In brief 

Challenges to patent term extensions remain a key area of disputes between patentees and generic/biosimilar drug suppliers in Australia. The decision of the Full Court of the Federal Court in Novartis AG v Pharmacor Limited [2025] FCAFC 33 reinforces the central role of claim construction in determining the validity of a patent term extension (PTE), as well as infringement questions.

Background 

Novartis filed a patent application on 16 January 2003, which was granted on 5 April 2007. For the purposes of the proceeding, the parties agreed claim 1 of the Patent could be read as follows:

A pharmaceutical composition comprising: 
(i)    the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof; and 
(ii)   a NEP inhibitor [sacubitril] or [sacubitrilat] or pharmaceutically acceptable salts thereof; and 
(iii)   a pharmaceutically acceptable carrier.

In order to be eligible for a PTE, section 70(2)(a) of the Patents Act 1990 (Cth) requires that at least one pharmaceutical substance per se be disclosed and claimed in the relevant patent. Novartis obtained a patent term extension, extending the term by the maximum 5 years, to 16 January 2028 based on the registration on the Australian Register of Therapeutic Goods (ARTG) of ENTRESTO, a film-coated tablet that contains an active pharmaceutical ingredient (API) which is a single salt complex of the anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the ratio of 1:1:3:2.5 (TSVH), as well as excipients.

Pharmacor later obtained ARTG registration of VALTRESTO, a film-coated tablet comprising an amorphous complex in which valsartan anions, sacubitril anions, and sodium cations are present in a 1:1:3 ratio (SVT1) and excipients. Novartis commenced proceedings against Pharmacor for threatened infringement of claim 1 of the Patent. 

Pharmacor denied infringement, arguing that claim 1 of the Patent does not cover a complex such as SVT1, and filed a cross-claim that similarly alleged Novartis’ PTE was wrongly granted because TSVH is a complex of one salt rather than a composition of two salts, as would be required for ENTRESTO to fall within the scope of claim 1 of the Patent. The construction of claim 1 was thus central to the issues of both infringement and the validity of the PTE.

The primary judge held that claim 1 should be construed as requiring integers (i) and (ii) to be separate components, and thus found that claim 1 did not encompass a complex formed from anionic valsartan, anionic sacubitril and pharmaceutically accepted cations. As a result, Novartis’ infringement case failed and its PTE was liable to be removed.

The Full Court decision 

On appeal, the Full Court upheld the decision at first instance, finding that there was no error in the primary judge’s construction of claim 1 of the Patent. In reaching its decision, the Full Court made the following key points:

1. Claim 1 is to a pharmaceutical composition, with the characteristics identified by integers (i) to (iii). The Full Court noted that the inclusion of “AT 1-antagonist” in integer (i) and “NEP inhibitor” in integer (ii) provided “adjectival clarity” to what followed, meaning the terms were each adjectives used to describe valsartan and its pharmaceutically acceptable salts, on the one hand, and sacubitril and its pharmaceutically acceptable salts, on the other hand. As such, a person skilled in the art would understand that integer (i) could not be satisfied by something that also satisfies integer (ii).
    
2. There was no ambiguity in claim 1 to suggest that it might cover a complex formed from valsartan and sacubitril or their pharmaceutically acceptable salts, and to read the claim otherwise would have been to ignore its clear terms. The conjunction “and” between integers (i) and (ii) required both (i) valsartan or a pharmaceutical salt thereof and (ii) sacubitril or a pharmaceutical salt thereof to be present, and to be distinct and separate components in the pharmaceutical composition as claimed.
    
3. The primary judge did not err in considering the specification of the Patent nor in observing that particular passages of the specification supported his reasons. The Full Court was satisfied that the relevant passages did not determine or drive the primary judge’s construction of claim 1, which would have been contrary to one of the key principles of claim construction. The Full Court considered one particular passage in detail, whereby the specification stated that “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 may also be a fixed combination.” The Full Court agreed with the primary judge that the word “together” could not be used to broaden the construction of claim 1 beyond its ordinary meaning to include a complex, and that to do so would be an impermissible use of the specification to place a “gloss” upon the words of the claim itself. The Full Court held that “together” simply meant “one after the other”.
    
4. A construction requiring both salts to be present, and separate, was consistent with not only the plain English meaning of the claim but with the meaning accepted by the expert witnesses in the case. The expert witnesses had agreed that the composition of claim 1 includes two APIs and their pharmaceutically acceptable salts. A complex, on the other hand, is a singular entity that cannot be divided into its constituent parts including its anions and cations in the solid. As a result, a complex would not fall within the scope of claim 1 as, in the case of TSVH or SVT1, each complex represents one salt (not two distinct and separate salts). A single salt complex would not have either the properties of a salt of valsartan or a salt of sacubitril.
    
5. Claim 1 is a product claim which on its proper construction relates to the state of components (i) and (ii) in the pharmaceutical composition prepared. Claim 1 is not a claim to the use of valsartan and sacubitril in the preparation of a pharmaceutical composition, or a claim to “something that happens” to the composition after it has been administered. 

Novartis submitted that a corollary of the primary judge’s construction of the claim is that even a solution prepared by dissolution of the two salts would not fall within the claim because once in solution the two salts no longer exist as salts but as anions and cations. The Full Court noted that the mere fact that there might be differences in whether a solid (tablet) or liquid (injectable) formulation fall within a claim is not exceptional in patent law. Indeed, the Full Court stated that this is simply a function of the language of the claim as defined by words of the patentee’s own choosing. 

By upholding the primary judge’s construction, the Full Court concluded that VALTRESTO was not within the scope of claim 1, and therefore Pharmacor had not threatened infringement of the Patent by seeking to supply VALTRESTO. Similarly, ENTRESTO was held not to be within the scope of claim 1, and therefore the PTE had been wrongly granted. 

Following the Full Court’s decision, Novartis applied for special leave to appeal to the High Court. The High Court refused the special leave application on 7 August 2025, and thus the Full Court’s decision stands.

Key Lessons 

The decision in Novartis v Pharmacor is an illustration of how claim construction can often be decisive in a patent dispute, and a reminder of the central role of the words of the claim. While construed through the eyes of a person skilled in the art and in light of the specification as a whole, Australian courts will not construe a claim to include things the patentee may have wanted to claim or may have sought to claim. The words of the claim are of the patentee’s own choosing. 

Here, the words “the AT 1-antagonist” and “a NEP inhibitor” do not appear to have been necessary to include in the claim, yet supported a narrow construction of the claim by providing “adjectival clarity”.