Of all the provisions that were newly introduced under the Raising the Bar Act 2012 (‘RTB Act’), the sufficiency and support requirements remain murky territory, primarily due to the absence of judicial consideration of these provisions. We know that these new provisions were modelled on European (i.e., higher) standards as set out in the Explanatory Memorandum accompanying the legislation. However, consideration of these provisions by the Australian Patent Office (the ‘Office’) in opposition decisions has, in the writer’s opinion, resulted in an approach that lacks a desired clarity, particularly in the biotechnology field. Although the support and enablement provisions are distinct statutory provisions, the consideration of each provision is often effectively the same by Examiners as the approaches that have evolved finds it almost impossible to practically distinguish between the two provisions. There seems to be something amiss with the Office’s approach to parsing sufficiency and support but until we receive judicial guidance, decisions from the Opposition Section of the Office are all we have as guidance.

The decision in Gliknik, Inc v CSL Behring Lengnau AG [2020] APO 46 is notable as the claims relate to the sufficiency and/or support with relation to therapeutic method claims and Swiss-style claims.

Australian Patent Application No. 2012392760 (the ‘Patent’) to CSL Behring Lengnau AG was opposed by Gliknik, Inc on a number of grounds, including lack of sufficiency under s40(2) and support under s40(3). The opposition succeeded only on these grounds. This article will focus only on sufficiency.

The relevant claims of the Patent are Claims 1 and 8. The salient portion of Claim 1 is reproduced 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…

Although Claim 1 is written as a compound claim, a compound “when used” is typically considered a de facto method claim under Australian practice (i.e., limits the claim scope to a particular application) and is not regarded as a claim to the compound per se. The Hearing Officer construed Claim 1 as equivalent to a treatment method, namely a method of treating an autoimmune or inflammatory disease in a mammalian subject by administering a polymeric protein consisting of six polypeptide monomer units having the limitations as recited in the remainder of Claim 1.

Claim 8 is a Swiss-style claim with the same structural and functional limitations as Claim 1. Pursuant to Australian jurisprudence, the Hearing Officer interpreted Claim 8 as a method of manufacture with an essential therapeutic purpose but no essential therapeutic effect.

The polymeric protein treatment as set out in the specification is an alternative to intravenous immunoglobulin treatment of autoimmune and inflammatory diseases.

In the absence of judicial guidance, the Office applies the Evolva approach for determining sufficiency. The Office considered sufficiency under the RTB Act was considered in Evolva SA [2017] APO 57 and the following approach adopted:

1. What is the scope of the invention as claimed?
2. What does the specification disclose to the skilled person?
3. 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?

In the present case, the threshold issue for the Hearing Officer, and the first of its kind, is the question of plausibility of therapeutic effectiveness (for method claims) or therapeutic purpose (for Swiss-style claims) for the purpose of sufficiency post-RTB Act.

In assessing plausibility, the Hearings Officer turned to a recent UK Supreme Court decision in Warner-Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56 (‘Warner’) that considered the plausibility requirements for Swiss-style claims. The Court in Warner set out seven principles by which to assess plausibility in the context of sufficiency. The Hearing Officer concluded from Warner that the disclosure of the specification (supplemented by the common general knowledge) must make the therapeutic effect or purpose plausible, and a mere speculative assertion is not sufficient. In the context of the Patent, does the disclosure of the specification make it plausible that the polymeric protein as claimed could treat any and all autoimmune inflammatory disease, or does it contain merely speculative assertions?

The specification lists a number of potential autoimmune and inflammatory diseases which may be applicable to the invention on the basis as being amenable to treatment with intravenous immunoglobulin but no rationale or mechanism for this is disclosed. Two indications with mechanisms of protection described in the specification are idiopathic thrombotic purpura (ITP) and a mouse model of arthritis. The specification did not include clinical trial data, or equivalent, showing treating subjects with the protein compounds. A prophetic example for a treatment method of ITP was included but did not seem relevant to the Hearing Officer’s analysis decision. Common general knowledge did not support further indications. From the balance of available evidence, the Hearing Officer considered that it is plausible on the face of the specification that the polymeric protein could be used as a treatment for ITP and arthritis, but that there is no more than speculative assertion that it could be an effective treatment for other autoimmune and inflammatory diseases.

Since none of the claims under consideration were limited to ITP and arthritis, the claims were found to lack sufficiency, although the Applicant has an opportunity to amend.

There are a couple of takeaway messages from this decision. First, the Warner decision referred to above can be turned to for considering plausibility. Second, sufficiency may have been arguable if the specification had included some type of mechanistic description of how the protein compounds could be used to treat autoimmune diseases or inflammatory diseases generally. The decision unfortunately does not describe the level of mechanistic description that may be sufficient but presumably, something would have been better than nothing.