CABINET CHAILLOT

T1128/19

Double patenting, divisional application, clarity

T1128/19
The applicant (appellant) filed an appeal against the decision of the examining division to refuse European patent application No. 16 167 900.6 (the application). The application is a divisional application of an earlier application which was subsequently granted (the parent patent).
In the decision under appeal, the examining division considered that the main and auxiliary requests 1 to 3 were not allowable under Article 97(2) EPC together with Article 125 EPC, since they were in contravention of the principle of prohibition of double patenting and that auxiliary request 4 was not allowable because claim 1 lacked clarity (Article 84 EPC).
The application relates to bispecific single chain antibody molecule comprising a first binding domain and a second binding domain.
In its appeal, the appellant challenged the legal basis in the EPC for the principle of prohibition of double patenting, either explicitly or implicitly by way of reference to national law (Article 125 EPC) for a prohibition of double patenting. In view of this the appellant proposed questions to be referred to the Enlarged Board of Appeal in this issue. However, since the filing of the appeal, the Enlarged Board of Appeal (EPA) issued decision G 4/19, which renders the questions proposed by the appellant moot. In this decision, the EBA held that -
"1. A European patent application can be refused under Articles 97(2) and 125 EPC if it claims the same subject-matter as a European patent which has been granted to the same applicant and does not form part of the state of the art pursuant to Article 54(2) and (3) EPC.
2. The application can be refused on that legal basis, irrespective of whether it a) was filed on the same date as, or
b) is an earlier application or a divisional application (Article 76(1) EPC) in respect of, or
c) claims the same priority (Article 88 EPC) as the European patent application leading to the European patent already granted".
The parent patent was granted to the same applicant as the applicant of the application under appeal.
To decide if the application under appeal was correctly refused because it contravenes the principle of prohibition of double patenting, it must further be determined whether "it claims the same subject-matter as a European patent which has been granted to the same applicant".
Claim 1 of the main request is a combination of claims 1 and 4 and a single embodiment from claim 5 of the granted patent. The wording of claim 1 of the application under appeal differs from that of the above mentioned claims of the patent in that it specifies that the first binding domain "is an antigen-interaction site".
The subject-matter of claim 1 of the main request is an explicit alternative defined in the claims of the parent patent, being a combination the claim 1 and 4 and an embodiment of claim 5 as granted.
The appellant was of the view that claim 1 of the main request relates to an antibody whereas claim 1 of the granted parent is not defined to be an antibody. In other words, the subject-matter of claim 1 was alleged to be a narrower selection from the subject-matter of claim 1 of the parent patent.
This argument is not convincing because the claim is for "a bispecific single chain antibody molecule". There is no technical reason to differentiate between an antibody and an antibody molecule, since it goes without saying that an antibody is a molecule.
The main request and auxiliary requests are not allowable in view of the prohibition of double patenting because they claim the same subject-matter as claimed in the parent patent.
Auxiliary request 4 - claim 1
The examining division held that the claim lacked clarity because the feature "for preclinical evaluation of safety, activity and or pharmacokinetic profile of these binding domains in primates and for use as drugs in humans" encompassed both in vitro and in vivo uses meaning that the category of the claim was not clear. Moreover, they considered that this wording also creates an ambiguity and hence a lack of clarity regarding the meaning of the term "for" in the claim.
The appellant contends that claim 1 of auxiliary request 4 encompasses only in vivo uses. As supported by the FDA's homepage on drug development, the preclinical research as mentioned in the claim included both in vivo and in vitro research. However, the preclinical evaluation of safety, activity and/or pharmacokinetic profile of the binding domains in primates mentioned in the claim referred only to in vivo methods, due the inclusion of the phrase "in primates".
The board is not convinced by this argument. The phrase "for use in the preclinical evaluation of safety, activity and/or pharmacokinetic profile of these binding domains in primates" is ambiguous - it can be interpreted as meaning that the claimed antibody molecule is for use in in vitro methods aimed at preclinical evaluation of safety, activity and/or pharmacokinetic profile of the binding domains where the ultimate patient is a primate. Alternatively, it can be understood as relating to in vivo methods done in primates.
In view of the above considerations, the board concludes that the examining division was right to hold that claim 1 lacks clarity.
The appeal is dismissed.

 

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