Extension of Patent Term for Pharmaceuticals in Australia

In September 2009, we reported on an Australian Patent Office (APO) decision relating to an application for an extension of patent term for a trans-dermal patch. The application for an extension of patent term was denied by the APO on the basis that the claim was not directed to a “pharmaceutical substance” as is required by Section 70(2)(a). Our report on the APO decision denying the application for an extension of patent term can be found at the below link. As you can see, we found the APO’s decision uncontroversial, given that the claim was limited by reference to a “backing layer”. LTS Lohmann Therapie Systeme AG and Schwartz Pharma Ltd and Commissioner of Patents [2010] AAT 809.

The patentee appealed the APO decision to the Administrative Appeals Tribunal (AAT). The AAT has now handed down a decision confirming the APO’s denial of the application for an extension of patent term. The AAT appeal decision can be found here: LTS Lohmann Therapie Systeme AG and Schwarz Pharma Ltd and Commissioner of Patents [2010] AATA 809 (22 October 2010).

Whilst we find the AAT’s confirmation of the original APO denial uncontroversial, we are concerned by the AAT’s reasoning and particularly by the AAT’s comments at paragraph 32 where the AAT is critical of an unrelated APO decision (the Organon decision) in which the APO granted an extension of term for a patent directed to a steroid-impregnated, polymeric implant. In the Organon decision, the APO formed the view that the proper approach to deciding whether a claim is directed to a “pharmaceutical substance” (and hence eligible for an extension of term) is to look at the level of integration between the formulation and the associated delivery device.

At paragraph 32 of the appeal decision, the AAT suggests that the proper approach is to narrowly construe the phrase “pharmaceutical substance” to mean “the active ingredient(s)”. If the AAT’s approach is correct, then an extension of term will only be available for patents which have claims directed to novel & inventive active(s). The presence in the claim of any non-active will disqualify the patent from an extension of term.

It is our view that the AAT has seriously erred in construing “pharmaceutical substance” in this extremely narrow way. Our view for a broader construction is supported by the fact that “pharmaceutical substance” is defined in Schedule 1 of the statute as meaning “a substance (including a mixture or compound of substances) for therapeutic use…”.

We now wait to see how the APO will deal with the next application for an extension of term where the claim is limited by reference to some non-active constituent.

Today’s post is by Guest Barista Bill Bennett of Pizzeys.

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