Life Sciences and Pharma IP Litigation 2025

AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks

Saved by an obvious mistake – ToolGen’s patent amendments The decision in ToolGen Incorporated v Fisher (No 3) [2024] FCA 539 serves as a useful remind - er of the ability to amend patent claims to correct an “obvious mistake”, even where the effect is to broaden the claims. Justice Nicholas had previously held that each of the claims of ToolGen’s patent application would, if granted, be invalid. ToolGen sought leave to amend the claims of the patent appli - cation pursuant to s 105(1A) of the Patents Act 1990 (Cth) (the “Patents Act”). ToolGen sought solace in s 102(3)(a) of the Pat - ents Act, arguing that claims 10 and 19 when read together contain an “obvious mistake”. Section 102(3)(a) provides that where an amend - ment is to correct a clerical error or an obvious mistake, the requirements in s 102 regarding the allowability of amendments do not apply. The claims of a patent serve to give the public notice of the limits of the monopoly. Because amendments are retrospective, amendments which broaden the claims are not allowed – they would turn earlier non-infringing activities into acts of infringement. The narrow exceptions to this rule are amendments for the purpose of cor - recting a clerical error or obvious mistake. The theory is that an obvious mistake cannot have misled a person skilled in the art. Justice Nicholas considered the principles rel - evant to what constitutes an obvious mistake, including: • both the error itself and the necessary correc - tion must be obvious to the person skilled in the art;

• “mistake” is a failure to express the real inten - tion of the writer of the specification; • the correction required does not cease to be “obvious” because there is more than one way of expressing it; and • it is not an obvious mistake if extraneous evidence, beyond what is required to put the court in the position of a person skilled in the art, is needed to show the mistake. Justice Nicholas considered that the skilled per - son would understand there to be a mistake in the “composite claim” (ie, claim 10 when read with claim 19) and that the relevant correction of the mistake was one which would be obvious to the person skilled in the art. His Honour consid - ered that the skilled person would clearly under - stand from reading the specification that the various embodiments of the system described included embodiments in which the guide RNA was created in vitro before introduction into the cell, as well as embodiments in which nucleic acid encoding the guide RNA was introduced into the cell where the guide RNA was subse - quently transcribed. His Honour further consid - ered that the skilled person would understand that claim 10 was directed at embodiments in which the guide RNA was produced in vivo and that claim 19 was directed at embodiments in which the guide RNA was an in vitro-transcribed RNA. The relevant correction would, therefore, involve re-writing the composite claim to eliminate the inconsistency in language between claims 10 and 19 so that, rather than referring to nucleic acid encoding a guide RNA, the composite claim instead referred to an in vitro-transcribed guide RNA. The result was that claim 10 would con - tinue to include use of a guide RNA produced in vivo and the composite claim would include use of a guide RNA produced in vitro.

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