CABINET CHAILLOT

T0505/20

Article 113(2) EPC, Rule 12(2) RPBA. Claims forming basis of the decision

T0505/20
European patent No. 2 279 254 ("the patent") is entitled "Novel lipid formulations for nucleic acid delivery". Two oppositions were filed and the Opposition Division decided that auxiliary request 1 submitted at the oral proceedings met the requirements of the EPC. The patent proprietor and the 2 opponents filed notice of appeal.
Opponent 1 (appellant I) submitted that the Opposition Division’s decision suffered from a substantial procedural violation as it was not based on the correct wording of claim 1 of auxiliary request 1.
Opponent 2 (appellant II) submitted that suitability "for systemic delivery" was not a requirement of claim 1 of auxiliary request 1 submitted at the oral proceedings before the Opposition Division.
Claim 1 of auxiliary request 1 submitted at the oral proceedings before the Opposition Division relates to a composition of a nucleic acid-lipid particle, and further defines its use as follows:
"for use in a method for the in vivo delivery of a nucleic acid, the method comprising administering said nucleic acid-lipid particle to a mammalian subject."
The Opposition Division based its decision on a differently worded claim 1 which contains the term "systemically" as part of the "for use" clause as follows: "for use in a method for the in vivo delivery of a nucleic acid, the method comprising systemically administering said nucleic acid-lipid particle to a mammalian subject."
The impugned decision is therefore not based on the text submitted by the patent proprietor, contrary to the requirements of Article 113(2) EPC.
The Opposition Division included the feature "systemic" in the formulation of the objective technical problem to be solved which it formulated as "the provision of alternative particles suitable for systemic delivery of nucleic acids in cells in vivo". With respect to the question of obviousness vis-à-vis document D1, taken to represent the closest prior art, the Opposition Division held that "There is no guidance in D1 as to which compositions falling within said ranges [of lipid components in the nucleic acid-lipid particles of document D1] would be suitable for systemic delivery of nucleic acids in cells in vivo." and concluded that the subject-matter of claim 1 and its dependent claims and hence auxiliary request 1 met the requirements of Article 56 EPC.
The Opposition Division erroneous consideration of a wrong wording of claim 1 was decisive for the Opposition Division’s decision to maintain the patent in amended form.
In this respect, the board is not persuaded by the patent proprietor's line of argument that the impugned decision did not turn on whether or not the word "systemically" was explicitly written in claim 1 of auxiliary request 1 because the Opposition Division viewed systemic delivery as an implicit feature of the claim.
Based on the above observations and considering that claim 1 of auxiliary request 1 as actually maintained by the Opposition Division does not contain the term "systemically" in the "for use" clause and is not limited to particles that are suitable particularly for "systemic" administration, the board concludes that the reasons given by the Opposition Division for holding auxiliary request 1 filed at the oral proceedings allowable do not relate to claim 1 of auxiliary request 1 as actually maintained by the Opposition Division. As a consequence, at least the conclusions reached by the Opposition Division with respect to Rule 80 and Article 56 EPC are not duly supported by the reasons given for the decision, i.e. the decision is not reasoned, contrary to the requirements of Rule 111(2) EPC.
As a further consequence of the Opposition Division’s failure to consider the valid claim 1 of auxiliary request 1 submitted at the oral proceedings, the appellants right to be heard (Article 113(1) EPC) was violated because the Opposition Division decided that the patent could be maintained in amended form on the basis of this claim request for reasons that the appellants were not given the opportunity to comment on.
These defects are considered by the board to constitute substantial procedural violations.
Pursuant to Article 111(1), second sentence, EPC, the board may either exercise any power within the competence of the department responsible for the decision appealed or remit the case to that department for further prosecution.
Remitting a case to the department of first instance requires special reasons (Article 11 RPBA). As a rule, fundamental deficiencies in first instance proceedings constitute such special reasons. A substantial procedural violation is a fundamental deficiency within the meaning of Article 11 RPBA.
Furthermore, as set out in Article 12(2) RPBA, the primary object of the appeal proceedings is to review the decision under appeal in a judicial manner. This principle would not be observed if the board were to give a first decision on the valid version of auxiliary request 1, i.e. the main request on appeal.
Thus, special reasons are present to remit the case to the Opposition Division for further prosecution.
The case is remitted to the Opposition Division for further prosecution.
In view of the substantial procedural violations noted above, the appeal fees are to be reimbursed in full.

 

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