An extension of term is only available in respect of a pharmaceutical substance per se that in substance falls within the scope of a claim of a patent, except for substances produced by a process involving the use of recombinant DNA technology.

The Explanatory Memorandum to the Intellectual Property Laws Amendment Bill 1997 noted that claims to pharmaceutical substances per se would usually be restricted to new and inventive substances.

The Memorandum also specified certain circumstances where an extension would not be available:

"Patents that claim pharmaceutical substances when produced by a particular process (product by process claims) will not be eligible unless that process involves the use of recombinant DNA technology. Claims which limit the use of a known substance to a particular environment, for example claims to pharmaceutical substances when used in a new and inventive method of treatment, are not considered to be claims to pharmaceutical substances per se."

This distinction is specifically evident as between the reference in the Act to 'pharmaceutical substances per se', and to 'pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology'. The use of the word 'per se' requires the claim to the substance to be unqualified by process, temporal, or environmental components.

Both s70(2)(a) and s70(2)(b) require that a claim of the patent must be directed to a pharmaceutical substance, not methods or processes involving pharmaceutical substances. Thus, the claim must define a pharmaceutical substance per se or a substance produced by recombinant DNA technology (Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 at [55]).

Claims to Substance

In order for the term of a patent to be extended, the patent must contain one or more claims to a pharmaceutical substance per se, for example:

a substance of formula ----- ;
substance X mixed with substance Y.

Substances for which extensions of term are available include both new compounds per se and novel and inventive formulations of known drugs.

Examples of claims that are not directed to substances per se are:

substance X when used .... ;
substance X when produced by method Y;
a method of preparing substance X;
a substance of formula ...., where component Y is produced by .... ;
'Swiss' style claims referring to substance X;
use of substance X in the treatment of Y;
substance X for use .... ;
(a specified quantum) of substance X;
an antiseptic comprising substance X.

Note: In some circumstances, a qualifying term, e.g. ‘for use’, ‘when used’ or ‘an antiseptic’, will have no limiting effect on a claim. That is, the claim with the limitation is of the same scope as the claim without the limitation. In these situations, the claim will be directed to a pharmaceutical substance per se. However, an objection should be taken if it is uncertain that the qualification has no limiting effect.

Note: A reference to a specified quantum of a substance contained within a composition or formulation is not always objectionable (see Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd [2013] FCA 658; iCeutica [2018] APO 76, 78).

Note: In limited circumstances, a substance may be new and inventive, but can only be defined by reference to the process by which it was made (for example, compound X obtainable by process Y) because the chemical structure or composition is undetermined. In this situation, a claim which defines the substance by reference to such method steps would be a claim to the substance per se (see Zentaris AG [2002] APO 41). See also Pharmacia Italia SpA v Mayne Pharma Pty Ltd [2006] FCA 305.

Case Law

Relevant case law includes the following:

Boehringer Ingelheim International v Commissioner of Patents [2000] FCA 1918

The meaning of the words "pharmaceutical substance per se" was fully considered by Heerey J:

“The 1990 Act in its present form manifests a policy which draws a distinction between, on the one hand, a pharmaceutical substance that is the subject of patent claim and, on the other hand, a pharmaceutical substance that forms part of a method or process claim. The specific exception to the latter (an exception which proves the rule) is the provision for recombinant DNA technology in s 70(2)(b).”

Thus, the extension right is only granted under s70 where there is a claim to a pharmaceutical product that is new and inventive, unless the exception under s70(2)(b) can be invoked.

This decision was upheld on appeal to the Full Court in Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647.

Celgene Corporation [2011] APO 37

In this case, the patent contained a claim to a pharmaceutical composition when used for treating a particular disorder. It was concluded that the claim was to a process and not a pharmaceutical substance per se and consequently the patent did not meet the requirements of s70.

The Children’s Medical Center Corporation [2011] APO 80

The claims under consideration were directed to a combination comprising an amount of thalidomide and an amount of a steroid. The reference to “combination” included combinations where the 2 drugs were presented as an admixture in a single unit dosage form, as well as combinations where the 2 drugs were presented as separate dosage forms of the individual drugs.

It was held that the term “pharmaceutical substance per se” is intended to be a pharmaceutical that is presented as a single entity, and not in the form of a kit or as separate dosage forms. Thus, the combination of thalidomide and at least one steroid did not constitute a pharmaceutical substance per se.

Celgene Corporation and Commissioner of Patents and Children's Medical Center Corporation (Joined Party) [2013] AATA 55 (1 February 2013)

The Celgene [2011] and Children’s Medical Center Corporation [2011] decisions were both appealed to the Administrative Appeals Tribunal, resulting in the decisions being affirmed.

LTS Lohmann Therapie-Systeme AG and Schwarz Pharma Limited [2009] APO 16 (21 August 2009)

The patent contained claims to a transdermal therapeutic system (a transdermal patch) comprising an inert backing layer, a matrix layer containing the active and a protective layer, which is to be removed before application. It was found that the claimed system comprised a pharmaceutical substance in combination with a separate integer (protective layer) and therefore did not constitute a pharmaceutical substance per se.

LTS Lohmann Therapie Systeme AG and Schwarz Pharma Ltd and Commissioner of Patents [2010] AATA 809 (22 October 2010)

The claims were amended and the Lohmann [2009] decision was appealed to the Administrative Appeals Tribunal, where the decision was affirmed.

The granted claims were amended to “pharmaceutical compound for the treatment of diseases adapted to be transdermally administered...” comprising a polymer matrix containing the active, an inert backing layer and a protective layer. However, the altered phrasing for the transdermal patch was not found to change the substance of what was claimed.

Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd

The relevant claims were directed to controlled release formulations of oxycodone characterised by dosage amounts, excipients and/or release profile. Claiming by result (i.e. the desired release profile) was found to have the effect of defining the necessary characteristics of the excipients to be selected in order to achieve that result, and the Court concluded that the pharmaceutical substance per se was the mixture of oxycodone and relevant excipients achieving the claimed result.

Commissioner of Patents v AbbVie Biotechnology Ltd

The Full Court of the Federal Court, overturning the AAT, held that Swiss claims are not claims to pharmaceutical substances. They are directed to (1) a method or process in which a substance is used to produce a medicament and (2) an additional method or process element characterised by a specific purpose for which the medicament is to be used.

iCeutica Pty Ltd

The Deputy Commissioner considered three patents for which the relevant product listed on the ARTG was a composition containing nanoparticulate diclofenac. While diclofenac was responsible for the relevant chemical or physico-chemical interaction, it was apparent that the particle size contributed to the solubility and activity of the diclofenac, and it was found that this physical form of the pharmaceutical constituted a pharmaceutical substance per se.

In two of these patents ([2018] APO 76, 78) the claims defined unit doses containing specific quantities of diclofenac. The Deputy Commissioner indicated that such a limitation “is only a feature of a pharmaceutical substance per se if it is selected so as to achieve the chemical or physico-chemical interaction with the human physiological system.” As the quantity identified in the claim was the same as that in the goods listed on the ARTG, it was a reasonable inference that it had been so selected, and was not merely an arbitrary or convenient selection, and the relevant pharmaceutical substance per se was the unit dose having the defined quantity of diclofenac.