Welcome to the new version of the Patents Manual. Please note there are changes to the numbering and sequence of the chapters and pages in the manual. You are encouraged to take the time to explore and familiarise yourself with this new structure. Meaning of "mixture or compound of substances"

Date Published

The definition of a “pharmaceutical substance” provided in schedule 1 refers to:

"a substance (including a mixture or compound of substances) for therapeutic use …”.

Other than the passing remarks made by Burchett J that the expression “a mixture or compound of substances” was unusual in a scientific context (Virbac (Australia) Pty Limited and Ancare Distributors Limited v Merck Patent GmbH [1994] FCA 1255), this phrase has not been the subject of judicial consideration. However, it has been the subject of Office decisions including Sanofi-Aventis [2007] APO 35 and N. V. Organon [2009] APO 8.

In Sanofi (supra), the claims were to a biphasic composition presented in the product as a bi-layered tablet.  In N. V. Organon (supra), the invention involved a steroidal mixture contained in a thermoplastic polymer core, over which was laid a permeable thermoplastic skin through which the steroidal mixture diffused and was delivered in use.

More specifically, in N. V. Organon (supra) it was stated:

“In this light it appears to me that 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, from Sanofi, “any purely physical integers” is excluded and indeed would not be a “pharmaceutical substance per se”.”

It was recognised that it may be difficult to determine whether a particular feature of a product is correctly considered part of a “substance” rather than a separate physical integer.  However, in the circumstances of that case, it was found that the product as a whole exhibited a level of integration or interaction between the component parts that was considered more characteristic of a pharmaceutical substance itself, rather than a substance combined with another element or integer.

It therefore follows that other inventions which potentially involve a spatial configuration need to be considered on their merits.

There is also a need to consider whether a composition claim encompasses a single pharmaceutical substance or a mixture or compound of substances. Where the claim is directed to a mixture or compound of substances, the same must also be found in the goods.

Amended Reasons

Amended Reason Date Amended
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