Taking a Back Seat in Opposition Proceedings: Seqirus Inc. v ModernaTX, Inc. [2025] APO 21

Oppositions typically involve the Opponent putting forward their best efforts to try and invalidate a patent application and likewise, involves the Applicant battling it out to defend their patent application to the best of their abilities, However, not all oppositions run this expected course. Rather, on rare occasions the Applicant may not participate much or even at all, when their patent application is challenged.

An example of this “back-seat” approach can be seen in the recent case of Seqirus Inc v ModernaTX, Inc. [2025] APO 21, which is discussed below – an unusual strategy on the Applicant’s part, but a strategy worth noting, nonetheless.

Background

ModernaTX, Inc is the Applicant for Australian patent application AU2017326423 (“the opposed application”), from which a divisional application was filed (AU2024200861). Seqirus Inc opposed grant of the accepted application, filing a notice to oppose under Section 59 of the Patents Act. The Statement of Grounds and Particulars outlined grounds of entitlement, manner of manufacture, novelty, inventive step, utility, sufficiency, clarity and support.

The invention of the opposed application concerns improved RNA compositions for use in therapeutic applications, the compositions of which are made using improved processes, for example in vitro-transcription (IVT) processes. Contrary to other methods in the art, which attempt to remove contaminants following production of RNA transcripts, the invention of the opposed application seeks to control the nature and levels of contaminants produced via the IVT processes. The invention further concerns methods for producing and purifying RNA, and methods for using the compositions and the therapeutic applications thereof.

Evidence

Whilst evidence in support was filed by the Opponent, the Applicant did not file evidence in answer. The Applicant did however make submissions that the two independent experts selected by the Opponent could not qualify as a relevant skilled person in the art, since both experts lacked qualifications and/or experience in relation to mRNA vaccine production or formulation at the relevant date. The matter was then set for hearing by written submissions.

The Hearing

The Hearing Officer examined the Opponent’s grounds for the opposition and the Applicant’s assertion regarding Opponent’s independent experts.

The Independent Experts

On the issue of the two independent experts, who each had expertise in gene regulation and RNA-protein interactions, the Hearing Officer considered that IVT is a standard technique that was known in the art at the relevant priority date. Although both experts were not immunologists, it was well known that a common issue with IVT procedures is that contaminants produced during IVT reactions results in strong rejection reactions in patients, compromising safety of the RNA product. The Hearing Officer also agreed with the Opponent that the opposed application related generally to an improved IVT reaction and therefore encompassed the production of mRNA, which falls within the competencies of both experts. Therefore, the experts were considered appropriate to give evidence as a person skilled in the art.

Inutility

The ground of inutility  is satisfied if the claim does not produce the desired result. In other words, everything within the scope of the claim must be useful (H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 at [247]) and the invention must achieve what the patentee intended for it to do, which is an assessment that relies on considering the specification as a whole (Artcraft Urban Group Pty Ltd v Streetworx Pty Ltd [2016] FCAFC 29 at [118]-[121]). Inutility must also be supported by evidence.

It was argued by the Opponent that claim 1 encompassed reaction mixtures and conditions which will not work or will not produce mRNA that is suitable for administration as a vaccine to a human subject. However, there was lack of evidence as to the failure of any of the particular embodiments disclosed in the application to fall within the scope of the claims. Thus, the grounds for inutility failed.

Novelty

With respect to novelty, 3 prior art documents were referred to by the Opponent. However, none of the prior art documents were considered to provide clear and unmistakeable directions to the claimed invention. Thus, the grounds for lack of novelty failed.

Inventive Step

Common General Knowledge

For inventive step, there was some reliance on common general knowledge by the Opponent.

As per Ranbaxy Laboratories Limited v AstraZeneca AB [2013] FCA 368; 101 IPR 11 at [217], a piece of knowledge only becomes common general knowledge if there is acceptance of that information amongst those engaged in the art. It is not sufficient for information to be disclosed in a scientific paper, for example, even if it is widely circulated. Rather, common general knowledge can only be found if the knowledge is generally known and accepted “without question” by those skilled in the art.

It was determined by the Hearing Officer that the evidence did establish a number of principles that are common general knowledge. For example, that IVT methods produce RNA products and that the reaction conditions of the IVT process may impact on the quality of the mRNA transcript that is produced, particularly if there is presence of unincorporated NTPs or if the mRNA produced is structurally incomplete in some way. This would consequently impact the therapeutic potential of the mRNA product, as such products may trigger inflammatory responses within the body.

However, the modified method as disclosed within the opposed application (modified to reduce the production of contaminants), was not considered common general knowledge. Some of the modification steps included using a concentration of GTP, or GTP plus GDP that is greater than another NTP, and having two or more NTPs at equimolar amounts.

The prior art was only considered to disclose use of modified NTPs and some reaction conditions, which was considered parameters that would be routinely chosen by a skilled person.

Combining Common General Knowledge With Each Prior Art document

The Examiner considered 3 prior art documents.

Of the three documents, only one was considered to render the claims to lack an inventive step, as the relevant document was considered to disclose maintaining GTP, CTP and ATP in equimolar concentrations.

In light of this finding, the Opponent succeeded in their ground for lack of inventive step

Clarity

When considering whether there was a clear enough and complete enough disclosure in the opposed application, the scope of monopoly sought must be justified by the technical contribution to the art, as disclosed by the specification (Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477 at [546]-[547]).

The Opponent argued that the claims were too broad, as it encompassed any amount of GTP or GTP plus GDP, greater than that of another NTP. The ranges and combinations therefore would be too great such that the concentrations of nucleotides used would not be able to produce an mRNA product that would be suitable for administration as a vaccine.  It was further argued that there is no guidance on how to select appropriate parameters to make an mRNA that can be administered as a vaccine. Specifically, the Opponent argued that the technical contribution as taught within the opposed application only included examples of a reaction mixture comprising a 4:2:1:1 ratio of GTP: ATP: CTP:UTP or a 2:2:1:1 ratio of GTP:ATP:CTP:UTP in the presence of GDP.

Since the Applicant did not file any evidence in answer, the Hearing Officer emphasised that all submissions made by the Applicant lacked evidentiary backing, such that there is a preference for the Opponent’s expert evidence.

The Hearing Officer considered that the disclosures as provided by the examples within the opposed application were such that a skilled person would be expected to work within the general bounds of IVT reactions to produce improved mRNA products. It was also agreed that the Applicant’s contribution to the art lies in providing a modified IVT reaction where GTP, or GTP plus GDP is greater than ATP by at least 2-fold and greater than CTP and UTP by at least 4-fold. Thus, the technical contribution to the art did not extend to encompass a general principle. Whilst there were found to be some claims that provided sufficient disclosure and enablement to a skilled person, the majority of claims were found to lack sufficient disclosure, which meant that the Opponent was successful on the grounds of sufficiency and support.

Closing Comments and Key Points

Overall, the opposition was successful on limited grounds, including lack of inventive step, support, sufficiency, and failing on the other grounds of clarity, novelty and lack of utility. The Applicant was consequently offered the opportunity to amend the claims to overcome the issues within 2 months from the decision date. Costs were also awarded against the Applicant in this case.

Lessons Learnt

This case reminds us of the importance of choosing the right independent expert to provide evidence as a person skilled in the art. Having an expert whose skill is not directly relevant to the technical field of the invention could potentially affect the reliability of evidence submitted during an opposition. In turn, this would consequently affect the weight on which the Hearing Officer would place on the evidence filed.

In this decision, sufficiency and support have once again proven to be effective as opposition grounds in invalidating a patent application. This highlights the crucial importance of ensuring that a quality patent application is drafted from the outset that would enable a skilled person to produce the invention across its entire scope as claimed in the patent application. 

Lack of Applicant Involvement

Noticeably, there was a lack of active involvement by the Applicant in this case, as they chose not to participate in the filing of evidence in response to the Opponent’s evidence in support. There are a few reasons for why this may be the case. For example, the application may have lost its commercial significance in the overall IP portfolio as held by the Applicant. They also may not have had the intention to defend it from the outset, perhaps because of financial reasons or other strategic IP reasons.

In this case, a divisional application was filed by the Applicant on 9 February 2024 – the same day on which the Applicant received the notice of opposition. This could explain the lack of participation on the Applicant’s behalf. Having a pending divisional application in the Applicant’s toolbox is especially beneficial as it allows the Applicant to have a second attempt at protecting their invention should the opposition on the parent application succeed. The divisional application may nevertheless have a slightly different scope of protection, as the Applicant may choose to address some of the issues during examination that were raised in the opposition on the parent case. This is particularly so because material from the opposition proceedings on the parent is also available to the Examiner when examining the divisional case.  

The Future

We will watch with interest regarding whether the Opponent seeks to oppose the corresponding divisional application, should it proceed to acceptance.

In the meantime, if you have any questions in relation to this case or the issues discussed within, please reach out to our team, who shall be happy to assist. You can reach us on 07 3369 2226 or by filling out our online contact form on our website.

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