What you need to know
- The 2013 Raising the Bar reforms to Australian patent law were intended to strengthen the statutory prohibition on amendments that introduce new material into patent specifications.
- Justice Beach of the Federal Court has provided the first judicial consideration of the test for added matter post- Raising the Bar, drawing guidance from authorities in the UK and Europe.
What you need to do
- It is important to provide a full disclosure of your invention at the time your patent application is filed, due to the prohibition on introducing new material at a later stage.
- Ensure that your patent application discloses your invention in terms that encompass all variants of the invention that you may later wish to claim.
The prohibition on added matter in patent amendments
In this case, Justice Beach of the Federal Court of Australia has provided the first judicial consideration of the prohibition on added matter under s 102(1) of the Patents Act 1990 (Cth), as amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth).
Section 102(1) provides that an amendment will not be allowed if the proposed amended specification would "claim or disclose matter that extends beyond that disclosed in the … specification as filed". This involves examining what is disclosed by the patent application as filed from the perspective of a skilled addressee, and considering whether the proposed amended specification would claim or disclose additional matter.
BASF's patent for plant-derived fish oil
BASF Plant Sciences GmbH (BASF) filed the patent application in this case. It relates to the production of polyunsaturated fatty acids (PUFAs) in plants.
At the heart of the claimed invention is a pathway for the synthesis of long-chain PUFAs, such as the omega-3 fatty acids found in fish oil. The pathway involves a sequence of enzymatic reactions to convert shorter-chain PUFAs into commercially desirable long-chain PUFAs. The two main types of reactions in the pathway are desaturation, undertaken by enzymes known as desaturases, and elongation, undertaken by enzymes known as elongases.
The claimed invention relates to isolating the genes for those enzymes in a species of microalgae, Ostreococcus lucimarinus, and introducing those genes into suitable oil-producing crops such as oilseed rape and sunflower. Performing the invention enables the production of the valuable fatty acids in transgenic commercial crops, essentially "growing fish oil on land".
After BASF's patent application was accepted, BASF applied to amend it and introduce new dependent claims. One may speculate that BASF's amendments were seeking to overcome a potential validity attack.
CSIRO unsuccessfully opposed BASF's amendments at the Australian Patent Office, and then appealed to the Federal Court.
Aligning Australia's new added matter test with the UK
Justice Beach observed that the Raising the Bar amendments to s 102(1) were intended to align Australia with the approach taken in the UK and Europe.
Justice Beach drew guidance from UK case law on the equivalent UK provision, s 76(2) of the Patents Act 1977 (UK). His Honour approved the judgment of Justice Kitchin (as he then was) in European Central Bank v Document Security Systems Inc [2007] EWHC 600 (Pat). In that case, Justice Kitchin held that the test for added matter was strict, and that subject matter will be impermissibly added "unless it is clearly and unambiguously disclosed in the application as filed".
Justice Beach also approved UK authority prohibiting "intermediate generalisations". An intermediate generalisation involves taking a feature that is only disclosed in a patent specification in one particular context (e.g. a particular example), stripping it of that context, and introducing it into a more general claim. In order to avoid a finding of added matter, it must be apparent to the skilled addressee that the feature is generally applicable to the claimed invention.
Justice Beach queried whether there was indeed much difference between the pre- and post- Raising the Bar tests for added matter in Australia. While declining to engage with that question, his Honour said that "if there is a difference in scope, then the distinction may be subtle".
Application of the law to this case
A particular paragraph of BASF's patent application as filed, which is described in the judgment as the "bridging paragraph", disclosed that the invention is directed to a particular enzyme, being a Δ6 ("delta-6") desaturase, with two relevant features:
- Feature A: Substrate specificity. It has the ability to bind to and convert a range of fatty acid substrates, being those substrates that are converted by the particular Δ6 desaturase from the microalgae Ostreococcus lucimarinus.
- Feature B: Conversion preference. It preferentially binds to and converts a particular fatty acid (alpha linolenic acid, or ALA) over another fatty acid (linoleic acid, or LA).
BASF's amendments sought to introduce new dependent claims that required the Δ6 desaturase to have Feature B, but not Feature A as well. In place of Feature A, the new dependent claims required the Δ6 desaturase to have at least 75% homology at the DNA level to the particular Δ6 desaturase from Ostreococcus lucimarinus.
Justice Beach considered that the bridging paragraph did not provide a clear and unambiguous disclosure of a Δ6 desaturase with Feature B in the absence of Feature A. Instead, the bridging paragraph disclosed a Δ6 desaturase with Feature B in conjunction with Feature A.
Justice Beach also considered that Feature A could not be equated with the 75% homology requirement that BASF sought to introduce into the claims. This was because two enzymes can have different substrate specificities and still have 75% homology to each other at the DNA level.
Justice Beach concluded that BASF's amendment sought to remove Feature B from the context in which it was disclosed in the application as filed (namely, in conjunction with Feature A). This was an example of an impermissible intermediate generalisation.
As a result, BASF's amendment was refused and CSIRO's appeal was upheld.
Expert evidence
Like many patent disputes, the decision in this case turned closely on the construction of the specification. BASF ultimately failed because it could not establish that the "bridging paragraph" would be read in a particular way.
In part, this was due to Justice Beach's preference for the evidence of CSIRO's expert, Dr Singh. Justice Beach was not critical of BASF's expert, Dr Stalker, but did conclude that Dr Singh had "the slight edge in terms of depth of detail on the precise questions". This was despite the fact that Dr Stalker has over 45 years of experience in molecular biology, including researching and commercialising genetically engineered plants.
The construction of the specification is, however, ultimately a question for the court and Justice Beach emphasised that expert evidence plays only a limited role.
Authors: Stuart D'Aloisio, Partner; Tim Rankin, Lawyer; and Elizabeth Arms, Lawyer.
