On 12 October 2020, IP Australia handed down its decision in the Gliknik, Inc. v CSL Behring Lengnau AG  APO 46 opposition in favour of the opponent (Gliknik) on the counts of insufficiency and lack of support. We explain this decision in further detail.
Despite the Raising the Bar Act (“RTB Act”) coming into full effect in April 2013, we are only now starting to receive some guidance as to how the sufficiency requirement has been interpreted at the Patent Office with respect to medical applications; namely, that the efficacy of a treatment across the full scope of the claim must be plausible from the disclosure in the specification for a method of treatment to be considered valid; and that the same threshold will be applied for a Swiss-type claim, despite there being no legislative requirement for a Swiss-type claim to be effective.
Briefly, the Applicant, CSL Behring Lengnau’s (“CSL”), owns a patent application (Australian patent application no.: 2012392760) directed to use of a very large number of engineered proteins for use in therapy in patients against a broad range of non-specified autoimmune or inflammatory diseases (of which there could be hundreds) as a substitute for intravenously administered immunoglobulin (IVIG). Two diseases with mechanisms of protection specifically described in the specification were idiopathic thrombocytopenic purpura (ITP; via Fc receptors) and arthritis (via DC-SIGN).
The application contained therapeutic method claims, and a Swiss-type claim directed to the same non-specific indications. The opponent, Gliknik, opposed the application on several grounds, but their only successful grounds were the allegations that the specification lacked support (given that the claims were directed to a broad range of unspecified diseases), and did not sufficiently disclose the invention as claimed (given the lack of examples directed to diseases other than the two which were exemplified).
The Applicant argued that the specification provides vast detail on how the engineered proteins can be used as a replacement for IVIG without limitation but failed to provide any rationale or mechanism of action for such a broad statement, with the specification going so far as to concede that the mechanism of action of IVIG was unclear. The question at hand then, was whether or not this assertion was merely speculative or if there was sufficient evidence to support the efficacy of the engineered proteins against all autoimmune and inflammatory diseases, i.e. across the full scope of the claim.
According to s40 of the Patents Act (as amended by the RTB Act):
(2) A complete specification must:
(a) disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art, and (Sufficiency)
(aa) disclose the best method known to the applicant of performing the invention, and (Sufficiency)
(b) where it relates to an application for a standard patent–end with a claim or claims defining the invention, and
(c) where it relates to an application for an innovation patent–end with at least one and no more than 5 claims defining the invention.
(3) The claim or claims must be clear and succinct and supported by matter disclosed in the specification. (Support)
(3A) The claim or claims must not rely on references to descriptions, drawings, graphics or photographs unless absolutely necessary to define the invention.
(4) The claim or claims must relate to one invention only.
Since, at the time of writing this decision, the sufficiency requirements were yet to face judicial scrutiny in Australia, the Delegate referred to the post-Raising the Bar “Evolva” Decision (Evolva SA  APO 57).
The approach adopted by the Deputy Commissioner in Evolva, and recited by the Delegate in the current case, was:
- What is the scope of the invention as claimed?
- What does the specification disclose to the skilled person?
- Does the specification provide an enabling disclosure of all the things that fall within the scope of the claims, and in particular:
(a) Is it plausible that the invention can be worked across the full scope of the claim?
(b) Can the invention be performed across the full scope of the claim without undue burden?
The main claims under consideration were claims 1 and 8, and the salient portion of claim 1 is copied below:
A polymeric protein consisting of six polypeptide monomer units when used in a method of treating an autoimmune or inflammatory disease in a mammalian subject.
Despite disguising itself as a compound claim, inclusion of the term “when used” in a claim is typically interpreted under Australian practice as a method claim, because it restricts the claim scope to a particular application. Thus, claim 1 was construed as a method of treating an autoimmune or inflammatory disease by administering an effective amount of the engineered protein. The term “effective amount” implies that the treatment must be capable of being effective.
Claim 8 is a Swiss-type claim with the same structural and functional features as Claim 1 with the format “Use of polymeric protein consisting of six polypeptide monomer units for the manufacture of a medicament for the treatment of an autoimmune or inflammatory disease…”. The present case represents the first time that the Patent Office has considered the plausibility of a Swiss-type claim.
Consistent with current Australian law, claim 8 was construed as a method of manufacture limited to an essential therapeutic purpose. Notably, unlike method of treatment claims, there is no legislative requirement that a Swiss-type claim actually exhibit the therapeutic effect that the product is said to contain. Thus, there is a plausibility of purpose in a Swiss-type claim, and not a plausibility of efficacy.
Without any relevant Australian jurisprudence upon which to rely, the Delegate turned to a UK Decision (Warner-Lambert Company LLC v Generics (UK) Ltd  UKSC 56). However, the British decision concerned itself with the plausibility of efficacy rather than purpose, leading the Delegate to raise the question: was the plausibility standard of therapeutic “effectiveness” (as appropriate for a method of treatment claim) different from that of a therapeutic “purpose”, as required for a Swiss-type claim?
Upon consideration, the Delegate determined that if the efficacy of a product is not plausible, then it must surely follow that an intention to treat could not be plausible. Thus, the Delegate concluded that it was appropriate to follow the UK Decision by substituting the word “efficacy” for “purpose”.
With this established, the Delegate then turned to the matter at hand and determined that whilst the specification provided sufficient disclosure to make the effective treatment of some diseases plausible (i.e. the 2 conditions specifically addressed in the Examples), the treatment of other conditions which were not exemplified was considered nothing more than speculative assertion. Since none of the claims were directed specifically to the plausible therapies, the claims were found to be insufficiently enabled because their subject matter failed the plausibility test of s 40(2)(a).
A similar conclusion was drawn in relation to support. The Delegate concluded that the technical contribution could only be located in the Examples, i.e. in terms of the protein’s ability to bind Fc and lectin, and their effect as identified in mouse models.
Since the actual mode of action of IVIG in the treatment of diseases other than ITP or arthritis was poorly understood, the Delegate concluded that the claims were only supported in so far as they applied to treatment of ITP or arthritis in the examples, since these were the only plausible indications. Thus, the plausibility of efficacy of claims directed broadly to the protein’s ability to treat non-specific autoimmune and inflammatory diseases was not supported by the specification.
What this decision reveals is that for a method of medical treatment to be sufficiently disclosed and supported, there must be, at the very minimum, some rudimentary test directed to each specific indication, or at the very least, a detailed description of a proposed mechanism of action of the drug which may make the application of that drug to a specific indication plausible.
In addition, we can see that the patent office’s approach to plausibility of method of treatment claims and Swiss-type claims is of a similar standard and that the efficacy of the treatment must be plausible for both types of claims to be valid.