T 0236/08 (Solid delivery systems for administration by inhalation) 10-05-2012

Summary of Facts and Submissions

I. European patent No. 0 773 781 based on application No. 95927856.5, originating from international patent application PCT/GB95/01861, was granted on the basis of a set of 20 claims. Independent claim 1 read as follows:

"1. A particulate composition, for therapeutic use, suitable for administration by inhalation, wherein the particles consist of a solid solution comprising a therapeutic agent and a glass-forming carbohydrate, higher than a monosaccharide, and that is capable of stabilising the agent during spray-drying and storage, with the proviso that when the therapeutic agent is insulin, the solution does not comprise citrate."

II. An opposition was filed against the granted patent. The patent was opposed under Article 100(a) EPC for lack of novelty and inventive step, under Article 100(b) EPC for insufficiency of disclosure, and under Article 100(c) EPC for added subject-matter.

III. In the decision pronounced on 6 November 2007, the European patent was maintained in amended form on the basis of the main request filed during oral proceedings before the opposition division (Articles 102(3) and 106(3) EPC 1973).

As regards the main request, the opposition division considered the subject-matter of amended claims 1-17 to meet the requirements of Articles 123(2) EPC. In particular, the expression "suitable for administration by inhalation" could be based on page 4, line 25 - page 6, line 3 in the application as filed. The expression "therapeutic agent" had a basis on page 10, lines 15-17 and on page 14, lines 9-13 and the combination with inhalation could be derived from page 5, line 6 - page 6, line 3. The expression "capable of stabilising the agent during spray-drying and storage" was based on the passage of page 17, line 34 - page 18, line 2.

The amended claim 1 did not infringe Article 123(3) EPC, since a composition without disclaimer could be based on claim 12 as granted.

The opposition division considered that the requirements of Article 83 EPC were met, as were the requirements of novelty under Article 54 EPC vis-à-vis the prior art. According to the opposition division, the requirements of Article 56 EPC were also met over the closest prior art.

The patentee's request for apportionment of costs was rejected, because the oral proceedings had been arranged not only at the requests of all parties, but also because the opposition division itself had needed further information on some points.

IV. Opponent 01 (appellant) filed an appeal against said decision.

V. With a letter dated 20 August 2008, the proprietor (respondent) filed a main request and auxiliary requests 1 to 7.

The main request corresponded to the main request as filed during oral proceedings before the opposition division. The new auxiliary request 1 corresponded to former auxiliary request 7 and auxiliary requests 2 to 4 corresponded to former auxiliary requests 4 to 6. Auxiliary requests 5 to 7 were new requests.

Independent claim 1 and dependent claims 2, 7 and 10 of the main request read as follows:

(a) main request:

"1. A particulate composition, for therapeutic use, suitable for administration by inhalation, wherein the particles consist of a solid solution comprising a therapeutic agent and a glass-forming carbohydrate and that is capable of stabilising the agent during spray-drying and storage wherein the particles further comprise a physiologically acceptable carboxylate, nitrate, sulfate or bisulfate glass, and wherein the carbohydrate is selected from disaccharides, trisaccharides and oligosaccharides, the corresponding sugar alcohols, polysaccharides and chemically modified carbohydrates."

"2. A composition according to claim 1, wherein the carbohydrate is a non-reducing glycoside of a polyhydroxy compound selected from sugar alcohols and other straight chain polyalcohols."

"7. A composition according to any preceding claims, wherein the therapeutic agent is a protein or peptide, nucleotide, oligonucleotide or nucleic acid."

"10. A composition according to Claim 7, wherein the therapeutic agent is insulin."

Independent claim 1 and either dependent claims 2, 10 or 11 of the respective auxiliary requests read as follows:

(b) auxiliary request 1:

"1. A particulate composition, for therapeutic use, suitable for administration by inhalation, wherein the particles consist of a solid solution comprising a therapeutic agent and a glass-forming carbohydrate, higher than a monosaccharide, and that is capable of stabilising the agent during spray-drying and storage wherein the particles further comprise a physiologically acceptable carboxylate, nitrate, sulfate or bisulfate glass, and wherein the particles are 0.1 to 10 mym in size."

"10. A composition according to Claim 7, wherein the therapeutic agent is insulin."

(c) auxiliary request 2:

"1. A particulate composition, for therapeutic use, suitable for administration by inhalation, wherein the particles consist of a solid solution comprising a therapeutic agent and a glass-forming carbohydrate, higher than a monosaccharide, and that is capable of stabilising the agent during spray-drying and storage wherein the particles further comprise an inhibitor of the Maillard reaction."

"11. A composition according to Claim 7, wherein the therapeutic agent is insulin."

(d) auxiliary request 3:

"1. A particulate composition, for therapeutic use, suitable for administration by inhalation, wherein the particles consist of a solid solution comprising a therapeutic agent and a glass-forming carbohydrate that is capable of stabilising the agent during spray-drying and storage, wherein the particles comprise a molecular water pump buffer and wherein the carbohydrate is selected from disaccharides, trisaccharides and oligosaccharides, the corresponding sugar alcohols, polysaccharides and chemically modified carbohydrates."

"10. A composition according to Claim 7, wherein the therapeutic agent is insulin."

(e) auxiliary request 4:

"1. A particulate composition, for therapeutic use, suitable for administration by inhalation, wherein the particles consist of a solid solution comprising a therapeutic agent and a glass-forming carbohydrate and that is capable of stabilising the agent during spray-drying and storage wherein the particles further comprise a physiologically acceptable carboxylate, nitrate, sulfate or bisulfate glass, and wherein the carbohydrate is selected from disaccharides, trisaccharides and oligosaccharides, the corresponding sugar alcohols, polysaccharides and chemically modified carbohydrates, wherein the therapeutic agent is a nucleotide, oligonucleotide, nucleic acid, an enzyme, a growth hormone, a growth factor, a monoclonal antibody, an interferon, an interleukin or a cytokine, cyclosporin A, estrogen, progesterone, testosterone,

SH-135 or tamoxifen."

"2. A composition according to claim 1, wherein the carbohydrate is a non-reducing glycoside of a polyhydroxy compound selected from sugar alcohols and other straight chain polyalcohols."

(f) auxiliary request 5:

"1. A particulate composition, for therapeutic use, suitable for administration by inhalation, wherein the particles consist of a solid solution comprising a therapeutic agent and a glass-forming carbohydrate and that is capable of stabilising the agent during spray-drying and storage wherein the particles further comprise a physiologically acceptable carboxylate, nitrate, sulfate or bisulfate glass, and wherein the carbohydrate is selected from disaccharides, trisaccharides and oligosaccharides, the corresponding sugar alcohols, polysaccharides and chemically modified carbohydrates."

"10. A composition according to Claim 7, wherein the therapeutic agent is insulin."

(g) auxiliary request 6:

"1. A particulate composition, for therapeutic use, suitable for administration by inhalation, wherein the particles consist of a solid solution comprising a therapeutic agent and a glass-forming carbohydrate and that is capable of stabilising the agent during spray-drying and storage wherein the particles further comprise a physiologically acceptable carboxylate glass, and wherein the carbohydrate is selected from disaccharides, trisaccharides and oligosaccharides, the corresponding sugar alcohols, polysaccharides and chemically modified carbohydrates."

"10. A composition according to Claim 7, wherein the therapeutic agent is insulin."

(h) auxiliary request 7:

"1. A particulate composition, for therapeutic use, suitable for administration by inhalation, wherein the particles consist of a solid solution comprising a therapeutic agent and a glass-forming carbohydrate and that is capable of stabilising the agent during spray-drying and storage wherein the particles further comprise a physiologically acceptable carboxylate glass, and wherein the carbohydrate is selected from disaccharides, trisaccharides, oligosaccharides and their corresponding sugar alcohols."

"10. A composition according to Claim 7, wherein the therapeutic agent is insulin."

VI. The board sent the parties a communication pursuant to Article 15(1) RPBA as an annex to the summons to oral proceedings, expressing the preliminary opinion that none of the requests met the requirements of Article 123(2) EPC.

In particular, the combination of the feature "suitable for administration by inhalation" in claim 1 of the main request with the subject-matter of dependent claims 2,7, 9 and 10 was not disclosed directly and unambiguously in the originally filed application.

Moreover, the feature of claim 1 "that is capable of stabilising the agent during spray-drying and storage" and the subject-matter of claims 15-17 of the main request had not basis in the application as originally filed.

Since these features and claims were present in all auxiliary requests, the objections raised against the main request applied mutatis-mutandis to all auxiliary requests.

VII. Opponent 02 announced with a letter dated 29 February 2012 that it would not be attending the hearing planned for 10 May 2012.

VIII. The respondent announced with a fax dated 23 March 2012 that it would not be attending, or represented at the oral proceedings before the board of appeal.

IX. The appellant announced with a letter dated 26 March 2012 that he would not be attending the hearing.

X. Oral proceedings took place on 10 May 2012 in the absence of the parties.

XI. The appellant's arguments during the written phase of the appeal proceedings can be summarised as follows:

As regards Article 123(2) EPC, it objected to the following features of claim 1:

- "suitable for administration by inhalation": the application as originally filed did not show any preference for this particular way of administration. Moreover, several examples had a technical teaching inconsistent with the scope of the claims.

- "a therapeutic agent": the originally filed application related to "guest substances" whose substitution by a therapeutic agent" had no basis.

- "wherein the carbohydrate is selected from disaccharides, trisaccharides and oligosaccharides, the corresponding sugar alcohols, polysaccharides and chemically modified carbohydrates": the basis for this feature was lacking in the original application.

- "that is capable of stabilising the agent during spray-drying": there is no basis for this feature in the originally filed application.

Further objections and arguments were also provided with regard to lack of disclosure (Article 83 EPC), and lack of novelty (Article 54 EPC) and inventive step

(Article 56 EPC).

XII. The respondent's arguments during the written phase of the appeal proceedings can be summarised as follows:

As regards Article 123(2) EPC, the respondent considered that the opposition division had correctly understood that a basis for the feature "suitable for administration by inhalation" could be found for example on page 5, line 6 to page 6, line 3 in the originally filed application and that the combination with "therapeutic agent" was disclosed on, for example, page 14, lines 9 to 13 in addition to page 5, line 6 to page 6, line 3.

As regards the term "wherein the carbohydrate is selected from disaccharides, trisaccharides and oligosaccharides, the corresponding sugar alcohols, polysaccharides and chemically modified carbohydrates", it had a basis in original claim 4 or on page 17, lines 25 to 28.

In response to the objections made to the feature "that is capable of stabilising the agent during spray-drying", the respondent referred to the decision of the opposition division.

Further objections and arguments were also provided with regard to lack of disclosure (Article 83 EPC), and lack of novelty (Article 54 EPC) and inventive step

(Article 56 EPC).

XIII. Opponent 02 did not provide any comment or argument in the written phase of the appeal proceedings.

XIV. The following requests were on file:

The appellant (opponent 01) requested that the decision under appeal be set aside and that European patent No. 0 773 781 be revoked.

The respondent (patentee) requested that the appeal be dismissed and that the patent be maintained in the version as agreed by the opposition division (main request), or alternatively that the decision under appeal be set aside and that the patent be maintained according to one of the auxiliary requests 1-7 filed with the response to the grounds of appeal.