22 August 2005

Novartis Fails to Describe Best Method

On 16 August 2005, the Delegate of the Commissioner of Patents handed down Novartis AG v Monsanto Co [2005] APO 36.

The matter arose out of an opposition by Monsanto to the grant of a patent to Novartis on Australian patent application no. 720095. The matter is interesting in that it sets out an example of an insufficient description of a preferred embodiment of an invention. Section 40 (2)(a) of the Australian Patents Act 1990 sets out that a complete specification must describe the invention fully, including the best method known to the applicant of performing the invention. The matter also canvassed the issues of novelty and inventive step.

The relevant claims are extensive and Bazpat will not repeat them here. In short, claim 1 is directed to a process for the control of weeds, where the process is characterised in that a "synergistic amount" of at least one herbicide is added to "a phospho-herbicide selected from the group comprising glufosinate and glyphosate". A further independent claim 14 is directed to a composition of "...glufosinate and a synergistic amount of at least one further herbicide selected from...". Yet a further independent claim 15 is directed to a composition of "...glyphosate and a synergistic amount of at least one further herbicide selected from ...".

The Delegate interpreted the claims as having "a synergistic amount" of the co-herbicide as an essential feature. The Delegate held that: "Synergy is established by comparing the effect of each of the components individually with the effect of the mixture of components. If the effect of the mixture is greater than the sum of the individual components, then there is synergy."

The Delegate pointed out that the specification indicated that the proportion of the active ingredients is preferably in the range of 1:100 to 1:0.001. There was no suggestion in the specification whether any ratio in that large range was more likely to be synergistic. No examples of a synergistic amount were given. In the words of the Delegate: "A person seeking to work the invention is confronted with the need to undertake a potentially huge amount of experimentation in order to find a suitable composition".

The specification was held to leave the reader without guidance of where success is likely, or even where success is possible. Thus, the Delegate held that the specification clearly failed to disclose a manner of carrying out the invention, and consequently did not fully describe the invention.

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