T 1592/11 11-05-2015

Reasons for the Decision

1. Admissibility of the appeal

1.1 In the impugned decision, the Opposition Division considered that the claims of the then filed auxiliary request satisfied the requirements of the EPC, in particular the requirements of novelty and inventive step in view of documents D1 to D6. The Opposition Division also indicated in the second paragraph of the minutes of oral proceedings that D7 was not admitted into the proceedings as it had been filed late and was not relevant.

1.2 In the statement of grounds of appeal the appellant-opponent challenged the position of the Opposition Division not to admit the late-filed document D7 and presented substantiated objections concerning novelty and inventive step of the claimed subject-matter on the basis of D7 and newly introduced documents D8 to D11.

1.3 The Board therefore finds that the appellant-opponent challenged at least one aspect of the impugned decision in a substantiated way. The statement of grounds of appeal thus contains at least one reason for setting aside the decision impugned, as required by Rule 99(2) EPC. Furthermore, according to established jurisprudence of the boards of appeal, an appeal is not to be considered inadmissible merely because it is based on evidence submitted for the first time with the statement of grounds of appeal (Case Law of the Boards of Appeal, 7th edition 2013, IV.E.2.6.5(a)). For the purpose of establishing the admissibility of the appeal it is moreover immaterial whether the arguments are, upon subsequent examination as to its merits, found to be unconvincing.

1.4 The appeal is therefore considered to be admissible.

2. Admissibility of late-filed documents and remittal

2.1 Documents D7 to D12 were introduced into the opposition and appeal proceedings well after the nine-month opposition period (Article 99(1) EPC). D7 was introduced during the opposition proceedings, D8 to D11 with the statement of grounds of appeal, and D12 shortly before the oral proceedings before the Board.

2.2 The respondent-proprietor is in principle right to say that the appellant-opponent could have introduced these documents in time into the first-instance proceedings. However, this is not the only criterion to be considered when deciding on their admissibility. In particular, the Board considers (for reasons explained in greater detail under points 3 to 3.4 below) that document D8 is prima facie relevant regarding the novelty of the subject-matter of claim 1 which the Opposition Division held allowable. Also D12 appeared to be prima facie of relevance for some of the auxiliary requests which the respondent-proprietor filed in order to overcome the novelty objection regarding D8 (these requests were subsequently withdrawn during oral proceedings).

The Board considers therefore that these prima facie relevant documents D8 and D12 are to be taken into consideration for assessing the patentability of the claimed subject-matter and that it would not be appropriate to disregard these documents under Article 114(2) EPC. They involved moreover no particular complexity and the time of their filing allowed a proper response from the respondent-proprietor. In fact, the respondent-proprietor filed a series of auxiliary requests responding both to the novelty objection regarding D8 and to the inventive-step objections involving D12.

2.3 The Board does not admit, however, documents D7 and D9 to D11 for the following reasons:

(i) D7 had not been admitted by the Opposition Division since it was found to be prima facie not relevant. Since the Board considers that the Opposition Division correctly exercised its discretion not to admit D7, the Board sees no reason to now decide otherwise. In fact, D7 is not relevant since it only discloses that the motor may be stopped (page 9, lines 18 to 19), i.e. its speed is then zero, which means that there is no longer any speed with which the drive mechanism acts.

(ii) D9 to D11 are also found, prima facie, to be of no relevance regarding novelty. D9 relates to an injection device for injecting contrast media from a syringe (abstract, first sentence), but not from a "medicament cartridge" as claimed. D10 relates to a metering apparatus with a pipette (column 1, first paragraph; column 2, second paragraph), rather than an injection apparatus for injecting a medicament. D11 relates to an infusion pump wherein the medicament is contained in a solution bag (64 in Figure 3; column 7, lines 27 to 34), whereby the pump of D11 lacks the claimed features of a medicament cartridge with a displaceable bung therein.

It is to be noted that documents D7 and D9 to D11 are in particular of no relevance for the present decision on the maintenance of the patent on the basis of auxiliary request XIIIii since no objection based on these documents was brought forward by the appellant-opponent against this request; see point IX above and point 8.1 below.

2.4 The respondent-proprietor considered that a remittal to the Opposition Division was just and equitable in order to have these documents considered by two instances. Also the appellant-opponent requested remittal if the Board considered any of the auxiliary requests to be novel, so as to allow inventive step to be considered regarding the combination of D8 with D12.

Article 111(1) EPC leaves it to the discretion of the Board whether to exercise any power within the competence of the department of first instance or to remit the case to that department. Hence, a party has no absolute right to have each individual issue considered by two instances (Case Law of the Boards of Appeal of the EPO, 7th edition 2013, IV.E.7.6.1). In the present case, the Board observes that the patent was granted in 2005, i.e. about ten years ago, and that remittal would prolong the already lengthy opposition proceedings. Moreover, as indicated above, the assessment of novelty over D8, and any possible consideration of inventive step involving also D12, were straight forward and the timing of the filing of the documents and of the amended claims allowed the other party and the Board enough time to prepare the case.

In view of the above circumstances and taking into consideration the imperative of procedural efficiency, the Board considers it appropriate to decide the case itself rather than remit it to the department of first instance pursuant to Article 111(1) EPC.

3. Main request

3.1 Document D8 discloses a device for injecting a medicament from a medicament cartridge comprising, in essence, a drive mechanism (12) for displacing a bung within the cartridge to expel the medicament (page 1, lines 11 to 18; page 4, lines 1 to 2 and 7 to 8). In the embodiment of Figure 9, a cartridge holder (112) for holding a medicament cartridge (100) with a bung (104) therein is disclosed (page 9, lines 29 to 32). The injection device of D8 comprises, moreover, an electronic control unit controlling the drive mechanism (page 7, lines 21 to 26) at two successive different speeds, such as the HIGH and LOW fluid rates shown in Figure 15A (page 17, lines 11 to 18), wherein the second speed is slower than the first speed.

3.2 The respondent-proprietor argued that in D8 the system is operated by a clinician activating a foot pedal, whilst in the claimed device the drive mechanism is under the control of an electronic control unit.

The Board does not accept this argument. Although the drive mechanism speed is adjusted through activation of a foot pedal (176 in Figure 10), the latter operates on a "control unit" (microprocessor 154 in Figure 10; page 12, line 12; page 14, lines 21 to 32) which controls the motor (66) of the drive mechanism (12). D8 discloses, moreover, that when the system detects a persistent abnormally high fluid exit pressure the speed is gradually decreased as shown in Figure 16A (page 18, lines 11 to 15). This is clearly done automatically by the electronic control unit without any intervention by the clinician, as summarised in D8 on page 5, lines 29 to 31.

3.3 The Board also dismisses the respondent-proprietor's contention that D8 disclosed an infusion pump, but not an injection device as claimed. Infusion and injection are certainly different ways to administer a drug, differing in the time used to deliver a dose. The device of D8 is capable of administering a drug over a "long" time interval (as in an "infusion") or over a "short" period of time (as in an "injection"). D8 in fact explicitly mentions that the infusion system is suitable for the "injection" of a drug (e.g. page 1, lines 11 to 17; page 4, lines 7 to 8).

3.4 It follows that the subject-matter of claim 1 of the main request (which the Opposition Division considered to be allowable) lacks novelty over document D8, contrary to Article 54(1) EPC.

4. Auxiliary request I

Claim 1 additionally defines that "the injection device is a device used by users to administer a dose of medicament to themselves."

This expression defines a method step which makes reference to the users using the claimed device. It is therefore uncertain which structural features of the device this method step intends to define. The expression certainly differs from one stating that the device was suitable for self-administration of the medicament, as alleged by the respondent-proprietor.

As a consequence, claim 1 does not satisfy the requirement of clarity of Article 84 EPC.

5. Auxiliary request IA

5.1 The respondent-proprietor filed this request during the oral proceedings, asserting that it formulated the invention more clearly than in auxiliary request XIII.

The Board notes however that, compared with claim 1 of auxiliary request XIII, claim 1 of the present request leaves out, in particular, the feature of the injection device comprising means to detect resistance to dispense.

5.2 It is the established jurisprudence of the boards of appeal that the appeal procedure is designed to ensure that the proceedings are as brief and concentrated as possible and ready for decision at the conclusion of oral proceedings. Therefore, amendments to the claims must be filed at the earliest possible moment and the Board may disregard amended claims if they are not submitted in good time prior to oral proceedings (Case Law of the Boards of Appeal, 7th edition 2013, IV.E.4.2.1). This practice corresponds to Article 13(1) RPBA, which gives a Board the discretion not to admit and consider amendments to the claims if they are not filed at the earliest possible moment, in particular if they are not filed in good time prior to oral proceedings. The Board must exercise that discretion in view inter alia of the complexity of the new subject-matter submitted, the current state of the proceedings and the need for procedural economy.

With regard to procedural economy, the factors to be examined in deciding whether a late-filed request is admissible include whether the subject-matter of the new claim is so clear and straightforward that it can be understood and allowed without further discussion (Case Law of the Boards of Appeal, 7th edition 2013, IV.E.4.2.3(a)).

5.3 In the present case the Board is of the view that claim 1, far from addressing any (actually not objected to) clarity deficiencies of claim 1 of auxiliary request XIII, as alleged by the respondent-proprietor, appears to broaden its subject-matter. In fact, the Board considers that the amendments are prima facie not clearly compliant with Article 123(2) EPC. Whilst the respondent-proprietor indicated that the amendments were based on original page 10, lines 14 to 21 (paragraph [0049] of the patent), the Board finds that the presently retained definition of the increased output force of the drive mechanism seems to be originally disclosed in said passage in combination with detection means for detecting a resistance to dispense the medicament which are absent form the definition in claim 1.

5.4 The Board consequently decides that auxiliary request IA is not admissible under Article 13(1) RPBA.

6. Auxiliary request XIII

6.1 Independent claim 3 is directed to "a method of dispensing a dose of medicament from [...] an injection device". The Board questioned the allowability of such a method under Article 53(c) EPC in its communication attached to the summons to oral proceedings. An objection under this ground had already been examined during the oral proceedings before the Opposition Division (paragraphs 5 to 8 of the minutes of oral proceedings).

6.2 By definition, a medicament is a substance used in therapy. Paragraph [0002] of the patent makes it clear moreover that the claimed method encompasses the step of administering insulin or an insulin-type medicament to a human body. Consequently, the claimed method which comprises (or, at least, encompasses) such a step is deemed to be a method of treatment by therapy under Article 53(c) EPC (G 1/07, point 3.2.5 of the Reasons).

The respondent-proprietor's argument that the claimed method did not necessarily encompass the step of administering a medicament to a human body, but could instead be used during a priming operation of the device in which a small amount of a medicament is dispensed without administering it to a human or animal body (as explained in paragraph [0025] of the patent), is hence irrelevant.

6.3 Since the claim comprises (or encompasses) the therapeutic step of dispensing a dose of medicament to the human body, respondent-proprietor's further assertion that the present method claims were only concerned with the operation of a device without any functional link between the claimed method and the effects produced by the device on the body (G 1/07, Reasons 4.3.2; T 245/87, Reasons 5.2) is not accepted by the Board either. There is no room to question the existence of such a link when the therapeutic step is comprised (or encompassed) by the claim. The present claim is explicitly directed to "a method of dispensing a dose of a medicament", rather than to the operation of a device as in T 245/87.

6.4 Consequently, the method of claim 3 of auxiliary request XIII is a method for treatment by therapy within the meaning of Article 53(c) EPC and therefore excepted from patentability.

7. Auxiliary request XIIIi

7.1 Independent claim 3 of this request defines "a method of dispensing a dose of medicament from [...] an injection device" including the disclaimer that "the medicament is not administered to a human or animal body".

7.2 Since a medicament is a substance used in therapy a method of dispensing a dose of medicament primarily implies that the medicament is administered to a human or animal body. To define that it is not appears to be an oxymoron. As such, the definition is unclear and not allowable under Article 84 EPC.

7.3 The respondent-proprietor argued that the patent specification included an example of a method of dispensing a medicament without any therapeutic effect. The disclosed example was a priming operation in which a small amount of medicament was ejected with the needle pointing upwards, without any medicament being administered to a human or animal body (paragraph [0025] of the patent).

The Board considers, however, that the disclosure of the priming operation of the device gives no support for defining it in other terms, particularly not in terms of the mentioned disclaimer. There is hence no support in the description for defining the priming of the device as a method of dispensing a dose of medicament from an injection device wherein "the medicament is not administered to a human or animal body".

7.4 For the above reasons, claim 3 of auxiliary request XIIIi is not considered to be allowable under Article 84 EPC.

8. Auxiliary request XIIIii

8.1 The subject-matter of the claims of this request is the same as that of the device claims of auxiliary request XIII filed by the respondent-proprietor on 2 April 2015. It was objected to by the appellant-opponent in its letter dated 20 April 2015 under Article 123(2) EPC and as lacking novelty regarding D8.

The Board does not find these objections convincing for the following reasons.

8.2 The preamble of claim 1 is based on originally filed claims 1, 4 and 9. On page 10, lines 14 to 21 of the original application (corresponding to paragraph [0049] of the patent), an embodiment is described in which the drive mechanism acts with two different successive speeds, the second speed being slower than the first speed. The second and third sentences of that paragraph explicitly state that the drive mechanism is slowed to deliver more output force when a resistance to dispensing the medicament is detected. This unambiguously means that more output force is delivered at the slower, second speed (i.e. more than the output force delivered at the first speed) for overcoming the resistance to dispense.

Consequently, claim 1 of auxiliary request XIIIii fulfils the requirements of Article 123(2) EPC.

8.3 Contrary to the the view of the appellant-opponent, the claimed device is also novel over D8 for the following reasons.

As indicated under point 3.2 above, the device of D8 comprises means for detecting resistance to dispense the medicament, and when an abnormally high fluid exit pressure persists, the speed is gradually decreased until it stops altogether, as shown in Figure 16A (page 18, lines 11 to 15). This is clearly done automatically by the electronic control unit without any intervention by the clinician, as summarised on page 5, lines 29 to 31. Consequently, the features of the last paragraph of the preamble of claim 1 of auxiliary request XIIIii are also known from D8.

D8 is silent, however, as to the output force of the drive mechanism when the speed of the drive mechanism is slowed down.

Consequently, claim 1 differs from D8 in the feature of the characterising portion, i.e. that "the drive mechanism is adapted to deliver more output force when operated at the second speed for overcoming the resistance to dispense."

As a consequence, the device of claim 1 of auxiliary request XIIIii satisfies the requirement of novelty in the sense of Article 54 EPC.

8.4 The appellant-opponent has not objected that the claimed subject-matter lacks an inventive step. The Board sees no objection under Article 56 EPC either.

8.4.1 The aforementioned differentiating feature solves the problem of allowing the medicament to be dispensed even in the presence of a detected resistance to dispensing, for example if the medicament, such as insulin, is cold and therefore more viscous and difficult to expel (as explained in paragraph [0049] of the patent).

8.4.2 In contrast to this, D8 teaches that when a high pressure is detected the flow rate of the drug is to be reduced in order to minimise subjective pain and potential tissue damage to the patient resulting from the high pressures during administration of the drug (page 3, lines 29 to 31). Increasing the output force of the drive mechanism as in the claimed device would therefore go against the purpose of reducing the flow rate of the drug stated in D8.

8.4.3 D12 is even less relevant in this respect since the device disclosed does not even inject the medicament at two different speeds as claimed. In D12, when the counter-pressure in tissue is higher than normal, the further delivery of insulin is prevented by stopping the electromotor altogether (column 7, lines 29 to 44).

8.4.4 Consequently, the subject-matter of claim 1 of auxiliary request XIIIii involves an inventive step in the sense of Article 56 EPC. This applies a fortiori to the preferred embodiment defined in dependent claim 2.