Federal Court of Australia

Novartis AG v Pharmacor Pty Limited [2025] FCAFC 33

ORDERS

THE COURT ORDERS THAT:

1.    The appeal be dismissed.

2.    The cross-appeal be dismissed.

3.    The interlocutory application filed by the appellants on 16 December 2024 be dismissed with costs.

4.    The appellants pay the respondent’s costs of the appeal and the cross-appeal.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

THE COURT:

INTRODUCTION

1    This is an appeal from the decision of Novartis AG v Pharmacor Pty Limited (No 3) [2024] FCA 1307 (J).  The appeal was brought on for an expedited hearing for reasons which are explained below.

2    The primary issue on the appeal concerned the construction of claim 1 of patent No. 2003206738 entitled “Pharmaceutical compositions comprising valsartan and NEP inhibitors”.

3    The appellants, Novartis AG and Novartis Pharmaceuticals Australia Pty Ltd (together, Novartis) contended that the primary judge erred in his construction of the claim and in failing to find that the respondent, Pharmacor Pty Limited, had threatened to engage in acts of infringement of that claim by signalling its intention to supply in Australia pharmaceutical products entered on the Australian Register of Therapeutic Goods (ARTG) identified in the primary judgment as Valtresto.

4    Novartis also contended that the primary judge’s construction of claim 1 led his Honour to err in concluding that an extension of term of the patent granted pursuant to s 70 of the Patents Act 1990 (Cth), granting an extension of term of the patent until 16 January 2028, was wrongly made. Novartis accepted that this ground of appeal turns on whether the appellants’ product, Entresto, is a product that falls within the scope of claim 1 of the patent, which raised the same construction issue.

5    By its notice of cross-appeal and notice of contention, Pharmacor advanced a fall-back position that if the Court concludes that Valtresto infringes claim 1, then claim 1 is not fairly based within the meaning of that term under s 40(3) of the Patents Act and the extension of term under s 70 was in any event wrongly granted because it does not satisfy the requirements of s 70(2)(a) of the Patents Act. The relevant form of the Patents Act is the form it took after the Patents Amendment Act 2001 (Cth) and before the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth).

6    Novartis filed an interlocutory application in the appeal on 16 December 2024 seeking orders including to the effect that, pending the issue of judgment in the present appeal, Pharmacor be restrained from causing Valtresto to become listed on the Pharmaceutical Benefits Scheme (PBS). In support of that application, it relied upon several affidavits, to which Pharmacor has responded. Pharmacor opposed that application.

7    The present appeal was listed on an urgent basis to enable argument to be heard in advance of 24 March 2025, being the date by which the Department of Health has indicated that it would require Pharmacor to withdraw its PBS application.

8    After hearing the parties’ arguments at the hearing of the appeal, we formed the view that the challenges to the primary judge’s decision must be rejected, and that the appeal should be dismissed.

9    As the appeal was dismissed, it was unnecessary for us to consider the cross-appeal, notice of contention or application for interlocutory relief. The cross-appeal and interlocutory application must necessarily also be dismissed.

10    We also determined that it was appropriate that the appellants should pay the respondent’s costs of the appeal, cross-appeal and interlocutory application.

11    Orders were made accordingly. These are our reasons for making those orders.

CONSTRUCTION

Claim 1

12    The parties agree that claim 1 of the patent may be expressed as follows, substituting in square brackets accepted terms for chemical formulae included in the claim, and adding “(iii)” within the claim at a position which the parties agree (and the primary judge found) that the person skilled in the art would:

1.    A pharmaceutical composition comprising:

(i)    the AT 1-antagonists valsartan or a pharmaceutically acceptable salt thereof; and

(ii)    the NEP inhibitor [sacubitril] or [sacubitrilat] or pharmaceutically acceptable salts thereof; and

(iii)    a pharmaceutically acceptable carrier.

The primary judge’s reasoning in relation to construction

13    The relevant scientific background appears at J [13]–[102].

14    Valsartan, which is mentioned in integer (i) of claim 1, is an angiotensin receptor blocker that had been shown to be effective in treating heart failure: J [62], [118].

15    Sacubitril is the name used in the primary judgment to describe the ethyl ester form of the neutral endopeptidase or NEP defined in integer (ii): J [112]. Sacubitrilat is described in the primary judgment as the free acid of sacubitril: J [112]. To abbreviate the reference to both together, the primary judge adopted the parties’ abbreviation sacubitril/at which we will also adopt.

16    The primary judge summarised the argument advanced by Novartis at trial at J [189]:

… Any pharmaceutical composition that comprises integers (i) to (iii) is within the claim, irrespective of whether it includes any other integers, and irrespective of the form of, or non-covalent association between the sacubitril/at (or salt), valsartan (or salt), and carrier. There is no limitation in the claim that excludes a pharmaceutical composition in which there are non-covalent bonds between the valsartan and sacubitril, in salt form or otherwise.

Claim 1 does not say, or require, that integers (i) to (iii) must each be discrete physical substances each with a unique set of physicochemical properties. Whether a pharmaceutical composition comprises each of integers (i) to (iii) is not answered by looking at how the composition was prepared, or by counting distinct ingredients or components used to make the composition, much less by counting salts.

17    In rejecting this argument, the primary judge found that claim 1 is a product claim for a pharmaceutical composition, by contrast with a method claim, such as using an identified active pharmaceutical ingredient or API in the manufacture of a medicament: J [194]. At J [195], the primary judge found that the composition is defined by identified components having their identified pharmacological activities in the state in which those components exist in the composition itself — meaning, in relation to the APIs:

(valsartan or a pharmaceutically acceptable salt of valsartan) + ([sacubitril or a pharmaceutically acceptable salt of sacubitril] or [sacubitrilat or a pharmaceutically acceptable salt of sacubitrilat]).

18    His Honour went on to say:

196.    Although, speaking generally, this composition can be seen as a combination, it is only a combination in the sense that it comprises more than one component. Claim 1 does not use the word “combination” (cf. claim 4), and does not claim a combination in the sense in which that term is sometimes used in patent law, particularly in the context of mechanical inventions, to describe a working interrelationship of known parts that produces something that is new and different from the separate working of those parts. The invention of claim 1 is not defined in terms that implies that integers (i) and (ii) are combined to produce a new chemical entity.

197.    Importantly, the composition is not defined by: (a) simply the intended pharmacological activity of each of its components; (b) the form of any substance from which each of its components is derived; or (c) the state of its components after the composition has been administered.

198.    So understood, there is no ambiguity in the way in which the pharmaceutical composition is claimed. Claim 1 does not claim, through integers (i) and (ii), a complex formed from valsartan and sacubitril/at or their pharmaceutically acceptable salts. Indeed, to read claim 1 as if it did would be to ignore its clear terms.

19    The primary judge noted at J [176] the submission advanced by Novartis that any pharmaceutical composition that comprises valsartan, or a pharmaceutically acceptable salt thereof, sacubitril/at or pharmaceutically acceptable salts thereof and a pharmaceutically acceptable carrier is within the claim:

irrespective of whether it includes any other integers, and irrespective of the form of, or non-covalent association between, the sacubitril/at (or salt), valsartan (or salt), and carrier…[A] “complex” (whether crystalline or amorphous) is one form of combination of integers (a) and (b).

20    The primary judge made the following findings in his explanation of the background science as to a “complex” in this context:

88.    A complex is a unique single entity consisting of two or more molecules (or charged molecules, i.e., ions) bound together by non-covalent bonds. As a solid, a complex exists as a single, distinct physical material in which all the solid particles have the same chemical composition. This material has a different identity and different properties to the physical materials of its component parts.

89.    A solid complex is distinct from a physical mixture of particles. A complex is typically formed by combining its constituent molecules in solution. This process is not equivalent to simply physically mixing the solid components together. It may require specific reaction conditions (e.g., specific temperature, pH, pressure, solvents, catalysts, and, potentially, the use of a complexing agent). The process may be driven by separating the solid complex from solution (e.g., by crystallisation).

90.    A complex in a solid state has its own unique set of physical properties, such as solubility, stability, hygroscopicity, melting point (or glass transition for amorphous materials), density, bulk density, powder flowability, adhesion, and physical appearance. Solid complexes also have their own set of analytical properties, such as infrared spectrum, Raman spectrum, solid state NMR spectrum, fluorescence behaviour and, for crystalline materials, X-ray powder diffraction pattern. These properties will be different from those of the separate components of the complex, even when those separate components are physically mixed.

91.    Therefore, a solid complex is not the mere sum of its constituent parts. In complexes that involve ions, the ions of opposite charge cannot be physically separated because of the great strength of ionic bonds.

92.    A complex can also exist in liquid and semi-solid pharmaceutical dosage forms.

93.    A complex can be used in pharmaceutical products to meet a range of product needs, including: (a) taste masking an API; (b) improving the solubility and absorption of an API; (c) retarding the release and absorption of an API; (d) enabling a product to have an adequate storage shelf life; and (e) minimising toxicity.

94.    The most important characteristic of complexes in solution, if they do not dissociate completely, is their stability, which can be measured by various, known means.

95.    A salt complex can be a so-called “double salt” that comprises one kind of cation and two kinds of anion, or one kind of anion and two kinds of cation, held together by ionic interaction. This does not mean that there are two salts present in the complex. It only means that there are two different ions of one particular charge, and one ion of the opposite charge, reacting to produce a new, single salt—the “double salt”. It is as if the salt-forming reaction has occurred twice to form the one, new salt.

(Emphasis added.)

21    None of these findings are challenged on appeal.

22    The primary judge concluded that a complex formed from valsartan and sacubitril/at or their pharmaceutically acceptable salts is not (a) valsartan or a salt of valsartan; (b) sacubitril or a salt of sacubitril; or (c) sacubitrilat or a salt of saculbitrilat, stating that “[i]n short, it is none of the things referred to in claim 1” (at J [199]).

23    The primary judge rejected a submission advanced by Novartis that referred to the expert evidence of Professor Roberts (a pharmaceutical scientist called by Pharmacor) and Professor Steed (an inorganic chemist called by Pharmacor) that, when discussing the Novartis product Entresto and the impugned Pharmacor product, Valtresto, the words “pharmaceutically acceptable salts thereof” as used in claim 1, can be read as referring to “salts” of valsartan and sacubitril/at in a salt complex involving valsartan anions and sacubitril/at anions, ionically bonded to, and counterbalanced by, sodium cations to achieve overall electroneutrality: J [200]. He found that each was using “salt” in a different sense to that in the claim, noting that each remained steadfast in their respective independent opinions that “TSVH” and “SVT1” are single entities that do not comprise distinct salts of valsartan and sacubitril/at: J [202].

24    The references to TSVH and SVT1 were explained by the primary judge earlier in his reasons. In addressing the composition of Entresto, the primary judge found that it is a film-coated tablet drug product that contains an active ingredient which is a salt complex of the anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the ratio of 1:1:3:2.5, termed TSVH, and excipients: J [96]. TSVH is a single crystalline complex material that comprises a repeating unit of 18 sodium cations, 6 sacubitril anions, 6 valsartan anions, and 15 water molecules in a coordinated complex arrangement involving ionic bonding, hydrogen bonding and a range of other non-covalent interactions: J [96].

25    The overall complex is a single physical material with a unique set of physicochemical properties: J [96].

26    The primary judge also concluded:

97.    The relevant experts agree that TSVH is a single salt. It is also a “double salt” but, as I have already said, this does not mean it is two salts. The anionic sacubitril, anionic valsartan, and sodium cations do not, and cannot, exist independently as distinct materials in the solid state.

98.    Following oral administration of the tablet, Entresto disintegrates. The salt complex, TSVH, is released and then dissolved in the gastrointestinal tract fluids. The pharmaceutical composition no longer exists. The salt complex dissociates into solvated anionic sacubitril and anionic valsartan. The anions are then protonated (i.e., they gain a hydrogen atom) into their free acid forms.

99.    TSVH was first synthesised in January 2006 following experimental work between March 2005 and January 2006.

100.    The relevant experts agree that the specification (discussed below) does not envisage or mention TSVH. However, TSVH is disclosed in an International Patent Application (PCT/US2006/043710) by Novartis AG, published as WO 2007/056546 A1, titled “Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor”.

(Emphasis added.)

27    The primary judge found, in relation to Valtresto:

101.    Valtresto is a film-coated tablet drug product for the treatment of chronic heart failure in patients with a reduced ejection fraction. It comes in three dosage strengths and comprises an amorphous complex, termed SVT1, and excipients, in which valsartan anions, sacubitril anions, and sodium cations are present in a 1:1:3 ratio.

102.    SVT1 is a single chemical entity with a single glass transition. Following oral administration, Valtresto, like Entresto, disintegrates and SVT1 dissociates.

(Emphasis in original.)

28    At J [202], the primary judge noted that Professor Roberts and Professor Steed remained steadfast in their respective opinions that TSVH and SVT1 are single entities and do not comprise distinct salts of valsartan and sacubitril/at. His Honour noted the disagreement between those experts and Professor White (an organic chemist called by Novartis) at J [209], who said, in relation to claim 1, that:

… there is no restriction that I can see regarding how the two components Valsartan and Sacubitril or their pharmaceutically acceptable salts may or may not be combined in order to prepare the claimed pharmaceutical composition.

29    At J [210], the primary judge stated:

The difficulty with this explanation, and Professor White’s particular reading of claim 1, is that it is directed to combining components (i) and (ii) to prepare a pharmaceutical composition.  It is not directed to the state of components (i) and (ii) when in the pharmaceutical composition. Put another way, Professor White’s explanation conflates the preparation of the pharmaceutical composition with the pharmaceutical composition as prepared. Only the latter is claimed in claim 1. Further, when examining and describing a complex, such as TSVH, Professor White’s approach was to view the components that were combined to make the complex and to look to the roles that each component played in forming the complex.

30    The primary judge separately considered that passages on pages 13 and 14 of the specification supported his construction of claim 1 (at J [203]–[224]) to which we refer below.

The construction appeal

31    Novartis advances numerous criticisms of the reasoning of the primary judge’s construction of claim 1 through multiple grounds of appeal. As these reasons are being delivered following an expedited appeal, we do not propose to restate the arguments advanced by both sides on appeal.

32    For the following reasons, we are unable to detect error on the part of the primary judge in reaching his conclusion as to the construction of claim 1.

33    First, claim 1 is for a pharmaceutical composition. In conceptualising the invention, it is a product that has the characteristics identified in the claim. Integers (i) to (iii) serve to identify those characteristics. The words “the AT 1-antagonists valsartan” in integer (i) serve to identify first, that the component must be an AT 1-antagonist and secondly, that it must be valsartan or a pharmaceutically acceptable salt (or PAS) thereof. The first provides adjectival clarity to the second. The words “NEP inhibitor” identified by reference to the chemical formulas in integer (ii), which are agreed to be references to sacubitril/at (and PASs thereof), are to be understood in a similar way. Each is given adjectival clarity by the descriptor “NEP inhibitor”. For that reason, the skilled person reading the claim would appreciate that integer (i) of claim 1 cannot be satisfied by something that also satisfies integer (ii).

34    Secondly, we respectfully agree with the primary judge’s finding at J [198] that claim 1 does not claim, through integers (i) and (ii), a complex formed from valsartan and sacubitril/at or their PAS, and that to read claim 1 as if it did would be to ignore its clear terms. We also agree that there is no ambiguity in the claim to suggest that a different reading of it is appropriate. The conjunction “and” between integers (i) and (ii) indicates that there must be both the AT 1-antagonist of integer (i) (or PAS thereof) and also the NEP sacubitril/at (or PAS thereof) of integer (ii) in the composition, as distinct and separate components of the composition, which construction is correct notwithstanding the presence of the defined term “comprising” in the claim. That construction is not only the plain import of the language of the claim but also the meaning accepted by the expert witnesses.

35    Relevantly, the experts agreed: (1) the composition of claim 1 includes two APIs or their PASs: J [209]; (2) insofar as claim 1 includes compositions requiring a PAS of valsartan and a PAS of sacubitril/at, it requires two salts: T472.45–473.12; and (3) in contrast with this, a complex is a singular entity or one salt: T474.28–46.

36    Further, the experts agreed that in claim 1 there must be (i) a PAS of valsartan which involves anionic valsartan ionically bound to cations and (ii) a PAS of sacubitril/at which involves sacubitril/at ionically bound to a cation: see e.g., T470.19–29, T473.27–474.14. The experts also agreed that a complex cannot be divided into its constituent parts including its anions and cations in the solid.

37    Thirdly, we are not satisfied that the primary judge erred in finding that Professor White adopted an erroneous approach that conflated the preparation of the pharmaceutical composition with the pharmaceutical composition as prepared: J [210], [212]. That Professor White took such an approach is evident in the passage of his evidence which is set out at J [209]. We also note that there was no appeal against the finding at J [162] that Professor White was not a member of the team that would comprise the person skilled in the art as referred to at J [153] and J [158].

38    Fourthly, as we have noted, claim 1 is a product claim. On its proper construction, it relates to the state of components (i) and (ii) when in the pharmaceutical composition as prepared. It is not components (i) and (ii) when involved in preparing a pharmaceutical composition. Nor is it a claim to something that happens to the pharmaceutical composition after it has been administered, including how it works in the body.

39    Fifthly, although Novartis criticises the approach of the primary judge in considering the question of construction by reference to the “complex” that he described, that was entirely because of the case that the parties ran before him, as examination of the question asked of the experts for the purposes of the joint expert report and the closing submissions of Novartis indicates. Taken in that context, we reject the contention that the primary judge erred by construing the claim with an eye to infringement. His Honour considered the question as presented to him at trial by the parties.

40    Sixthly, as demonstrated by the evidence referred to above, there was a sound scientific justification for the primary judge to conclude that a salt complex or “double salt” did not fall within the scope of claim 1. That is primarily because, as his Honour’s findings at J [88]–[95] and J [199] demonstrate, a “double salt” does not involve two separate salts, but is a single salt with neither the properties of a salt of valsartan or a salt of sacubitril/at. Although on appeal Novartis challenged the foundation for these views, we are not satisfied that the primary judge erred at J [193]–[224] in concluding that the evidence supported his conclusion on this topic.

41    Seventhly, in our view, the primary judge adopted an orthodox approach to construction by turning to the body of the specification to consider whether the disclosure supported his understanding of the claims. He was, in that context, referred by the parties to two passages appearing on page 13 and page 14.

42    To provide context, we note that extracts from the specification can be found at J [103]–[141].

43    As the primary judge notes at J [118], the specification addresses the effects of combining valsartan with NEP inhibitors and at pages 7 to 8 says:

It has surprisingly been found that, a combination of valsartan and a NEP inhibitor achieves greater therapeutic effect than the administration of valsartan, ACE inhibitors or NEP inhibitors alone and promotes less angioedema than is seen with the administration of a vasopeptidase inhibitor alone. Greater efficacy can also be documented as a prolonged duration of action. The duration of action can be monitored as either the time to return to baseline prior to the next dose or as the area under the curve (AUC) and is expressed as the product of the change in blood pressure in millimeters of mercury (change in mmHg) and the duration of the effect (minutes, hours or days).

Further benefits are that lower doses of the individual drugs to be combined according to the present invention can be used to reduce the dosage, for example, that the dosages need not only often be smaller but are also applied less frequently, or can be used to diminish the incidence of side effects. The combined administration of valsartan or a pharmaceutically acceptable salt thereof and a NEP inhibitor or a pharmaceutically acceptable salt thereof results in a significant response in a greater percentage of treated patients, that is, a greater responder rate results, regardless of the underlying etiology of the condition. This is in accordance with the desires and requirements of the patients to be treated.

It can be shown that combination therapy with valsartan and a NEP inhibitor results in a more effective antihypertensive therapy (whether for malignant, essential, reno-vascular, diabetic, isolated systolic, or other secondary type of hypertension) through improved efficacy as well as a greater responder rate. The combination is also useful in the treatment or prevention of heart failure such as (acute and chronic) congestive heart failure. It can further be shown that a valsartan and NEP inhibitor therapy proves to be beneficial in the treatment and prevention of myocardial infarction and its sequelae.

44    The specification goes on to summarise the methodology of certain representative studies carried out with the combination of valsartan and sacubitril before saying on a passage bridging pages 12 and 13:

In one aspect … the object of this invention [is] to provide a pharmaceutical combination composition, e.g. for the treatment or prevention of a condition or disease selected from the group consisting of hypertension, heart failure such as (acute and chronic) congestive heart failure, and myocardial infarction and its sequelae, which composition comprises (i) the AT 1-antagonists valsartan or a pharmaceutically acceptable salt thereof and (ii) a NEP inhibitor or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier. A further active ingredient may be a diuretic, especially hydrochlorothiazide.

45    The first passage upon which the primary judge particularly focussed, and to which the parties directed attention on appeal, is on page 13 and follows immediately from that quoted above:

In this composition, components (i) and (ii) can be obtained and administered together, one after the other or separately in one combined unit dose form or in two separate unit dose forms. The unit dose form may also be a fixed combination.

46    The primary judge also referred to the following passages at J [123] and [124]:

Page 14 includes the following statement on which the parties also relied in respect of the proper construction of claim 1:

A therapeutically effective amount of each of the component of the combination of the present invention may be administered simultaneously or sequentially and in any order.

Over the following pages, the specification discusses: (a) how pharmaceutical compositions according to the invention can be prepared; (b) typical pharmaceutically acceptable carriers for use in the formulations that are described; (c) combining separate pharmaceutical compositions (a valsartan pharmaceutical composition and a NEP inhibitor pharmaceutical composition) as two separate units in kit form; (d) methods of administering the pharmaceutical compositions; (e) the dosages of valsartan; and (f) the dosages of NEP inhibitors.

47    The relevant part of the primary judgment appears at J [203]–[209]:

The construction of claim 1 which I accept is supported by the passages on pp 13 and 14 of the specification to which I have drawn attention: see [121] and [123] above.

The passage on p 13 talks of components (i) and (ii) as separate components which can be administered “together” or “separately”. The word “together” cannot be used to broaden the construction of claim 1 beyond its ordinary language to include a complex formed from those components. This would be an impermissible use of the specification to place a gloss upon the words of the claim itself. In any event, the passage on p 13 makes clear the intended meaning of “together”. That meaning is “one after the other”, thereby supporting the separate identities of components (i) and (ii) as chemical entities.

The word “separately” in this passage also supports the construction of claim 1 which I accept. The relevant phrase is “separately in one combined unit dose form”, meaning that while components (i) and (ii) are in a combined unit dose, they are nevertheless, in that dose form, separate from one another. The passage makes clear that this dose form may be a fixed combination, meaning that that component (i) and component (ii) are present in a fixed amounts.

The passage on p 13 also envisages administration of component (i) and component (ii) in “two separate unit dose forms”. Once again, this supports the separateness, in administration, of component (i) and component (ii) and hence the separate chemical identities of the components. When read in the context of the whole passage, this part appears to contemplate the possibility that the separate unit dose forms may not be administered “together” (i.e., in the sense of one after the other), but at different times. Once again, the separate unit dose forms can be fixed dose forms.

The passage on p 14 is consistent with all these possibilities. A “therapeutically effective amount” of “each” component of the combination may be administered “simultaneously or sequentially and in any order”.

The relevant experts agree that the administration described in the passages on pp 13 and 14 specifies the separate dosing of components (i) and (ii).

In my view, the passages on pp 13 and 14 cannot be read, sensibly, to refer to the administration of a complex, which is a single chemical entity…

48    No error has been shown in these reasons of the primary judge. In particular, the primary judge observed that the passages in the specification supported his reasons — they did not determine or drive the construction by him of claim 1, as Novartis submitted. Nor was there any misinterpretation by the primary judge of these passages in the specification.

49    Further, we respectfully agree with the primary judge that the passage on page 13 of the specification talks of components (i) and (ii) as separate components which can be administered “together” or “separately” and that the word “together” cannot be used to broaden the construction of claim 1 beyond its ordinary meaning to include a complex formed from those components because this would be an impermissible use of the specification to place a gloss upon the words of the claim itself.

50    We also agree that the meaning of “together” is “one after the other” as found by the primary judge at J [204].

51    Finally, we are not satisfied that the primary judge erred in finding at J [222] that:

the pharmaceutical composition of claim 1 cannot be in the form of a solution in which the pharmaceutically acceptable salts of valsartan and sacubitril/at have dissociated into anionic valsartan and anionic sacubitril/at.  This is because, in that solution, the salts no longer exist as such. The anions of valsartan and sacubitril/at are not bound to cations.

52    This finding was supported by the evidence of the experts at the hearing. Further, we do not accept Novartis’ submission to the effect that it would be a perverse outcome if the claim encompassed a solid of salts but, when the salts were put in solution as a means of administering them, they were not within the claim. The primary judge found at J [221] that a pharmaceutical composition in accordance with claim 1 can be prepared in the form of a solution, and it simply depends on the choice of an appropriate solvent. That finding is entirely consistent with the expert evidence that such solutions existed, as referred to in J [220]. That there may be differences in whether a tablet or injectable formulation falls within the claim is unexceptional; it is a function of the language of the claim, which is in words of the patentee’s choosing.

INFRINGEMENT

53    In ground 3 of the appeal, Novartis contends that the primary judge erred in his construction of claim 1 and that the conclusion that Valtresto did not infringe was premised on this error. It follows that our conclusion in relation to the question of construction is determinative of ground 3.

PATENT TERM EXTENSION

54    Grounds 4, 5 and 6 were also dependent upon our acceptance of Novartis’ contention that the primary judge erred in his construction of claim 1. It follows that our conclusion in relation to the question of construction is determinative of grounds 4, 5 and 6.

Associate:

Dated:    24 March 2025

SCHEDULE OF PARTIES