Scales of justice

Nearly six years ago, Australia ‘raised the bar’ in relation to the written description requirements for Australian patents. 

However, to date, the new requirements have only received scant attention from the Federal Court of Australia. This vacuum has highlighted potential future challenges in applying the new law.

Specifically, the amendments brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) (the Raising the Bar Act) replaced, among other things, sub-sections 40(2)(a) and 40(3) of the Patents Act 1990 (Cth). This aspect of the Raising the Bar Act applies to all patent applications for which examination had not been requested by Friday 12 April 2013.

The disclosure requirement for complete patent applications in sub-section 40(2)(a) was amended to conform substantially to the corresponding UK provisions, such that the complete specification must “disclose the invention in a manner which is clear enough and complete enough for an invention to be performed by a person skilled in the relevant art”.

Further, the ‘old test’ for fair basis in sub-section 40(3) has been replaced with a requirement based on UK/European law that that the claims are “supported by” the description. The ‘old test’ for fair basis is whether there is a real and reasonably clear disclosure in the body of the specification or priority document of what is then claimed. It was essentially limited to a textual comparison between the claims and the body of the specification or priority document that does not involve any European style inquiry into ‘technical contribution to the art’.

In the absence of any judicial consideration, the Australian Patent Office (IP Australia) has been developing its own case law for applying the new provisions. In Evolva SA [2017] APO 57 at [45] the delegate of the Commissioner of Patents set out a process of construing the specification and determining compliance with sub-section 40(2)(a) including the consideration of plausibility in relation to claims of excessive breadth. In doing so, the delegate noted (at [59]), in accordance with then leading UK authorities, that “the threshold for plausibility is a low one, and may be based on the slimmest of evidence”.

Since then, the UK Supreme Court has handed down its judgement in Warner-Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56 in which the issue of plausibility was considered in-depth. While the UK Supreme Court unanimously agreed that it was implausible that pregabalin would be effective at treating any type of pain (claim 1) and all neuropathic pain (claim 3) including peripheral and central pain. The majority in the UK Supreme Court disagreed with the principle that plausibility is a “low, threshold test”. This shift in the UK authorities has since had to be reconciled in a further decision of a delegate of the Commissioner of Patents in Gary B Cox v MacroGenics, Inc. [2019] APO 13.

It will be interesting to see how the Federal Court will approach any future developments in UK and European law in applying these provisions. The Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 relating to the Raising the Bar Act states that “the intention is that paragraph 40(2)(a) be given, as close as is practicable, the same effect as the corresponding provisions of UK legislation and the European Patent Convention”. However, what do we do if the UK Supreme Court changes course (as it seemingly has in Actavis UK Limited v Eli Lilly and Company [2017] UKSC 48 in relation to infringement)? Will we simply follow it lockstep? We will have to wait and see.

If you have any questions or require expert advice, please don't hesitate to contact us. 

Our Expert Project Lead

Related Content