Catchwords: PATENTS – opposition to the grant of a patent under s59 – grounds of novelty, inventive step, clear enough and complete enough disclosure, support and utility – reg 5.23 request refused – lack of novelty and inventive step not established – lack of clear enough and complete enough disclosure and support – claims do not lack utility – costs awarded against applicant.

Representation: Counsel for the applicant: Patrick Flynn
Patent attorney for the applicant: Douglas Horton of Spruson & Ferguson and Andrew Rankine of Spruson & Ferguson Lawyers
Patent attorney for the opponent: Declan McKeveney and Patrick McManamny of FB Rice

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE

Patent Application: 2020202755

Title:Delivery of mRNA for the augmentation of proteins and enzymes in human genetic diseases

Patent Applicant: Translate Bio, Inc.
Date of Decision: 18 February 2025
DECISION

The opposed application lacks clear enough and complete enough disclosure as well as support for all claims.
Translate Bio, Inc. is allowed a period of two months from the date of this decision to propose amendments to overcome this deficiency.
I award costs according to Schedule 8 against Translate Bio, Inc.
REASONS FOR DECISION

Background

Australian patent application 2020202755 (the opposed application) was filed by Shire Human Genetic Therapies (Shire) on 24 April 2020. It is a divisional of 2018203895 (the parent application), which in turn is a divisional of 2016250459, itself a divisional of 2014250713 and the original application is 2010326132, filed on 30 November 2010, claiming priority from US 61/265653 (the priority document) filed on 1 December 2009. The priority claim was challenged and will be discussed below. While nothing turns on this point, all earlier applications have been granted without opposition and 2023201438 has been filed as a further divisional application from the opposed application.
The opposed application was accepted on 21 November 2022 with the notice of acceptance advertised on 8 December 2022. Shire proposed post-acceptance amendments to the specification on 23 December 2022 to correct typographical errors. The amendment was advertised on 19 January 2023 and formally allowed on 27 March 2023.
A notice of opposition to the grant of the opposed application under section 59 of the Patents Act 1990 (the Act) was filed by Kings Patent & Trade Marks Attorneys Pty Ltd on 8 March 2023. The opponent was amended to JLTF Holdings Pty Ltd (JLTF Holdings) on 6 June 2023. A statement of grounds and particulars was filed by JLTF Holdings on 8 June 2023, identifying the following grounds of opposition: entitlement, manner of manufacture, novelty, inventive step, utility, clear enough and complete enough disclosure, best method, support and clarity. JLTF Holdings then filed the…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

Continue reading Seqirus, Inc. v Translate Bio, Inc

Details

AGLC: Seqirus, Inc. v Translate Bio, Inc [2025] APO 5
Case: [2025] APO 5
Decision Date: 18 February 2025

CaseChat Overview and Summary

This case concerned an opposition to the grant of an Australian patent application 2020202755 filed by Translate Bio, Inc. Seqirus, Inc. (the opponent) opposed the grant of the application on several grounds. The opposition was heard by M. Umehara, a delegate of the Commissioner of Patents. The delegate found that the opposition was successful on the grounds of lack of clear enough and complete enough disclosure as well as support for all claims. The applicant was granted a period of two months from the date of this decision to propose amendments to overcome this deficiency. Costs were awarded to the opponent in accordance with Schedule 8.

Orders