Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd [2019] FCAFC 28

FEDERAL COURT OF AUSTRALIA

Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd [2019] FCAFC 28 Appeal from: Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd (No 3) [2018] FCA 2060

File number: NSD 2398 of 2018

Judges: JAGOT, YATES AND MOSHINSKY JJ

Date of judgment: 22 February 2019

Catchwords: [PRACTICE AND PROCEDURE- patents – interlocutory injunction application – prima facie case – validity of patents – novelty – balance of convenience - leave to appeal dismissed.

Cases cited: GenRx Pty Ltd v Sanofi-Aventis [2007] FCA 148 House v The King (1936) 55 CLR 499 Interpharma Pty Ltd v Commissioner of Patents [[2008] FCA 1498 Janssen Sciences Ireland UC v Alphapharm Pty Ltd [2017] FCA 1399 Love v Thwaites & Anor (No 4) [2012] VSC 521 Love v Thwaites & Anor [2014] VSCA 56 Samsung Electronics Company Ltd v Apple Inc (2011) 217 FCR 238 Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd (No 3) [2018] FCA 2060 Warner-Lambert Co LLC v Apotex Pty Ltd [2014] FCAFC 59

Date of hearing: 8 February 2019

Registry: New South Wales

Division: General

National Practice Area: Intellectual Property

Sub-area: Patents and Associated Statutes

Category: Catchwords

Number of paragraphs: 54

Counsel for the Applicants: C Dimitriadis SC with A R Lang

Solicitor for Applicants: Jones Day

Counsel for the Respondent: T D Cordiner QC with J S Cooke

Solicitor for the Respondent: MinterEllison

ORDERS NSD 2398 of 2018

BETWEEN: SANOFI- AVENTIS DEUTSCHLAND GMBH & ANOR

Applicants

AND: ALPHAPHARM PTY LTD

Respondent

JUDGES: JAGOT, YATES AND MOSHINSKY JJ DATE OF ORDER: 22 Feburary 2019

THE COURT ORDERS THAT:

1. The application for leave to appeal be dismissed. 2. The applicants pay the respondent's costs of the application as agreed or taxed. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

THE COURT: 1 This application for leave to appeal concerns the primary judge's refusal to grant the applicants, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Australia Ltd (together, Sanofi), an interlocutory injunction to restrain the respondent, Alphapharm Pty Ltd, from launching its SEMGLEE insulin glargine (rDNA) solution for injection injector pen, referred to as the Semglee product: Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd (No 3) [2018] FCA 2060. 2 Sanofi contends that the primary judge's refusal to grant the interlocutory injunction is attended by sufficient doubt to justify the Full Court reconsidering the matter and that, assuming the primary judge's decision to be wrong, it would suffer substantial injustice. The latter condition of substantial injustice if the decision is wrong is satisfied and, as a result, it was decided that the application for leave to appeal and the appeal should be heard together. 3 We consider that the application for leave to appeal should be refused. The primary judge's decision is not attended by sufficient doubt to justify the Full Court reconsidering the application for an interlocutory injunction. 4 The draft notice of appeal identifies 11 alleged errors, many containing multiple aspects each said to constitute error. 5 One answer to the entirety of the applicants' complaints is that while the primary judge was satisfied that Alphapharm's product was within the scope of claim 1 of Sanofi's patent, Alphapharm's lack of novelty case was sufficiently strong to make it doubtful that Sanofi had established a prima facie case of infringement, a conclusion which necessarily affected, adversely to Sanofi, the probability of it succeeding at the final hearing if the evidence remained the same. In the face of his conclusion about the lack of strength of Sanofi's prima facie case, the primary judge weighed all of the relevant discretionary considerations and concluded that while these were "quite evenly balanced" they weighed in favour of the refusal of interlocutory relief having regard to his evaluation on the available evidence that Sanofi's loss would be more readily able to be calculated and compensated by damages if no interlocutory injunction were granted than the harm Alphapharm would suffer if an interlocutory injunction were granted: at [188]-[189]. Faced with orthodox reasoning of this kind, in relation to the making of an order which is discretionary and based on evaluative judgments about which reasonable minds may differ, Sanofi's allegations of error have no inherent attraction for appellate intervention. Sanofi's appeal grounds and submissions lend further weight to the impression that the application for leave is an attempt to re-run the entirety of the application before the primary judge under the guise of a multiplicity of alleged errors which, on analysis, dissolve into nothing more than dissatisfaction with the primary judge's evaluation of all of the relevant circumstances. 6 Another answer is that Sanofi's submissions are affected by a fundamental misreading of the primary judge's reasons (one of many, it might be said, as will become apparent). According to Sanofi the primary judge refused interlocutory relief based on the balance of convenience, not on the question of prima facie case. Sanofi submitted: While the PJ considered that Sanofi's response to Alphapharm's novelty case faced "difficulties" (J [118]), his Honour accepted that Sanofi had a clear prima facie case of infringement (J [117]). Further, notwithstanding the PJ's reasons on novelty, which themselves involved errors in approach for reasons developed below, his Honour made no finding that Sanofi did not have a relevant prima facie case. That is apparent from J [5], in which the PJ expressly based his Honour's decision upon the balance of convenience and justice. For these reasons, and further because the probability of success required to establish a relevant prima facie case depends in turn upon the balance of convenience, these submissions address first the issue of the balance of convenience in Section B, and secondly the question of prima facie case in Section C. 7 This is misconceived. It is clear from [117] to [119] that the primary judge was satisfied that Sanofi had made out a clear prima facie case only that the Semglee product fell within claim 1 of the patent, but not of infringement of the patent. The only relevant prima facie case is that of infringement and, in that respect, as the primary judge said at [118] it is "axiomatic that an invalid patent cannot be infringed" and Alphapharm's lack of novelty case was sufficiently strong to make it "doubtful that Sanofi has established a prima facie case of infringement of valid claims": [119]. The attempts throughout Sanofi's submissions to recast the primary judge's findings on this and other bases must be rejected. The attempts colour the entirety of Sanofi's submissions. 8 As Alphapharm submitted, it is also not correct that the "probability of success required to establish a relevant prima facie case depends in turn upon the balance of convenience". Again, this misconception has affected the entirety of Sanofi's submissions. The strength of the prima facie case is relevant to the balance of convenience, but the weighing process involved in evaluating where the balance of convenience lies does not affect the assessment of the existence or strength of the prima facie case. As was said in Samsung at [59] "[t]he critical integer in the test …is the need for the Court to assess the strength of the probability of ultimate success on the part of the plaintiff. The strength of that probability will depend upon the nature of the rights asserted and the practical consequences likely to flow from the grant of the injunction which is sought". Moreover, as noted below, it cannot be doubted that the primary judge fully appreciated this given his statements at [119] and [189] which discuss these concepts in terms. 9 The consequence is that it is neither appropriate nor possible to address Sanofi's appeal grounds in terms. It is also telling that Sanofi's submissions do not themselves relate to the individual grounds of appeal, presumably because it is not possible to do so. What is clear is that Sanofi's submissions are all affected by these basic misconceptions. 10 Given our observations above, we also do not accept Sanofi's approach of dealing with the balance of convenience issues before the prima facie case issue. As the respondent noted, the effect of Sanofi's approach is to circumvent the principle that "[t]he apparent strength of the parties' substantive cases will often be an important consideration to be weighed in the balance of convenience": Samsung at [67]. Sanofi's attempt, it should be noted, is made in the face of the primary judge's statement at [31] that: The point set out in [67] of Samsung is of relevance in the present application. Alphapharm, whilst contesting infringement, also contends that it has a sufficiently strong case of invalidity so as to weigh materially in its favour on the question of balance of convenience. 11 The primary judge's conclusions about the prima facie case issue were expressed in these terms: 117 …Accordingly, as the evidence stands, Sanofi has established a clear prima facie case that the Semglee product falls within claim 1. 118 Whilst Sanofi has made out a clear prima facie case that the Semglee product falls within the scope of claim 1 of the Patent, this does not lead to the conclusion that it has established a prima facie case of infringement of those claims. It is axiomatic that an invalid patent cannot be infringed. Taking into account what I consider on the basis of the present evidence and the parties' submissions to be the position, in my view the lack of novelty case advanced by Alphapharm is sufficiently strong (at the provisional level) to qualify (in the sense contemplated in Interpharma [Interpharma Pty Ltd v Commissioner of Patents [2008] FCA 1498; (2008) 79 IPR 261] at [17]) the conclusion that Sanofi has a probability of success. I am not prepared to say that Sanofi's defence of the invalidity challenge is unarguable. It may well be that on a final hearing it will meet the difficulties to which I have referred in relation to the construction of claim 1 of the Patent and the prior art documents. But difficulties they are. They affect the assessment at the present time of the probability that if on a final hearing the evidence remains the same Sanofi will be entitled to final injunctive relief for the infringement of claim 1. 119 In my view it is doubtful that Sanofi has established a prima facie case of infringement of valid claims. That alone is likely to be sufficient to warrant the conclusion that relief should be refused. However, the question of whether or not an applicant has demonstrated a sufficient likelihood of success to justify the preservation of the status quo (O'Neill [Australian Broadcasting Corporation v O'Neill [2006] HCA 46; (2006) 227 CLR 57] at [65]) requires consideration of the basket of discretionary matters to which I refer below. 12 Sanofi contends that while the primary judge identified the correct principles at [32] to [34] of the reasons, he departed from those principles when deciding the application. The primary judge had said: 32 In this context it is apposite to note that a countervailing argument for invalidity must be considered with some care. It is not sufficient to balance the scales by establishing a triable revocation case on the cross-claim. If that is as far as it goes, then assuming that the applicant for relief has shown a triable issue on infringement, the conclusion would remain that the applicant has a triable question. As Jessup J said in Interpharma Pty Ltd v Commissioner of Patents [2008] FCA 1498; (2008) 79 IPR 261: [17] As a matter of analysis, unless the case for invalidity is sufficiently strong (at the provisional level) to qualify the conclusion that, overall, the applicant has a serious question, or a probability of success, the court should move to consider the adequacy of damages, the balance of convenience and other discretionary matters. It is the applicant's title to interlocutory relief which is under consideration, and the bottom-line question, as it were, is whether the applicant has a serious question, or a probability of success, not whether the respondent does in relation to some point of defence raised or foreshadowed. 33 This passage has been adopted as correct by a number of single judges of this Court; Janssen Sciences Ireland UC v Alphapharm Pty Ltd [2017] FCA 1399 (Yates J) at [96]; Merck Sharp & Dohme Corp v Apotex Pty Ltd [2012] FCA 928; 97 IPR 414 (Jagot J) at [5]; Organic Marketing Australia Pty Ltd v Woolworths Ltd [2011] FCA 279 at [60] (Katzmann J) and myself in F. Hoffman-La Roche AG v Sandoz Pty Ltd [2018] FCA 874; (2018) 134 IPR 172 at [28]. 34 In Samsung [Samsung Electronics Co Ltd v Apple Inc [2011] FCAFC 146; (2011) 217 FCR 238], the Full Court considered the correct approach to be taken to the examination of the strength of the prima facie case. In relation to one of the patents in suit (the "Touch Screen Patent") it determined that the alleged infringer, Samsung, had not established a prima facie case of invalidity; Samsung at [140] and [150]. However, the Full Court nevertheless concluded that an interlocutory injunction was not appropriate because the construction case concerning infringement was insufficiently strong. Of note, are comments in relation to infringement of claim 6 of the Touch Screen Patent, where their Honours concluded: [120] It is not for this Full Court to determine, as on a final hearing, the scope of claim 6 or whether the Galaxy Tab 10.1 infringes that claim. It is necessary, however, for us to make some evaluation of the strength of Apple's case for infringement of that claim, recognising that we do not have the benefit of all the evidence that the parties might see fit to call at the final hearing on the question of the construction of the touch screen of the Galaxy Tab 10.1 and on the question of the common general knowledge as it assists to inform the question of the construction of claim 6. [121] It is sufficient for us to express the view that, on the present state of the evidence, there is a real and substantial prospect that the importation into and supply in Australia of the Galaxy Tab 10.1 will not infringe claim 6 of the Touch Screen Patent. We have referred to a number of difficulties that confront Apple in making good its case on infringement. It may well be that, on a final hearing, Apple will meet these difficulties. But difficulties they are. Whilst we would not be prepared to say that Apple's case on infringement is not open to be argued, the difficulties to which we have referred do affect the assessment at the present time of the probability that, if on a final hearing the evidence remains the same, Apple will be found to be entitled to final injunctive relief for infringement of that claim. If Apple has established a prima facie case at all (which we doubt), it is founded upon a construction argument which, if the evidence remains as it is, is unlikely to succeed at trial. 13 Sanofi's identification of the alleged errors in application of the correctly stated principles exposes yet further problems. Sanofi contends that the primary judge conflated the questions of validity and infringement and put "the questions of validity and infringement on an equal footing, … contrary to the principles and approach explained in Janssen [Janssen Sciences Ireland UC v Alphapharm Pty Ltd [2017] FCA 1399] and earlier cases such as Interpharma Pty Ltd v Commissioner of Patents [[2008] FCA 1498] (2008) 79 IPR 261 at [17]". 14 The submission is without substance. The approach in Interpharma and Janssen is clear. A case for invalidity which is merely arguable, of itself, does not undermine the existence of a prima facie case of infringement which has otherwise been found to exist. However, a sufficiently strong case of invalidity may well qualify the conclusion that there is a prima facie case of infringement at all. Far from reasoning contrary to the approach in Interpharma and Janssen, the primary judge was applying the same reasoning, albeit with an outcome not to Sanofi's liking because his Honour was satisfied that Alphapharm's case on invalidity was sufficiently strong to qualify (indeed, virtually to negate altogether) Sanofi's prima facie case of infringement. Further, it is Sanofi's submissions which have conflated the relevance of the competing cases on invalidity. What is relevant is the strength of the case that the claim or claims said to be infringed are invalid. The primary judge at [118] found that "the lack of novelty case advanced by Alphapharm is sufficiently strong (at the provisional level) to qualify (in the sense contemplated in Interpharma [Interpharma Pty Ltd v Commissioner of Patents [2008] FCA 1498; (2008) 79 IPR 261] at [17]) the conclusion that Sanofi has a probability of success". Yet Sanofi's submissions focus on the strength of its case in favour of validity, saying this: …the PJ identified "difficulties" in relation to the construction advanced by Sanofi,… However, notwithstanding those "difficulties", the PJ found that Sanofi's position on construction was "not … unarguable" (that is, it was arguable). 15 Read in the context of [117] to [119] and the reasoning as a whole it is apparent that Sanofi's "not unarguable" case on construction did not affect the primary judge's conclusion that Alphapharm's invalidity case was sufficiently strong to leave Sanofi with a weak prima facie case of infringement. Contrary to Sanofi's submission, the primary judge did consider Sanofi's construction, but he also considered that Alphapharm's lack of novelty case was sufficiently strong, in effect, to undermine Sanofi's prima facie case. This reality is inescapable but never acknowledged or confronted in Sanofi's submissions. Instead, Sanofi contends that his Honour erred in principle in his approach to the prima facie case. It should be apparent that this proposition is untenable for the reasons already given. 16 The only argument for Sanofi about the prima facie case which does confront the reality of his Honour's reasons is the submission that the primary judge should have reached a contrary view about the competing constructions. 17 Claim 1 of the patent, recorded at [35] of the primary judge's reasons (with integer numbers added) is: (1) A drug delivery device comprising: (2) a housing with a proximal end and a distal end, (3) a cartridge adapted to accommodate a drug, (4) a cartridge retaining member adapted to retain the cartridge, (5) the cartridge retaining member being secured to the housing, (6) wherein a spring washer arranged within the housing so as to exert a force on the cartridge and to secure the cartridge against movement with respect to the cartridge retaining member, (7) the spring washer being arranged so as to abut the cartridge on a side of the cartridge that faces the proximal end of the housing. 18 At [36] the primary judge recorded: The parties agree that there are two substantive arguments raised, the first concerns the words "the cartridge retaining member being secured to the housing" (integer (5)) and the second concerns the words "cartridge retaining member adapted to retain the cartridge" (integer (4)). 19 Integer (4), the so-called second construction issue, turned out to be determinative. It is sufficient to focus on that issue here and we accept that we are in as good a position as the primary judge to consider this issue. 20 At [58] the primary judge recorded the orthodox proposition that: It is not for this Court, as on a final hearing, to determine the scope of claim 1 or whether or not it is anticipated by one or other of the prior art documents. It is necessary, however, to make an evaluation of the strength of Sanofi's case, recognising that the Court does not have the benefit of all of the evidence that the parties might consider fit to call at the final hearing, including, for instance, going to the question of common general knowledge as it assists to inform the question of the claim and the prior art. 21 The primary judge identified the competing constructions of the ultimately determinative issue at [65] in these terms: The second construction issue concerns the meaning of "a cartridge retaining member adapted to retain the cartridge", namely integer (4) in claim 1. Sanofi contends first, that the cartridge retaining member must hold the cartridge in position. Secondly, that it must be held in a three dimensional position. That is, sideways movement, as well as axial movement of the cartridge out of the device, must be prevented. Thirdly, Sanofi contends that this argument is supported by the language in the specification which identifies that the cartridge must be placed "in" or "into" the cartridge retaining member. Sanofi submits that its construction corresponds with the purpose of the invention, being the principal aim of allowing for improved operability with respect to dosage control and/or improved reproducibility of the dosage in connection with different cartridges. Alphapharm disputes that the second and third propositions advanced by Sanofi are limitations imposed within claim 1. It contends that the only requirement is that the member be adapted to retain the cartridge in the sense that it prevents the cartridge from falling out of the device. 22 At [67] to [73] the primary judge explained why he would not read the claim in the way Sanofi proposed. The primary judge then considered the expert evidence in passing at [74] to [78] on the basis that he would do so "leaving to one side the limited role that an expert may take on matters of claim construction": at [74]. His Honour then moved to the prior art concluding that at least two of the prior art documents presented a sufficiently strong prospect, assuming the evidence will remain as it is, that the claims of the patent lacked novelty. It is in this context that the primary judge made the observations at [117] to [119]. None of those observations support the allegations of error by the primary judge. The inescapable fact is that unless Sanofi can undermine the primary judge's conclusion that Alphapharm's lack of novelty case was sufficiently strong to virtually negate Sanofi's prima facie case of infringement, none of its contentions of error of principle in respect of the weakness of Sanofi's prima facie case are sustainable. 23 Sanofi's case that a "cartridge retaining member adapted to retain the cartridge" must retain the cartridge in all directions, so that a member merely retaining the cartridge in the axial direction (that is, along the long axis of the device), it said, is supported by integer (6) that the spring washer secures the cartridge against movement, which should be understood as all movement. Further, dependent claims 2 to 5 refer to the spring washer securing against types of movement including axial movement. The specification refers to reducing axial movement (p 2 line 12) but there are other references to the spring washer keeping the cartridge "fixed" (for example, p 2 line 21). At pp 5 and 12 there are references to the spring washer exerting a force on the cartridge to secure it against displacement "in particular against axial displacement" indicating that all forms of displacement are relevant. The expert evidence is relevant as the patent is to be construed through the eyes of the skilled addressee. As such, according to Sanofi, the primary judge should not have put the expert evidence aside, which (Sanofi said) his Honour effectively did. Mr Milijasevic's evidence was that a principal objective of the invention was accurate dosing and integer (4) involves a member which holds the cartridge in a manner which prevents its displacement, that is, to prevent axial displacement and maintain axial alignment, the cartridge being held in a specific three dimensional position relative to the housing. 24 Sanofi also submitted that the primary judge's reasoning at [69] to [73], in fact, supports its construction. That is, the primary judge accepted the ordinary meaning of "retain" as "hold in place or position" at [69], but confined that holding in place to a single axial alignment when the meaning of the word as it appears in the claim is not so confined. 25 For all these reasons, Sanofi submitted that its construction was more than reasonably arguable so that Alphapharm's construction was not sufficiently strong to effectively negate Sanofi's prima facie case of infringement. Sanofi also contended that the primary judge misunderstood its construction at [73] because it did not contend that the cartridge must be "wholly or almost entirely within" the "cartridge retaining member". 26 Alphapharm submitted: The primary judge held that the words used in the specification, understood in context, bear their ordinary meaning rather than being terms of art: J[41]. As the primary judge observed at J[68], neither party submitted that the words in the claim have a technical or scientific meaning that would be different to their ordinary English meaning ascribed in that context. Sanofi does not seek to appeal this finding. That being so, in accordance with well-established authority, as the primary judge noted, the construction of the specification insofar as it uses words of ordinary English language is for the Court and not a matter for expert evidence: J[41], [66]. Having determined this, the fact that there was disagreement between Sanofi's expert, Mr Milijasevic, and Alphapharm's expert, Mr Bilney, as to, inter alia, the meaning of "cartridge retaining member adapted to retain the cartridge", was beside the point: cf SS[38]. The primary judge was not obliged to consider either expert's views on the construction of claims using ordinary English words and was entitled to prefer one construction over the other based upon his own assessment. The present case is distinguishable from Warner-Lambert Co LLC v Apotex Pty Ltd (2014) 311 ALR 632 in which there were "factual disputes" (see [94]) based on competing expert evidence directed towards whether pharmacists were likely to prescribe pregabalin for pain or for seizures. In any event, the primary judge did not evaluate the strength of Sanofi's prima facie case by resolving which of the experts' opinions as to the meaning of "cartridge retaining member adapted to retain the cartridge" he preferred. Rather, his Honour considered what he understood the phrase to mean in the claim and in the context of the specification. Having done so, his Honour then indicated at J[74] to [78] that he had "some disquiet about the approach of Mr Milijasevic" which approach did "not accord with the correct approach to claim construction." As discussed below, his Honour was justified in that conclusion. 27 Sanofi's submission that the primary judge at [73] misunderstood its argument on construction may be rejected immediately. Sanofi expressly put to the primary judge that the "key consideration is that the cartridge is secured against movement with respect to the cartridge retaining member" and "that's achieved by …the placing of the cartridge in or the receipt of the cartridge in or within the cartridge retaining member, and the securing of that member in turn to the housing". 28 Further, as Alphapharm submitted, on analysis, Sanofi's submissions as to construction raise no issue of principle. The primary judge evaluated the material and reached a view on the basis of that material which was necessarily provisional given the interlocutory nature of the hearing. He was prepared to accept that Sanofi's case was not unarguable because of the necessarily provisional nature of the hearing and the fact that the evidence might be different at the final hearing, but no more. No error is apparent in the primary judge's evaluation. In any event, the specification and claims support the primary judge's provisional view. 29 Thus, said Alphapharm, it is apparent from p 2 lines 4 to 16 of the specification that the device is designed to deal with cartridges of different lengths which need to be retained, meaning that axial movement is able to be prevented. Page 5 lines 5 to 12 have to be read against lines 13 to 17 which refers to displacement (meaning any, not all displacement) and is expressing a preference for preventing axial displacement. Page 7 lines 21 and 26 refer only to preventing displacement in the distal direction (that is, axial displacement). Page 8 refers to other types of movement but in the context of other aspects of the device. Page 9 line 18 returns to the cartridge, with the focus being movement in only the axial direction (distal and proximal) being eliminated. So too p 10 discloses that the cartridge retaining member enables precision of drug delivery by eliminating axial movement. Further, Figure 1 of the patent discloses nothing preventing any form of movement other than axial movement. Nothing in the specification refers to preventing movement of the cartridge in a lateral direction. 30 Alphapharm also pointed out that claim 1 cannot be construed as requiring the cartridge retaining member to prevent all movement in the context of a specification where the preference is to prevent only axial movement. This, it said, is reinforced by the fact that the spring washer only faces the proximal end of the housing. 31 In our view, the primary judge's provisional conclusion that, in context, integer (4) does not require that movement of the cartridge in all directions be prevented and requires only the prevention of axial movement, does not reveal apparent error such as to warrant reconsideration at this stage. Contrary to Sanofi's submission, we would understand the primary judge as having so concluded at [69] to [80]. We also see no error in his Honour's conclusion that this provisional construction, taken with the prior art, meant that Alphapharm's invalidity case was sufficiently strong to undermine Sanofi's prima facie case of infringement. As the primary judge noted at [90] in respect of one of the prior art documents "Sanofi does not dispute that if the second construction argument advanced by Alphapharm is accepted, then integer [4] is disclosed by Schofield". 32 We note that Alphapharm went further and submitted that integer (4) would be satisfied by a cartridge retaining member adapted to retain the cartridge that prevented any movement of the cartridge in any direction. It is not apparent to us that the primary judge took this view. We do not consider it appropriate to discuss this alternative construction other than to say it was not the provisional view of the primary judge (a provisional view with which, as noted, we see no apparent error for the purpose of this leave application). 33 The primary judge was thus entitled at [67] to consider that Sanofi's construction confronted "considerable difficulties". No error is apparent in his Honour having so characterised Sanofi's construction argument, against Sanofi's submission that its construction should have been characterised as "reasonably arguable". 34 His Honour also did not resolve the matter based on the prior art disclosing retention of a cartridge in all three directions. Alphapharm put this case but, in our view, it is clear from his Honour's reasons as a whole, and [105] to [106] in particular, that he was not purporting to resolve this issue. This alleged error, accordingly, does not arise. 35 It follows that none of Sanofi's contentions of error by the primary judge in respect of the prima facie case are sustainable. In turn, this affects Sanofi's complaints about the primary judge's evaluation of the balance of convenience. The balance of convenience was to be evaluated on the basis that the prima facie case of infringement was weak, so much so that the primary judge considered it to be doubtful that Sanofi had even established such a case. As his Honour said at [119] this alone was likely to be sufficient to mean that interlocutory relief should be refused. Yet in recognition of the very fact which he is now alleged by Sanofi to have given insufficient weight, the sufficiency of the likelihood of success so as to justify preserving the status quo, the primary judge proceeded to deal with the balance of convenience: at [119]. This fact renders Sanofi's arguments about the balance of convenience virtually unarguable but we discuss them with the brevity they deserve having regard to the evaluative character of the exercise which the primary judge was undertaking and the restraint on appellate intervention which must be observed for such matters (in contrast, we consider, to the construction issue): Samsung at [38], citing House v The King (1936) 55 CLR 499 at 504-505. 36 Sanofi's primary complaint about the balance of convenience is that the primary judge did not give sufficient weight to the preservation of the status quo and specifically Sanofi's long-standing role as the market incumbent, a factor given prominence in other matters: for example, GenRx Pty Ltd v Sanofi-Aventis [2007] FCA 1485; (2007) 73 IPR 502 at [15] and Warner-Lambert Co LLC v Apotex Pty Ltd [2014] FCAFC 59; (2014) 311 ALR 632 at [98]. According to Sanofi his Honour also erred in his assessment of the harm and the relativities of the harm. Sanofi's four glargine products would all be affected by the launch of Alphapharm's Semglee product. The primary judge acknowledged this at [145] to [153] in terms of revenue effects on all four products from the mandatory 25% price drop and also price erosion. The primary judge also accepted that there would be market share impacts at [154] to [156] and, at [157], consequential damage to Sanofi's business in Australia. Sanofi said that having found these "substantial and irreversible" consequences for Sanofi if interlocutory relief was refused and Sanofi succeeded at a final hearing, the primary judge recorded this in [162]: Moreover, Sanofi considers that the Court would be required to consider the ongoing loss into the future, including assessing hypothetical matters such as the extent to which the PBS price would in any event have fluctuated in the counterfactual world. 37 Sanofi also contended that the primary judge's conclusions from [163] are at a high level of generality and do not confront the reality of the fact that it could not be inferred that damages would be an adequate remedy in all relevant respects. 38 Similarly, Sanofi said that in dealing with the consequences for Alphapharm from [169] the primary judge overlooked that Alphapharm could nevertheless enter the market for insulin glargine, the only restraint would relate to the device. According to Sanofi, his Honour also should not have given any material weight to Alphapharm's loss of a first mover advantage. The primary judge said that: 176 The evidence available to me does not permit firm conclusions in relation to first mover advantage in terms of likely market share or the duration of any such advantage. As I noted in Hoffman at [204], logic suggests that typically there will be some advantage but the variables make it difficult to assess. As discussed above, there is evidence that Eli Lilly has obtained ARTG listing for its own insulin glargine U100 product. That listing has been in place since November 2014 and it received a positive PBAC recommendation in March 2015. Although Eli Lilly has launched this product elsewhere in the world, it has not done so in Australia. It is not known whether the Eli Lilly devices fall within the scope of the claims of the Patent. The evidence does not permit any more than the conclusion that there is a possibility that that product may be launched in Australia, but Alphapharm has itself increased the risk that it will lose a first mover advantage by delaying its launch until 1 April 2019. 177 Nevertheless, on the basis of the evidence now available, I consider that it is more likely than not that, if not restrained, the launch of the Semglee product in April 2019 will be the first biosimilar in the market for insulin glargine. Alphapharm is likely to accrue advantages by doing so, although the extent and duration of those advantages are not possible to predict in advance. As I noted in Hoffman at [204], this plays to the benefit of Alphapharm in the calculation of where the balance of convenience lies. The difficulty in knowing precisely what advantage Alphapharm would have as a first mover and the contest between the parties in this respect further emphasises the difficulty of assessing any claim pursuant to an undertaking as to damages. 39 Further, Sanofi submitted that no weight should have been given to the relative difficulty of assessing the damages of Sanofi and Alphapharm. 40 None of these submissions are persuasive. 41 For one thing, Sanofi itself made submissions about the very issue which it now says the primary judge should have given no weight, the relative difficulty of the damages of Sanofi and Alphapharm being assessed. Having done so, it cannot complain merely because the primary judge preferred Alphapharm's submissions to those of Sanofi about this issue which both parties chose to contest. And as Alphapharm submitted, the primary judge accepted the categories of harm Sanofi identified, leaving aside the alleged international price reductions. The primary judge cannot have erred by not giving details about how losses in potential counter-factual scenarios could be calculated given that his Honour accepted at [163] only that Sanofi's losses would be "generally capable of being remedied by an award of damages", despite there being potential complications: at [163]. This conclusion also puts paid to Sanofi's submission that the primary judge characterised its losses as "irreversible". As Alphapharm said, the primary judge accepted at [149] that the price reductions should be treated as irreversible, but plainly from [163] did not consider that damages would be an inadequate remedy for Sanofi. 42 We do not accept Sanofi's submission that the primary judge, in effect, was bound to explain how, contrary to Sanofi's submission, damages would generally be an adequate remedy in any greater detail than appears at [163] in which this was said: If Alphapharm enters the market and is subsequently found to infringe the Patent, then Sanofi will be able to pursue damages (or an account of profits). The market share of Sanofi Australia prior to the launch will be a known fact. The market consequences caused by the introduction of the Semglee product will be apparent from the figures. It is true that there may be complications, such as those identified by Sanofi, but the starting point of the market and the various actions of those involved will be known. By contrast, in the event that Alphapharm is restrained the question of what would have happened in the market will be highly speculative. 43 The validity of these observations in the particular circumstances of this case, one of which was that noted by the primary judge at [174], cannot reasonably be doubted. At [174] the primary judge said this: Depending on the speed of the success of Toujeo, the market for the Semglee product could diminish or even disappear before any interlocutory injunction is lifted after a final hearing, especially if (as is not unusual in these cases) an appeal is involved. A significant aspect of the subject matter of the proceedings – being Alphapharm's ability to sell the Semglee product including in competition with the Lantus SoloStar – will be removed before the litigation is resolved. It is not possible to say, on the basis of the present evidence, how likely this could be other than to observe that it is a real possibility. 44 This conclusion also attracted an allegation of error by Sanofi based on its unsupported assertion that Alphapharm could enter the insulin glargine market with another non-infringing drug delivery device. However, and as Alphapharm submitted, this submission lacked the support of an evidentiary foundation. There was no evidence from Sanofi that Alphapharm could avoid the losses it identified by finding a different drug delivery method. Alphapharm had its Semglee product and it was obvious that the losses it identified would be the natural and ordinary consequence of an interlocutory injunction. If it had wanted to contend to the contrary, Sanofi had to do more than make an unsubstantiated assertion: Love v Thwaites & Anor (No 4) [2012] VSC 521 at [58] and Love v Thwaites & Anor [2014] VSCA 56 at [47]. 45 Nor is it possible to accept that the primary judge's assessment of a "real possibility" of the market disappearing involved the kind of error in an evaluative process which would justify appellate intervention at this stage. There was evidence supporting this as a realistic possibility and the primary judge was entitled to see this as a significant aspect of the weighing of the balance of convenience. 46 As a result, the weighing of the balance of convenience in this case was affected by the specific circumstance that the primary judge had evidence that the market for Alphapharm's Semglee product was diminishing because of another Sanofi product. This "real possibility" in the present case, which the primary judge rightly considered in the weighing exercise, undermines Sanofi's submission that the primary judge was expressing some principle of general application about the relative difficulty of assessing damages as between an innovator and generic drug company. His Honour was doing no such thing. As a result, the judgment does not establish any principle or support Sanofi's submission that his Honour's approach "would tend systematically to favour a market disruptor over a market incumbent". 47 Nor do we accept that his Honour was bound to identify any or all of the various hypotheses which might ultimately found a claim for damages by Sanofi. The level of generality at which the primary judge dealt with the issue of the relative difficulty of assessing damages as between Sanofi and Alphapharm was appropriate to the available evidence and the circumstances of the case. The primary judge understood Sanofi's contentions about the difficulties involved in hypothetical lost sales, competing products, third parties, and future pricing, both actual and hypothetical, as is apparent from [160] to [168], but simply did not accept that they were relatively as difficult as calculating Alphapharm's potential losses in all of the circumstances. No more needed to be said to support the conclusion that Alphapharm's losses would be relatively more difficult to assess than Sanofi's in the circumstances of this case than the primary judge in fact said. We reject any suggestion that the primary judge had to identify methods of assessing loss, let alone specific "counter-factual" hypotheses against which to test his evaluation that in the circumstances of this case it would be generally possible for Sanofi's losses to be compensated by damages, but not so for Alphapharm. 48 Otherwise, to the extent that Sanofi submitted that the primary judge disregarded the consequential impacts on the business of Sanofi Australia, the submission cannot stand in the face of [157] to [158] of his Honour's reasons. As noted, his Honour was entitled to reach an overall view at [163] that "the effects of the launch of the Semglee product are generally capable of being remedied by an award of damages". It cannot be accepted that because his Honour, rightly in our view, expressed his conclusion in this way, that he "overlooked" or "put aside" this head of damage in weighing the balance of convenience. To the extent that Sanofi also relied on reduction of prices overseas being also disregarded, there is a complete answer in [153] of the primary judge's reasons. For a judge to say, as his Honour did in [153], "there is insufficient evidence as to the nature, size and consequences of International Reference Pricing for it to play a significant role in my assessment of the balance of convenience" does not involve the alleged error of "putting aside" a relevant consideration. 49 Nor can it be said that the primary judge was not entitled to give some weight to Alphapharm's first mover advantage. It may be accepted that the primary judge could not quantify or reach firm conclusions about the first mover advantage: [175] to [177]. The conclusion at [177], that "on the basis of the evidence now available, I consider that it is more likely than not that, if not restrained, the launch of the Semglee product in April 2019 will be the first biosimilar in the market for insulin glargine. Alphapharm is likely to accrue advantages by doing so, although the extent and duration of those advantages are not possible to predict in advance", is unexceptionable. The criticism of the primary judge for making the comment at [176] that "logic suggests that typically there will be some [first mover] advantage but the variables make it difficult to assess" is without foundation. His Honour was not operating in a fact free zone devoid of common sense or understanding. There was evidence of loss of such advantage but it did not permit "firm conclusions". That does not mean, however, that no conclusions at all could be drawn or that the primary judge erred in giving some weight to the issue. Ultimately, Sanofi could say nothing more than that this should have been given no weight similarly to (according to Sanofi) its international pricing issue being given no weight (although, as we have noted, the primary judge's specific finding was that there was insufficient evidence for this to play a significant role in the assessment of the balance of convenience). This is very far from the kind of clear error which would warrant appellate intervention in respect of an evaluation of evidence. Indeed, it discloses no error of any kind. 50 Apart from this, if by referring to its status as the "market incumbent" in its submissions for leave to appeal (and on the appeal should leave be granted), Sanofi intended to refer to the importance of preserving the status quo, this is the very reason the primary judge gave at [119] for moving to consider the balance of convenience despite the weakness of Sanofi's prima facie case. The entire purpose of the primary judge's evaluation of the balance of convenience was directed to working out if the status quo should be preserved by enabling the sufficiency of Sanofi's prospects of success to be measured against the "basket of discretionary considerations", as his Honour put it in [119]. This explains the conclusion at [189] that: To these considerations I add my conclusions going to the weakness of Sanofi's prima facie case, to which I have referred in Section 3. Taken together, they lead me to the firm conclusion that there is insufficient likelihood of success, in all of the circumstances including the matters to which I have had in relation to the balance of convenience, to justify the grant of the relief that Sanofi seeks. Accordingly, the interlocutory application must be dismissed. 51 In other words, Sanofi had not demonstrated a sufficient likelihood of success in all of the circumstances to justify the preserving of the status quo. Each case turns on its own facts so it is not the point that in GenRx and Warner Lambert the preservation of the status quo was given considerable weight. In neither case was the strength of the prima facie case undermined in the same way as in the present case. In neither case was there a suggestion of market circumstances similar to the present case given the primary judge's reference in [174] to the real possibility of Alphapharm's prospective market disappearing as a "significant aspect" of this matter. Faced with the primary judge's reasons, Sanofi's submission that his Honour failed to take into account the disruption of the status quo as a material consideration is untenable. His Honour weighed all those matters but the balance favoured Alphapharm not Sanofi. 52 Sanofi's complaint that the primary judge erred by treating as irrelevant Sanofi's pending application to amend the claims may be briefly rejected. If the amendment application is granted the novelty argument would be moot. The primary judge correctly said at [185] that "as Sanofi accepts, the application for interlocutory relief is to be determined having regard to the scope of Sanofi's present monopoly rights as conferred by the Patent, rather than potential rights in the event that it prosecutes its amendment application to conclusion and is permitted to amend; see Interpharma at [33]." As Alphapharm submitted: 24. First, contrary to SS [43], as the primary judge held at J [185], Sanofi had accepted at an interlocutory hearing on 30 August 2018 (T4.29-32) that the application for interlocutory relief was to be determined having regard to the scope of Sanofi's present monopoly rights as conferred by the Patent, rather than potential rights in the event that it prosecutes its amendment application to conclusion and is permitted to amend. Sanofi does not challenge this finding in its notice of appeal. 25. Secondly, the primary judge had earlier held in Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd (2018) 135 IPR 396 (First Decision) at [10] that "...the interlocutory rights of Sanofi will be considered, having regard to the unamended version of the patent." 26. Thirdly, Sanofi's application for amendment has yet to be heard and determined such that Sanofi has no rights to enforce in the form of the proposed amended claims. Had the primary judge considered the proposed amended claims in the manner suggested by Sanofi, then he would necessarily have found that Sanofi had no prima facie case in respect of those claims in the sense described in Beecham. 27. Fourthly, the primary judge did not have all the surrounding facts before him to be able to properly consider whether the exercise of discretion under s 105(1) of the Patents Act 1990 (Cth) would favour amendment. As Jessup J held in CSL Ltd v Novo Nordisk Pharmaceuticals Pty Ltd (No 2) (2010) 190 FCR 522 at [56], "a court considering a s 105 application will be ill-equipped to give the matter the attention it deserves if some relevant facts have not been disclosed". Sanofi has reserved the right to file further evidence in support of its amendment application and Alphapharm had not yet been given an opportunity to file evidence or seek discovery from Sanofi on that application. Indeed, in the First Decision his Honour granted Sanofi's application to set aside Alphapharm's notice to produce documents relevant to the discretion. 28. Fifthly, on the current state of the evidence, the primary judge would have held that the amendment application would be unlikely to be allowed because of Sanofi's failure to make full and frank disclosure and because of the unreasonable delay in seeking to amend, given Sanofi was on notice since at least 2015 that the claims were likely anticipated by Schofield and Burren. 29. Sixthly, in any event, Alphapharm did not file evidence in respect of these claims in light of the First Decision and because Sanofi's amendment application was yet to be determined. Contrary to SS [43], Dr Stark's opinion, to the effect that particular features identified in the specification were present in the Semglee product, was not able to be properly understood in the context of the claims as they were proposed to be amended because he did not explain how he construed any of the features of those proposed claims (see J [115] in respect of the relevant integer of claim 1). 53 None of the alleged errors exist and, in any event, the allegations themselves, in terms, are not of a character which would justify appellate intervention at this stage given the evaluative nature of the task the primary judge was performing. 54 The decision of the primary judge is not attended by sufficient doubt to warrant its reconsideration. Leave to appeal should be refused, with costs. I certify that the preceding fifty-four (54) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justices Jagot, Yates and Moshinsky.

Associate: Dated: 22 February 2019