Thus,

an answer to at least some of the referred questions is

required to enable the referring board to reach a decision on

the appeal before it.

9 The referring board's discretionary decision to directly admit

the opponent's test data but to postpone a decision on the

patent proprietor's test data is not subject to a review by

the Enlarged Board in the course of proceedings under

Article 112(1) (a) EPC. Hence, it does not prejudice the

admissibility of the referring board's decision to refer to

the Enlarged Board points of law it judged decisive in respect

of the patent proprietor's evidence.

Question 1

10 The first question is directed to the point of law of whether

a deciding body is required to deviate from the principle of

free evaluation of evidence in respect of post-published

evidence submitted as the exclusive support of an alleged

technical effect when assessing inventive step.

11 The principle of free evaluation of evidence entails a key

rule of procedural law governing the patent granting

proceedings before the administrative departments of the EPO

and the boards of appeal as the first and final judicial

instance (see G 1/12, point 31 of the Reasons; G 3/97 and

G 4/97, point 5 of the Reasons).

12 In consequence, the principle of free evaluation of evidence

does not appear to allow disregarding evidence per se insofar

as it is submitted and relied upon by a party in support of an

inference which is challenged and is decisive for the final

decision. Disregarding such evidence as a matter of principle

would deprive the party submitting and relying on such

evidence of a basic legal procedural right generally

recognised in the contracting states and enshrined in

Articles 113(1) and 117(1) EPC.

Questions 2 and 3

13 Notwithstanding the aforementioned considerations in respect

of the principle of free evaluation of evidence, the Enlarged

Board accepts that the gist of the matter underlying the

present referral gives rise to the need to provide some

guidance on the issues referred to in questions 2 and 3.

14 In this respect, the Enlarged Board notes that the points of

law which led to the referral arose in the context of the

assessment of inventive step of the claimed subject-matter.

The referring board explicitly acknowledged sufficiency of

disclosure of the claimed invention in the framework of

Articles 100(b) and 83 EPC. The Enlarged Board, therefore,

does not consider it appropriate to extend the clear scope of

the referral beyond what the referring board identified as

decisive for its decision, i.e. the significance of post-

published evidence relied upon in respect of a purported

technical effect when assessing whether the claimed subject-

matter involves an inventive step in terms of Article 56 EPC.

15 The Enlarged Board understands from the case law of the boards

of appeal and of courts of the EPC Contracting States as well

as from various submissions and observations received during

the present referral proceedings 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. The technical effect relied upon,

even at a later stage, needs to be encompassed by that

technical teaching and to embody the same invention.

16 It is then on the basis of the application documents and this

technical teaching that a purported technical effect relied

upon for inventive step is to be assessed as to whether the

skilled person, having the common general knowledge in mind,

would have had any significant reason to doubt it.

17 In the absence of any such doubts, the reliance on post-

published evidence, such as experimental data, for the

purported technical effect would seem to serve as a potential

source for a deciding body to conclude whether or not it is

convinced of said technical effect when deciding on the

inventiveness of the claimed subject-matter.

18 However, whether such evidence could also successfully be

relied upon in the event that the skilled person, on the basis

of the application as originally filed together with the

common general knowledge, had significant doubts in respect of

the purported technical effect, appears questionable.