The Federal Court has dismissed a challenge by Cipla to the validity of a patent term extension (PTE) of Novo Nordisk’s VICTOZA (liraglutide) formulation patent in Cipla Australia Pty Ltd v Novo Nordisk A/S [2024] FCA 1414 (Cipla).
The Court confirmed that formulation claims are eligible for PTE in Australia. The decision is further welcome news for pharmaceutical patentees, coming just one day after the High Court’s rejection of the Commonwealth’s claim for damages against Sanofi (reported here).
PTE provisions
Under the Patents Act 1990 (Cth) (the Act), a PTE of up to 5 years may be available for pharmaceutical patents in Australia where they in substance claim and disclose a relevant pharmaceutical substance, being either a pharmaceutical substance per se or a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology.
Further, goods containing the relevant pharmaceutical substance must be registered on the Australian Register of Therapeutic Goods (ARTG) and at least 5 years must have elapsed between the date of the patent and the first regulatory approval of a relevant pharmaceutical substance.
Relevantly, the Act defines a “pharmaceutical substance” as:
… a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:
- a chemical interaction, or physico‑chemical interaction, with a human physiological system; or
- action on an infectious agent, or on a toxin or other poison, in a human body;
but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing. [emphasis added]
Background
Novo Nordisk obtained a PTE in respect of Australian Patent No. 2004290862 (the 862 Patent), directed to GLP-1 agonist formulations comprising a tonicity agent (propylene glycol) and a buffer (disodium phosphate dihydrate), based on the registration of VICTOZA on the ARTG. Under the PTE, the patent would expire on 26 August 2025, as opposed to 18 November 2024.
Cipla, seeking to launch its own generic liraglutide formulation, challenged the validity of the PTE. In a many-pronged attack, Cipla submitted that a formulation is not a relevant “pharmaceutical substance” for the purpose of PTE for the following reasons:[i]
- the history, ordinary meaning, and underlying policy of the Act show that a “pharmaceutical substance” could not be a formulation;
- the case law supports an interpretation that excludes formulations; and
- even if formulations were eligible for PTE, the 862 Patent is not eligible because the excipients do not individually or together have a “therapeutic use” separate from the active pharmaceutical ingredient (API), liragludtide.
In Cipla, Perram J rejected all of Cipla’s submissions. We summarise the key elements of the decision below.
Ordinary meaning of “pharmaceutical substance” includes a formulation
Cipla submitted that use of the word “application” within the definition of “pharmaceutical substance” contemplates a target in the human physiological system (i.e., the target to which the substance is “applied”). On this interpretation, only the API (not a formulation) is “applied” in the relevant sense.
Perram J refused to read in a reference to “target” into the definition of “application”, because a “target” may be the whole human body. For example, one would not say that a person “applied” ibuprofen throughout their body in the same way an ointment is “applied” to a wound.[ii] Rather, his Honour considered the meaning of the term “application” to refer to “the act of putting to special use or purpose”. Further, the express clarification in parentheses that a substance “include[es] a mixture or compound of substances”, did not support Cipla’s interpretation.
Thus, Perram J found that the term “pharmaceutical substance” includes formulations.
“Pharmaceutical substance” was intended to include a formulation
Perram J considered that the Explanatory Memorandum (EM) of the Patents Amendment Act 1989 (Cth), which first introduced the PTE provisions, disclosed a clear intention of Parliament to adopt a meaning of “pharmaceutical substance” largely synonymous with the meaning of “therapeutic substance” found in the Customs (Prohibited Imports) Regulations 1956 (Cth) (Customs Regulations).[iii] At the time the PTE provisions were enacted, a “therapeutic substance” was defined in the Customs Regulations to include a formulation, where a “formulation” is a “substance, including a mixture or compound of substances, that has a therapeutic use”.[iv]
Cipla argued that the EM accompanying the introduction of the s 119A springboarding provision into the Act in 2006, which defines the concept of a “pharmaceutical patent” as including “a product or formulation incorporating a pharmaceutical substance”, supports the proposition that a formulation is not a pharmaceutical substance.[v] However, having regard to the purpose of s 119A, i.e., to give springboarding protections, Perram J considered that the EM was not concerned with differentiating between pharmaceutical substances and the formulation of pharmaceutical substances for the purposes of PTE.[vi] Cipla’s argument based on the interpretation of s 119A was therefore rejected.
Ultimately, Perram J was satisfied that a “pharmaceutical substance” within the meaning of the PTE provisions was always intended to include a formulation. [vii]
Consistency in case law
Perram J also considered the previous case law on the meaning of a “pharmaceutical substance” and dismissed a number of cases as having no relevance to the issue.[viii] However, two decisions were considered relevant. First, in Pharmacia,[ix] a PTE was upheld for claims directed to a solution comprising a anthracycline glycoside salt and a physiologically acceptable acid. Second, in Spirit,[x] a PTE was upheld for claims directed to a controlled-release formulation of oxycodone. Both Pharmacia and Spirit were said to support the inclusion of formulations in the definition of “pharmaceutical substance”.
Perram J also considered Alphapharm (HC),[xi] which was concerned with extensions of time to file PTE applications. In that case, the majority of the High Court explained at footnote 40 that:
Relevantly, [the PTE provision] covers standard patents for pharmaceutical substances per se … hence patents for pharmaceutical methods or tablets do not fall within the scheme.
Cipla argued that reference to “tablets” in this footnote also supports the proposition that formulations cannot be “pharmaceutical substances”. However, Perram J interpreted this passage as speaking only to “pharmaceutical substances per se”,[xii] and not “pharmaceutical substances” generally.[xiii] In that regard, his Honour also queried why the reference to “tablet” in footnote 40 was included at all (indeed, claims to tablets are generally considered at least by the Patent Office to be eligible for PTE), but given the High Court’s footnote was not a considered obiter dictum the Court was not bound to follow it.[xiv]
Thus, Perram J concluded that it was not reasonably clear from the case law that a pharmaceutical substance cannot be a formulation.[xv]
Excipients not required to have a “therapeutic use”
Perram J went on to consider Cipla’s alternative case that each element of a formulation must be for a “therapeutic use”, and was distinguished from Spirit in which the controlled release excipient separately qualified as a pharmaceutical substance.[xvi] His Honour considered Cipla’s arguments in this regard to be substantially the same as its primary case and should be rejected for the same reasons.
Given that the statutory interpretation question was already resolved, the Court’s comments here are in obiter.
Conclusion
Pending any (successful) appeal, the decision in Cipla confirms that formulation patents are eligible for PTE in Australia. The decision also indicates that the presence of non-active ingredients in the claimed formulation does not preclude PTE eligibility.
If you have any questions in relation to this decision or PTE in Australia, please contact Claire Gregg (cgregg@dcc.com) or Dev Dutt Sharma (dduttsharma@dcc.com).
[i] Patents Act 1990 (Cth), Sch 1
[ii] Cipla Australia Pty Ltd v Novo Nordisk A/S [2024] FCA 1414 at (Cipla) [119]
[iii] Cipla at [56]
[iv] Cipla at [57]
[v] Cipla at [90]
[vi] Cipla at [102]
[vii] Cipla at [71], [78], [93]
[viii] Cipla at [145]-[146] (Boehringer Ingelheim International v Commissioner for Patents [2000] FCA 1918 and on appeal); [148] (Prejay Holdings Ltd v Commissioner of Patents [2003] FCAFC 77); [153] (Pharmacia Italia SpA v Mayne Pharma Pty Ltd [2006] FCA 305 on the application of s 119A); [165]-[166] (Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559); and [170] (Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd [2013] FCA 658)
[ix] Pharmacia Italia SpA v Mayne Pharma Pty Ltd [2006] FCA 305; 69 IPR 1
[x] Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd [2013] FCA 658; 216 FCR 344
[xi] Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCA 42
[xii] Previous caselaw has clarified that “per se” has been held to mean that a PTE cannot be given to claims for methods: See Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647 at [37]
[xiii] Cipla at [176]
[xiv] Cipla at [186]
[xv] Cipla at [181]
[xvi] Cipla at [189]-[191]