A system of substance
The decision of the Deputy Commissioner of Patents in N. V. Organon [2009] APO 8 in relation to an application for an extension of patent term may have significant implications for innovators in the medical technologies industry.
Section 70 of the Patents Act 1990 (Cth) provides for the possibility of extending the term of a patent relating to a pharmaceutical substance to compensate the patentee for delays in obtaining regulatory approval for the substance. The requirement that the patent relate to a “pharmaceutical substance per se” has resulted in the section being understood to exclude medical devices. For example in Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647 the provision was held not to apply to a patent relating to a container including a spray composition and a nozzle for nasal administration.
In the present case, Organon sought an extension of term of its patent relating to a drug delivery system which involved the slow release of particular steroidal mixtures contained in a thermoplastic polymer core over which was laid a permeable thermoplastic skin. Following an adverse report by the delegate considering the application the patentee requested a hearing of the application.
a pharmaceutical substance (including a mixture or compound of substances) can include a compound with a controlled spatial configuration if, as a whole, it can still be considered a pharmaceutical “substance” but the combination of such a substance with what would reasonably be considered a separate physical device, layer or structure or …“any purely physical integers” is excluded
With respect to the drug delivery system in issue, the Deputy Commissioner stated that “the thermoplastic materials … have a physical purpose to position, contain and provide for the controlled release of the steroidal components” and that “there are also two distinct and adjacent physical layers or regions that differ in composition, that is, the core and skin.” These factors “could well suggest that the thermoplastic core and skin are more in the nature of separate physical integers.”
However, having regard to expert evidence filed by the patentee, it was held that “the steroidal components … are mixed with and necessarily diffuse through the thermoplastic materials in the core and skin regions and as such the product as a whole exhibits 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, the application for extension was allowed.