In this decision,1 the Australian Patent Office sought to clarify the position regarding the circumstances in which a patent relevantly claiming a drug delivery device may be susceptible to patent term extension.
The relevant product, having received Australian regulatory approval, NUVARING is a contraceptive and/or HRT device in the form of a ring, adapted for the slow release of a steroidal mixture. The key features of the patent claim include a steroidal mixture contained in a 'thermoplastic polymer core' over which is laid a 'permeable thermoplastic skin'.
The question for consideration was whether NUVARING is ‘a pharmaceutical substance per se’ relevantly falling within the scope of a claim of the subject patent. According to the Patents Act 1990 (Cth), a ‘pharmaceutical substance’ is ‘a substance (including a mixture or compound of substances) for therapeutic use…’.
In finding for the Applicant, the Commissioner stated:
…it appears to me that a pharmaceutical substance [within the meaning of the Act] 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.
While the Commissioner accepted that the thermoplastic core and skin of NUVARING might be viewed as ‘separate physical integers’, in the light of expert evidence the Commissioner concluded that:
… the steroidal components in NUVARING 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, in my view, is more characteristic of a pharmaceutical substance in itself rather than a substance combined with another element or thing.
What you should take from this decision is that the Office’s earlier view as expressed in Lohmann (LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12) – that a patent cannot be extended if the substance has a specific spatial configuration of the entity in the substance – now ‘ceases to be persuasive’.
It is not clear whether we should now expect to see a different outcome from that in Lohmann the next time that the Office considers eligibility of a patent that relevantly claims a transdermal delivery system of the type considered in Lohmann for term extension. In the meantime, the door would now appear to be open to delivery devices infused or impregnated with a chemical entity.
This article was written by Tom Gumley, Partner, Freehills Patent & Trade Mark Attorneys.
Endnotes
1. Abstract of decisions – N. V. Organon [2009] APO 8 (28 May 2009)
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