Novartis AG v Pharmacor Pty Ltd: Australia’s Updated Approach to Patent Claim Construction
Earlier this year, the Full Court of the Federal Court of Australia provided some guidance in relation to interpretation of patent claims. In Novartis AG v Pharmacor Pty Limited [2025] FCAFC 33, the decision of the Full Court appears to suggest that patent claim interpretation may have shifted towards literal interpretation as opposed to purposive interpretation.
Background
Novartis alleged that Pharmacor infringed Patent No. 2003206738 through its supply of Valtresto®. Valtresto® contains a crystalline complex of the anionic forms of both valsartan and sacubitril, and sodium cations in a 1:1:3 complex. Pharmacor challenged the infringement claim and the validity of a Patent Term Extension (PTE) granted (based on Entresto®) on the Patent. This article will be centered around the infringement and thus interpretation of the claims.
The claims of the Patent are directed towards a pharmaceutical composition comprising:
- the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof; (valsartan)
- the NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-p-phenylphenylmethyl)-4amino-2R-methylbutanoic acid ethyl ester or (2R,4S)-5-Bipheny-4-y-4-(3carboxypropionylamino)-2-methyl-pentanoic acid or pharmaceutically acceptable salts thereof; (sacubitril or sacubitrilat)
- and a pharmaceutically acceptable carrier.
Entresto® is an oral tablet containing a crystalline complex of the anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the ratio of 1:1:3:2.5, and excipients. It should be apparent that Entresto® and Valtresto® both relate to single crystalline complexes.
Pharmacor argued that Valtresto® is a single salt complex, whereas the claims of the patent required two distinct salts. As such, Pharmacor argued that the PTE granted on the patent was invalid and there could also be no infringement when a crystalline complex is provided.
Ultimately, the Federal Court ruled that Entresto® is not just a combination of valsartan and sacubitril but is a single crystalline complex. It was further found that this single crystalline complex was not claimed or disclosed in the patent. As such, the Federal Court ruled that an invalid PTE had been granted, and that there was no infringement.
Present Case
Novartis appealed the decision. Novartis argued that claim 1 should be construed to cover any combination of valsartan and sacubitril, irrespective of form.
Novartis argued that the specification taught the advantages of combining valsartan and sacubitril in the treatment of heart failure, and referred to general language in the specification to support the broader interpretation of the claim (namely that the specification taught administration of valsartan and sacubitril could be ‘together, ‘separately’ or ‘a fixed combination’). Novartis contended that the specification supported how the ingredients could be formulated and administered, and that this included in the form of a single crystalline complex.
The Full Court took into consideration the disclosure of the specification but did not find them persuasive. It was found that these terms related to simultaneous or sequential administration and did not extend to a single crystalline complex. To support this, it was noted that the specification did not mention or even contemplate a salt complex. As such, it was found that there was no enabling description and no suggestion that a single crystalline complex formed part of the invention.
On an aside, it was also noted by the Full Court that another application had been filed that was directed towards the single crystalline complex.
Take Aways
The present decision highlights the importance of drafting patent specifications with the appropriate scope and description in mind. The scope of a claim cannot be extended beyond the teachings of the specification. In this regard, the claims must be fully supported by the specification. This decision affirms that you cannot rely on the specification to broaden the interpretation of claim without meaningful disclosure in the specification.
Finally, this case underscores the importance of ensuring that the specification and claims are aligned with the commercial interests of the Applicant (in this case, the commercial embodiment). It is vital that the specification is drafted to ensure that the desired claim breadth and scope is supported. This can have serious implications in relation to both infringement and patent term extensions.
If you have further queries about the drafting and prosecution of patents, infringement proceedings, or recent patent law developments in Australia, please contact MBIP via email on mail@mbip.com.au or via our online form. Our experienced team of attorneys would be glad to assist.
