EP 3 134 432 B1 relates to MND promoter chimeric antigen receptors (CARs), and use of these compositions to effectively treat various cancers or tumours.
Brief outline of the case
The opposition was rejected and the opponent appealed.
The board decided that the OD had correctly exercised its discretion in admitting the late filed CPA=D16 in the procedure.
The board held that the patent as granted lacked IS and did not remit.
The patent was thus revoked.
The case is interesting in its interpretation of G 2/21 and the reasons for non-remittal.
The opponent’s point of view
The OD had correctly exercised its discretion when admitting D16.
The new evidence filed by the proprietor should not be admitted, as it constituted a late filed amendment to the proprietor’s appeal case under Art 13(1) RPBA.
The proprietor had failed to identify the new data as an amendment and had not provided adequate justification for its filing at this stage of the proceedings. Moreover it had not offered any explanation for its late submission. The stated justification – aligning the present appeal with a corresponding divisional case – was not a valid reason under Art 13(1) RPBA.
Contrary to the proprietor’s assertion, G 2/21 was not applicable to the present case and did not have precedence over the requirements of Art 13(1) RPBA.
The proprietor’s point of view
Admissibility of D16
D16 should not have been admitted by the OD because it had been filed shortly before the OP before the OD, without any justification, despite having been available to the opponent before expiry of the opposition period. The late submission was a procedurally unfair attempt to ambush the respondent.
The OD’s decision to admit D16 based on the argument that one or two months were ample time to review it was not a proper justification for its admittance.
Late filed experimental data
The additional experimental evidence provided in reply to the appeal, showing the sustained anti-leukaemia activity associated with anti-CD19 CAR T cells driven by the MND promoter – was entirely consistent with what is provided in paragraph [0072] of the patent which clearly stated that a benefit of using the MND promoter was persistent, sustained expression of CAR polypeptides.
The additional experimental evidence had been submitted as early as possible. G 2/21 enshrined the principle of free evaluation of evidence under the EPC, as outlined in Art 113(1) and Art 117(1), allowing any means of evidence to be assessed, regardless of its filing date.
This principle ensured that evidence crucial for demonstrating a technical effect relevant to inventive step cannot be disregarded merely because it was submitted after the filing date. The relevant standard for inventive step assessment was what the skilled person, using common general knowledge, would understand from the application as filed. The technical effect had to be encompassed by the original teaching and embodied by the same invention, even if considered later.
In the present case, the MND promoter had always been central to the invention.
The ruling in G 2/21 had precedence over the RPBA, especially over Art 13 RPBA, such that evidence to prove a technical effect relied upon for acknowledgement of inventive step of the claimed subject-matter could be filed by the proprietor at any stage of the proceedings and had to be admitted and considered by the board under all circumstances.
Request for remittal
The proprietor requested that the case be remitted to the OD “for discussion regarding maintenance of the patent in amended form” should the MR not be granted.
The board’s decision
Admissibility of D16
D16 was considered to represent the CPA in the assessment of inventive step and the decision under appeal is thus based on D16 within the meaning of Art 12(2) RPBA. On appeal, the opponent maintained its objection of lack of IS based on D16 representing the CPA.
In the present case, the board saw no legal basis, and none was relied upon by the proprietor, which would allow D16, which had been admitted by the OD and considered in the decision under appeal to represent the CPA, to be excluded from the appeal proceedings.
The board saw no error in the manner in which the OD exercised its discretion, and D16 was thus part of the appeal proceedings under Art 12(2) RPBA.
Late filed experimental data by the proprietor
More than two years after filing the reply to the statement of grounds of appeal, the proprietor filed new evidence in the form of a direct comparative example.
For the board, the proprietor’s approach with G 2/21 is incorrect. While G 2/21 confirms the principle of free evaluation of evidence, the issues of whether evidence filed at a particular stage in the proceedings before the board forms part of the proceedings or is subject to admittance by the board are distinct issues.
The latter issues are to be decided upon on the basis of the provisions governing the proceedings before the boards, in particular Art 114(2) and the RPBA.
As the evidence and related submissions were first presented after the proprietor’s reply to the grounds of appeal and before notification of the board’s communication under Art 15(1) RPBA drawing attention to matters likely to be dealt with at the oral proceedings, Art 13(1) RPBA applied.
The proprietor did not provide any arguments as to why the new evidence was submitted only at this late stage of the appeal proceedings even though the comparative evidence in Example 5 of the patent was already disputed from the onset of the opposition proceedings, and IS continued to be an issue on appeal.
Moreover, as submitted by the opponent, the proprietor provided no details on how the additional experiments submitted late were performed or of the exact structure of the CAR used therein. Thus, the admittance of the experimental data would have raised further issues and admitting them, and the related arguments, would have been detrimental to procedural economy.
The aim of filing these submissions as stated by the proprietor, namely to align this case with case T 250/24, relating to a divisional application, was also no convincing justification for submitting them at this late stage of the current proceedings.
No remittal
The board noted that a set of claims of an AR had been filed during the opposition proceedings. However, in the appeal proceedings, the proprietor did not pursue maintenance of the patent in amended form on the basis of that AR, nor did it file any other AR relating to an amended version of the patent which could be considered by the board in the event that the decision under appeal was to be set aside.
The only request presented for consideration and decision in appeal proceedings was the patent as granted. In the absence of any AR, there is no basis for remitting the case to the OD.
Comments
Admissibility of D16
If a late filed piece of PA is prima facie relevant, it ought to be admitted by the OD, irrespective of the state of the procedure, cf. Guidelines E-VI, 2. As on top, D16 was part of the appealed decision, it could not be ignored in appeal.
Late-filed experimental data
The board made clear that G 2/21 was not an automatic door opener for any late filed experimental data supporting IS. The RPBA apply next to G 2/21.
Whether the RPBA can overrule a decision of the EBA remains to be seen. At least any evidence of a technical effect supporting IS should be filed as early as possible in appeal, i.e. immediately with the appeal of the proprietor, or in reply of the appeal of the opponent.
The filing of evidence under G 2/21 should not allow a proprietor to submit evidence it should have had submitted earlier.
The position of the present board is clear and not absent of any logic.
For example, it clearly questions the position of the board in T 2716/19, commented in this blog, in which the proprietor filed experimental data it had kept 18 years behind, and took pretext of G 2/21 to file it after such a long time.
At least experimental data should be of such quality and completeness that the opposite party has the possibility of checking it in due time. This is however nothing new under the sun.
The present decision shows once more, that G 2/21 is not one of the best decisions of the EBA. In view of the divergent interpretations of G 2/21 by the boards, it has increased confusion, and certainly not simplified matters.
The topic in T 250/24 was added mater and not IS, so that the excuse of the proprietor to align both procedures was rather week.
No remittal
According to Art 12(4) RPBA, only AR which have been “validly raised and maintained” in fist instance can be dealt with in appeal or lead to remittal.
As AR1 was filed merely with indicating that claims 1 and 2 as granted were combined, it cannot be said that AR1 was even “admissibly raised”, as it did not give any reason as to why objections against the MR were overcome by AR1. It was also not “maintained” in opposition or appeal.
A board will only remit if there are admissibly raised and maintained AR.
On the procedure
As the subject-matter of D16 is “use of chimeric antigen receptor (=CAR) modified T cells to treat cancer”, it is surprising that neither the ISR established by the USPTO, nor the SESR mentioned this document.
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