Australian Patent Office allows patent term extension for a drug delivery system for two or more active substances

The Australian Patent Office has recently handed down a case, N. V. Organon [2009] APO 8 (298 May 2009) which impacts the type of subject matter which is eligible for a patent term extension in Australia, particularly relating to formulations and delivery devices. The test for whether a product qualifies for a patent term extension now appears to be whether there is "integration" between the active ingredient and the other feature.

The Intellectual Property Laws Amendment Act (1998) amended the Australian Patents Act 1990 to provide, inter alia, for an extension of term for pharmaceutical patents. The scheme allows patentees to apply for an extension of term of up to 5 years for a standard patent that claims a pharmaceutical substance.

In order for a patent to be eligible for an extension, it must satisfy the criteria set out in section 70(2) of the Australian Patent Act:

• one or more pharmaceutical substances per se must be in substance disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification, or
• one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance falls within the scope of the claim or claims of that specification.

Pharmaceutical substance in the Australian Act is defined in Schedule 1 as 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 physico-chemical 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 in vitro testing.

In the case in question, the patentee applied for an extension of term of the patent based on its patent relating to a drug delivery system adapted to the slow release of particular steroidal mixtures such as for the purpose of contraception or hormone replacement therapy. A key aspect of the invention is that the steroidal mixture is contained in a thermoplastic polymer core over which is laid a permeable thermoplastic skin. It was considered whether the product as claimed in the patent was a pharmaceutical substance within the meaning of the Act and more particularly whether it was a substance for therapeutic use as provided in the definition given in Schedule 1.

The Commissioner held that

"the definition of a pharmaceutical substance encompasses 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 is excluded. 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 but in the present case 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 was considered more characteristic of a pharmaceutical substance in itself rather than a substance combined with another element or thing.
Consequently the application to extend the term of the patent was allowed. "

In its decision, the Australian Patent Office followed a line of reasoning similar to that expressed by Advocate General Leger in the ECJ MIT case.