Elanco Sheepish as Patent Application Not Inventive

Elanco Australasia Pty Ltd v Abbey Laboratories Pty Ltd [2024] FCA 640

This recent decision handed down by Justice Burley in Elanco Australasia Pty Ltd v Abbey Laboratories Pty Ltd [2024] FCA 640 on 14 June 2024 is the latest example of the ballooning number of patent decisions regarding Australia’s agricultural sector.  Burley J’s decision highlights the key considerations for inventive step, including (a) defining the nature of the invention; and (b) the role of expert evidence in determining the common general knowledge.

Background to the Elanco Appeal
Elanco Australasia Pty Ltd (Elanco) appealed from two decisions of the Commissioner of Patents allowing an opposition by Abbey Laboratories Pty Ltd (Abbey) to the grant of AU2014280848 entitled “Ectoparasitic treatment method and composition” (the Elanco Application).  The Elanco Application related to methods of treating biting lice on sheep and goats using the insecticide thiacloprid.  The first opposition decision related to the Elanco Application in unamended form and the second opposition decision related to the Elanco Application in amended form, the amendments being designed to overcome the Delegate’s findings in the first opposition decision.

The First and Second Abbey Oppositions
In the first opposition filed in August 2018, Abbey alleged that the Elanco Application should not proceed to grant on multiple grounds: lack of clear enough and complete enough disclosure, lack of support; lack of clarity; lack of novelty; lack of inventive step; and secret use.  In a decision handed down on 4 June 2020, Abbey succeeded on the grounds of lack of support (claims 1 – 10), lack of novelty (claims 1 and 4 – 11) and lack of inventive step (claims 1 – 3, 6 and 7).

In the second opposition commenced in July 2020, Abbey alleged only lack of inventive step against the amended Elanco Application, and ultimately succeeded on this ground in a decision handed down on 26 July 2021.

In August 2021, Elanco appealed the inventive step finding in both the first and second opposition decisions.  However, the parties ultimately agreed that:

1. the sole issue between them was whether the amended Elanco Application involved an inventive step in light of the common general knowledge and the content of a Trade Advice Notice (published in February 2013) related to an application by Bayer Australia Ltd (Animal Health) for the registration of a new product called “Piranha Dip for Sheep” containing thiacloprid (480 g/L); and
2. this issue could be determined by examination of claim 1 on the basis that none of the other claims would involve an inventive step if claim 1 did not.

Burley J Finds Elanco Invention Obvious
In his decision handed down on 14 June 2024, Justice Burley upheld the second opposition decision, finding the invention claimed in claim 1 to be obvious i.e. to lack an inventive step.  His Honour held that:

• the evidence showed that the process of ascertaining a dose level range was routine to the skilled team and that it would be conducted at the proof of concept stage;
• the skilled team would be confident, in commencing its proof of concept studies, that it would obtain an efficacious backlining treatment using thiacloprid; and
• on the basis of the promising information in the Trade Advice Notice, the skilled team would, if it did not find an efficacious dose in initial proof of concept studies, vary the range until they did.

This decision continues the upward trend we are seeing in patent disputes between competitors in the agricultural sector.  Justice Burley’s decision highlights the key considerations the Court takes into account when determining the question of inventive step.  In particular, Justice Burley’s decision highlights the central importance of defining the nature of the invention and the role of expert evidence in determining what is the scope of the common general knowledge and whether or not the claimed invention involves an inventive step. No appeal has been filed.

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