Ten Years of Raising the Bar – To be or not to be: an intermediate generalisation

According to section 102(1) of the Patents Act 1990 (Cth) as amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth), an Australian patent specification may not be amended in such a way that it contains subject matter which extends beyond the content of the application as filed.

The Federal Court of Australia in Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH [2020] FCA 328 (CSIRO v BASF) clarified that when assessing added subject matter according to section 102(1) post the RTB Act, the claimed subject matter must be directly and unambiguously derivable from the application as filed.

The required disclosure may be express or implied. However, matter added by way of an intermediate generalisation – where a feature(s) disclosed in one context is introduced into the specification stripped of that context – is not permitted.


The case law

The claims in CSIRO v BASF related to a process for the production of polyunsaturated fatty acids in plants that involves expression of various destaurases and elongases, including a Δ6-desaturase isolated from Ostreococcus lucimarinus having a sequence shown in SEQ ID NO:14.

The application as filed defined the invention as follows:

The invention, the subject of the present application, is directed to the following:

  • a CoA-dependent delta-6 desaturase having the substrate specificity of the delta-6 desaturase shown in SEQ ID NO:14 (feature A), and
  • the above CoA-dependent delta-6 desaturase which has a preference for conversion of alpha linolenic acid compared to linoleic acid (feature B).” (emphasis added).


BASF amended the claims during opposition proceedings to define the CoA-dependent Δ6 desaturase as:

–      having at least 75% identity to a nucleotide sequence which codes for a polypeptide as shown in SEQ ID NO: 14 (feature C); and

–      that preferentially converts alpha linolenic acid compared to linoleic acid (feature B).

The trial judge considered that the specification as filed only disclosed a Δ6-desaturase which has the ALA conversion preference (feature B) in the context of the Δ6-desaturase also having “the substrate specificity” feature of the Δ6-desaturase shown in SEQ ID NO: 14 (feature A).

As such, whether the amendment added subject matter depended on what is meant by “substrate specificity” of the Δ6-desaturase shown in SEQ ID NO: 14. That is, whether the % identity definition of the CoA-dependent Δ6-desaturase (feature C) equates with a CoA-dependent Δ6-desaturase having the substrate specificity of the Δ6-desaturase shown in SEQ ID NO:14 (feature A).

Based on the evidence, the trial judge considered that feature C is not coterminous with the required substrate specificity (feature A) and, as such, concluded that BASF impermissibly sought to strip the conversion preference (feature B) from the context in which it is disclosed in the application as filed. The amendment therefore constituted an impermissible intermediate generalisation of the originally disclosed information that introduced matter that extended beyond that disclosed in the specification as filed and hence was not allowable under section 102(1) of the Act as it now stands.


What does this mean?

Most patent claims are generalisations from one or more particular embodiments of an invention because it is unlikely that every possible way of carrying out the invention has been developed at the time of filing a patent application. It is our job as patent attorneys to generalise the invention in the language of the claims, considering the prior art known at the time, so that the patent application gives the applicant a fair scope of protection to allow them to continue to develop their invention and/or to keep competitors out of the field.

Subject matter may be inadvertently added to an application during prosecution and opposition proceedings where new prior art objections give rise to amendments to the claims so as to provide a useful scope of protection but distinguish the claimed invention from the newly cited art.  

To avoid added matter problems, it is important at the drafting stage to make it clear which features of the invention are optional and what the alternative features might be. Where features are presented as specific to an embodiment, it can be useful to explain how such features can be generalised to work with other embodiments.

Regardless of the care taken at the drafting stage or when amending the claims during prosecution/opposition proceedings, we expect to continue to see an increase in the number of added matter attacks raised by opponents during opposition proceedings. Applicants may therefore want to make only minimal amendments to the claims to deal with specific objections raised by the Examiner during prosecution. Where possible, amendments based on dependent claims rather than the description, drawings, or examples are to be preferred.

Amendments made after grant must also comply with section 102(1). However, it is important to note that once a patent is granted, it is not possible to object to an amendment made during prosecution or opposition based solely on added matter as it is not a standalone ground for revocation in Australia.

BSc(Hons) Phd MIPLaw

Danielle has extensive experience as a patent attorney with expertise in patent strategy, protection and enforcement in the Biotech sector.  She has a strong understanding of global patent and regulatory exclusivities (including data and market exclusivities) and has facilitated entry of several biopharmaceuticals (including antibodies and antisense molecules), diagnostics, cellular therapeutics, and agricultural products (including transgenic plants) to market.