4. Identity of invention
4.6. Enabling disclosure in the priority document
The decisions below highlight that the priority document must disclose the invention claimed in the subsequent application in such a way that it can be carried out by a person skilled in the art.
In T 81/87 (OJ 1990, 250) the board took the view that the argument that the skilled person would supplement the disclosure from his common general knowledge to make it work, should any difficulty be encountered, was no excuse when this was a feature of the definition of the invention, and was missing, not envisaged by the inventor and not implied by the description. In order to give rise to priority rights the essential elements, i.e. the features of the invention, in the priority document had to be either expressly disclosed or directly and unambiguously implied in the text as filed; missing elements recognised as essential only later on were not part of the disclosure, and gaps with regard to basic constituents could not be retrospectively filled by relying on knowledge acquired in this manner. It could become a misuse of the priority system if some parties in a competitive situation were allowed to jump ahead of others on the basis of mere expectations and by omitting the critical features of the invention altogether. This decision was followed in e.g. T 301/87, OJ 1990, 335, and in T 296/93, OJ 1995, 627.
The board in T 301/87 (OJ 1990, 335) considered that if an entity itself is disclosed to the skilled person, this does not necessarily mean that a component part is also disclosed for the purpose of priority if this cannot be envisaged directly and unambiguously as such, and requires considerable investigation to reveal its identity.
In T 296/93 (OJ 1995, 627) the board was not convinced by the respondent’s (opponent's) argument that the priority document was deficient in respect of relevant technical information necessary for reducing the claimed invention to practice by the person skilled in the art without undue burden. See also T 207/94 (OJ 1999, 273), T 767/93, T 20/04.
In T 919/93 the board found that certain passages in the European application as filed, essential for the application to meet the requirements of Art. 83 EPC 1973, had no counterpart in the priority document, which was thus not enabling for the claimed subject-matter.
In T 843/03 the board referred to the requirement that the priority document provide an enabling disclosure (T 81/87, OJ 1990, 250; T 193/95). It had been established in a number of boards of appeal decisions that sufficiency of disclosure presupposes that the skilled person is able to obtain substantially all embodiments falling within the ambit of the claims and that the skilled person, in order to reach this goal, may not be confronted with an undue burden. Based on previous case law on the requirement of Art. 83 EPC 1973 (T 19/90, OJ 1990, 476) and on the novelty requirement (T 464/94) the board concluded that, when an applicant provided a technical disclosure and prima facie evidence as to certain technical elements in an application, it was the EPO which had the burden of proof when judging that something was not shown. The board held that the examining division had not taken the legally appropriate approach when deciding to the disadvantage of the applicant with the reason that "[…] no absolute fact can be deduced from figure 7 as to whether it shows correctly formed HPV 16 particles or not". The board did not see full proof of such facts as a requirement within the framework of the EPC and could not see any serious doubts of the examining division substantiated by verifiable facts.
In T 903/05 the board considered that the claimed selection, made from only one list of entities, was directly and unambiguously derivable from the priority document in the sense of G 2/98. Since the enablement of the disclosure of this document had explicitly not been challenged, the board saw no reason to doubt it. Beyond the issue of enablement, the board saw no legal basis for imposing additional criteria such as the presence of experimental data in the priority document (see also T 1834/09). In T 411/19, however, concerning claim 1, which was directed to a second medical use, the board found that the priority document P1 contained no experimental data or other evidence of any kind that went beyond a mere allegation that the peptides defined therein were indeed suitable for the treatment of the disorders listed. It could therefore not be concluded that P1 provided even an initial plausibility that the claimed compounds were suitable for treating the disorders in question. Thus, P1 did not disclose the invention of claim 1 in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. For case law on Art. 83 EPC following G 2/21 (OJ 2023, A85), see chapter II.C.7.2. The Enlarged Board departed from the concept of "plausibility".
According to the board in T 107/09, the antibody MR1 was indispensable in order to reproduce the invention of claim 1. The "written" disclosure in the earlier US application from which priority was claimed, even if supplemented by common general knowledge, would not enable the skilled person to carry out the invention. The hybridoma cell line producing the antibody MR1 had been deposited with the American Type Culture Collection (ATCC) only after the filing date of the earlier application. In view of the absence of explicit provisions in the EPC as to when a deposit of biological material had to be made in relation to an earlier application (R. 28 EPC 1973 being concerned with European applications), the board referred in particular to decision G 1/03, according to which the requirement of sufficiency of disclosure had to be complied with – in relation to an earlier application from which priority was claimed – at the date of filing of that application. Thus, the board reasoned, if the deposit of biological material was necessary for the requirement of sufficiency of disclosure to be fulfilled for a "priority application", the deposit of this material had to have been made no later than the date of filing of that earlier application. This was not the case here.
- T 0883/23
In T 883/23 the board had to decide whether claim 1 of the main request was entitled to claim priority from the earliest priority application (P1). P1 disclosed a method for treating pancreatic cancer in a human subject who has not previously received chemotherapy involving the administration of MM-398 liposomal irinotecan, wherein the liposomal irinotecan was administered in combination with oxaliplatin, leucovorin and 5-fluorouracil (claim 3). P1 defined doses of 60 or 80 mg/m2 liposomal irinotecan (claim 5) and 60, 75 or 85 mg/m2 oxaliplatin (claim 8)..
Example 4 of the patent presented the results of a dose escalation/de-escalation study demonstrating the tolerability of the selected dose combination of claim 1 of the main request, as opposed to the intolerable and thus unsuitable alternative dose combinations defined in claims 5 and 8 of P1. The board observed that information concerning the tolerability of the selected dose combination of claim 1 of the main request was not revealed in P1. In particular, this information was not provided by the mere outline for the dose escalation/de-escalation study in P1, which the patent proprietor relied on as a pointer to the subject-matter of claim 1 of the main request with reference to T 1261/21. The board noted that in T 1261/21 the competent board had explained that a "pointer" in an original disclosure was an implicit or explicit indication or hint towards a combination of features, which demonstrated that this combination of features did not represent an arbitrary combination of features only conceptually comprised, but was actually envisaged in the original disclosure. However, the competent board had emphasised that what information a skilled person would directly and unambiguously derive from the original disclosure remained to be assessed on a case-by-case basis.
According to the board, in the present case, P1 provided with the outline for the dose escalation/de-escalation study only a conditional proposal for the use of a combination of 60 mg/m2 liposomal irinotecan and 60 mg/m2 oxaliplatin as part of a study still to be carried out. This proposal could not be considered to provide any pointer to the combination of 60 mg/m2 liposomal irinotecan and 60 mg/m2 oxaliplatin uniquely tolerable in first-line treatment of patients with metastatic pancreatic cancer as defined in claim 1 of the main request.
The board rejected the patent proprietor's argument that P1 described the same subject-matter as defined in claim 1 of the main request, which should in accordance with G 2/98 therefore benefit from the priority of P1, regardless of any additional technical effects, such as the results of the dose escalation/de-escalation study, which may have been described only in the subsequent application from which the patent was derived. The board observed that, according to the established jurisprudence of the Boards of Appeal, attaining the claimed therapeutic effect was regarded as a functional technical feature of claims in the format of Art. 54(5) EPC. Notably, the tolerability of the defined treatment was a prerequisite for the therapeutic efficacy (T 2506/12). The tolerability of the dose combination as defined in claim 1 of the main request, as opposed to the intolerability of the alternative combinations with higher doses of claims 5 and 8 and the dose escalation/de-escalation scheme in P1, was thus a functional technical feature of the subject-matter defined in claim 1 of the main request. This feature concerned information which was not directly and unambiguously derivable from P1.
The board further observed that the Enlarged Board determined in G 2/98 that it is a condition for the compliance with the requirement of "the same invention" that the claimed subject-matter is directly and unambiguously derivable from the earlier application. However, the Enlarged Board did not conclude that the requirement of "the same invention" is necessarily satisfied if this condition is fulfilled, irrespective of any technical information associated with the claimed subject-matter, which is only described in the subsequent patent application. Notably, the established jurisprudence confirmed the need for sufficient disclosure of the claimed invention in the priority document.