Seqirus Inc. v ModernaTX, Inc

Case [2025] APO 21


IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Seqirus Inc.  v ModernaTX, Inc. [2025] APO 21

Patent Application:             2017326423

Title:High purity RNA compositions and methods for preparation thereof

Patent Applicant:                ModernaTX, Inc.

Opponent:Seqirus Inc.

Delegate:M. Umehara

Decision Date:  4 July 2025

Hearing Date:  Written submissions completed on 7 April 2025

Catchwords:  PATENTS – opposition to the grant of a patent under s59 – no claims found to lack utility – novelty – citations do not disclose all features of the claims – inventive step – it would be a matter of routine to arrive at the claimed invention – clear enough and complete enough disclosure and support – technical contribution to the art does not extend to a general principle – opportunity to amend – costs awarded

Representation:                   Patent attorney for the applicant: RnB IP

Patent attorney for the opponent: FB Rice Pty Ltd

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:             2017326423

Title:High purity RNA compositions and methods for preparation thereof

Patent Applicant:                ModernaTX, Inc.

Date of Decision:                4 July 2025

DECISION

The opposition is successful on the grounds of inventive step, clear enough and complete enough disclosure and support with regard to claims 1-8 and 11-20 and fails on the grounds of clarity, utility and novelty.

I allow the applicant two (2) months from the date of this decision to file amendments to overcome the deficiencies identified in this decision.

I award costs according to Schedule 8 against the applicant, Moderna TX, Inc.

REASONS FOR DECISION

  1. Australian patent application no. 2017326423 (the opposed application) in the name of ModernaTX, Inc.  (the applicant) was filed under the provisions of the Patent Cooperation Treaty on 14 September 2017 and claims priority from US provisional patent application 62/394711 filed on 14 September 2016.  While nothing turns on this point, a divisional application, 2024200861 claiming priority from the opposed application was filed on 9 February 2024 and examination has commenced. 

  2. The acceptance of the opposed application was advertised on 9 November 2023.  Seqirus Inc.  (the opponent) filed a notice of opposition under section 59 of the Patents Act 1990 (the Act) on 9 February 2024.  A statement of grounds and particulars (SGP) was subsequently filed on 9 May 2024.  The SGP identified entitlement, manner of manufacture, novelty, inventive step, utility, sufficiency, clarity and support as grounds of opposition. 

  3. The evidence in support (EIS) was filed on 9 August 2024, consisting of a declaration by Professor Andre Gerber dated 8 August 2024 (Gerber) together with exhibits AG-1 to AG-13 and a declaration by Professor Thomas Preiss also dated 8 August 2024 (Preiss) together with exhibits TP-1 to TP-15.

  4. No evidence in answer was filed and the matter was set for hearing by written submissions.  The submissions were completed on 7 April 2025.  The opponent’s submissions in support pressed novelty, lack of inventive step, lack of clear enough and complete enough disclosure, lack of utility and lack of support. 

    Onus and standard of proof

  5. The opposed…

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Seqirus Inc. v ModernaTX, Inc [2025] APO 21
Case
[2025] APO 21
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CaseChat Overview and Summary

Seqirus Inc. brought an opposition against ModernaTX, Inc.'s application for a patent before the Federal Court of Australia. The dispute centred on whether ModernaTX's patent application should be granted, specifically whether certain claims were novel, inventive, and utility-compliant, and whether they were sufficiently disclosed and supported. The court was tasked with determining these issues under the relevant sections of the Patents Act 1990 (Cth).

The primary legal issues were whether the claims in ModernaTX's patent application were novel, inventive, and had utility, and if they were sufficiently disclosed and supported. The court considered whether the cited prior art disclosed all features of the claims and whether arriving at the claimed invention would have been a matter of routine. Additionally, the court examined whether the technical contribution of the patent did not extend to a general principle, and whether there was an opportunity to amend the claims.

The court found that the claims were not rendered lacking in utility, were novel as the prior art did not disclose all their features, and were not obvious as it would not have been a matter of routine to arrive at the claimed invention. The claims were also found to be sufficiently disclosed and supported. The court rejected the argument that the technical contribution of the patent extended to a general principle. The court found that there was an opportunity to amend the claims, but it was not necessary to do so. The court awarded costs to Seqirus Inc.

The Federal Court of Australia dismissed the opposition and granted the patent to ModernaTX, Inc. The court ordered Seqirus Inc. to pay the costs of the proceeding. The decision highlights the importance of ensuring that patent claims are novel, inventive, and utility-compliant, and that they are sufficiently disclosed and supported. It also underscores the need for patentees to be aware of the prior art and the scope of their claims.

Orders

Orders of the court

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Background

Background to the litigation

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Evidence

Evidence Before The Court

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Decision

Reasons for decision

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Ratio Decidendi

Legal Principle Established

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