Cytec Industries Inc. v Nalco Company [2021] FCA 970
In a recent opposition appeal decision of the Federal Court of Australia, Nalco Company’s Australian patent application no. 2012220990 was found invalid for lack of support and lack of clear enough and complete enough disclosure (sufficiency).1
The decision highlights the Court’s approach in considering the meaning of claim terms that might on first glance be considered conventional, and emphasises the need to consider whether the claims are commensurate with the technical contribution provided by the specification. Toby Thompson and Tim Fyfe discuss.
The technology
The technology of the application related to the “Bayer process”, an industrial process used to extract alumina from bauxite. Precipitation of aluminosilicate scale can occur during the process, forming obstructions and affecting efficiency. The patent application was directed to methods for reducing scale during the Bayer process, involving use of additive compositions containing certain small molecules.
Support and sufficiency
A key issue in the proceedings was the requirement in claim 1 for:
“a composition comprising at least one small molecule selected from the group consisting of compounds (I)…(LX) within a product mixture formed from the reaction of…”
The judge first decided that the language of claim 1 encompassed a composition made up of a single type of small molecule, alongside encompassing mixtures of small molecules. Such a finding is uncontroversial, and most practitioners would agree that it is common when drafting to use “at least one” to cover situations where either a single component or multiple components are to be protected.
Having arrived at that construction, the judge went on to hold that the claims lacked support as a result. The specification described the small molecules as being produced by the reaction of three components, which resulted in the production of complex mixtures of small molecules. However, there was no disclosure regarding how to produce a single small molecule, or how to separate components of the product mixture. Whilst embodiments of claim 1 involving mixtures of small molecules were supported, embodiments involving only a single type of small molecule were not.2
For similar reasons, the judge also found that the specification did not disclose the claimed invention in a clear and complete enough manner for it to be performed by a person skilled in the art (insufficient). Insofar as the claims included a product mixture made up of a single type of small molecule, undue experimentation was required to perform the invention.3
Vulnerability of claims containing conventional terms
The decision in Cytec v Nalco follows on the heels of MSD v Wyeth last year, where use of an apparently conventional drafting term also resulted in invalidity (see our article here). In that case, the term “comprising” resulted in claims directed to vaccine compositions being held to lack support, insofar as the claims encompassed vaccines having additional polypeptide-protein conjugates beyond the thirteen specified.4 The decision in MSD v Wyeth also cemented that evaluation of compliance with Australian support provisions involves assessment of the technical contribution to the art disclosed by the specification, and requires that the breadth of the monopoly claimed must be justified by that technical contribution.5
On the face of it, these decisions might cause concern that other patents containing similar commonly used claim terms might also be vulnerable. However, in both MSD v Wyeth and Cytec v Nalco, the decisions were heavily dependent on the facts. As discussed above, in Cytec v Nalco there was a lack of disclosure in the specification relating to production or isolation of single small molecule products. The expert evidence further indicated that a skilled person would not have known how to obtain a single small molecule. In MSD v Wyeth, the evidence supported that the selection of additional serotypes beyond the 13 specified in the claims would be a complex and difficult process. Given that, it should not be assumed that all Australian patents using terms such as “at least one” or “comprising” are likely to be considered to lack support or be insufficient.
However, these decisions highlight the approach of the Australian courts, not only in carefully considering the language of the claims, but in also evaluating whether all embodiments falling within the claims can be obtained based on the specification and the common general knowledge. We can also expect that challengers will continue to raise lack of support and insufficiency attacks in invalidity proceedings. As a result, particularly for cases where litigation may be anticipated, patentees should consider whether the claims of their patents reflect the technical contribution to the art.
Grace period applicable to “novelty-only” patent publications
An unsuccessful lack of novelty attack was also made by Cytec based on an earlier filed-later published “whole of contents” Nalco publication “WO 873”. In confirming that the Australian grace period provisions are applicable to such documents, the judge confirmed the position taken by the Australian Patent Office in recent years,6 providing additional clarity in this area.
The judge disagreed with the Opponent’s view that the 12-month grace period only applied to prior art documents which had already been published by the priority date of the claim, holding that a reading down of the words “publicly available” in section 24 of the Patents Act to exclude prior unpublished patent specifications from the grace period provisions, was unwarranted.
For more information regarding this case, or if you have questions regarding how to navigate Australia’s support and sufficiency requirements, please get in touch with a member of our team.
1Cytec Industries Inc. v Nalco Company [2021] FCA 970.
2Cytec Industries Inc. v Nalco Company [2021] FCA 970, [129]-[133].
3Cytec Industries Inc. v Nalco Company [2021] FCA 970, [149].
4Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477;
5Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477, [547].
6Biogen Idec MA Inc. [2014] APO 25; Rozenberg & Co Pty Ltd. v Velin-Pharma A/S [2017] APO 61