SHL Medical AG v Sanofi-Aventis Deutschland GmbH [2025] APO 43

1. The Application was filed on 2 June 2016 under the provisions of the PCT claiming priority from EP 15170596.9 which was filed on 3 June 2015. Acceptance of the Application was advertised on 10 December 2020. A notice of opposition to the grant of the Application under section 59 (the S59 Opposition) of the Patents Act 1990 (the Act) was filed by SHL Medical AG (the Opponent) on 17 March 2021.

1. The S59 Opposition took relatively minor detours with an extension of time under section 223(2)(a) allowed on 25 May 2021 for filing the opposition notice, an amendment to the S59 SGP allowed on 6 October 2021 and the decision of 17 February 2023[1] allowing an extension under Regulation 5.9(2)(a) for filing the evidence in reply.

1. On 22 December 2021, the same day as the evidence in answer being due, the Applicant proposed post-acceptance amendments to the specification. The journey to an allowable amendment was unfortunately very long and protracted, even relative to the S59 Opposition detours. A total of seven (7) adverse reports were issued with all but the last report requiring reminders to be sent to the Applicant for a response to be filed in order to progress the S59 Opposition in a timely manner. As well as the initial amendment, further amendments were filed on 12 July 2022, 20 April 2023, 30 August 2023, 8 January 2024 and 4 June 2024. The Opponent provided comments in relation to the amendments on 13 January 2022, 19 July 2022, 4 August 2022, 29 January 2024 and 25 June 2024, which were also considered by the Examiner. The amendment filed on 4 June 2024 was considered allowable by the Examiner after further response was filed on 29 August 2024.

1. The allowance of the amendment was advertised on 3 October 2024, nearly three years after the initial request. The Opponent filed a notice of opposition to the allowance of the amendment under S104 on 29 November 2024 (the S104 Opposition). A statement of grounds and particulars for the S104 opposition (S104 SGP) was filed on 23 December 2024, which was then amended on 15 April 2025 (amended S104 SGP).

1. Both parties expressed their intentions to file evidence in relation to the S104 Opposition. The following evidence was filed in relation to the S104 Opposition:

1. I am mindful that the S59 Opposition has been delayed significantly as a result of the S104 matter. It was heard by video conference held on 20 November 2025.

The Opposed Amendment is not allowable because, as a result of the amendment and after acceptance, a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment.

The Opposed Amendment is not allowable because, as a result of the amendment and after acceptance, the specification would not comply with subsection 40(2), (3) or (3A).

1. Both grounds were pressed at the hearing. However, the Opponent made certain concessions in relation to some of the particularised aspects, such as clarity of certain terms used in the claims.

1. The Opponent did not pursue s102(1) as a ground of opposition at any point. At the hearing, the Opponent stated that it was unnecessary to raise this ground as their case under s102(2)(a) and s102(2)(b) was so strong.

1. The substantive amendments to the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) apply to the present case. The standard of proof in opposition proceedings, including oppositions under s104(4), is the balance of probabilities. The opponent bears the onus of proof.

1. Pursuant to s104(5), the Commissioner must not allow an amendment that is not allowable under s102. S102(1) and s102(2) of the Act as they apply to the Application are as follows:

(1) An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim or disclose matter that extends beyond that disclosed in the following documents taken together:

(a) the complete specification as filed;

(b) other prescribed documents (if any).

(2) An amendment of a complete specification is not allowable after the relevant time if, as a result of the amendment:

(a) a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment; or

(b) the specification would not comply with subsection 40(2), (3) or (3A).

1. Notably the legislation requires that the failure to meet the requirements of s102(1) and s102(2) must be the result of the amendment, with the relevant point in time in this case being the accepted Application.

s102(2)(a) - claim would not in substance fall within the scope of the claims before amendment

1. A useful test for the allowability of amendments was suggested in relation to s31(1) of the Patents Act 1949 (UK) as "would the amendment make anything an infringement which would not have been an infringement before the amendment?"[3] Although the wording of s102(2)(a) differs from the wording of the then s31(1) of the British Act, this approach was adopted by the Commissioner[4] and the Federal Court has also accepted the continuing relevance of this approach.[5]

s102(2)(b) - specification would not comply with subsection 40(2), (3) or (3A)

1. As the Opponent pressed that the specification does not comply with s40(2)(a) with respect to sufficiency and s40(3) with respect to lack of clarity and support, it is necessary to set out the principles associated with these parts of the Act. However, it is not before me to determine whether the complete specification provides sufficient disclosure, or whether the present claims lack support. Instead, I must simply determine if the amendment gives rise to issues under s102 of the Patents Act.

s40(2)(a) - clear enough and complete enough disclosure (sufficiency)

1. Section 40(2)(a) requires that the complete specification make the necessary disclosure to enable the claimed invention.[6] Whether an invention is disclosed in a manner which is clear enough and complete enough depends on whether, given what is contained in the specification, the person skilled in the art can readily perform the invention without undue burden or experimentation beyond the ordinary steps of trial and error, or the need for further invention.[7]

1. It is not sufficient for the specification to provide a starting point from which the person skilled in the art may reach another invention by the use of the common general knowledge.[8] The mere fact that it would be obvious to the person skilled in the art to use the disclosure in the specification to produce what is claimed is not enough if, properly characterised, the disclosure in the specification and the claim are for different inventions.

s40(3) - claim(s) must be supported by matter disclosed in the specification

1. Burley J discussed the requirements for support:

"In CSR Building Products Ltd v United States Gypsum Company [2015] APO 72, Dr S D Barker adopted the summary provided by Aldous J in Schering Biotech at 252 - 253, which has been often followed in the United Kingdom (emphasis added):

...to decide whether the claims are supported by the description it is necessary to ascertain what is the invention which is specified in the claims and then compare that with the invention which has been described in the specification. Thereafter the court's task is to decide whether the invention in the claims is supported by the description. I do not believe that the mere mention in the specification of features appearing in the claim will necessarily be a sufficient support. The word 'support' means more than that and requires the description to be the base which can fairly entitle the patentee to a monopoly of the width claimed.

That approach encapsulates broadly the claim support obligation under s 40(3). To it may be added the requirement that the technical contribution to the art must be ascertained. Where it is a product, it is that which must be supported in the sense that the technical contribution to the art disclosed by the specification must justify the breath of the monopoly claimed."[9]

1. It is therefore the case that, under s40(3), the matter in a claim of a specification must be supported by an enabling disclosure in the description and any drawings, graphics, photographs and sequence listing (i.e., the body of the specification).

1. Bennett J discussed the correct approach to the construction of claims:

"the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear ... while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole ... it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification ... terms in the claim which are unclear may be defined or clarified by reference to the body of the specification"[10]

1. The requirement for clarity will be satisfied if there would be "no difficulty in a third party ascertaining whether or not what he proposes to do falls within the ambit of the claim."[11] Further, "Lack of precise definition in claims is not fatal to their validity, so long as they provide a workable standard suitable to their intended use."[12]

1. As is usually the case, critical to the present matter is proper construction of the specification and claims. Here, I note the comments of Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd:

"It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date."[13]

1. Furthermore, the correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd:

"...the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear ... while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole ... it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification ... terms in the claim which are unclear may be defined or clarified by reference to the body of the specification."[14]

1. The construction of the specification and claimed invention is performed by the person skilled in the art as in Root Quality Pty Ltd v Root Control Technologies Pty Ltd:

"The skilled addressee, or the judge adopting the mantle of the skilled addressee, is relevant for a variety of purposes in patent law. He is the person to whom the patent is addressed and who must construe it."[15]

1. The nature of the person skilled in the art is considered in KD Kanopy Australasia Pty Ltd v Insta Image Pty Ltd:

"The hypothetical skilled person is a person acquainted with the surrounding circumstances of the state of the art and manufacture at the relevant time_: Kimberly Clark Australia Pty Ltd v Arico Trading International Pty Ltd_ (2001) 207 CLR 1; [2001] HCA 8 at [24]. They are likely to have a 'practical interest in the subject matter of the invention': Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183 at 242 and may often work in the art with which the invention is connected."[16]

1. Valensi & Another v British Radio Corporation provides further consideration of the person skilled in the art:

"We think that the effect of these cases as a whole is to show that the hypothetical addressee is not a person of exceptional skill and knowledge, that he is not expected to exercise any invention nor any prolonged research inquiry or experiment. He must, however, be prepared to display a reasonable degree of skill and common knowledge of the art in working trials and to correct obvious errors in the specification if a means of correcting them can readily be found."[17]

1. The declarants in the present matter are Mr Clemens and Mr Wilson, who are both engineers specialising in the field of medical devices.[18] The Opponent noted that although Mr Wilson did not have relevant experience in autoinjector devices before the priority date, it may not be material where there is no dispute between the experts on the issue of what is disclosed by the Application.[19] I note that Mr Wilson was active in the field of medical devices including injection devices at the priority date and moved into the autoinjector field just 6 months later.[20]

1. I am satisfied that the declarants are well placed to give evidence in relation to the present matter.

1. The specification at acceptance consisted of 18 pages of description, 10 figures and 16 claims.

1. The described invention is directed to a syringe support within an autoinjector where the components, particularly the syringe, are securely arranged within a housing.[21] Broadly, there is provided an autoinjector comprising:

"a housing, wherein the housing comprises a syringe support for supporting an axial position of a syringe relative to the housing of the autoinjector, wherein the syringe support comprises:

• - a projecting portion which projects from the syringe support in a distal direction, and
• - a flexible portion which axially adjoins the projecting portion and axially extends from the projecting portion in the distal direction and which is adapted to axially bias the syringe in the distal direction within the housing when the syringe is assembled."[22]

1. The syringe support provides a secure arrangement of the syringe within the housing and ensures that the syringe is inserted to full insertion depth without moving backwards under force of piercing the skin.[23] The syringe support of the invention further allows for accommodating syringes with different lengths within manufacturing tolerances to be housed.[24] On final assembly of the syringe into the housing of the autoinjector, the flexible portion deflects axially, thereby providing an axial force on the syringe flange to bias it forward and to prevent accidental de-booting of the syringe.[25]

1. The syringe support may comprise a number of projecting portions with adjoining flexible portions that interact with the flange of the syringe for providing length compensation and damping effect.[26] Furthermore, the flexible portions may be arranged around the circumference of the syringe flange or symmetrically arranged opposed to each other on the syringe support to reliably hold the syringe in position.[27] This reduces the risk of breakage where the flexible portions are adapted to provide a secure axial support and positioning of the syringe relative to the housing.[28]

1. For simplicity, Figure 9 shows the front part 2.1 and the rear part 2.2 of the housing for the autoinjector of the invention, which are correspondingly adapted to couple with each other:

1. Figures 2 and 3 are schematic views of the rear part of the housing comprising the syringe support:

1. In these figures, the syringe support 15 comprises two projecting portions 15.3, each having a flexible portion 15.1 at their distal end.[29] The flexible portions 15.1 are integrally formed with and adjoin axially in the distal direction D with the projecting portions 15.3.[30] In the shown embodiment, the projecting portions 15.3 are part of the rear of the housing 2.2 and project from a proximal end 2.4 inwardly in the distal direction D.[31]

1. The flexible portions 15.1 are designed as elastic spring portions.[32] One end of each flexible portion 15.1 is attached to the corresponding projecting portion 15.3 and the opposite distal end is a free end.[33]

1. As a result of the amendments, the specification contains description pages 1-17 as filed on 12 July 2022, claim page 18 as filed on 8 January 2024, claim page 19 as filed on 4 June 2024, and drawings pages as accepted. At the hearing, I noted that the amendments to the claims pages result in claim 8 being missing. Both parties agreed that the amendments for consideration should be taken to cancel both pages 18 and 19 and substitute with the clean pages 18 and 19 filed on 4 June 2024. The clean pages included the full set of claims 1-17, in sequential order.

1. The present matter deals with the specification as proposed to be amended above, including clean pages 18 and 19 filed on 4 June 2024 for the claims.

1. The amendments proposed to the description are mainly to the consistory clause in at page 2, with added features underlined, is as follows:

In accordance with the present invention, there is provided an autoinjector comprising:

a housing, wherein the housing comprises a syringe support for supporting an axial position of a syringe relative to a housing of an autoinjector, wherein the syringe support comprises:

- a projecting portion which projects from the syringe support in a distal direction,

- a flexible portion which axially adjoins the projecting portion and axially extends from the projecting portion in the distal direction and which is adapted to axially bias the syringe in the distal direction within the housing when the syringe is assembled, wherein the flexible portion is adapted to accommodate to syringes having variable lengths within the housing in the distal direction, and wherein the flexible portion is axially deflected and stressed so that the variable lengths of the syringes can be compensated and an axial movement of the syringe is prevented during storage, transportation, drop and use, and

- a further flexible portion, wherein the flexible portions are arranged distally on the syringe support, wherein the flexible portions are arranged opposed to each other, and wherein the flexible portions are of U-shaped or V-shaped design.

1. Further amendments proposed to the description pages are editorial in nature.

1. In the earlier amendments filed at the same time as the amendments to the description, similar amendments reflecting the new consistory clause were made to the claims. The claims were further amended to address objections raised by the Examiner in line with the Opponent's comments.

1. For brevity I will introduce proposed claim 1, the only independent claim, with added features underlined and features removed struck through. I note however that the Opponent takes issue with various aspects of the claim set, and I will address each of these in more detail where required.

a housing, wherein the housing comprises a syringe support for supporting an axial position of a syringe relative to the housing of the autoinjector, wherein the syringe support comprises:

• - a projecting portion which projects from the syringe support in a distal direction, and
• - a flexible portion which axially adjoins the projecting portion and axially extends from the projecting portion in the distal direction and which is adapted to axially bias the syringe in the distal direction within the housing when the syringe is assembled., and
• - a further flexible portion, wherein the flexible portions are adapted to accommodate to syringes having variable lengths within the housing in the distal direction, and wherein the flexible portions are axially deflected and stressed so that the variable lengths of the syringes can be compensated and an axial movement of the syringe is prevented during storage, transportation, drop and use, and wherein the flexible portions are arranged distally on the syringe support, wherein the flexible portions are arranged opposed to each other, and wherein the flexible portions are of U-shaped or V-shaped design.

1. New claims 13-17 were added which further define various aspects of the autoinjector according to proposed claim 1.

1. The specification does not provide a definition for a "projecting portion". It is only generally described and relates to a portion of the syringe support that projects from the proximal end in the direction of the distal direction. The projecting portions are also referred to as "rigid arms"[34] and are made of material that is preferably stronger than the flexible portions.[35] The figures also show the projecting portion as a rigid arm extending from the base of the syringe support. No other embodiment is shown or described.

1. I understand that a projecting portion is a component of the syringe support which simply projects from the base. While it is typically depicted as a rigid arm in the specification, it does not need to have any particular shape. It is simply an intermediate component between the base of the syringe support and the flexible portion.

1. The specification does not provide a definition for a "flexible portion" either. It is also generally described and relates to a portion of the syringe support that axially adjoins the projecting portion and which is adapted to axially bias the syringe in the distal direction within the housing by contacting a flange of the syringe.[36] The flexible portion is also referred to as "compliant backstop" for the syringe within the housing. I understand that a flexible portion is a component of the syringe support which is made of a flexible material and is of a size and shape capable of axial deflection. In the claims as proposed to be amended, the shape of the flexible portions are defined as U-shaped or V-shaped.

1. The amended claims refer to a flexible portion and a further flexible portion, as well as flexible portions in the plural. The specification generally refers to the singular flexible portion when describing its function, material composition and shape. Alternative embodiments are described with reference to flexible portions in the plural. The specification does not mention a "further flexible portion" anywhere in any context. However, I understand that it simply refers to an additional flexible portion such that a flexible portion and a further flexible portion would make up two flexible portions.

Construction - the flexible portions are arranged opposed to each other

1. Proposed claim 1 defines that the flexible portions are arranged distally on the syringe support and are arranged opposed to each other. Furthermore, the flexible portions are required to achieve a functional arrangement whereby they are axially deflected and stressed such that syringes having variable lengths are accommodated within the housing and the axial movement of the syringe is prevented during storage, transportation, drop and use.

1. Although conceded at the hearing, the Opponent initially submitted that Mr Clemen's understanding of the arrangement of the flexible members being such that they work against each other should be preferred.[37] However, this interpretation necessarily results in a non-functional product.[38] Unsurprisingly, the Applicant prefers Mr Wilson's understanding of the arrangement of the flexible members being such that they are "radially opposed, facing each other across the central axis."[39]

1. I note that where the specification describes embodiments having multiple flexible portions arranged opposed to each other, it states "the flexible portions may be arranged around the circumference of the syringe flange, thus the syringe is reliably held in position."[40] In particular, "[m]ore than two flexible portions may be provided and may be symmetrically arranged on the syringe support."[41]

1. The described arrangement accords with the functional requirements for the flexible portions whilst also allowing for them to be arranged opposed to each other. Similarly, the drawings show an arrangement where flexible portions are arranged symmetrically around the central axis Consequently, I prefer Mr Wilson's interpretation. It is generally preferrable to avoid construction that would necessarily result in a non-functional product where there is a reasonable alternative that is also functional. I understand that the flexible portion and the further flexible portion to be arranged in parallel along the sides of the housing barrel, facing each other across the central axis.

1. The Opponent's submissions centred around the relationship between projecting portions and flexible portions as described. Where the accepted claims defined a syringe support comprising a projecting portion and a flexible portion, the amendment proposes to add a further flexible portion to the syringe support. At the hearing, the Opponent pointed to parts of the specification where arrangements of the flexible portions and projecting portions were discussed to highlight that there is a one-to-one relationship between these two parts such that where there is a flexible portion there is always a corresponding projecting portion.[42]

1. In contrast, the Applicant pointed to passages of the description where there was no clear grammatical limitation of one flexible portion per projecting portion. For example:

"Furthermore, the syringe support may comprise a number of projecting portions with adjoined flexible portions that interact with the flange of the syringe..."[43]

"In a further embodiment, at least two flexible portions are arranged distally on the syringe support."[44]

1. At the hearing, the Applicant stressed the importance of purposive construction and avoiding over-meticulous verbal analysis when reading the claims. To this end, it was submitted at the hearing that the incorporation of flexible portions into autoinjectors better reflected the nature of the invention rather than the relationship between flexible portions and projecting portions. The functional features achieved by the components of the syringe support such as accommodating syringes of variable lengths and preventing axial movement of the syringe was emphasised in preference to the specific wording of a syringe support comprising a projecting portion, a flexible portion and a further flexible portion.

s102(2)(a) - Does the scope of the claims after amendment fall outside the scope of the claims before amendment?

1. The Opponent submitted that the amendment impermissibly broadens the scope of claim 1 insofar as it requires a further flexible portion to be present and claim 14 insofar as it defines two flexible portions adjoining one projecting portion.[45] The Opponent submitted that accepted claim 1 required a one-to-one relationship between the projecting portion and the flexible portion.[46] According to the Opponent, the requirement for a further flexible portion to be present would necessarily broaden the scope of the claims.[47] The Opponent submitted there was no disclosure or teaching in the specification as accepted of more than one flexible portion arranged on a single projecting portion.[48]

1. In contrast, the Applicant submitted that "Claim 1 in the Accepted Specification in no way recites any features which exclude the presence of further flexible portions."[49] To this end, the Applicant submitted that some of the dependent claims prior to amendment had also recited "'at least one' flexible portion" (emphasis in original).[50]

1. The Applicant further pointed to accepted claim 15 which was said to also related to an embodiment comprising two projecting portions and two flexible portions.[51] I note that this claim does not refer to such an embodiment. The Applicant was likely referring to claim 15 as originally filed. Accepted claim 14 does however relate to an embodiment comprising at least two rigid projecting portions wherein each of the projecting portions comprises one flexible portion.

1. Consistent with the inclusive nature of the word "comprise" and its variants as used in the specification,[52] an autoinjector would necessarily require more components than just a housing and a syringe support. For example, a drive mechanism would be essential for an autoinjector. Consequently, claim 1 prior to amendment included, at a minimum rather than as a definitive list of components, a housing with a syringe support having at least one projecting portion and at least one flexible portion. As well as their presence, the components were further defined by their relative and functional relationships.

1. I note that there was no explicit or implicit requirement for a one-to-one relationship between the flexible portion and the projecting portion defined in the claims at acceptance. Therefore, I consider that the addition of a further flexible portion to the syringe support is a narrowing of the scope. Furthermore, the amendment introduces more restrictive functional relationships between the components. Consequently, the further flexible portion can only be added in ways which achieve the functional outcomes and in appropriate relative positions to the first flexible portion.

1. I also note that the specification does not require the projecting portion to have any particular shape. While the figures represent the projecting portion as narrow arms, the claims at acceptance were not limited to such an embodiment.

1. The proposed amendment would not make embodiments which were not infringing previously now an infringement.[53] Consequently, this ground is not made out.

s102(2)(b) - Does the amendment introduce an issue of lack of sufficiency?

1. The Opponent submitted that the specification does not provide any description or examples as to how the arrangement of two flexible portions on a single projecting portion could be achieved.[54] At the hearing, the Opponent pointed to Mr Wilson needing to engage his own ingenuity to come up with possible arrangements and what might be possible[55] rather than what was available to him in the specification. In this regard, the Opponent submitted at the hearing that providing a starting point for research and experimentation was not sufficient disclosure to enable the whole breadth of the invention.

1. The Applicant responded that the embodiment having one flexible portion attached to a corresponding projecting portion is simply a preferred embodiment and that the claims as accepted always encompassed alternative arrangements where multiple flexible portions adjoined a single projecting portion.[56] The Applicant further submitted that Mr Wilson's ability to provide suitable examples of embodiments two flexible portions per projecting portion showed there was no undue burden for a skilled person to implement this arrangement.[57]

1. In the present case, there is no controversy in saying that the only embodiment clearly described is the preferred embodiment having a syringe support with a pair of projecting portions with a corresponding flexible portion on each projecting portion. A possible interpretation is that the claims before the amendment implicitly claimed the one-to-one arrangement to the exclusion of other arrangements and the addition of a further flexible portion disrupts this one-to-one arrangement such that a previously unknown embodiment is now claimed.

1. However, neither the specification nor the claims prior to amendment explicitly required a one-to-one relationship between the flexible portions and the projecting portions in order to work the invention. Where the specification relates to the one-to-one relationship, it is in the context of describing preferred or alternative embodiments. If the one-to-one relationship was essential to the working of the invention, such relationship would not be left to be implied from the drawings or the absence of additional features being present in the preferred embodiments.

1. Despite the strong preference for a one-to-one arrangement, the specification points to the purpose of incorporating the flexible portion as being to provide an axial force on the syringe flange to bias it forward in the autoinjector housing and thereby prevent axial movement without unduly stressing the syringe.[58] This function can be achieved by any number of arrangements between the flexible portion(s) and the projection portion(s), as demonstrated by Mr Wilson. Insofar as the further flexible portion in proposed claim 1 being a component of the syringe support with defined functional and positional relationships to the other components of the syringe support, the range of possible arrangements for the further flexible portion is quite limited and in line with the described invention.

1. In any event, claim 1 as accepted only referred to a syringe support comprising a projecting portion and a flexible portion, despite a pair of projecting portions and flexible portions being the preferred embodiment. The dependent claims at acceptance included embodiments with a syringe support comprising a pair of projecting portions and flexible portions. It is clear that claim 1 as accepted encompassed embodiments beyond the preferred embodiment. Rather than a new sufficiency issue resulting from the proposed amendments, if there is an issue, it also existed at acceptance.

1. Therefore, the proposed amendment does not introduce an issue of lack of sufficiency. I do not consider that the proposed introduction of a further flexible portion causes a new issue of lack of sufficiency. Even if I am wrong and there is insufficient disclosure of a syringe support comprising a projecting portion, flexible portion and a further flexible portion, it would fall within a broader insufficiency issue which existed at acceptance and prior to the present amendment being proposed. Consequently, this ground is not made out.

s102(2)(b) - Does the amendment introduce an issue of lack of support?

1. The Opponent submitted that "There is no disclosure in the specification of an arrangement in which a projecting portion has multiple flexible portions.[59] The Opponent submitted that this embodiment is materially different from the nature of the invention disclosed in the specification and the claims as accepted.[60]

1. Surprisingly, the Applicant accepted at the hearing that the claims encompass embodiments which are not supported by the specification. However, the Applicant also submitted that the issue of support raised by the Opponent is not a new issue resulting from the amendment as the accepted claims did not exclude the possibility of other components being present in addition to the projecting portion and the flexible portion and they did not impose a one-to-one relationship between the projecting portion and the flexible portion.

1. If the Applicant is asserting that any amendment to add a feature is automatically allowable so long as that feature was not expressly excluded in the claims prior to amendment, this must be wrong. However, the general invention described in the specification relates to the incorporation of a flexible portion into the syringe support of an autoinjector rather than any particular arrangement between flexible portions and projecting portions.[61] At the hearing, the Applicant reinforced that it is the presence of the flexible portion that provides the benefits of the invention even if the specification only explicitly describes one particular arrangement of the components.

1. In Perfect Day, the specification described a food composition that includes casein and may further include other milk proteins but the claimed invention related to a food composition that comprised rALA and rBLG proteins as the only milk proteins and thereby excluded casein.[62] There was a single consistory clause in the specification which was identical to the claim. However, the body of the specification positively stated that casein was essential to the formation of micelles which were very important for the optimum behaviour of milk and that the absence of casein would therefore lead to a bad mouth feel.[63] The claimed invention was therefore said to be materially different from the nature of the invention disclosed in the specification.

1. The Application shares some similarities to Perfect Day, as well as some differences. Analogous to Perfect Day, the specification only provides detailed description and examples of embodiments having a one-to-one relationship between the flexible portion and the projecting portion. Also analogously, the statements relating to multiple flexible portions within the syringe support in the Application are present in the form of consistory clauses or alternative embodiments.

1. In contrast to Perfect Day, the Application does not suggest that any extraneous flexible portions on the syringe support without a corresponding projecting portion would cause the autoinjector to fail or that such an embodiment would cause the syringe to be prone to breakage. Similarly, the statements relating to multiple flexible portions within the syringe support are not limited to a single sentence within the totality of a specification which otherwise contradicted it. While there is no doubt that embodiments having a one-to-one relationship between the flexible portions and the projecting portions are strongly preferred, I do not consider the invention of the claims as proposed to be amended is materially different from the invention of the accepted claims.

1. Therefore, the proposed amendment does not introduce an issue of lack of support. The Applicant has conceded that there may be support issues but they existed at acceptance and prior to the present amendment being proposed. Consequently, this ground is not made out.

s102(2)(b) - Does the amendment introduce an issue of lack of clarity?

1. At the hearing, the Opponent conceded on this point. I also do not find any issues of clarity introduced as a result of the amendment that cannot be readily resolved. Consequently, this ground is not made out.

1. None of the grounds are made out. The features of the proposed claims fall within the scope of the claims prior to amendment. The amendment does not introduce issues of lack of sufficiency, support or clarity. Consequently, the amendment is allowable.

1. The opposition to the S104 amendments is unsuccessful. Costs generally follow the event. I see no reason to depart from that approach. I therefore award costs according to Schedule 8 against the Opponent, SHL Medical AG.

[1] SHL Medical AG - Switzerland v Sanofi-Aventis Deutschland GmbH [2023] APO 12.