T 0534/18 (Liquid nicotine formulation / McNeil AB) 18-09-2020

Summary of Facts and Submissions

I. European patent 2 186 507 (hereinafter "the patent"), which derives from from a divisional application with respect to the earlier application EP02793665.7 (hereinafter "the parent application"), was granted on the basis of 16 claims. The parent application was originally published as international application WO03/055486.

The independent claim 1 as granted related to:

"A pharmaceutical formulation for use in the treatment of addiction to tobacco or nicotine comprising nicotine and characterized in that

(i) the nicotine is present as a free nicotine base;

(ii) the pharmaceutical formulation is a buffered alkaline liquid formulation for administration to the oral cavity of a subject by spraying, dropping or pipetting; and in that

(iii) the nicotine is co-administered with a buffering agent."

II. The patent was opposed on the grounds that its subject-matter lacked inventive step, that the claimed invention was not sufficiently disclosed and that the patent comprised subject-matter extending beyond the content of the parent application as filed.

The opposition division decided to revoke the patent.

The decision was based on the main request relating to the patent as granted, auxiliary requests 1 and 3-4 as filed on 10 August 2017 and auxiliary request 2 filed during the oral proceedings held on 13 October 2017.

The opposition division found that the subject-matter in accordance with claim 1 of the main request and auxiliary requests 1, 3 and 4 included subject-matter extending beyond the content of the parent application as filed and that the subject-matter of claim 1 of the auxiliary requests 2 and 3 resulted in a broadening of the scope of protection.

According to the opposition division the original applications described the defined therapeutic indication as preferred and provided a clear basis for the expression "buffered alkaline liquid formulation".

However, the opposition division was of the opinion that claim 1 as granted resulted from an unallowable combined selection of the nicotine form present in the formulation ("nicotine free base form") and the alkalizing means ("buffered alkaline").

Moreover, the opposition division held the feature defining that the nicotine is co-administered with a buffering agent meant that the buffered formulation containing the nicotine was to be administered together with a separate buffering agent. The application as filed and the parent application only related to formulations comprising nicotine which might be alkalized by including a buffering agent and provided no basis for the defined co-administration with a separate buffering agent.

In the reasons for the decision the opposition division did not express its opinion as to the further raised grounds of opposition.

III. The patent proprietor filed an appeal against this decision. In the statement setting out the grounds of appeal on 27 April 2018 the appellant-patent proprietor relied on the patent as granted (main request) and submitted new auxiliary requests 1-6 as well as the following document:

D9 Online Medical dictionary - "Co-administration"

IV. With the reply of 12 September 2018 the respondent-opponent requested that the appeal be dismissed and auxiliarily that oral proceedings be held.

V. With the summons of 12 July 2019 the Board invited the parties to attend oral proceedings on 4 September 2020.

In a communication pursuant to Article 15(1) RPBA issued on 14 July 2020 the Board expressed the preliminary opinion that the patent as granted did not include subject-matter extending beyond the content of the parent application or the divisional application as filed and informed the parties that it intended to remit the case to the opposition division if this opinion were confirmed.

VI. The respondent-opponent replied on 12 August 2020 that it withdrew its request for oral proceedings if the Board were to decide on issues regarding Articles 123(2), 123(3) and 76 EPC without addressing the issues of sufficiency and inventive step.

With its communication of 18 August 2020 the Board informed the parties that the oral proceedings appointed for 4 September 2020 were cancelled.

VII. The arguments of the appellant-patent proprietor, in as far as relevant to the present decision, can be summarised as follows:

The liquid formulation for use in therapy of claim 1 as granted found its basis in claims 29 and 30 of the application as filed and claims 51 and 52 of the parent application. The defined therapeutic use regarding addiction to tobacco or nicotine was originally described as preferred. Moreover, the original disclosure clearly disclosed that the nicotine can be present as free nicotine, which is the form predominantly absorbed through the mucosa, and specifically tought that it is preferable to use a buffering agent in combination with nicotine base.

The original disclosure further explained that administration of nicotine with a buffering agent allowed for rapid nicotine uptake whereas absorption would be slower in case nicotine is not co-administered with a buffer according to the invention. Such co-administration did not require administration with a further separate buffer, but meant that the nicotine is administered at the same time as the buffering agent, which would also follow from the definition of the term "co-administration" in document D9.

VIII. The arguments of the respondent-opponent, in as far as relevant to the present decision, can be summarised as follows:

The term "alkaline" in the expression "buffered alkaline liquid formulation" in claim 1 as granted did not find an appropriate basis in the original disclosure. References in the original disclosure to the capacity of the formulation to raise the pH of the saliva in the mouth to above 7 were not equivalent. Moreover, the disclosure that the composition may be alkalized meant that its pH may be increased, but not that the pH was raised to above 7.

The original disclosure described that the nicotine could be in any form, including the free base form, salt form and derivative forms, and that the alkalization could be performed by buffering, pH regulation or both. Moreover, the original disclosure presented addiction to tobacco or nicotine as part of a list of possible diseases to be treated using the described formulations. Accordingly, claim 1 as granted resulted from a multiple new selection concerning the nicotine form, the alkalization means and the disease to be treated.

The feature of claim 1 as granted that the nicotine was to be co-administered with a buffering agent implied administration of the buffered nicotine composition with a separate buffering agent, for which the original disclosure provided no basis.

Dependent claims 5 and 6 as granted comprised further added subject-matter in view of the defined dependencies, which extended beyond the dependencies of the corresponding claims of the parent application.

Dependent claims 14-16 as granted comprised further added subject-matter concerning the definition of the amount of nicotine which is delivered.

IX. The appellant-patent proprietor requested that the decision under appeal be set aside and that the patent be maintained as granted (main request) or maintained on the basis of one of auxiliary requests 1-6 as filed with its statement setting out the grounds of appeal. The appellant-patent proprietor further requested that the case be remitted to the opposition division if the Board finds that any of the main or auxiliary requests meets the requirements of Article 123(2) EPC.

X. The respondent-opponent requested that the appeal be dismissed.