In a recent decision of the Full Court of the Federal Court of Australia in Novartis AG v Pharmacor Pty Limited [2025] FCAFC 33, the Full Court was once again asked to consider an appeal from a first instance decision of a single judge of the Federal Court (which we covered in a previous post), to revoke a pharmaceutical patent term extension previously granted by IP Australia.

Claim construction featured prominently in the case and highlights the seemingly narrow approach that the Court can take in construing patent claims and the importance of precise drafting to ensure that the claims capture all intended embodiments.  

In the end, the Full Court dismissed Novartis’ appeal from the first instance decision, which invalidated a patent term extension (PTE) based on Novartis' blood pressure medication, Entresto. On appeal, Novartis argued that the primary judge erred in the construction of the main claim of the patent resulting in the finding that the patent did not support the PTE and that Pharmacor’s product Valtresto did not infringe the claim.

The Full Court upheld the first instance decision, reinforcing that a PTE under section 70 of the Patents Act 1990 (Cth) will only be available where the pharmaceutical substance claimed and disclosed in the patent is the same as the substance contained in the goods registered in the Australian Register of Therapeutic Goods (ARTG).

Background

The dispute centred on whether Pharmacor threatened infringement of claim 1 of Novartis’ Australian Patent 2003206738 by intending to supply a generic product, Valtresto, and whether the grant of a PTE, which extended the patent term from January 2024 to January 2028 is valid.

Central to the appeal is the construction of claim 1 of the patent, which reads:

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 main issue is whether complexes formed from valsartan and sacubitril/at, which is the active ingredient in Novartis’ Entresto (e.g. a salt complex, termed TSVH) and Pharmacor’s Valtresto (e.g. anamorphous complex, termed SVT1), fall within the scope of claim 1.

Novartis argued for a broad construction: that any composition containing the listed ingredients in any form, including as part of a complex, is within the scope of claim 1. The primary judge rejected this, finding that the claim required valsartan and sacubitril or their pharmaceutically acceptable salts to exist as distinct components in the composition.

Relevantly, the first instance decision concluded, with the relevant experts in agreement, that the specification does not envisage or mention the salt complex TSVH.

Reasoning and Decision

In upholding the primary judge’s narrow construction of claim 1, the Full Court held that the language of the claim, particularly the enumeration of components (i), (ii), and (iii) separated by the word “and”, and the use of “comprising”, necessitated the presence of the separate components in the composition, not a novel complex formed from them.

The Full Court also concluded that claim 1 is a product claim, focused on the final composition, specifically the state of components (i) and (ii) as they exist in the prepared composition, and not a claim to the process of preparing the composition or what happens to the composition after administration.

The Full Court also agreed with the primary judge that claim 1 does not extend to a salt complex or “double salt” formed from valsartan and sacubitril/at, citing expert evidence that the salt complex is a single salt, not two separate salts, with neither the properties of a salt of valsartan or a salt of sacubitril/at.

Lastly, the Court turned to the body of the specification to support their construction of claim 1, in particular, key parts of the specification indicating that the components (i) and (ii) can be “administered together, one after the other or separately in one combined unit dose form or in two separate unit dose forms”.  

In this regard, the Court held 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.”

The Full Court ultimately held that the primary judge did not err in his construction of claim 1, that the claim does not encompass complexes. Because TSVH did not fall within claim 1, the PTE granted on the basis of Entresto failed to satisfy the threshold requirement of section 70(2)(a). For the same reasons, there is also no finding of infringement by Pharmacor’s Valtresto.

For more information about this decision or about pharmaceutical patent term extensions generally, please contact Daniel or Catrina.