Principles on inventive step and “routine formulation steps” rammed home in Australian patent case

Animal health company Abbey Laboratories (Abbey) has successfully defeated Elanco Australasia’s (Elanco) third bite at trying to get a granted Australian patent for an invention directed at a specific dosage range of an active ingredient for the treatment of lice on sheep. 

Abbey twice opposed the patent application proceeding to grant before IP Australia (including with an amended claim set), and Elanco appealed the decisions of the Delegate to the Federal Court of Australia.

In a decision handed down on 14 June 2024, Burley J has dismissed Elanco’s appeal. The judge found that Abbey had established that proof of concept studies were a matter of routine formulation steps, and that the identification of a specific dosage range of an active for the treatment of lice in this case lacked an inventive step.  

Two oppositions before IP Australia

In the first opposition before IP Australia, Abbey had opposed the patent application proceeding to grant on the basis that the patent lacked novelty in view of a Trade Advice Notice that had been published before the priority date of the patent by the Australian Pesticides and Veterinary Medicines Authority (APVMA), and lack of inventive step (amongst others).  

Trade Advice Notices are prepared by the APVMA when it is considering an application for registration of an agricultural or veterinary chemical.  It provides a summary of the APVMA’s residue and trade assessment.  

The relevant Trade Advice Notice relied on here related to an application by Bayer Australia (the prior applicant for the patent before it was assigned to Elanco) for the registration of a new sheep dip product called “Piranha Dip for Sheep”, containing an approved active constituent thiacloprid (480 g/L).

The first opposition was allowed by the Delegate, based on lack of novelty, and lack of inventive step. Elanco then sought to amend the patent application to try and overcome those findings by limiting its claims to application of thiacloprid by backlining (otherwise referred to as a “pour-on formulation”). 

A second opposition hearing ensued in respect of the amended patent application. Abbey argued that the amendments were not sufficient to overcome the lack of inventive step ground in view of the common general knowledge, and the information in the Trade Advice Notice.  The Delegate again refused the patent application. 

Elanco appealed to the Federal Court of Australia, seeking to challenge findings of the Delegate in both the first and second oppositions. 

Appeal to the Federal Court of Australia

Background

Appeals from decisions of the Australian patent office to the Federal Court involve a hearing de novo. 

To invalidate a claim under Australian…