How to use post-filing experimental data to help establish sufficiency and support

The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 was introduced in Australia with the intention of aligning Australia’s written description requirements with those in the UK and Europe. Under the new Act, a specification must 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 (section 40(2)(a)) and the claims must be supported by the matter disclosed in the specification (section 40(3)).

 

In some cases, patent applicants can submit data not included in the specification as filed (so called post-filing data) in an effort to overcome section 40 objections. But there are currently no guidelines in Australia’s Patent Manual of Practice and Procedure concerning the use of post-filing data.  A recent decision in BASF Corporation [2019] APO 34 confirms that post-filing data can assist in overcoming section 40 objections provided the data is confirmatory in nature.

 

Background

The decision in BASF relates to two patent applications – Application No. 2017204400 (the 400 application) and Application No. 2017204506 (the 506 application) – filed by BASF Corporation (the Applicant).  The 400 application relates to synergistic mixtures of Bacillus subtilis MBI600 and a second compound selected from a range of fungicidal or insecticidal compounds and plant growth regulators. The 506 application 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 applications describe several strategies by which synergy may be assessed and disclose data demonstrating synergistic mixtures, none of which were claimed.

The issues and findings  

In maintaining support and sufficiency objections against both applications, the Examiner adopted the two-step enquiry set out in Evolva SA [2017] APO 57:

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 Examiner was satisfied that there would be no undue burden for the skilled person to perform the claimed invention as the claims were substantially narrowed during prosecution. However, the Examiner alleged that the applications failed the plausibility test (step (a)). In response, the Applicant submitted post-filing experimental data showing synergistic activity of some of the claimed mixtures. This was rejected by the Examiner who alleged that the specifications were speculative, and in the absence of a principal of general application supporting broad applicability of synergy at the filing date, the post-filing evidence of synergy cannot be used to demonstrate sufficiency (and support) of the specifications. The Examiner referred to the UK Supreme Court judgement in Warner-Lambert v Generics & Anr [2018] UKSC 56 (Warner-Lambert; previously reported here) which states (emphasis added):

“Sufficiency of disclosure must be satisfied at the effective date of the patent, ie on the basis of the information in the patent application together with the common general knowledge then available to the skilled person. Acknowledging sufficiency of disclosure on the basis of relevant technical information produced only after this date 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…”

The Applicant requested the matter be heard by the Patent Office. With regard to the role of post-filing data, the Delegate noted the absence of authority on this issue and observed “This is a matter which has not received attention following the implementation of the Raising the Bar Act, and so, in accordance with the guidance in the Explanatory Memorandum, I will have regard to UK and European case law as to the role of such evidence in relation to questions of support and sufficiency.”

Turning then to UK authorities, the Delegate cited Lord Sumption in Warner-Lambert at [72]:

“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.”

The Applicant argued that the post-filing evidence submitted in this case: 1) supplemented the evidence contained in the specifications; and 2) refuted the contentions of the Examiner regarding the unpredictability of synergy. The Applicant submitted declaratory evidence from an inventor attesting that the disclosure in the specifications 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. Accepting the Applicant’s evidence, the Delegate found that the post-filing data confirmed the expectation of the skilled person having regard to the specification as filed and the common general knowledge as at the filing date.  Accordingly, the claims were found to be fully supported and sufficiently enabled by the specification as filed.

Implications

This decision confirms that post-filing experimental data can help establish sufficiency and support provided the data confirms the information disclosed in the specification as understood by a skilled person in the art.  In our experience, post-filing data can be, and has been, persuasive in overcoming written description objections.