ToolGen is a Korean company involved in the development of gene editing products and services.
In particular, ToolGen is focused on CRISPR/Cas technologies that allow DNA to be cut and edited with precision. The potential therapeutic implications of such technology are immense and there is a wealth of research and patent documents in the area.
ToolGen filed a CRISPR/Cas-related Patent Cooperation Treaty application, with national phase entry in Australian claiming priority from three provisional applications. The three priority applications and their filing dates are provided below.
⦁ P1: US Provisional Patent Application 61/717,324 filed 23 October 2012;
⦁ P2: US Provisional Patent Application 61/803/599 filed 20 March 2013; and
⦁ P3: US Provisional Patent Application 61/837,481 filed 20 June 2013.
ToolGen’s Australian application was granted and subsequently opposed. ToolGen then appealed the opposition decision to the Federal Court of Australia.
The Court considered several matters in their decision, however our focus in this article is the matter of sufficiency of disclosure required to claim priority.
Under Australian law, each claim is entitled to claim priority from an earlier application, provided the earlier application discloses the claimed invention in a manner that is clear enough, and complete enough for the invention to be performed by a person skilled in the relevant art.
Importantly, the priority date of a claim is of relevance when assessing the claim against the criteria of novelty and inventive step.
In the complete Australian application, independent claims 1 and 10 were directed to an invention comprising a Type II CRISPR/Cas system. Notably, Type II CRISPR-Cas includes several bacterial species suitable for deriving Cas.
The complete application relied on the priority dates P1-P3, with P1 being the earliest priority. P1 is a relatively short document; it does not include any claims and resembles a journal article to which an additional paragraph headed “Summary of the Invention” had been added.
P1 plainly disclosed a system for cleaving DNA using Cas derived from the bacteria S. pyogenes. P1 disclosed, in a general sense, the existence of Cas proteins derived from other bacterial species and the possibility that they may be used to mediate DNA cleavage in eukaryotic cells.
Notably, the possibility of using Cas proteins derived from other bacterial species was simply described as a possibility, without further discussion.
ToolGen argued that P1 disclosed a Cas derived from any bacterial species. The Court rejected that argument because they did not consider P1 to identify any principle of general application that would permit the skilled addressee to determine whether Cas proteins derived from any particular bacterial species might be suitable.
It was held that P1 did not disclose any such system either explicitly or implicitly. That is, the disclosure was not a disclosure enabling the person skilled in the art to perform the invention. The claims were therefore not entitled to the priority date of P1.
Because P1 could not be relied on for priority, ToolGen had to rely on their later priorities P2 and P3 which fully disclosed their invention.
However, there had been three journal articles published after the filing date of P1 but before the filing date of P3 which rendered ToolGen’s application neither novel nor inventive, accordingly, ToolGen’s patent was found to be invalid.
This case is a stark reminder to 1) ensure that provisional applications are drafted with both detailed general applications and detailed specific applications and 2) regularly update provisional applications if the invention is developed beyond what is initially disclosed.
Speak to the team at Kings today if you want to avoid a similar situation with your invention.
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