Enablement and support in Australian Patents and the role of post-filing experimental data.

BY: HEDIE MEKA PhD

The ramifications of the increased stringency for enablement and support in Australian patents that were brought into force by the Raising the Bar Act [2013] (‘RTB’) continue to be felt by applicants. Heretofore, the role of post-filing experimental data as part of a defence to an allegation of lack of enablement and support since enactment of the RTB had not been considered. The Australian Patent Office (‘APO’) decision in BASF Corporation [2019] APO 34 provides a first guidance on this point.

As a reminder, the RTB amendments to s40 intend to align the requirements of enablement and support in Australian patents to those of overseas jurisdictions, and more particularly, the UK and Europe. Briefly, s40(2)(a) requires that the claimed invention be described in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art. This requires that the specification provides sufficient information to enable the skilled person to perform the invention across the scope of the claims without undue burden or the need for further invention. S40(3) requires that the claims must be supported by matter disclosed in the specification.

At the time of the present decision and indeed subsequent to the decision, there is no material judicial guidance for interpreting s40(2)(a) and s40(3) as amended under the RTB. Even though it was the intention of the legislators to adopt UK and European case law for the consideration of enablement and support in Australian patents, it remains to be seen how the Courts will interpret the wishes of the legislators. In the interim, examination practice at the APO relating to enablement and support in Australian patents is influenced by their interpretation of corresponding UK and European legislation and jurisprudence.

The present decision relates to Australian application numbers 2017204400 and 2017204506 in the name of BASF. For each application, multiple examination reports issued (up to five for 2017204506). s40 objections to enablement and support were maintained by the Examiner. The Applicant sought to be heard in relation to the outstanding objections to both applications.

AU2017204400 broadly relates to synergistic mixtures of Bacillus subtilis MBI600 and a second compound selected from a wide range of fungicidal or insecticidal compounds and plant growth regulators.

AU2017204506 broadly relates to synergistic mixtures of Bacillus pumilus INR7 and a second compound selected from a wide range of fungicidal or insecticidal compounds and plant growth regulators, or Bacillus subtilis MBI600.

The respective claims were narrowed significantly during examination. The Examples section of each specification provided very limited experimental data of synergistic mixtures, none of which were presently claimed. The specifications describe a number of exemplary strategies by which synergy may be assessed.

The similarity of the inventions as disclosed resulted in similar s40 enablement and support objections by the Examiner. In a nutshell, the Examiner considered that s40(2)(a) relating to enablement is not fulfilled since each specification is speculative and merely asserts that synergy is present in many thousands of combinations selected from quite long lists of compounds with no experimental data to back up the claims of synergy. Consequently, the Examiner asserted the plausibility standard is not met pursuant to the APO decision set down in Evolva SA [2017] APO 57. The Evolva decision adopts the UK test for s40(2)(a) enablement as set out in Warner-Lambert Company LLC v Generics (UK) Limited (t/a Mylan) and ors [2018] UKSC 56, and is reproduced below:

Does the specification provide an enabling disclosure of all the things that fall within the scope of the claims, and in particular:

  • 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?

The undue burden standard was not in contention as the claims were narrowed during prosecution. The issue of plausibility remained in contention despite the limitation to the claims. During examination, the Applicant provided post-filing experimental data demonstrating synergistic activity of some of the claimed mixtures. This data was not present in the specification as filed. Relying upon the UK Warner-Lambert decision, the Examiner rejected consideration of the post-filing data on the basis that sufficiency of disclosure must be satisfied at the effective date of the patent. Warner-Lambert went on further to state that acknowledging sufficiency using post-filing experimental data “would lead to granting a patent for a technical teaching which was achieved, and, thus, for an invention which was made, at a date later than the effective date of the patent.

In light of the Examiner’s view that each specification is speculative and without a cogent technical theory supporting broad applicability of synergy at the filing date, the post-filing experimental data of synergy cannot be relied upon to support the sufficiency of the specification. The Examiner seemed to accept that common general knowledge and a coherent technical theory can provide some plausibility that an invention can work across the full scope and thus avoid the need for experimental data.

In contrast to the Examiner, the Delegate determined that post-filing experimental data does have a role in s40 issues. The Delegate referred to the following passage from Warner-Lambert:

This does not mean that subsequent data is never admissible in a dispute about sufficiency, but the purpose for which it is admitted is strictly limited. Where the asserted therapeutic effect is plausible in the light of the disclosure in the patent, subsequent data may sometimes be admissible either to confirm that or else to refute a challenger’s contention that it does not actually work … it cannot be a substitute for sufficient disclosure in the specification. (emphasis added)

Accordingly, post-filing experimental data per se cannot render an insufficient specification as sufficient.

BASF submitted that the post-filing experimental data supplemented the evidence contained in the specifications and refuted the contentions of the Examiner regarding the unpredictability of synergy, and was thus admissable.

A declaration by one of the inventors, Dr Liebmann, was submitted prior to the hearing. Dr Liebmann declared that the observation in the specification of synergy between a particular Bacillus and a chemical pesticide having a given mechanism of action makes it more or less likely that synergy will be observed with a different chemical pesticide with a different mechanism of action. Furthermore, this understanding derived from the specification by a person of skill in the art as of the filling date is confirmed by the post-filing experimental data. Accordingly, the Delegate accepted that in the face of declaratory evidence and the absence of contradictory evidence, the claimed synergy is not “entirely unpredictable” (as was the Examiner’s position). The specifications were found to comply with the enablement and support requirements of s40.

This case demonstrates that post-filing experimental data has a role in addressing s40 issues, provided that the data is confirmatory in nature or provides evidence to refute an alleger’s contention that the invention does not work. The case also underscores the persuasive role that an expert declaration can play, particularly once consideration of the case on its merits moves from the Examiner. As a footnote, with the exception of a manner of manufacture objection for a kit claim, all of the Examiner’s outstanding objections (novelty, inventive step, s40(2)(a) and s40(3)) were overturned by the Delegate. Once again, this case is a reminder of the power of requesting a hearing in the face of stubborn examination.