T 0290/10 (imidazoquinoline amines/3M) 21-07-2014

1. The appeals are admissible.

2. Opponent's request for a decision in written proceedings

Both parties requested oral proceedings as an auxiliary measure (see point 1.2 on page 1 of patent proprietor's letter dated 26 April 2010; see point III c) on page 7 of opponent's letter dated 10 September 2010). Hence oral proceedings before the board were appointed. Both parties subsequently stated that they would not attend the oral proceedings (see point XVIII above).

Article 15(3) of the Rules of Procedure of the Boards of Appeal (RPBA) reads as follows:

"The Board shall not be obliged to delay any step in the proceedings, including its decision, by reason only of the absence at the oral proceedings of any party duly summoned who may then be treated as relying only on its written case" (see the Supplementary publication to OJ EPO 1/2014, 44-53).

Therefore, it is within the board's discretion whether or not to delay any step in the proceedings due to the absence of the parties.

In the present case, the board considered that the parties had sufficient opportunity to comment on the grounds on which this decision is based. Moreover, in the parties' letters filed after the summons to oral proceedings there was nothing that indicated that the parties wished to file further submissions or evidence. Hence, the board did not decide in written proceedings but it maintained the date of oral proceedings and announced its decision at the end of those proceedings.

3. Opponent's request that the submissions of the patent proprietor dated 22 December 2010 and documents (D27) to (D29) enclosed therewith be not admitted into the proceedings

3.1 The patent proprietor's reply to the opponent's grounds of appeal was electronically filed on 16 December 2010 with a letter of the same date. Hence, this reply to the other party's grounds of appeal was filed within the time limit which was set and extended twice by the former board (see points VII, IX and XII above). The re-filing of this letter by fax of 22 December 2010 does not alter the board's conclusion on the observance of the time limit for reply.

According to Article 13(1) RPBA, it is within the discretion of the board to admit and consider any amendment to a party's case after it has filed its grounds of appeal or reply. Since, as set out above, the patent proprietor's reply to the opponent's grounds for appeal was filed in due time, the provisions of Article 13(1) RPBA do not apply in the present case. This is not altered by the fact that, due to the several extensions of the four-month time limit for reply, the patent proprietor could also respond in its letter dated 16 December 2010 to the opponent's reply to the patent proprietor's grounds of appeal.

3.2 However, even if the provisions of Article 13(1) RPBA did apply in the present case, the board would have admitted the submissions and documents filed with letter dated 16 December 2010 into the proceedings, for the reasons as follow.

The criteria to be employed by the board when exercising its discretion under Article 13(1) RPBA are inter alia the complexity of the new subject-matter submitted, the current state of the proceedings and the need for procedural economy.

First of all, the letter dated 16 December 2010 is a response to the opponent's arguments presented in its grounds of appeal and its further letter dated

10 September 2010. The three documents introduced therewith are to provide evidence as to why the opponent's arguments were not deemed to be conclusive.

The opponent did not argue that these submissions were complex nor has the board reasons to consider the submitted letter of seven pages and the three documents to be complex. Since they were duly filed within the (extended) time limit set for reply to the opponent's grounds of appeal, they were filed early in the appeal proceedings. The opponent had also an opportunity to respond to the submissions and documents and the board could also take these submissions into account when summoning the parties to oral proceedings. Hence, the admission of these submissions and documents into the present appeal proceedings did not affect the procedural economy.

Since the patent proprietor's letter dated 16 December 2010 is a direct response to the opponent's arguments presented in its grounds of appeal and in its further letter dated 10 September 2010, the board had no discretion under Article 12(4) RPBA not to admit the submissions and documents filed with said letter into the appeal proceedings.

4. Article 100(b) EPC 1973

4.1 The following is a citation from decision T 270/90 (OJ EPO 1993, 725, point 2.1 of the Reasons):

"As far as each of the parties to the proceedings is concerned, they carry the separate burdens of proof of any fact they allege."

4.2 The opponent argued that it was impossible that all the imidazoquinoline amines were useful for the treatment of asthma and allergy. However, the opponent has not provided any evidence in support of these arguments; it referred to decision T 352/07 of 4 February 2010 in support of its argument. First of all, the objected feature in T 352/07, a "platinum compound having antitumor effects", was much more generally defined than the "imidazoquinoline amines" of present claim 1. Finally, further functional features, namely the tumor to be treated and the antibodies to be used, played also a role in the decision that the requirements of Article 83 EPC were not met (see point 4.2 of the Reasons of T 352/07). Hence, the case to be decided in T 352/07 is not comparable to the present one.

4.3 For these reasons and in the absence of any further objection of insufficient disclosure, the board concludes that the ground for opposition under Article 100(b) EPC 1973 does not prejudice the maintenance of the patent.

5. Priority

The patent in suit claims the priorities of

- U.S. patent application No. 60/029,301 filed on 25 October 1996, and

- U.S. patent application No. 60/045,331 filed on 1 May 1997.

As is evident from documents (D25) and (D26), the abstract (D3) was published in January 1997 (see, e. g., the date indicated in the header on page 128 of (D26)). Therefore, document (D3) is considered as prior art according to Article 54(2) EPC 1973 if and to the extent that the present claims do not enjoy the priority of 25 October 1996.

Hence, it has to be assessed to which extent the present claims enjoy said priority. In the following, U.S. patent application No. 60/029,301 is denoted as the first priority document.

5.1 Claim 1 of the main request

Whereas the opponent argued that the first priority document disclosed asthma and allergy only in the context of eosinophilia, the patent proprietor considered that the treatment of these diseases was disclosed on page 3, lines 15 ff. of said document (see points XVI and XVII above).

The passage cited by the patent proprietor reads as follows:

"These observations are important since it is clear that certain diseases are actually TH2-mediated diseases. The hallmark of some of these diseases is over-production of IgE and eosinophilia.

These conditions include asthma, allergy, ..."(emphasis added by the board).

Due to the fact, that a new paragraph starts with the sentence "These conditions include asthma, allergy ...", it is indeed not absolutely clear whether these "conditions" refer to the "over-production of IgE and eosinophilia" or to other parts of the previous paragraph.

Therefore, this citation has to be interpreted in the light of the first priority document as a whole.

In the remaining parts of the first priority document, asthma is mentioned

- in the first paragraph of page 1 and in line 3 of page 2 ("... for example, asthma caused by pulmonary eosinophilia");

- on page 4, lines 1-3 ("Treatment of asthma and other diseases ... Chronic pulmonary inflammation involving eosinophil infiltration is a characteristic hallmark feature of bronchial asthma."); and

- in the third paragraph on page 5 ("... will be useful for the treatment of atopic diseases associated with eosinophilia such as asthma ...").

In all these parts of the first priority document, asthma is associated with eosinophilia. Therefore, it is apparent to the person skilled in the art that also the passage on page 3 cited above refers to asthma associated with eosinophilia.

Hence, claim 1 of the main request which refers to asthma in general does not enjoy the first priority under Article 87(1) EPC 1973.

5.2 Claim 3 and 4 of the main request

The feature "whereby the induction of IL-4 and/or IL-5 cytokines is inhibited" of claim 3 is not disclosed in the first priority document (see the last sentence of the chapter "Conclusion" on page 5 which mentions "through inhibition of IL-4 and IL-5 production and thus eosinophilia"; see also the last sentence on page 3; see page 2, 2nd para., lines 9 ff which mentions as examples IL-3, IL-4, IL-5 and GM-CSF).

The first priority document also does not mention eczema (see present claims 3 and 4), let alone the feature "oral or nasal inhalation" in present claim 4 (note that the term "aerosol inhalation" disclosed in the first priority document on page 5, line 3 of the second paragraph is limited to aerosols).

5.3 Hence, independent claims 1, 3 and 4 of the main request do not enjoy the first priority.

6. Main request, first and second auxiliary requests - inventive step

6.1 As can be seen from point XV a) above, claim 4 of the main request concerns the oral or nasal inhalation of imidazoquinoline amines. It is identical with claim 4 of the first auxiliary request and claim 3 of the second auxiliary request.

6.2 As stated under point 5.2 above, this claim does not enjoy the first priority claimed. Consequently, document (D3) belongs to the state of the art under Article 54(2) EPC 1973 for this claim.

Document (D3) draws the conclusion from the experiments disclosed therein that imiquimod "may be an effective agent in the treatment of chronic eosinophilic airway inflammation" (see the last sentence of the document).

Imiquimod is one of the two most preferred active agents according to the patent in suit (see paragraph [0012] on page 3).

The subject-matter of claim 4 of the main request (and claim 4 of the first auxiliary request and claim 3 of the second auxiliary request) differs from the one disclosed in document (D3) in that the latter does not disclose oral or nasal inhalation. An unexpected effect of nasal or oral inhalation as compared to other modes of application has not been demonstrated by the patent proprietor.

6.3 The problem to be solved in view of document (D3) is therefore the provision of a different kind of administration of imiquimod.

6.4 Pharmaceutical compositions against chronic airway inflammations in the form of sprays for inhalation are most common (e. g. corticoid sprays against asthma, nasal sprays against allergic rhinitis). The fact that not every drug is suitable for oral or nasal inhalation would not have prevented the person skilled in the art from trying the obvious, i. e. from testing whether imiquimod is effective against chronic eosinophilic airway inflammations when inhaled nasally or orally.

6.5 Therefore, it was obvious for the person skilled in the art to administer imiquimod by oral or nasal inhalation in order to treat chronic eosinophilic airway inflammations and thus to make use of the teaching of claim 4 of the main request, claim 4 of the first auxiliary request and claim 3 of the second auxiliary request.

6.6 The board can only decide on a request as a whole. For this reason, the main request, the first and the second auxiliary request were not allowed.

7. Third auxiliary request

7.1 The only independent claim of this request is identical with claim 1 of the main request. This claim does not enjoy the first priority (namely that of 25 October 1996; see point 5.1 above). Consequently, document (D3), which was published in January 1997, forms part of the state of the art for this claim.

7.2 Document (D3) suggests that imiquimod "may be an effective agent in the treatment of chronic eosinophilic airway inflammation" (see the last sentence of the document).

7.3 Claim 1 of the third auxiliary request is a Swiss-type claim related to "the treatment of a disease selected from the group consisting of asthma and allergy".

7.4 The subject-matter of this claim differs from the one disclosed in document (D3) in that (D3) does not disclose the treatment of asthma and/or allergy.

7.5 The problem to be solved by the subject-matter of this claim in view of document (D3) may be considered as the provision of a new therapeutic application of imiquimod or other imidazoquinoline amines. In view of the data found in the patent in suit, the board is satisfied that the imidazoquinoline amines are indeed effective in the treatment of asthma and/or allergies.

7.6 The opponent argued that the use for the treatment of asthma and allergy was obvious as the patent in suit states that eosinophilia "is a hallmark of many TH2 mediated diseases, such as asthma, allergy, and atopic dermatitis" (see page 2, line 41).

7.7 However, neither is there any indication in the patent in suit that it was generally known to the person skilled in the art that eosinophilia is a hallmark of asthma and allergy, nor has the opponent provided any evidence in this respect. As to its burden of proof, reference is made to point 4.1 above.

Nor has the board found any evidence to this respect in the documents the parties relied upon during the appeal proceedings (see point XIV above).

7.8 For these reasons, the board proceeds from the fact that the person skilled in the art having read document (D3) would not have considered the use of imiquimod or other imidazoquinoline amines for the treatment of asthma or allergy.

7.9 Hence, the subject-matter of claim 1 of the third auxiliary request is based on an inventive step. The same applies to the remaining claims of this request as they are dependent from claim 1.

7.10 Further objections were not raised against the claims of this request.

7.11 Neither did the opponent object against the description adapted to the claims of this request, nor has the board found any reason to do so.

7.12 Hence, the patent as amended according to the third auxiliary request meets the requirements of the EPC.