AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks
Amendments to correct obvious mistakes are an exception to the rule in s 102 of the Patents Act that amendments must not broaden the scope of the claims. Although amendments to cor - rect mistakes can be allowed, even in a manner which broadens the claims, both the mistake and its correction must be obvious. Term extensions remain in the firing line As we reported in the 2024 Trends & Develop - ments report in this guide, the patent term exten - sion (PTE) regime continues to be a contentious battleground in Australian litigation. A patentee may apply for a PTE if certain condi - tions are met, including that a “pharmaceutical substance per se” is “in substance disclosed” in the specification and “in substance fall[s] within the scope” of the claims. In Novartis AG v Pharmacor Pty Limited (No 3) [2024] FCA 1307, Novartis sought a PTE in rela - tion to goods containing, or consisting of, the pharmaceutical substance included in the ARTG as: “ENTRESTO sacubitril/valsartan (combined as a sodium salt hydrate complex)”. Novartis obtained the PTE in relation to its patent titled “Pharmaceutical compositions comprising val - sartan and NEP inhibitors”, of which claim 1 is to pharmaceutical compositions comprising an NEP inhibitor, such as sacubitril, and an AT 1-antagonist, such as valsartan, and salts there - of.
Pharmacor challenged the validity of the PTE on the basis that Entresto contains “TSVH”, a single crystalline complex of the anionic forms of sacubitril and valsartan. Pharmacor argued that because the claims related to two separate salts of sacubitril and valsartan, TSVH was not disclosed and claimed in the patent. Novartis responded that the two distinct mol - ecules had not lost their identities in forming the complex, pointing to the ARTG certificate which refers to Entresto as “sacubitril/valsartan (com - bined as a sodium salt hydrate complex)”. Justice Yates agreed with Pharmacor, finding that two pharmaceutical substances per se were disclosed and fell within the scope of claim 1, of which Entresto comprised neither. His Honour found that TSVH was a different compound with a unique set of physiochemical properties, and was not disclosed “or even envisaged” in the patent. Novartis v Pharmacor is yet another decision highlighting the nuances of Australia’s PTE provi - sions. While the Australian regime has historical - ly been considered a relatively patentee-friendly one, more recent Federal Court judgments have tested its limits.
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