Gliknik, Inc. v CSL Behring Lengnau AG [2020] APO 46 ("Gliknik") concerned a patent application for engineered proteins intended for use as replacements for intravenous immunoglobulin. The application included claims directed to methods of treating autoimmune or inflammatory diseases as well as a Swiss-style claim directed to the same diseases. Gliknik, Inc. opposed the application on several grounds including that the specification did not sufficiently disclose the invention as claimed.
The standard for "sufficient" disclosure was raised in Australia following the commencement of the Intellectual Property Laws Amendments (Raising the Bar) Act 2012 and its assessment has been approached by the Australian Patent Office with the following two-step enquiry:
- Is it plausible that the invention can be worked across the full scope of the claim?
- Can the invention be performed across the full scope of the claim without undue burden?
In Gliknik, the Patent Office considered for the first time the plausibility of a Swiss-style claim. Following the principles recently set out by the Full Federal Court in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116, the Delegate observed that Swiss-style claims confer a monopoly in respect of a method of making a medicament. They are not product claims, nor are they method of treatment claims - the monopoly extends to the point where the medicament is made.
Nevertheless, Swiss-style claims are purpose-limited in the sense that the medicament resulting from the method is characterised by the therapeutic purpose for which it is manufactured, as specified in the claim. Unlike method of treatment claims, however, a Swiss-style claim does not require that the therapeutic effect be achieved. Our analysis of Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116, including the court's construction of Swiss-style claims, is available here.
Having construed the claims, the Delegate in Gliknik then considered whether the plausibility standard of therapeutic effectiveness (for method of treatment claims) differed from that of therapeutic purpose (for Swiss-style claims). In the absence of Australian jurisprudence, the Delegate turned to UK authorities, and in particular, the principles set out by Sumption LJ in Warner-Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56. Although that case concerned the plausibility of efficacy rather than purpose, the Delegate reasoned that, if the efficacy of a product is not plausible, then it would follow that an intention to treat would not be plausible. The Delegate concluded that substituting the word "efficacy" for "purpose" in Sumption LJ's comments would not provide any substantial difference to the plausibility analysis.
Turning then to the disclosure of the specification, and the evidence of the common general knowledge in the field, the Delegate found it plausible that the engineered proteins of the invention could effectively treat some, but not all, conditions specified in the claims. For certain conditions, the specification provided no more than a speculative assertion and so the claims were found to be insufficiently enabled.
This decision shows that the Australian Patent Office will apply a similar standard of plausibility to method of treatment claims as it will to Swiss-style claims. For each type of claim, the disclosure of the specification, supplemented by the common general knowledge, must make the efficacy of the treatment plausible.
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