Key points
- "[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 [] 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."
- "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"
- To rephrase this statement slightly: if technical effect ... is a feature of the claim, the issue of whether it has been shown that this effect is achieved is a question of sufficiency of disclosure under Article 83 EPC. This was also noted in G 2/03.
- "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." [r.74.3]
- In other words, it is necessary under Art. 83 for second medical use claims that the patent (or patent application) at the filing date renders it credible that the known therapeutic agent, i.e. the product, is suitable for the claimed therapeutic application.
- Note, the Enlarged Board does not say that the opponent must show that it was not credible on the basis of the patent application (as filed) on the filing date the recited therapeutic agent was suitable for the claimed therapeutic application.
- Clearly, it is the application as filed, as understood by the skilled person on the filing date in the light of common general knowledge of the skilled person on that date, that must render it credible that the recited therapeutic agent is suitable for the therapeutic application specified in the claim under examination.
- Note, the Enlarged Board does not say that the application as filed must provide full proof that the recited therapeutic agent is suitable for the therapeutic application specified in the claim under examination.
- Note, the Enlarged Board says, "renders it credible". A purely verbal statement that a compound is suitable for treating disease X may not always be sufficient to meed this requirement (in fact, may often be insufficient) even though (at least under currently prevailing case law) such a statement would be fine as disclosure under Art. 123(2) for a corresponding second medical use claim.
- Note, the Enlarged Board's requirement logically extends to allegedly novelty-destroying prior art for second medical use claims.
- The requirement, probably, also extends to non-medical use claims ("use of compound X for purpose Z"), and to first medical use claims ("compound X for use as medicament"), for the latter the application as filed must render it credible that the recited compound is suitable for a therapeutic application.
- The Enlarged Board does not mention serious doubts substantiated by verifiable facts, i.e facts to be adduced by the opponent. Because the Enlarged Board specifically mentions that "it is necessary that the patent ... renders it credible", the Enlarged Board's holding appears to be directed not in the least to opposition proceedings.
- The Enlarged Board's reasoning to arrive at this conclusion regarding sufficiency is remarkably brief, though building on the preceding extensive review of the case law on inventive step in the decision. The Enlarged Board observes that "the technical effect ... is a feature of the claim", and then the above-cited r.74.3 follows. This paragraph is followed by a summary of some decisions of Technical Boards of Appeal on sufficiency.
- The precise function of the reference to G 2/08 is not entirely clear to me. It might be noted that G 2/08, r.5.3 mentioned that "the exclusion from patentability of [medical methods] seemed actually to be based on socio-ethical and public health considerations."
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:
"The patent specification provides no
evidence at all relating to the invention in claim 6 [...]
The appellant provided post-published evidence
showing that steroid hormones such as needed to carry out the use according to
claim 6 were later structurally identified and that they, indeed, have an
effect on AP-1 stimulated transcription. [...]
On the basis of the disclosures of these post-published documents, it was argued by the appellant that by carrying out the claimed invention, one would necessarily obtain pharmaceutical compositions since it was by following the teachings of the patent in suit that the post-published results had been obtained. Consequently, in the appellant's opinion, sufficiency of disclosure had to be acknowledged. The board cannot share this opinion. Sufficiency of disclosure must be satisfied at the effective date of the patent, ie on the basis of the information in the patent application together with the common general knowledge then available to the skilled person. Acknowledging sufficiency of disclosure on the basis of relevant technical information produced only after this date would lead to granting a patent for a technical teaching which was achieved, and, thus, for an invention which was made, at a date later than the effective date of the patent. The general principle that the extent of monopoly conferred by a patent should correspond to, and be justified by, the technical contribution to the art, has to be kept in mind
[...] It
is required that the patent provides some information in the form of, for
example, experimental tests, to the avail that the claimed compound has a
direct effect on a metabolic mechanism specifically involved in the disease,
this mechanism being either known from the prior art or demonstrated in the
patent per se. [...] Once this evidence is available from the patent
application, then post-published (so-called) expert evidence (if any) may be
taken into account, but only to back-up the findings in the patent application
in relation to the use of the ingredient as a pharmaceutical, and not to
establish sufficiency of disclosure on their own."
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):
"[...] if a
therapeutic application is to be accepted as sufficiently disclosed, the
application or the patent, respectively, and/or the common general knowledge
has to provide some information rendering it technically plausible for the
skilled person that the claimed compounds can be applied for the claimed
therapeutic use (T 219/01 of 15 December 2004; T 609/02 of 27 October
2004)[...]
In the decision
under appeal the examining division considered that no conclusion could be
drawn from data in the application demonstrating an immunoprotective effect for
the 30 kDa protein or the 32A kDa protein. It supported its view by referring
to evidence in document D1 describing differing immunological properties of the
30 kDa and the 32A kDa proteins in a skin test for assaying the induction of
delayed-type hypersensitivity[...]
However, the authors of document D1 see a possible reason for this difference in the fact that the 32A kDa protein is "more efficiently released from the bacilli, and the dose of this antigen may therefore be markedly reduced by use of killed cells for sensitization"(page 381, left-hand column). Thus, the failure to induce a reaction is not necessarily ascribable to the immunological capabilities of the protein, but to the low quantities present in the killed bacteria used for sensitisation. Hence, in the board's view, the results in document D1 pointed to by the examining division are not conclusive evidence of a difference in the immunological reactivities of the two proteins. Therefore, the extrapolability of data in the application concerning the immunoprotective effect of the 30 kDa protein to the 32A kDa protein cannot be called into doubt by the disclosure in document Dl."
T 754/11, point 25 of the Reasons (emphasis added):
"As stated by the opposition division the provision of experimental evidence for
the claimed medical uses is not necessary as long as the underlying
physiological mechanisms make such use plausible (cf. inter alia, T 609/02 of
27 October 2004, point 9 of the "Reasons for the Decision").
Target-specific RNA degradation is sufficiently disclosed in Examples 1 to 3 of
the patent application to make also credible the target-specific degradation of
the disease-associated RNAs mentioned in claims 13 to 16. Furthermore, page 8, line 30, to page 9, line 26, provide guidance on
how to prepare a composition for therapeutic applications. Finally, there
is also ample post-published evidence on file to confirm this conclusion (cf.
inter alia, page 159, Table 1 of document D36). This evidence can be taken into
account because it only supports the findings and disclosure of the patent (cf.
T 609/02, supra)."
T 760/12,
point 3.3, 3.10 and 3.15 of the Reasons (emphasis added):
"These [claims 6 and 7] being second
medical use claims, the technical effect, which is the therapeutic effect, is
expressed in the claim. When the technical effect is expressed in the claim,
the issue of whether this effect is indeed achieved over the whole scope of the
claim is a question of sufficiency of disclosure (G 1/03, OJ 2004, 413, Reasons
2.5.2). Hence, under Article 83 EPC, unless this is already known to the
skilled person at the priority date, the application must disclose the
suitability of the product to be manufactured for the claimed therapeutic
application (T 609/02, Reasons 9). Thus, in order to establish whether the
requirement of sufficiency of disclosure is met, it has to be assessed whether the application discloses the potential
suitability of the substance as defined in the claim to exert a therapeutic
effect on a tumour or angiogenesis-related disorder which is associated with
activation of c-met. [...]
Hence, the patent essentially teaches to antagonise the beta chain in order to interfere with c-met activation, but this teaching was already derivable from the prior art, including D5, which had disclosed that the beta subunit of HGF was "crucial for the optimum activation of Met receptor induced by HGF/SF" (D5, page 7446, right column, lines 11 to 13). However, the patent does not demonstrate that any monoclonal antibody with the functional characteristics as defined in the claim (binding to activated HGF beta chain and inhibiting the binding of said activated HGF beta chain to c-met) would inhibit c-met activation. The skilled person would thus have to embark on a research programme without any teaching in the application on how to achieve the desired effect of inhibiting c-met activation with a single monoclonal antibody (T 1466/05, Reasons 16). Hence the board concludes that it is not sufficiently disclosed in the patent that a single monoclonal antibody as defined in the claim potentially exerts the therapeutic effect as claimed.[...]
As to D30 and D41, these are post-published
documents and hence not available to the skilled person at the effective date
of the patent. Moreover, they do not establish that the teachings of the patent
enabled the production of antibodies with the functional characteristics as
claimed, in particular the claimed therapeutic effect, because the antibodies
disclosed therein are not directed against the activated beta chain."
T 895/13, points 15 to 18 of the Reasons (emphasis added):
"However, as a matter of fact, the claimed
vaccine which is based on tetanus toxoid as the carrier has not been
exemplified in the patent. No data are reported in the patent for meningococcal
conjugates using tetanus toxoid as the carrier.
In view of the
well-established phenomenon of carrier suppression, in particular in the
context of tetanus toxoid
and the known unpredictability of carrier
suppression in the context of conjugate vaccines ([...], the results obtained in the patent with CRM197 as the carrier do not
make it plausible that meningococcal conjugates using tetanus toxoid as the
carrier are suitable for the successful immunisation of patients that had been
pre-immunised with tetanus toxoid. Under these circumstances, post-published
evidence cannot be taken into account for the establishment of sufficiency of
disclosure
In view of the above considerations and in the
light of decision T 609/02, the subject-matter of claim 1 of the main request
fails to meet the requirements of Article 83 EPC and the request is therefore
not allowable."
T 1045/13,
points 3.2 and 3.3 of the Reasons (emphasis added):
"To sum up, the appellant has chosen to
rely solely on experimental evidence in support of the therapeutic treatment as
claimed in claim 1. The experimental
evidence on file fails however to provide evidence for the effects claimed.
The examples do not cover the whole scope of
the claim and do not provide evidence of therapeutic efficacy that meets
scientific standards (statistically significant number of patients, control
group). Effective treatment of the medical conditions under consideration has
thus not been shown. Consequently, the board comes to the conclusion that the
subject-matter of claim 1 is not sufficiently disclosed (Article 83 EPC)."
T 2059/13,
points 4.5.3 and 4.6 of the Reasons (emphasis added):
"For these reasons, there is no evidence
on file showing that the person skilled in the art was in the possession of
common general knowledge at the filing date of the patent in suit which,
together with the disclosure of the application as filed, led to the direct and
unambiguous conclusion that 5-HT1A agonists in general, or any of the compounds
of formula (1) in particular, were useful in the treatment of any type of
bipolar disorder.
Hence, the
application as filed in combination with the common knowledge at the filing
date did not disclose the suitability of any of the compounds of formula (1) in
the treatment of any type of bipolar disorder. Consequently, the minimum
requirements set out in T 609/02 for taking into account post-published
evidence are not met."
T 887/14, points 3.6.11 to 3.6.13 of the Reasons:
"With regard to whether it is plausible
that other macrocyclic lactones of the same class recited in claim 1 would also
share synergy with spinosad, the board notes that the patent itself provides a
plausible mechanistic explanation of why this would be the case [...]. In the
absence of any evidence to the contrary, the board sees no reason not to accept
this as a reasonable assumption. The board also sees no reason to reject said
explanation due to the lack of in vivo data in the patent, as argued by the
appellant, since as mentioned above, the in vitro test according to example 2
thereof may be considered in vivo at least as far as the fleas are concerned.
In view of the above, the tests of example 2
of the patent, D12, D13, D14, D15 and D26 plausibly demonstrate that synergy is
present in the majority of ratios tested, the only concrete exception being the
1:1 ratio described in D12 (see "Conclusions") which is said to
"reflect a purely additive interaction" (between spinosad and
milbemycin).
Consequently the board is in no doubt that it
would be within the routine ability of the skilled person to arrive at
appropriate synergistic ratios of spinosad to the specific macrolactone recited
in claim 1 without undue burden."
T 321/15,
points 3.2.5 and 3.3 of the Reasons (emphasis added):
"Taking all these facts together, the
board acknowledges that at the priority date of the patent in suit the
administration to infants at risk of developing obesity later in life of the
claimed nutritional composition could plausibly/credibly achieve the claimed
therapeutic effects. With respect to the post-published D15 and D16, they need
not be taken into account for the assessment of sufficiency of disclosure, more
specifically the suitability of the claimed nutritional compositions for the
achievement of the claimed therapeutic effects. According to the case law of
the boards of appeal of the EPO, such post-published
documents can only confirm the expectations of the skilled person reading the
patent in suit and having knowledge of the prior-art documents D1 and D2 (T
609/02, points 9 and 13 of the Reasons). Whether these documents indeed confirm
the reasonable expectations of the skilled person can be left undecided since
the board is already convinced of the invoked plausibility as stated
above."
T 1680/17, point 3 of the Reasons (emphasis added):
"Consequently, the data presented in the application as filed and depicted in the published patent renders it plausible that the claimed composition is suitable for use in the treatment of breast cancer. Post-published evidence, in the form of document (35), was filed as confirmation. Hence, the invention as defined in the claims is sufficiently disclosed in the patent and the ground for opposition under Article 100(b) EPC does not prejudice the maintenance of the patent."
T 1571/19,
points 1.2 and 1.16 of the Reasons (emphasis added):
"Attaining
the claimed therapeutic effects is a functional technical feature
characterising claim 1. Thus, in order to meet the
requirement of sufficiency of disclosure, the patent must render it plausible
that the claimed feed composition is suitable for treating the diseases
indicated in the claim [...]
For these reasons, and considering the fact that the content of n-3 fatty acids, EPA in particular, was considerably higher in the CMS diet than in the reference diet, it is plausible that, as postulated in paragraphs [0009], [0010], [0011] and [0061] of the opposed patent, compositions comprising n-3 fatty acids in the claimed proportions are suitable for treating and preventing the relevant disorders. [...] However, there is no evidence that the skilled person, relying on the information given in the opposed patent and on common general knowledge, would not have been able to prepare a composition as described in claim 1 which is suitable for treating the relevant diseases. It has thus been concluded that the claimed invention is sufficiently disclosed (Article 83 EPC)."
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