3d Dna Medical Background

Priority Entitlement in Australia: CRISPR Patent Update for Overseas Associates

The Australian Federal Court, in ToolGen Incorporated v Fisher (No 2) [2023] FCA 794, discussed priority claim as one of the major factors contributing to the patent applicant’s unsuccessful appeal. The Court found that the claims both lacked entitlement to the earliest priority date and lacked novelty and inventiveness. This decision reminds us of the importance that care is taken when drafting a provisional patent application. This article will focus on the priority date issue and whether a claim is entitled to the priority date.


3d Dna Medical Background

ToolGen’s Australian patent No. 2013335451 is an Australian national phase entry from PCT/KR2013/009488 which ultimately claims priority from three US provisional patent applications:

US Provisional Patent Application 61/717,324 filed 23 October 2012 (herein referred to as ‘P1’);

US Provisional Patent Application 61/803/599 filed 20 March 2013 (herein referred to as ‘P2’); and

US Provisional Patent Application 61/837,481 filed 20 June 2013 (herein referred to as ‘P3’).

ToolGen’s application related to CRISPR/Cas systems and the use of these systems to introduce a site-specific, double stranded break at a target nucleic acid sequence in a eukaryotic cell. The grant of the application was successfully opposed, with the Commissioner of Patents’ decision being appealed to the Australian Federal Court.  

As mentioned above, one of the key issues to this case was whether the claims were entitled to claim priority to the priority US provisional patent applications. For a claim to be entitled to claim priority from a priority document, it must be enabled and supported by the priority document. The priority date test in Australia is the same as the test for enablement and support (commonly referred to as external enablement and support). The requirements for enablement and support are discussed in Section 40(2)(a) and 40(3) of the Patents Act 1990 (Cth), respectively.

Section 40(2)(a) of the Patents Act 1990 (Cth) states that a complete specification must disclose the
invention in a manner which is clear enough and complete enough for the invention to be performed
by a person skilled in the relevant art. 

Section 40(3) of the Patents Act 1990 (Cth) states that the claims must be supported by the matter
disclosed in the specification.

In the present case, it was contended that the claims were not entitled to P1 because the priority document did not enable or support the claims of the patent. As a result of this, it was argued that the claims were only entitled to the priority date of P3 and that journal articles published between the filing of P1 and P3 were relevant to novelty and inventive step.

During the case, it was noted that P1 appeared to be a journal article that was submitted as a provisional patent application. There were no claims in the provisional patent application.

Ultimately, the Court found that P1 did not provide an enabling disclosure of the claimed invention. In this regard, the Court commented that P1 did not provide a clear enough or complete enough disclosure of the invention to be performed by the person skilled in the art. In this regard, it was found that there would be uncertainty as to whether the claimed invention would work across the full scope thereof, and that significant research would be required, and this would not be routine.

Whilst enablement and support have an overlapping requirement, it should be noted that providing an enabling disclosure does not necessarily mean that the same claims are supported thereby. In the present case, the Court found that P1 did not support the claimed invention for similar reasons.

Ultimately, the claims were found that they were not entitled to the priority date afforded by P1. As a result, the claims were only entitled to the priority date afforded by P3 and the intervening disclosures between these two provisional patent applications became relevant for novelty and inventive step.

Best Practice

The present case highlights the importance of ensuring that a priority document is prepared with care. As can be seen in the present case, there are significant ramifications in not carefully drafting a provisional patent application and subsequent disclosure. Furthermore, if there are any concerns regarding the provisional patent application then developments occurring after the filing thereof should be kept confidential until included in either a new provisional patent application or complete application.

If you have any questions regarding the present article or relating to a priority claim, then please do not hesitate to contact us.