Trimming the fat from impermissible patent amendments

Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH [2020] FCA 328

(12 March 2020)

http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/cth/FCA/2020/328.html

Patents – amendment – appeal from Commissioner’s decision – whether specification as amended would claim or disclose matter that extends beyond the specification as filed – section 102(1) post Raising The Bar

BASF sought, and obtained from the Commissioner of Patents, amendment of its patent application titled “Process for the production of polyunsaturated fatty acids in transgenic organisms”. CSIRO opposed the amendment and failed. It appealed that decision, which appeal was heard and allowed by Justice Beach: Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH [2020] FCA 328. The primary question was whether, as CSIRO contended, the amendments were not allowable pursuant to s 102(1) of the Patents Act 1990 (Cth) because “as a result of the amendment, the specification would claim or disclose matter that extends beyond that disclosed in” the complete specification as filed.

A question posed in the proceeding was whether s 102(1) is now stricter than it was prior to the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth). Beach J observed that he did not propose to “indulge in any disquisition concerning the differences, if any between the scope of the old s 102(1) and the new s 102(1). As a trial judge that is not my task. And to do so runs the risk of getting lost in some jurisprudential twilight zone outside the dimensions of the documents and the science that I need to consider”.

Suffice to say that Beach J did conclude that the test under the present s 102(1) was a strict one and that the UK authorities on the equivalent provision there provided suitable guidance. The principles that His Honour identified were as follows. First, “subject matter will be impermissibly added unless the matter is clearly and unambiguously disclosed in the application as filed”. Second, “the required disclosure may be express or implied, but on any view must be clearly and unambiguously so. In this regard, a patent applicant is not permitted to add by amendment matter simply because it would have been obvious to the skilled person.” Thirdly, “context is important. A patent applicant cannot extract features disclosed in one context and introduce them into a specification stripped of that context. So, the concept of intermediate generalisation as discussed in the UK authorities applies to s 102(1) in its construction and application.”

As to “intermediate generalisations” his Honour apparently adopted the description Pumfrey J gave them in Palmaz’s European Patents (UK) [1998] EWHC Patents 350; [1999] RPC 47 at 71:

If the specification discloses distinct sub-classes of the overall inventive concept, then it should be possible to amend down to one or other of those sub-classes, whether or not they are presented as inventively distinct in the specification before amendment. The difficulty comes when it is sought to take features which are only disclosed in a particular context and which are not disclosed as having any inventive significance and introduce them into the claim deprived of that context. This is a process sometimes called ‘intermediate generalisation’.

The context which will make the amendment unlawful is often a “limitation” on the integer or other context that is missing when it is sought to be added by amendment without that limitation or other context. Therefore the taking of an integer, whose independent significance is nowhere disclosed, from an embodiment of the invention which includes other limiting features cannot be incorporated into the “inventive concept shorn of its original context”. That is not to say that only features expressly asserted as being inventive in the specification may be added to a claim by amendment. The question is whether the specification allows for the integer to be added to other embodiments without the limitations found in the context in which it is revealed in the specification as filed. Or put another way, would it be apparent to the skilled person that the integer has general applicability? Where the claim is to a combination, the question is whether the features now combined were disclosed as a combination in the application as filed.

Beach J observed that “intermediate generalisations” are really just a sub-set of impermissibly added subject matter. Accordingly, Beach J posed the relevant question as “whether the skilled person is being presented with any new information about the invention which is not directly and unambiguously apparent from the original disclosure” but noting that “even if a feature was suggested to be technically significant, an impermissible intermediate generalisation may take place if by the amendment the feature is used in a manner significantly different from its original context.”

After a comprehensive review of the scientific evidence and the specification as filed and amended, Beach J found that the specification as filed disclosed an invention to an enzyme (CoA-dependent Δ6-desaturase) that, first, must have a preference for converting a certain fatty acid over another (alpha-linolenic acid (ALA) over linoleic acid (LA)) and, secondly, also must have the same substrate specificity as the enzyme shown in a particular sequence identified in the specification (and not one with, say, 75% homology to the same). Furthermore, his Honour found that the term “substrate specificity” described precise specificity of the enzyme for certain substrates, not, as BASF contended, a broader specificity.

Turning then to the amendments, His Honour observed that certain claims as amended would claim an enzyme which must have 75% homology to the specified sequence (which, BASF accepted, was not the same as having the same substrate specificity of the enzyme shown in that sequence) and a preference for conversion of ALA compared to LA. His Honour found that this involved the impermissible addition of matter because the preferential conversion integer was stripped of its original context in the specification as filed (i.e. that the enzyme must also have “substrate specificity) and was added into a different context.

As an aside, the authors note that it is important to oppose amendments like this because, once made, the only recourse in respect of an amendment wrongly made is to assert a shift in priority date of the claim. However, the provisions relating to the priority date of an amended claim, quite remarkably, use a different, arguably much less strict test, than applies under s 102 of the Act. Section 114 of the Act, read with reg 3.14, only shifts the priority date to the date of amendment when the newly claimed invention is only disclosed in a manner that is clear enough and complete enough for the invention to be performed by a person skilled in the art as a result of the amendment. That is, for the purposes of determining the priority date of an amended claim, it does not matter if the amendment was wrongly made and the claimed invention involved added subject matter.

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