It’s good to be heard – the APO determines section 40 requirements

The Australian Patent Office’s decision in The University of British Columbia [2020] APO 15 (20 March 2020) considers how the “raised bar” requirements of support (section 40(3)), enablement (section 40(2)(a)) and best method (section 40(2)(aa)) are to be assessed. The decision is a reminder that these requirements are now more onerous than they were previously in Australia, and (with respect to the ‘best method’ requirement) in other major jurisdictions. When drafting specifications intended for prosecution in Australia, especially in biotechnology and pharmaceutical areas which are often struck by unpredictability, inventors should provide, and attorneys must include, not only as much detail as possible on the experimental methods for producing, evaluating and testing but also the best method known to perform the claimed invention. 

 

Background

The claimed invention related to antibodies exhibiting selectivity for the ‘eta’ isoform of the 14-3-3 protein over other isoforms of that protein. The ability of the antibodies to discriminate between the isoforms has utility in the diagnosis of inflammatory conditions such as arthritis. The claims, as proposed to be amended, were directed to methods of determining the presence of the eta isoform of the 14-3-3 protein in a sample using the antibodies, and kits containing an immobilised antibody.

The applicant (The University of British Columbia) requested a hearing after receiving a third adverse examination report for its patent application (No. 2015202689), which maintained objections raised under section 40 with respect to the requirements for clear enough and complete enough disclosure, support and best method of performance. The Examiner reserved his opinion on novelty and inventive step pending resolution of the section 40 issues. The applicant submitted a declaration from the inventor, Dr Marotta, during prosecution. This declaration proved to be very useful for the hearing and was closely considered by the Delegate, as detailed below.   

Issues and findings

The Delegate (Dr Stephen Barker, the Deputy Commissioner of Patents) considered the following section 40 issues:

a)   Section 40(2)(a) – enablement
b)   Section 40(3) – support
c)   Section 40(2)(aa) – best method

In relation to the first issue, enablement, the Delegate cited the approach taken in the earlier Patent Office decision Evolva SA [2017] APO 57 (Evolva), which confirmed that enablement of a claim should be determined according to a 2-step approach involving “plausibility” and “undue burden”. The Delegate stated that the Evolva decision “sets out a proper understanding of the law” (emphasis added) and noted at [7] the guidance in Evolva as to relevant factors for enablement:   

“EP and UK decisions have provided some general guidance on factors that come into consideration, including: uncertainty and a lack of predictability, incomplete experimental details and a lack of guidance in the specification including instructions on how to proceed in case of failure.”

Turning to the question of “plausibility” the Delegate further cited Evolva at [43]:

“the scope of the monopoly, as defined in the claims, must correspond to the technical contribution the patentee has made to the art. If the assertions made in the specification are not plausible then it cannot be reasonably said that the patentee has made a contribution to the art.”

and at [44]:

“an invention that is plausible may still fail on sufficiency if the specification essentially sets out a research programme and there is an undue burden of experimentation required to put it into practice. If an invention is implausible then it would inherently require an undue burden of experimentation to put it into practice (if at all).”

Applying the approach from Evolva and on the basis of Dr Marotta’s declaration, the Delegate was satisfied that the specification provided a general method of producing hybridomas and sufficient description of how to distinguish hybridomas that produce the desired antibodies. He accepted that the required testing is routine in the art and is not onerous.

As to the second issue, support, the Commissioner cited CSR Building Products Limited v United States Gypsum Company [2015] APO 72 (CSR), which suggested that to meet the (relatively) new Australian requirement of support, the claims should correspond to the technical contribution to the art. The Delegate referred to the indication in CSR at [113] that:

“An important question will often be whether the technical contribution to the art is a general principle or the specific examples in the specification.”

The Delegate found that both the specification and information provided by Dr Marotta indicated that the technical contribution was the use of select epitopes to produce antibodies selective to the eta isoform. Accordingly, the Commissioner decided there was a principle of general application and thus the claims, although broader than the examples disclosed in the specification, were supported.    

For the final issue, best method, which is not a major consideration in jurisdictions outside of Australia (i.e. Europe and the US), the Commissioner referred to Kineta, Inc [2017] APO 45 (Kineta) at [18]:

“it is necessary to determine what method is disclosed in the specification, and then to ask whether there is any evidence that the applicant was aware of a better method of performing the invention.”

The Delegate explained at [21] that the specification identified four immunogens and their use in preparing hybridomas for producing the antibodies of interest, and that there was no evidence that the applicant was aware of a better method.

The objections raised under section 40 were therefore all overruled by the Delegate. However, the application will now undergo examination for novelty and inventive step. The deadline for acceptance is 3 months post the date of the hearing and may be extended upon request by the applicant at the discretion of the Commissioner.  

Implications

This recent decision highlights some of the leading Patent Office decisions in Australia regarding enablement (Evolva), support (CSR) and best method (Kineta). While assessment of these requirements will continue to be required on a case-by-case basis, the findings here shed further light on how the Australian Patent Office is likely to assess section 40 provisions, particularly given the limited guidance provided by Australian courts on the “raised bar” requirements of sufficiency and support.   

When drafting specifications in the areas of biotechnology and pharmaceuticals intended for prosecution in Australia, it is important that inventors provide, and attorneys must include, not only as much detail as possible on the experimental methods for producing, evaluating and testing but also the best method known to perform the claimed invention. 

The decision is also a good reminder that a declaration from the inventor (in some cases more preferably from an independent expert) can assist in showing that a skilled person can perform the claimed invention on the basis of the disclosure in the specification. Further, the ability to request a hearing is worth considering to address an Examiner’s maintenance of objections in Australia. This effectively “stops the clock” on the acceptance deadline and provides an opportunity for the matter to be heard by a hearing officer who may take a different view to the primary and/or supervisory Examiner.