For some time since the introduction of the pharmaceutical extension of term provisions in 1999, the Patent Office has steadfastly refused to grant extensions of term to patents in respect of drug delivery systems, relying on an early decision in which a Delegate of the Commissioner held that only mixtures (having an uncontrolled spatial configuration of the entities present) or chemical (rather than pharmaceutical) compounds qualify as a ”pharmaceutical substance". However, following on from the decision of Sanofi-Aventis  APO 35, reported in our emag - IP Update - September 2008 issue, the Patent Office now appears to have accepted a broader definition for the term, opening the way for patent term extensions for drug delivery systems.
N.V Organon (2009) APO 8
FACTS OF THE CASE
The Patentee applied to extend the term of Australian Patent No 726934 relating to a drug delivery system adapted to the slow release of particular steroidal mixtures, such as for use in contraception or hormone replacement therapy, in which the steroidal mixture is contained in a thermoplastic polymer core overlaid with permeable thermoplastic skin. The patentee applied for an extension of term based on the inclusion of NUVARING® in the Australian Register of Therapeutic Goods (ARTG). The application was refused by the Australian Patent Office on the basis that the drug delivery system was not a ”pharmaceutical substance” for the purpose of section 70(2)(a). The patentee subsequently requested a hearing.
In order to be eligible for an extension of term, a patent must claim and in substance disclose one or more pharmaceutical substances per se, and a product which consists of or contains that pharmaceutical substance must be included in the ARTG. The term ”pharmaceutical substance” is defined in Schedule 1 of The Patents Act 1990 to mean a ”substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves: (a) a chemical interaction, or physicochemical interaction, with a human physiological system; or (b) 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.” There was no question that the registered product fell within the scope of the granted claims, was in substance disclosed in the specification and that it involved a chemical interaction or physico-chemical interaction, with a human physiological system, and so the inquiry turned on whether NUVARING® was ”a substance (including a mixture or compound of substances)”.
In considering the matter, the Deputy Commissioner reviewed the relevant previous decisions and approvingly cited the decision of the Deputy Commissioner in Sanofi-Aventis, in which it was held that a ”compound”, in the definition of a pharmaceutical substance, includes ”a compound that is formed by combining elements or parts, or creating a union of parts”. In accepting this definition, the Deputy Commissioner then asked ”whether the characteristics of what is claimed more predominately lies with it being a substance rather than a substance in combination with separate integer.” It was noted that the thermoplastic materials in NUVARING® have a physical purpose to position, contain and provide for the controlled release of the steroidal components, and as such, the product as a whole was considered to exhibit a level of integration or interaction between the component parts that is more characteristic of a pharmaceutical substance in itself rather than a substance combined with another element or thing. Accordingly, it was held that NUVARING® qualified as a pharmaceutical substance.
LTS Lohmann Therapie-Systeme AG and Schwarz Pharma Limited  APO 16
FACTS OF THE CASE
The patentee applied to extend Australian Patent No 746856, which related to a transdermal patch to delver the D2 receptor agonist rotigotine for treating Parkinson's syndrome, on the basis of the inclusion of NEUPRO® in the ARTG. Claim 1 defined a pharmaceutical compound comprising an effective amount of rotigotine free base, an acrylate or silicone based non-aqueous polymer adhesive, an inert backing layer and a protective layer which is to be removed prior to administration. During the application process, the patentee submitted that the pharmaceutical compound as claimed comprised the polymer matrix and rotigotine and that the backing and protective layers were separate and subsidiary physical integers that in no way contribute to the working of the therapeutic substance and the pharmaceutical compound. Nevertheless, the application was refused by the Australian Patent Office on the basis that the subject matter of the claims related to a device having three distinct layers and was not a ”pharmaceutical substance” for the purpose of section 70(2)(a).
Whilst the patentee attempted to argue that the backing and protective layers were not essential features of the invention, the Examiner rejected this argument, noting that the patentee had clearly limited the claimed product to having those features, and accordingly the question for consideration was whether the NEUPRO® product constitutes a ”substance (including a mixture of compound of substances)”.
The Deputy Commissioner took guidance from the N.V. Organon decision and applied the test: ”whether the characteristics of what is claimed more predominately lie with it being a substance, rather than a substance in combination with a separate integer” and observed that the presence of an inert backing layer and protective layer would not be fatal if the patentee could demonstrate that the product as a whole shows a level of integration or interaction between the component parts such that it would fall within the definition of a pharmaceutical substance. However, the Deputy Commissioner also noted the patentee's earlier submissions that the backing and protective layers were separate and subsidiary physical integers that in no way contribute to the working of the therapeutic substance and was of the view that this was wholly inconsistent with NEUPRO® as a whole being considered ”a substance (including a mixture or compound of substances)”.
At the hearing the patentee submitted that, like the thermoplastic materials in the N.V. Organon product, the inert backing layer had a physical purpose to position, contain and provide for the controlled release of the active ingredient. Ultimately, however, the Deputy Commissioner did not consider the nature of the backing layer to be critical to her decision. The protective layer, which is removed before use, was not considered to integrate or interact in any way with the other component parts of NEUPRO® and accordingly, the ”presence of this layer at least” was held to render the claimed product a pharmaceutical substance in combination with a separate integer. Accordingly, the request for extension of term was refused.
The N.V. Organon decision has pleasingly further broadened the definition of a ”pharmaceutical substance”, which, building on the Sanofi-Aventis decision, now can be said to encompass a compound that is formed by combining elements or parts, or creating a union of parts such that the product as a whole shows a level of integration or interaction between the component parts. In light of this, patents claiming drug delivery systems, which were previously denied extension, may now be eligible. Notwithstanding that the patentee in the LTS Lohmann Therapie- Systeme decision was unsuccessful, the Deputy Commissioner did not express any view one way or another with regard to the patentee's submission that the backing layer had a physical purpose, and the refusal to extend the patent would appear to be more connected with the inclusion in the claim of a separate removable protective layer, rather than the nature of the product itself. Had the claims not included this feature, the outcome may well have been quite different