T 0139/18 (Pre-filled syringe/ALLERGAN) 09-08-2021

Reasons for the Decision

1. The appeal is admissible. It meets the requirements of Articles 106 to 108 and Rule 99(2) EPC.

2. Admittance of the main request - Rule 139 EPC and Article 13(2) RPBA 2020

The appellant filed the claims of the main request with its letter dated 24 June 2021 to replace the claims of a previous main request filed with the statement of grounds of appeal. The replacement of the claim request was requested as a correction under Rule 139 EPC.

The board decided to admit the new main request into the appeal proceedings because the replacement of the previous main request can be allowed under Rule 139 EPC and is not precluded by Article 13(2) RPBA 2020. Considering the board's judgment on the issue of novelty in relation to the main request (see point 4), the board does not need to give details of the decision to admit the main request.

3. Admittance of auxiliary request 2 - Rule 139 EPC and Article 13(2) RPBA 2020

The appellant filed the claims of auxiliary request 2 with its letter dated 24 June 2021 to replace the claims of a previous auxiliary request 2 which had been filed with the statement of grounds of appeal. The circumstances and considerations in relation to auxiliary request 2 are identical to those of the main request.

In view of the board's judgment on the issue of novelty (see point 5), the board does not need to give further details on its decision to admit auxiliary request 2.

4. Novelty over D4 - claim 1 of the main request (Article 54(1) and (3) EPC)

4.1 Document D4 is an international patent application which validly entered the regional phase before the EPO. It was published after the filing date of the contested patent, but its filing and priority dates are earlier than the respective dates of the contested patent.

In the decision under appeal (section 5.3.2), the opposition division held that D4 was prior art under Article 54(3) EPC. This aspect of the decision was not contested by the appellant (see statement of grounds of appeal, page 2, penultimate paragraph), therefore it is not part of these appeal proceedings.

4.2 D4 discloses (page 5, paragraph 2) anti-angiogenic compositions for intra-ocular injection comprising a TKI and a hyaluronic acid component. The TKI is a VEGF inhibitor and constitutes the anti-angiogenic component (page 7, line 25 and following paragraphs). The hyaluronic acid component is the viscosity inducing component (page 11, lines 12-14). As in the contested patent, the viscosity values in D4 are in relation to a shear rate of 0.1/second at 25°C (page 6, lines 25-26). These values range from 10 to 300 000 cps, but viscosities of at least 70 000 cps are particularly preferred (page 11, lines 26-29 and page 20, lines 26-29).

Having regard to the above, the question of whether the subject-matter of claim 1 of the main request is anticipated by D4 boils down to assessing whether D4 discloses a composition in which the anti-angiogenic component is a macromolecule and the polymeric hyaluronate component is present in an amount of 1-4 %(w/v). In D4, the compositions containing 1-4 %(w/v) of polymeric hyaluronate component are associated with the formation of high-viscosity gels that are advantageously marketed in pre-filled syringes (page 22, lines 21-24; page 61, lines 15-20; page 62, lines 10-14).

4.3 Regarding the anti-angiogenic component, the respondent referred to the passage bridging pages 10 and 11 of D4. The passage discloses that the TKI component includes a macromolecule, such as a protein, peptide, nucleic acid, modified nucleic acid or a peptide nucleic acid. Therein, it is stated that "[a]dditionally, or alternative, the TKI component may comprise an organic molecule other than a macromolecule". Non-macromolecular TKI components are also referred to as "small molecules".

Thus the passage bridging pages 10 and 11 of D4 presents a choice between macromolecular and small anti-angiogenic components (or their combination); choosing the macromolecular component involves one selection.

4.3.1 On this point, the appellant noted that D4 extensively discloses small molecules (pages 29-51) and that the compositions in the examples contain only small molecules. Therefore macromolecular components had to be considered as being less preferred than small molecules, and their selection went against the general teaching of D4.

4.3.2 The board disagrees. The paragraph bridging pages 10 and 11 discloses macromolecules and small molecules at the same level of preference, and there is no specific disclosure in D4 giving greater preference to small molecules. The fact that D4 describes more examples of small molecules does not necessarily mean that they are generally more preferred. In fact, the passage on page 10, lines 10-34 also recites several examples of macromolecules, including proteins and nucleic acids. Therefore the board does not see that the selection of a macromolecule from the choices presented in the paragraph bridging pages 10 and 11 is precluded.

4.4 With respect to the concentration of the polymeric hyaluronate component, the parties referred to the two embodiments disclosed on page 22, lines 16-24 of D4. The passage reads as follows (emphasis added by the board).

"In one embodiment, the present compositions include a polymeric hyaluronate component in an amount in a range about 0.05% to about 0.5%(w/v). In a further useful embodiment, the hyaluronate component is present in an amount in a range of about 1% to about 4%(w/v) of the composition. In this latter case, the very high polymer viscosity forms a gel that slows particle sedimentation and diffusion of dissolved solutes upon injection in the eye. Such a composition may be marketed in pre-filled syringes since the gel cannot be easily removed by a needle and syringe from a bulk container."

Considering that the choice of a macromolecule as the active component already involved one selection, the issue of novelty hinges on whether the choice of the second embodiment on page 22, lines 16-24 constitutes an additional selection. For the reasons explained below, the board concurs with the respondent that, in view of the general teaching of D4, the embodiment relating to 1-4 %(w/v) hyaluronate component was preferred and did not require a selection to be made.

4.4.1 First of all, the board notes that the language of the text introducing the embodiments is not the same in both cases. The composition with the lower hyaluronate content is referred to as "an embodiment" while the composition with the higher hyaluronate content is "a further useful embodiment". Although the board does not necessarily concur with the respondent that this automatically means that the second embodiment is preferred, it certainly points towards a difference of appreciation between the two embodiments.

4.4.2 As indicated above (point 4.2), D4 describes compositions with viscosities in the range 10-300 000 cps, but viscosities of at least 70 000 cps are particularly preferred (page 11, lines 26-29 and page 20, lines 26-29). It is generally known that higher concentrations of viscosity inducing agent produce higher viscosities. Hence it is reasonable to assume that the embodiment containing higher concentrations of hyaluronate component would provide compositions within the higher (i.e. preferred) range of viscosities.

4.4.3 In that respect, the appellant argued that D4 does not disclose a correlation between viscosities above 70 000 cps and hyaluronate concentrations in the range of 1-4 %(w/v). It then referred to the passage on page 21, lines 15-20, which states that the specific amount of viscosity inducing component employed depends on several factors, e.g. the molecular weight of the viscosity inducing component. This means that, in theory, hyaluronate components of high molecular weight could provide viscosities beyond 70 000 cps at concentrations within the range of 0.05-0.5 %(w/v) and, conversely, hyaluronate components of low molecular weight might not achieve a viscosity of 70 000 cps at concentrations within the range of 1-4 %(w/v).

The board accepts that molecular weight and other factors have an influence on the amount of hyaluronate component that needs to be added to the composition to achieve a given viscosity. However, the board concurs with the respondent that the appellant's argument cannot counter the clear teaching in D4 that viscosities above 70 000 cps are preferred and that these are achieved by hyaluronate concentrations within the range of 1-4 %(w/v) rather than 0.05-0.5 %(w/v). This teaching may be derived from the following sections of D4:

Examples 2-8 show that compositions comprising 0.05-0.5 %(w/v) of a sodium hyaluronate with an average molecular weight of 0.6 million daltons have a viscosity of 20-500 cps. However, the same sodium hyaluronate used in examples 9-13 at concentrations of 2.0-3.0 %(w/v) produces viscosities of 100 000- 300 000 cps. These results are in line with the teaching in the paragraph bridging pages 13 and 14, which associates viscosities of 80 000-300 000 cps with hyaluronate concentrations of 2-3 %(w/v). In addition, the passage on page 22, lines 16-24 states that the compositions containing 1-4 %(w/v) hyaluronate exhibit very high polymer viscosity.

4.4.4 Consequently, the board holds that the second embodiment on page 22, lines 16-24 of D4 is preferred and that its choice does not constitute a selection.

4.5 In summary, D4 discloses a preferred embodiment which is a gel composition for intra-ocular injection having a viscosity of at least 70 000 cps at a shear rate of 0.1/second at 25°C and comprising 1-4% (w/v) of a polymeric hyaluronate component. It also discloses that, due to its high viscosity, this preferred composition is to be marketed as a pre-filled syringe.

In addition, as a result of a single selection, the therapeutically active ingredient is a macromolecular TKI, i.e. a macromolecular anti-angiogenic component which is a VEGF inhibitor.

Hence D4 discloses the combination of features in claim 1 of the main request. The claim therefore does not meet the requirements of Article 54(1) and (3) EPC.

5. Novelty over D4 - claim 1 of auxiliary requests 1 to 3 (Article 54(1) and (3) EPC)

As conceded by the appellant in the discussion of the admission of the main request, claim 1 of auxiliary request 1 defines essentially the same subject-matter as claim 1 of the main request. Therefore it too lacks novelty over D4.

Claims 1 of auxiliary requests 2 and 3 correspond to claim 1 of the main request and auxiliary request 1, respectively, with the additional limitation that the MAAC has been restricted to option (ii), i.e. the VEGF inhibitor is a nucleic acid or a polypeptide. As noted by the respondent, the paragraph bridging pages 10 and 11 of D4 discloses nucleic acids, proteins and peptides as examples of macromolecular TKIs. Hence the choice of the MAAC to be a nucleic acid or a polypeptide still represents a single selection and cannot confer novelty on the subject-matter of claim 1 of auxiliary requests 2 and 3.

6. Admittance of auxiliary request 4 - Article 13(2) RPBA 2020

The appellant filed the claims of auxiliary request 4 at the oral proceedings once the board had come to the conclusion that the subject-matter of all the claim requests then on file lacked novelty over D4.

According to Article 13(2) RPBA 2020, any amendment to a party's case at such a late stage of the proceedings is, in principle, not taken into account unless there are exceptional circumstances which have been justified with cogent reasons by the party concerned.

The appellant justified the filing of new claims by a development of the arguments on file occasioned by the citing of the passage on page 20, lines 26-29 of D4 in the board's preliminary opinion.

This passage was cited by the board in the context of the argument that higher-viscosity compositions were generally preferred in D4, so the choice of the compositions with a higher hyaluronate content did not constitute a selection from a list of equivalent items.

The passage cited by the board conveys essentially the same information as the one on page 11, lines 26-29 cited in the decision under appeal (page 24, paragraph 3) in support of exactly this argument. That passage on page 11 of D4 had also been cited by the respondent in its reply to the statement of grounds of appeal (page 4, paragraph 4) in the context of novelty over D4, although the respondent did not explicitly outline the argument that higher-viscosity compositions were generally preferred; the argument came to the fore with the board's preliminary opinion.

The board considers that this shift of the focus of the respondent's argument to align with the reasons in the appealed decision underlined in the board's preliminary opinion is part of the normal development of a case. Therefore it does not amount to exceptional circumstances within the meaning of Article 13(2) RPBA 2020.

Furthermore, the respondent is right in that, considering that the patent had been revoked for lack of novelty over D4, a claim request clearly overcoming the opposition division's finding of lack of novelty could have been filed at the outset of the appeal proceedings. However, when lodging the appeal, the appellant confined itself to defending claim requests that had been considered in the decision under appeal. Furthermore, auxiliary request 4 could also still have been submitted in written proceedings as a direct response to the board's preliminary opinion, which had been issued more than eight months before the date of the oral proceedings. Instead, the appellant chose to submit this claim request only at the end of the oral proceedings, i.e. at the latest stage of the appeal proceedings. Therefore the development of the case referred to by the appellant does not constitute cogent reasons which might justify this late filing.

In conclusion, the board decided not to admit auxiliary request 4 into the proceedings pursuant to Article 13(2) RPBA 2020.