T 2102/09 (Terfenadine carboxylate and the treatment of allergic disorders/SUNOVION PHARMACEUTICALS) 11-03-2013

Summary of Facts and Submissions

I. European patent No. 0 815 860, based on European patent application No. 97104837.6, was filed as a divisional application of application No. 93918584.9 filed as an international patent application published as WO 94/03170 (root application), and was granted with 15 claims.

Claim 1 as granted read as follows:

"1. Use of a composition comprising a compound of formula I:

FORMULA/TABLE/GRAPHIC

or a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for use in an anti-histaminic treatment in which the induction of cardiac arrhythmia is avoided, said treatment comprising administering a therapeutically effective amount of a compound of formula I to a human patient whose hepatic function is not impaired."

II. Oppositions were filed and revocation of the patent in its entirety was requested in particular pursuant to Article 100(c) (the subject-matter of the patent extends beyond the content of the application, or earlier application, as filed) and 100(a) EPC (lack of novelty and lack of inventive step). Opponent O1 also filed insufficiency of disclosure as ground for opposition (Article 100(b) EPC).

III. The documents cited inter alia in the opposition and appeal proceedings included the following:

D1 US 4254129

D2 WO 93/23047

D53 Monthly index of medical specialities (Mims), UK, issue of May 1992 (Anti-allergic drugs)

D54B Goodman and Gilman, The Pharmacological Basis of Therapeutics, sixth edition, 1980, pages 609-646

D55 A. Goodman and Gilman, The Pharmacological Basis of Therapeutics, seventh edition, 1985, pages 302-321

D56 J.T. Barbey et al., Proceedings of a Symposium, American Journal of Rhinology, 1999, vol. 13, No. 3, 235-243

IV. The present appeal lies from a decision of the opposition division revoking the patent (Article 101(2) EPC).

V. The opposition division's decision was based on the main (and sole) request, which was the set of claims as granted.

The opposition division considered that the grounds of opposition under Article 100(c) EPC prejudiced the maintenance of the patent as granted.

It considered that since claim 1 as granted contained a disclaimer "which had not been expressed in the application as originally filed", the criteria set out in the Enlarged Board of Appeal decisions G 01/03, OJ EPO, 2004, 413 and G 02/03, OJ EPO, 2004, 428 applied.

It was of the opinion that the amendment in claim 1 as granted, concerning the definition of the human patient to which the medicament was to be administered as one "whose hepatic function is not impaired", introduced subject-matter which extended beyond the content of the application as filed.

Additionally, the opposition division expressed the opinion that the subject-matter in claims 1 to 8 and 13 to 16 as granted lacked novelty in view of documents D1 and D2 (the European application deriving from the PCT application published as WO 93/23047).

VI. The patentee (appellant) lodged an appeal against said decision, and filed grounds thereto. With its grounds of appeal the appellant filed documents D54B, D55 and D56, together with auxiliary requests 1 to 4 (as working version and as clean version).

VII. Respondents O1 and O2 filed counter-arguments to the grounds of appeal.

VIII. The appellant filed a letter dated 17 December 2010 in reply to the respondents' counter-arguments.

IX. The board sent a communication pursuant to Article 15(1) RPBA as an annex to the summons to oral proceedings.

In said communication the board expressed inter alia a preliminary opinion in relation to the assessment of the grounds of opposition under Article 100(c) and 100(a) EPC (novelty). In said communication the board pointed out that the examination of added matter had to be made using the principles developed in the jurisprudence of the boards of appeal. Within this context the board cited the Enlarged Board of Appeal decision G 02/10, OJ EPO, 2012, 376, to show that the requirements of Articles 123(2) and 76(1) EPC applied also to claims containing a disclaimer.

X. With a letter dated 28 February 2013 the appellant filed seven auxiliary requests, i.e. auxiliary requests 1 to 7.

Auxiliary request 1 contains one single claim which is identical to claim 1 as granted.

Claim 1 of auxiliary request 2 reads as follows:

"1. Use of a composition comprising a compound of formula I:

FORMULA/TABLE/GRAPHIC

or a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for use in an anti-histaminic treatment for providing symptomatic relief from sneezing, rhinorrhea or lacrimation associated with an allergic disorder, cough, cold or flu, in which the induction of cardiac arrhythmia is avoided, said treatment comprising administering a therapeutically effective amount of a compound of formula I to a human patient whose hepatic function is not impaired" (emphasis added).

Claim 1 of auxiliary request 3 reads as follows:

"3. Use of a pharmaceutically acceptable salt of a compound of formula I:

FORMULA/TABLE/GRAPHIC

or a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for use in an anti-histaminic treatment of allergic rhinitis, solar urticaria or symptomatic dermographism, in which the induction of cardiac arrhythmia is avoided, said treatment comprising administering a therapeutically effective amount of a compound of formula I to a human patient whose hepatic function is not impaired" (emphasis added).

Claim 1 of auxiliary request 4 reads as follows:

"1. Use of a pharmaceutically acceptable salt of a compound of formula I:

FORMULA/TABLE/GRAPHIC

or a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for use in an anti-histaminic treatment of allergic rhinitis, in which the induction of cardiac arrhythmia is avoided, said treatment comprising administering a therapeutically effective amount of a compound of formula I to a human patient whose hepatic function is not impaired" (emphasis added).

Claim 1 of auxiliary request 5 reads as follows:

"1. Use of a pharmaceutically acceptable salt of a compound of formula I:

FORMULA/TABLE/GRAPHIC

or a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for use in an anti-histaminic treatment for providing symptomatic relief from sneezing, rhinorrhea or lacrimation associated with an allergic disorder, cough, cold or flu, in which the induction of cardiac arrhythmia is avoided, said treatment comprising administering a compound of formula I in an amount of 20-200 mg/day to a human patient whose hepatic function is not impaired" (emphasis added).

Claim 1 of auxiliary request 6 reads as follows:

"1. Use of a pharmaceutically acceptable salt of a compound of formula I:

FORMULA/TABLE/GRAPHIC

or a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for use in an anti-histaminic treatment for providing symptomatic relief from sneezing, rhinorrhea or lacrimation associated with an allergic disorder, cough, cold or flu, in which the induction of cardiac arrhythmia is avoided, said treatment comprising administering a therapeutically effective amount of a compound of formula I to a human patient whose hepatic function is not impaired, wherein the composition is a tablet or capsule containing 30 mg, 60 mg or 90 mg dose of the compound of formula I, or pharmaceutically acceptable salt thereof" (emphasis added).

Claim 1 of auxiliary request 7 reads as follows:

"1. Use of a pharmaceutically acceptable salt of a compound of formula I:

FORMULA/TABLE/GRAPHIC

or a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for use in an anti-histaminic treatment in which the induction of cardiac arrhythmia is avoided, said treatment comprising administering a therapeutically effective amount of a compound of formula I to a human patient whose hepatic function is not impaired, wherein the composition further comprises a therapeutically effective amount of a decongestant" (emphasis added).

XI. Oral proceedings took place on 11 March 2013. During the oral proceedings the board decided to admit into the proceedings auxiliary requests 3 and 4 and not to admit into the proceedings auxiliary requests 1, 2 and 5 to 7, all filed with the letter dated 28 February 2013.

XII. The appellant's arguments, as far as relevant for the present decision, may be summarised as follows.

(a) Admissibility of the auxiliary requests filed with the letter dated 28 February 2013

Auxiliary requests 1 to 7 had been filed in reply to objections raised in the board's communication sent as an annex to the summons. They should be admitted into the proceeding since they did not raise any new issues and the amendments were clear and easy to understand. Some of the requests were the same as previous requests filed in response to the opposition division's decision.

Auxiliary request 1 contained only one single claim which was identical to claim 1 as granted; the dependent claims had been deleted in order to overcome possible objections pursuant to Article 100(c) EPC. The amendments in claim 1 of auxiliary request 2 narrowed the scope of the claim in order to overcome novelty and possible inventive step objections. The request derived from the previous auxiliary request 1, with further restrictions. The amendments addressed objections under Article 123(2) EPC and avoidance of possible double patenting with the deletion of "dermal irritation". Auxiliary requests 3 and 4 were identical to auxiliary requests 2 and 4, respectively, which had been filed with the grounds of appeal. These requests, which had long been on file, had been filed to overcome novelty objections. Auxiliary request 5 contained one single claim in order to avoid possible attacks under Article 123(2) EPC. The amendment concerning the treatment was similar to that of auxiliary request 2. Moreover, the specifications of the amounts of the drug per day addressed potential lack of novelty objections. The amounts appeared in claims 4 and 5 as granted. The amendments were simple to understand and did not raise new issues. Auxiliary request 6 also contained a single claim. The amendment concerning the treatment was similar to that of auxiliary request 2. Moreover, the specification of the dosage form was made in order to address novelty issues. These amendments were not difficult to understand. Auxiliary request 7 contained one single claim which incorporated the decongestant, as was the case of claim 11 as granted. The amendment was easy to understand.

The appellant further stressed that the amendments in the auxiliary requests filed with the letter dated 28 February 2013 could not have taken the respondents by surprise since the claims were the same as or very similar to those filed with the grounds of appeal.

Moreover, the appellant argued that during the opposition proceedings it had been of the opinion that the set of claims as granted was allowable. Only when reading the reasons in the opposition division's decision had it become aware of the problems in relation to Article 100(c) EPC. When the application was undergoing prosecution the case law had been more generous in relation to admissibility of disclaimers. The case law in relation to disclaimers had changed through the years. This justified the filing of the auxiliary requests with the grounds of appeal. It did not make sense to file auxiliary requests before knowing the reasons why the opposition division considered that the disclaimer was not allowable under Article 100(c) EPC.

(b) Main request (set of claims as granted)

The appellant submitted that claim 1 as granted found it basis in the root application as filed. The requirements of Articles 123(2) and 76(1) EPC were met. In particular, terfenadine carboxylic acid was disclosed in the root application to be useful in an anti-histaminic treatment (of a human patient) which did not induce significant cardiac arrhythmia (page 11, lines 9-21). Terfenadine carboxylic acid (terfenadine carboxylate) was disclosed as the most preferred active compound on page 15, lines 9-10, of the root application as filed. Furthermore, page 16, first paragraph, of the root application as filed provided an allowable basis for the use claim in Swiss-type form. The appellant acknowledged, however, that there was no verbatim basis in the root application as filed for the disclaimer in claim 1 as granted concerning the phrase "to a human patient whose hepatic function is not impaired".

In its communication sent as an annex to the summons to oral proceedings the board had cited the Enlarged Board of Appeal decision G 2/10. In point 4.5.1 of the reasons, the disclosure test was explained, namely that "after the amendment the skilled person may not be presented with new technical information". Thus, according to decision G 2/10, the skilled person should not be presented with technical information which he would not derive directly and unambiguously from the application as filed, using common general knowledge. At the end of point 4.5.2 of the reasons, decision G 2/10 stipulated that "the point of reference for assessing an amended claim for its compatibility with Article 123(2) EPC is the subject-matter which the claim contains after the amendment. In other words, it is the subject-matter remaining in the claim after the amendment". In point 4.5.4 of the reasons, decision G 2/10 stressed the need for technical assessment of the case under consideration requiring an assessment of the overall circumstances of the individual case and that "the test to be applied is whether the skilled person would, using common general knowledge, regard the remaining claimed subject-matter as explicitly or

implicitly, but directly and unambiguously, disclosed

in the application as filed". This test had to be performed regardless of whether the disclaimer was a "disclosed" or an "undisclosed" disclaimer. The subject-matter remaining in claim 1 after the introduction of the amendment concerned the treatment of the hepatically non-impaired population, i.e. the "normal" population. Therefore, the skilled person would immediately understand from the content of the root application as filed that the compound of formula I would be administered to patients with non-impaired hepatic function. This was knowledge by default which was directly and unambiguously derivable from the root application as filed. The particular recommendations given for patients with impaired hepatic function (page 20, lines 21-22, of the root application as filed) implied that the "normal" population also received the anti-histaminic treatment disclosed in the root application. Therefore, the amendment did not add new subject-matter. The discussion about the content of documents D1 and D2 was irrelevant since the claim as granted did not extend to subject-matter undisclosed in the root application as filed.

The appellant also referred to Enlarged Board of Appeal decision G 1/93, OJ EPO 1994, 541, which expressed the following in relation to the problem of added subject-matter: "With regard to Article 123(2) EPC, the underlying idea is clearly that an applicant shall not be allowed to improve his position by adding subject-matter not disclosed in the application as filed, which would give him an unwarranted advantage and could be damaging to the legal security of third parties relying on the content of the original application". The amendment under dispute did not confer on the patentee an unwarranted advantage since the anti-histaminic treatment reflected the normal situation, i.e. it addressed the "normal" population, and thus, the amendment would never provide inventive step over the prior art. Nor did the disclaimer result in defining a new patient group in the claim, because all human patients without hepatic impairment were members of the group of human patients in general. The hepatically impaired patients corresponded to an abnormal population of patients to be treated since the skilled person knew that the drug was metabolised through the liver. Moreover, document D2 set a definition for hepatic impairment as one "which inhibits the normal liver function". This was what the skilled person would understand. In this context the appellant referred to document D53. When asked by the board about the case when a patient was temporarily hepatically impaired, the appellant again cited document D53 and added that it was well known to the skilled person what hepatic impairment was. The appellant submitted that document D53, which was an extract from the monthly index of medical specialities published in the UK, was aimed at general practitioners (GPs) and served as background information for their prescriptions of drugs. The appellant pointed to page 236, TriludanR, which contained Terfenadine as active drug, in particular "S/P: Hepatic impairment, QT prolongation" (emphasis added). Thus, "hepatic impairment" was a well known term commonly used in the field which did not require further explanations. As a result, it would also be known to the skilled person what a non-impaired liver function was. The appellant further submitted that respondent O1 had contended that "hepatically impaired" had a special meaning in relation to terfenadine, However, if this was the case the skilled person would know what was meant. In fact the only special meaning for "hepatic impairment" was the general meaning reflected in document D2.

The appellant stated at the oral proceedings that if the findings in decision G 2/10 were considered not to be applicable to the present case, then an alternative route of argumentation in relation to the Enlarged Board of Appeal decisions G 1/03 and G 2/03 had been developed. The appellant referred to its written submissions during appeal proceedings. With its grounds of appeal the appellant had argued that the amendment concerning the disclaimer "to a human patient whose hepatic function is not impaired" had been introduced during prosecution of the application in order to restore novelty over D2. The phrase "to a human patient whose hepatic function is not impaired" did not disclaim more than necessary since the disclosure of D2 which formed part of the state of the art under Article 54(3) EPC was restricted to the use of terfenadine carboxylate as an anti-histaminic for treating hepatically impaired persons. Claims 8 to 22 in D2, some of which covered the use of terfenadine carboxylate for treating non-hepatically impaired patients, had been added upon filing the application D2. The treatment of non-hepatically impaired patients had no basis in either of the two priority documents.

Additionally, the disclaimer present in claim 1 as granted did not provide a technical contribution to the claimed invention. There was no breach of the criteria set out in Enlarged Board of Appeal decisions G 1/03 and G 2/03. Additionally, document D1 did not provide a direct and unambiguous disclosure of an anti-histaminic treatment in any human patient group. Therefore, the disclaimer did not serve to render the subject-matter claimed novel over document D1.

Moreover, the appellant stressed that its main line of argumentation was that decision G 2/10 reflected all circumstances underlying the investigation of added subject-matter after introduction of a disclaimer (G 2/10, point 2.1 of the reasons). Decision G 2/10 had shown that the application of the criteria set out in decision G 1/03 was not the relevant test for assessing whether the subject-matter remaining in the claim after the introduction of the disclaimer was disclosed in the application as filed (G 2/10, end of point 1 and point 2.1 of the reasons). The reasons for the introduction were irrelevant, what mattered was whether the remaining subject-matter was directly and unambiguously disclosed in the application as filed.

Additionally, decision G 1/03 made it very clear that a disclaimer for excluding a conflicting application under Article 54(3) EPC was allowable. Such a disclaimer excluding subject-matter only for legal reasons did not infringe Article 123(2) EPC (G 1/03 point 2.1, in particular 2.1.3, of the reasons). The disclaimer in claim 1 as granted actually removed what was disclosed in the conflicting application D2 and had a right to the priority dates. Document D2 disclosed the anti-histaminic treatment using terfenadine carboxylate for hepatically impaired patients (page 2, second and third paragraphs, pages 4 and 5). This was the content of D2 which had a right to the priority dates. The subject-matter in claims 8 to 22 relating to the treatment of non-impaired patients was not covered by the priority documents and thus was not part of the prior art under Article 54(3) EPC. The passages quoted by the respondents, such as the second paragraph on page 4 of D2, should be read within the context of document D2, which concerned hepatically impaired patients. Although document D2 cited document D1 as disclosing that terfenadine carboxylate was an anti-histaminic agent (page 1, last paragraph), such a reading of the disclosure in document D1 was questionable. In particular, document D1 disclosed the substituted piperidine derivatives to be useful as antihistamines, antiallergy agents, and bronchodilators (column 1, first paragraph, lines 29-31). Terfenadine carboxylate was disclosed in column 3 and example 3. Further, in column 5, D1 suggested that the compounds were useful as antihistamines, antiallergy agents and bronchodilators. However, the skilled person would know that not all compounds would have all the activities. Moreover, the test disclosed in column 6 of document D1 mentioned that terfenadine carboxylate attained a significant reduction in histamine-induced isolated guinea pig ileal muscle contraction. However, the ability to oppose histamine-induced guinea pig ileal muscle contraction in vitro was not sole indicator of an anti-histaminic activity and many substances which were not histamine (H1) receptor antagonists would prevent histamine-induced contraction in this test, such as salbutamol and other beta-adrenoceptor antagonists, theophylline and other phosphodiesterase inhibitors. A reduction of histamine in the test mentioned in document D1 did not mean that the compound was inevitably a blocker of histaminic receptors. Additionally, the appellant cited document D54B and stated that the skilled person would have thought that the compounds in document D1 were either anti-histaminic or bronchodilators, but not both at the same time. Moreover, contrary to the statement in document D2, document D1 did not disclose any oral activity for terfenadine carboxylate. Additionally, the amendment did not imply any unwarranted advantage over document D1 since it concerned administration to the normal population.

As regards respondent O1's comment that page 8, lines 23-25 of the root application did not mention hepatic impairment, the appellant stated that the skilled person would also make use of his common general knowledge.

The appellant added in relation to document D2 that the fact that claims directed to the treatment of non-hepatically impaired patients were introduced when the international application was filed was an indication that the applicant of D2 thought that document D1 did not disclose that feature. D1 did not directly and unambiguously disclose that terfenadine carboxylate was an anti-histaminic agent useful for an anti-histaminic treatment. Moreover, document D54B referred on page 623 to H1-blocking agents, but document D1 did not teach whether terfenadine carboxylate was a H1-blocking agent. The appellant further stated that its root application disclosed for the first time the use of terfenadine carboxylate in an anti-histaminic treatment for the normal population.

(c) Auxiliary requests 3 and 4 (Articles 100(c), 123(2), 76(1) EPC)

The basis for the amendment "of allergic rhinitis, solar urticaria or symptomatic dermographism" in claim 1 of auxiliary request 3 was to be found on page 13, lines 1 to 3, page 11, line 6 and page 19, lines 4-6. The claim had been narrowed down to more preferred embodiments which had been individualised in the root application as filed. The arguments submitted for the main request applied mutatis mutandis to the rest of the claim. The new features did not change the situation in relation to the allowability of the disclaimer, since the non-hepatically impaired patients were disclosed in the root application as filed.

The appellant submitted that analogous reasons applied to claim 1 of auxiliary request 4, in which the limitation to "allergic rhinitis" concerned the most preferred embodiment (page 13 of root application as filed).

XIII. Respondent O1's arguments, as far as relevant for the present decision, may be summarised as follows.

(a) Admissibility of the auxiliary requests filed with the letter dated 28 February 2013

Respondent O1 objected to the "extremely late" filing of these auxiliary requests, namely more than five years after oppositions had been filed. During opposition proceedings the patent proprietor had not filed any auxiliary request, in order to force a remittal to the department of first instance as result of the appeal proceedings. Such a procedural strategy should not be allowed, it was an abuse of procedure. Therefore, the auxiliary requests which were identical to those filed with the grounds of appeal should not be admitted (Article 12 RPBA).

Additionally, the auxiliary requests which were filed for the first time with the letter dated 28 February 2013 should not be admitted into the proceedings since they had been filed less than one month before the oral proceedings and opened new issues (Article 13 RPBA). The appellant had known about the issues pursuant to Articles 100(c) and 123(2) EPC for a long time and had not needed to wait until a board's communication was issued in order to amend the claims. The amended claims included lists of specific ailments, so these amendments opened new substantive issues. It was not reasonable to expect the respondents to deal with the substantive amendments introduced in the newly filed sets of claims. Deletion of ailments within a given list was not a simple thing, since it had to be investigated whether unallowable selections had taken place. Moreover, combinations of the treatment of certain disorders with certain dosages or dosage forms opened new issues under Article 123(2) EPC.

Respondent O1 submitted that the opposition division had already cited Enlarged Board of Appeal decisions G 1/03 and G 2/03 in the communication sent with the summons to oral proceedings. However, the patentee had not filed any amended sets of claims in preparation for the oral proceedings before the opposition division. Respondent O1 further submitted that the minutes of the oral proceedings before the opposition division indicated that, after the announcement that the set of claims as granted failed on grounds pursuant to Article 100(c) EPC, the patentee had been asked whether or not it wished to submit any further requests. The patentee had replied that it did not.

(b) Main request (set of claims as granted)

Respondent O1 referred to its written submissions during opposition and appeal proceedings. It submitted in particular that claim 1 as granted contained the phrase "to a human patient whose hepatic function is not impaired" which had been added as a disclaimer during prosecution of the application, in order to distinguish the patient group from those in document D2. However, the disclaimer in claim 1 as granted was insufficient to establish novelty over document D2. The disclosure in document D2 was broader than what had been excluded in claim 1. Document D2 contained a summary of the content of document D1 (inter alia page 1, lines 20-23, page 3, lines 29-34). Document D2 acknowledged that terfenadine carboxylic acid was known as an anti-histaminic agent (inter alia, page 4, lines 8-10). In terms of the general teaching in document D2 there was no difference between hepatically impaired and hepatically not impaired patients. The claims in document D2 for which priority was validly claimed were restricted to hepatically impaired patients, to distinguish the claimed subject-matter from what had been known in document D1. However, the teaching in document D2 was not restricted to what was claimed. Therefore, the disclaimer in claim 1 as granted was inadmissible. In fact, the actual meaning of the disclaimer was unclear since nowhere in the patent was it explained what was meant by the expression "a human patient whose hepatic function is not impaired". One had to turn to document D2, page 4, lines 18-25, to find a definition of an "hepatically impaired patient". The disclaimer took the opposite direction, requiring that the hepatic function was not impaired. Therefore, the meaning in the disclaimer was not necessarily the same. Additionally, the root application of the patent in suit recommended that children, patients aged over 65 years and those with impaired renal or hepatic function initially received low doses (page 20, lines 20-22). However, it was not clear whether the meaning of "impaired hepatic function" given in this passage of the root application was the same as in the disclaimer in granted claim 1. In particular, the question arose whether patients who might have an impaired hepatic function owing to alcohol consumption were encompassed by granted claim 1. The anti-histaminic treatment which was acknowledged in document D2 to be known from document D1 concerned doses within a range of 1-50 mg, 1 to 4 times per day.

The disclaimer in claim 1 as granted was further inadmissible since it affected the technical contribution of the subject-matter claimed not only in relation to document D2, which formed part of the prior art under Article 54(3) EPC, but also in relation to document D1 which was state of the art under Article 54(2) EPC. Therefore, granted claim 1 contained added subject-matter within the meaning of Article 100(c) EPC.

Additionally, respondent O1 argued that the Enlarged Board of Appeal decision G 2/10 concerned a different situation, namely one in which the disclaimed subject-matter was disclosed in the application as filed. The disclaimed subject-matter was not an embodiment of the invention and there was no basis in the root application as filed for excluding the group concerning hepatically impaired patients. Moreover, since the disclaimer had been introduced in view of existing prior art it had to be the assessed whether or not it made a technical contribution. The disclaimer was not admissible under the criteria set out in decisions G 1/03 and G 2/03. Moreover, the expression "hepatic impairment" had a special meaning depending on the specific scenario. The appellant had used a general term concerning a specific drug, terfenadine, within another context, terfenadine carboxylate, introducing new technical information into the claim. Document D2 had been very specific when defining "hepatic impairment". The amendment in claim 1 as granted concerned unallowable added subject-matter since it did not exclude the content of D2 itself. The amendment followed a purpose in respect of the prior art which could not be ignored. The subject-matter claimed in claim 1 as granted related to an unallowable selection of the subject-matter initially disclosed which concerned the anti-histaminic treatment of all patients without making any distinction. The only exception was that for some patients a lower dose was recommended. Additionally, respondent O1 summarised its position in relation to the disclaimer by saying that it had objected to its meaning, its basis in the root application as filed, and the argument that it fulfilled the function for which it had been introduced.

Respondent O1 further argued that the expression "hepatically impaired" had different meanings depending on the situation. Hepatic impairment in document D2 related to very specific situations which had also to do with terfenadine and the cardiac events experienced in the patients. This was partly reflected on page 8, last paragraph, of the root application. However, there was no mention of hepatic impairment in this paragraph of the root application. The mention on page 20, line 22, of impaired hepatic function was made within a different context. Therefore, the disclaimer was an undisclosed disclaimer and decisions G 1/03 and G 2/03 were relevant. Respondent O1 also argued that the appellant's argumentation that the disclaimer was admissible since it excluded the subject-matter of a conflicting application under Article 54(3) EPC was not correct. In particular, the disclaimer was not appropriate since the subject-matter claimed was not disclosed for the first time in the patent in suit. All passages cited from D2 concerning the teaching that terfenadine carboxylate had an anti-histaminic activity were covered by the priority. The content of these passages could not be separated from the patient subgroups since anti-histaminic activity was not dependent on liver impairment. Document D2 disclosed that terfenadine carboxylate was histamine H1-receptor antagonist on page 4, lines 7-10, without depending on document D1. Thus, the appellant's argument that some compounds in document D1 had anti-histaminic activity and some did not was irrelevant. Moreover, document D54B disclosed on page 623 the pharmacological properties of H1-blocking agents and stated that their activity was predictable from interaction with H1-receptors. Moreover, on page 624, D54B mentioned the guinea pig ileum model as well known. Consequently, document D1 was certainly novelty-destroying and document D2 was novelty-destroying with or without the disclaimer.

(c) Auxiliary requests 3 and 4 (Articles 100(c), 123(2), 76(1) EPC)

The arguments submitted for the main request applied mutatis mutandis to auxiliary requests 3 and 4. Additionally, document D2 referred explicitly to "seasonal allergic rhinitis" (page 4).

XIV. Respondent's O2 arguments, as far as relevant for the present decision, may be summarised as follows:

(a) Admissibility of the auxiliary requests filed with the letter dated 28 February 2013

Respondent O2 agreed with respondent O1 that the auxiliary requests filed with the letter dated 28 February 2013 should not be admitted into the proceedings. In particular, the auxiliary requests had been filed too late and opened new complex issues in relation to Article 123(2) EPC.

(b) Main request (set of claims as granted)

Respondent O2 referred to its written submissions in the appeal proceedings and stated that it endorsed respondent's O1 arguments in relation to the grounds of opposition pursuant to Article 100(c) EPC and claim 1 of the main request.

Moreover, respondent O2 questioned whether the patients whose hepatic function was not impaired were "normal" patients. When determining whether a hepatic function was impaired certain parameters were to be measured. Therefore, the question arose as to whether or not patients under liver stress fell within the definition. Document D53 was not useful since it did not establish the common general knowledge in relation to the disputed term. The disclaimer was not admissible, since it did not suffice to establish novelty and it did not fulfil the requirements of Article 123(2) (and Article 76(1)) EPC.

(c) Auxiliary requests 3 and 4 (Articles 100(c), 123(2), 76(1) EPC)

Respondent O2 did not add any comments in relation to auxiliary requests 3 and 4.

XV. The appellant (patentee) requested that the decision under appeal be set aside and that the patent be maintained as granted (main request), or alternatively that the patent be maintained in amended form on the basis of one of the auxiliary requests 1 to 7 filed with the letter of 28 February 2013, and that the case be remitted to the department of first instance for further prosecution.

The respondents (opponents) requested that the appeal be dismissed.