A recent decision in the Federal Court, Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH  FCA 328 (13 March 2020), has highlighted the difficulties encountered when trying to make post-acceptance amendments to correct deficiencies in the claims or specification of a patent in Australia. In particular, care must be taken to ensure that there is contextual support in the specification as filed for the proposed amendment to avoid it being deemed as an ‘impermissible intermediate generalisation’.
An ’intermediate generalisation’ may occur when a feature is disclosed in the context of a specific embodiment in the specification and is then introduced into a claim in circumstances which strip it of the context of the embodiment. While the feature may be clearly and unambiguously disclosed in the specification in combination with companion features, the introduction of the feature souls (i.e. in the absence of the companion features or context of the embodiment) will constitute “added subject matter”.
Under s 102(1), a post-acceptance amendment is not allowable if as a result of the amendment, the specification would claim or disclose matter that extends beyond that disclosed in the complete specification as filed and any other prescribed documents, when taken together.
BASF Plant Science GmbH (‘BASF’) requested amendments to the specification and claims of its accepted application during opposition proceedings. CSIRO opposed the amendments but they were initially found to be allowable by IP Australia. CSIRO subsequently appealed the decision to the Federal Court.
The decision largely turned on the fact that the specification as filed included a statement which referred to the invention as a combination of the following features:
- A CoA-dependent delta-6-desaturase having the substrate specificity of the delta-6-desaturase shown in SEQ ID No:14
- The above CoA-dependent delta-6-desaturase which has a preference for conversion of alpha linolenic acid compared to linoleic acid.
During prosecution of BASF’s application, claim 1 was amended to define a group of homologous desaturases having “at least 75% identity to a nucleotide sequence which codes for a polypeptide as shown in SEQ ID NO:14”. Claim 1 consequently encompassed a broader group of desaturases which had been disclosed in the specification as filed.
When subsequently requesting its post-acceptance amendments, BASF relied on the second clause of the statement above to introduce two dependant claims which defined that the desaturase homologues (i.e. having at least 75% identity of the desaturase shown in SEQ ID No: 14) “preferentially converts alpha-linoleic acid compared to linoleic acid”.
Beach J found that the proposed amendments were an impermissible intermediate generalisation because the specification as filed did not clearly and unambiguously disclose that the desaturase homologues had the same conversion preferences. Notably, the only place in the specification of the application as filed where the ability of the desaturase to preferentially convert alpha linolenic acid was disclosed, was the above statement and this ‘preferential conversion’ feature was disclosed in the context of being an attribute of one specific desaturase, not clearly attributable to the broader group of desaturases.
CSIRO’s appeal was successful and BASF’s proposed amendments were disallowed.
Test for Added Matter
This decision shifts the Australian position closer to the United Kingdom’s approach to ‘added subject matter’. Beach J has provided guidelines as to how to apply s 102(1), noting that the test is a strict one.
Firstly, the subject matter must be clearly and unambiguously disclosed in the application as filed.
Secondly, although the required disclosure may be express or implied, it must still be clearly and unambiguously disclosed. Subject matter which would have been obvious to the skilled person is not permitted.
Thirdly, one cannot extract features disclosed in one context and introduce them into a specification stripped of that context, otherwise the proposed amendment is no more than an impermissible intermediate generalisation.
Other Takeaways for Patent Holders
It has always been beneficial to include several examples in a patent specification to comply with best method and sufficiency requirements. But it may also be prudent to ‘deconstruct’ examples at the outset, during the drafting process, to ensure that particular features inherent in the examples find support in their own right within the specification in the absence of association with companion features.
For example, if an example includes a combination of features A+B+C, then the specification should ideally describe features A, B and C in their own right and discuss the technical function which they contribute to the invention. Similarly, it is preferable to ensure that various combinations of features found in the examples (e.g. A+B, A+C, B+C) are clearly and unambiguously disclosed as well as the technical significance of these combinations.
Patent specifications also need to be carefully reviewed prior to filing to identify and address statements which have the potential to come back to haunt the patentee when it later wishes to propose amendments. If the lone statement in BASF’s specification could have been expanded upon in the description to unambiguously disclose that the broader group of desaturase homologues also included the ‘preferential conversion’ attribute, BASF’s proposed amendment would have been unlikely to have been considered as an impermissible intermediate generalisation.
Unfortunately, the widespread practice of amending consistory clauses to mirror claim amendments or the removal of offending object statements during prosecution will not necessarily remedy potential vulnerabilities in the specification because it is the application as filed which will be used as the comparator when requesting post-acceptance amendments.
Other Takeaways for Patent Litigators
This is another in a long line of Australian cases where the Achilles heel has been the inability of the patent owner to make post-acceptance amendments to correct defects in the claims and specification. Parties engaged in opposition or litigation would be prudent to complete an analysis of the specification as filed and apply the test provided by Beach J to any proposed claim amendments.