Biosimilars Deals 2021

Introduction

Seqirus has successfully opposed Moderna’s:

• AU2015249553 patent application (AU553) for nucleic acid vaccines; and
• AU2017326423 (AU423) for high purity RNA compositions and methods for preparation of these compositions.

Seqirus invalidated all of the AU553 claims and claims 1-8 and 11-20 of AU423 on the grounds of obviousness, insufficiency and lack of support.

Moderna was given two months from the date of each decision to file amendments to overcome the deficiencies identified in the decisions. Moderna applied to amend AU533 but IP Australia considered that, while allowable, the proposed amendments did not overcome the deficiencies identified in the decision. Moderna subsequently withdrew AU553 in December 2025, leaving one live divisional application in the same patent family. As no amendments were filed on AU423, the Commissioner of Patents refused AU423 on 24 September 2025, again leaving one live divisional application in the same patent family.

Background

AU553’s only independent claim, claim 1, claimed:

A nucleic acid vaccine comprising one or more mRNA polynucleotides having an open reading frame encoding an antigenic polypeptide, formulated in a cationic lipid nanoparticle having a molar ratio of about 20-60% cationic lipid: about 5-25% non-cationic lipid: about 25-55% sterol; and about 0.5-15% PEG-modified lipid.

AU423 included two independent claims (claims 1 and 16) as follows:

1.  A method of producing a messenger ribonucleic acid (mRNA) that is suitable for administration as a vaccine to a human subject, wherein the mRNA comprises an open reading frame encoding a vaccine antigen, the method comprising incubating a reaction mixture comprising a deoxyribonucleic acid (DNA), an RNA polymerase that initiates with a GTP or GDP, a buffer, adenosine triphosphate (ATP), cytidine triphosphate (CTP), uridine triphosphate (UTP), and guanosine triphosphate (GTP), thereby producing the mRNA, wherein:

(i) the concentration of GTP is greater than the concentration of one or more of ATP, CTP, and UTP, and two or more of ATP, CTP, and UTP are in equimolar concentrations; and/or

(ii) the reaction further comprises guanosine diphosphate (GDP), the concentration of GTP plus GDP is greater than the concentration of one or more of ATP, CTP, and UTP, and two or more of GTP, ATP, CTP, and UTP are in equimolar concentrations.

16.  A method of producing a messenger ribonucleic acid (mRNA) that is suitable for administration as a vaccine to a human subject, wherein the mRNA comprises an open reading frame encoding a vaccine antigen, the method comprising incubating a reaction mixture comprising a deoxyribonucleic acid (DNA), a T7 RNA polymerase, a buffer, adenosine triphosphate (ATP), cytidine triphosphate (CTP), uridine triphosphate (UTP), and guanosine triphosphate (GTP), thereby producing the mRNA,

wherein the concentration of GTP is greater than the concentration of one or more of ATP, CTP, and UTP, and two or more of ATP, CTP, and UTP are in equimolar concentrations,

wherein the UTP is a modified UTP comprising 2’-O-methylribose, pseudouridine (ψ), N1-methylpseudouridine (m1ψ), 2-thiouridine, 4-thiouridine, 2-thio-1-methyl-1-deaza- pseudouridine, 2-thio-1-methyl-pseudouridine, 2-thio-5-aza-uridine , 2-thio-dihydropseudouridine, 2-thio-dihydrouridine, 2-thio-pseudouridine, 4-methoxy-2-thio-pseudouridine, 4-methoxy-pseudouridine, 4-thio-1-methyl-pseudouridine, 4-thio-pseudouridine, 5-aza-uridine, dihydropseudouridine, or 5-methoxyuridine.

Key Issues

Seqirus pressed the same five grounds of invalidity in its oppositions to AU553 and AU423: lack of novelty, obviousness, insufficiency, lack of support and inutility. Notably, Moderna did not file any evidence in answer in the opposition to AU423.

AU553 and AU423: Lack of Novelty

Seqirus alleged that the claims of AU533 were anticipated by three prior art patent applications. The Delegate determined that none of the cited prior art anticipated the claimed invention, as none of the cited prior art provided clear and unmistakeable directions to make the claimed invention.

Seqirus again alleged that the claims of AU423 were anticipated by three prior art documents (a patent application and two journal articles), with the Delegate finding that that none of the cited prior art anticipated the claimed invention, as none of the cited prior art provided clear and unmistakeable directions to make the claimed invention.

AU553 and AU423: Obviousness

AU553: Seqirus alleged that the claimed invention in AU553 was obvious when considered in light of the common general knowledge (CGK), either alone or separately with a number of prior art documents.

Based on the evidence before him, the Delegate found that, in light of the CGK alone, a skilled addressee would not be directly led as a matter of course to formulate a nucleic acid vaccine comprising a mRNA encoding an antigenic polypeptide, formulated in a lipid nanoparticle (LNP) having the four components in the defined ratios, as defined in AU553’s claim 1, with a reasonable expectation of success. The Delegate provided the following reasons for this decision:

• First, the CGK taught away from using mRNA LNP vaccines, instead teaching that either self-amplifying RNA (saRNA) or mRNA and protamine was required to achieve an immune response.
• Secondly, there was no motivation in the CGK for the skilled addressee to replace protamine with LNPs. The Delegate did not consider that the skilled addressee would be directly led as a matter of course to combine the use of mRNA with an LNP in a vaccine, as it was CGK that LNPs used with small interfering RNA (siRNA) gave an undesirable inflammatory response associated with a transient IgM response.
• Thirdly, while it was known that an LNP formulation with the four claim 1 lipid components could be used to encapsulate siRNA, there was still considerable uncertainty in the CGK as to whether such an LNP could successfully encapsulate mRNA encoding an antigenic polypeptide and produce a meaningful antigen specific immune response.  As a result, the Delegate did not consider that there would be a reasonable expectation of success that an LNP could successfully encapsulate mRNA encoding an antigenic polypeptide and produce a meaningful antigen specific immune response.
• Fourthly, it was considered surprising when siRNA/LNP technology was in fact applied to mRNA.

The Delegate then went on to consider obviousness in light of the CGK and a number of prior art documents (each considered separately). Seqirus ultimately proved obviousness in light of the CGK and each of WO 2013/151736 A2 (“In Vivo Production of Proteins”, which was also cited for novelty) and WO 2013/185069 A1 (“Pulmonary Delivery of mRNA to Non-Lung Target Cells”). The Delegate found:

• In respect of CGK + WO 2013/151736 A2, that a skilled addressee would be directly led as a matter of course and with a reasonable expectation of success, to develop an mRNA LNP vaccine encoding an antigenic polypeptide. WO 2013/151736 A2 disclosed compositions and methods for the preparation, manufacture and therapeutic use of polynucleotides, primary transcripts and mRNA molecules. Although the expert evidence noted that a functional immune response required a certain level of translation from mRNA to antigen, the word “vaccine” as it was used in AU553 merely required a composition that improved immunity. Accordingly, there would be the requisite expectation of success as the level of translation would be sufficient to produce an antigen specific immune response. This expectation of success did not require an immune response at the level of a commercially successful vaccine.
• In respect of CGK + WO 2013/185069 A1, that a skilled addressee would also be directly led as a matter of course and with a reasonable expectation of success, to develop an mRNA LNP vaccine encoding an antigenic polypeptide. WO 2013/185069 A1 disclosed compositions comprising mRNA formulated for pulmonary administration and related methods for the delivery of mRNA, that a suitable lipid carrier vehicle included a lipid nanoparticle, and an IT spray experiment in mice with firefly luciferase (FFL) mRNA lipid nanoparticle formulation of HGT5001:DOPE:Cholesterol:DMG-PEG2K at a molar ratio of 40:20:35:5.

AU423: Seqirus also alleged that the claimed invention in AU423 was obvious when considered in light of the CGK, either alone or separately with three prior art documents. Based on the evidence before her, the Delegate found that, although in vitro-transcription (IVT) reaction methods were known and it was also known that many factors could affect the resulting product, Seqirus had not established that the claims were obvious in light of the CGK alone.

The Delegate then went on to consider obviousness in light of the CGK and the three prior art documents (each considered separately). Seqirus ultimately proved that claims 1-8 and 11-20 were obvious in light of the CGK and the prior art article: “Self-coded 3’-Extension of Run-off Transcripts Produces Aberrant Products during in Vitro Transcription with T7 RNA Polymerase”, Triana-Alonso et al., Journal of Biological Chemistry, 1995, vol. 270, iss. 11, pp. 6298-6307. The Delegate noted that:

• the AU423 claims were directed to methods of producing mRNA by IVT where the reaction mixture had been modified to reduce the production of contaminants; and
• the prior art article taught that the preferential reduction of UTP concentration relative to the other nucleotides (NTPs) “leads to faithful transcription and good yields, irrespective of the nucleotide composition of the template.”

Accordingly, the Delegate was satisfied that the expert evidence supported a conclusion that simply encoding a known vaccine antigen in place of the model peptides of the prior art article did not require further invention, and that AU423’s claims 1-8 and 11-20 were obvious. The Delegate considered that features of the IVT process, such as the use of modified NTPs, choice of polymerase and reaction temperature, were routinely chosen by the skilled addressee depending on the nature of the desired product and components used in the reaction mixture, with well-defined reaction conditions and components known in the art. The Delegate did, however, consider that claims 9 and 10 were inventive over the CGK and the prior art article as the article did not teach maintaining GTP, CTP and ATP in equimolar concentrations.

AU 553 and AU423: Inutility

Seqirus’ AU553 utility challenge failed as the Delegate considered that Seqirus had failed to provide any evidence of a formulation within the scope of claim 1 that did not attain the result promised for the invention by the patentee, the promise being that a composition comprising an mRNA encoding an antigenic polypeptide formulated in a LNP having the components in the molar ratios as defined in claim 1 would function as a vaccine (i.e. would produce an antigen specific immune response).

Seqirus’ AU423 utility challenge also failed as the Delegate considered that Seqirus had raised doubts and concerns regarding the likely outcomes of the claimed process, but that this amounted to mere speculation rather than any evidence to show that the claims included within their scope any particular embodiment that would not be useful or would not achieve at least some aspect of the benefits promised in the specification.

AU553: Insufficiency: Clear and Complete Enough Disclosure

The Delegate noted that, to satisfy the sufficiency requirement, the skilled person must be able to perform the invention across the scope of the claim without undue burden or inventive skill. The Delegate considered that the claimed invention defined a nucleic acid vaccine (or a composition that improves immunity) comprising one or more mRNA polynucleotides having an open reading frame encoding a polypeptide that is capable of stimulating an antigen specific immune response, formulated in a cationic lipid nanoparticle having a molar ratio of about 20-60% cationic lipid: about 5-25% non-cationic lipid: about 25-55% sterol: and about 0.5-15% PEG-modified lipid. The Delegate further considered that the specification disclosed:

• the formulation of modified mRNA using lipidoids;
• mRNA LNP vaccines having a molar ratio of 50% cationic lipid (DLin-KC2-DMA or DLin-MC3-DMA), 10% non-cationic lipid (DSPC), 38.5% sterol (Cholesterol) and 1.5% PEG-modified lipid (PEG-DOMG), and the use of those vaccines to express antigenic polypeptides (influenza haemaglutinin antigen and MRSA); and
• a number of examples analysing the immunogenicity of mRNA vaccines encoding a variety of antigenic polypeptides (See Example 17-21), but that none of these examples disclosed the use of an LNP. The Delegate also note that none of the LNP examples disclosed varied the composition of the LNP other than varying the cationic lipid between KC2 and MC3.

The Delegate assessed the issue of sufficiency by asking two questions:

• Whether it was plausible that the invention could be worked across the full scope of the claim; and
• Whether the invention could be performed across the full scope of the claim without undue burden.

The Delegate answered the first question in the affirmative and the second question in the negative, leading the Delegate to conclude that the patent was invalid for insufficiency.

On the question of plausibility, the Delegate noted that, while plausibility may be a low threshold, it was not satisfied by mere speculation or assertion. That said, while there was expert evidence doubting whether successful encapsulation of mRNA could occur across the full scope of the claims, a mere “doubt” was not sufficient to establish a lack of plausibility. Further, while the chemical structure of the cationic lipid might have an impact on transfection efficiency, this potential shortcoming was not enough to meet the threshold that the LNP mRNA vaccine over the scope of claim 1 would not be “technically credible” or “believable” in its ability to produce an immune response.

On the question of undue burden, the Delegate considered that the evidence showed that there would be an undue burden on the skilled addressee to test which cationic lipids would result in an LNP comprising mRNA encoding an antigenic polypeptide which results in an antigen specific immune response, and that, accordingly, claim 1 was not clearly and completely enough disclosed. The Delegate did not, however, agree with Seqirus’ submission that there was not a clear and complete enough disclosure for a mRNA LNP vaccine encoding any antigenic peptide or in relation to the potential toxicity of a particular cationic lipid component.

AU 553: Lack of Support

To determine whether the support requirements were satisfied, the Delegate construed the claims (to determine the scope of the invention as claimed) and the description (to determine the technical contribution to the art) and then formed a view on whether the claims were supported by the technical contribution to the art.

The Delegate ultimately determined that claim 1 lacked support as the scope of the cationic lipid component extended beyond the applicant’s technical contribution to the art, as the description only taught the use of the cationic lipid being either DLin-KC2-DMA or DLin-MC3-DMA. Claims 3-67 were dependent on claim 1 and did not introduce any features that remedied this lack of support. Claim 2, however, was supported with respect to the cationic lipid, as this claim was limited to DLin-KC2-DMA and DLin-MC3-DMA which were shown in the specification to provide suitable LNPs that provide an immune response.

AU423: Insufficiency: Clear and Complete Enough Disclosure + Lack of Support

The Delegate addressed the questions of insufficiency and lack of support together in the AU423 opposition.

The Delegate noted that AU423 specification only included data showing the effective suppression of contaminants with the alpha and GDP alpha reactions performed with 30 mM GTP, 15 mM ATP, 7.5 mM CTP and 7.5 mM UTP (4:2:1:1 ratio of GTP:ATP:CTP:UTP) or 30 mM GDP, 15 mM GTP, 15 mM ATP, 7.5 mM CTP and 7.5 mM UTP (4:2:2:1:1 ratio of GDP:GTP:ATP:CTP:UTP). AU423 did not provide any guidance, beyond the examples, regarding appropriately choosing the relative amounts of the NTPs to ensure improved RNA products were obtained. This meant that the skilled addressee was expected to work within the general bounds of IVT reactions to produce mRNA products with improved purity, with AU423 only teaching the use of a selected NTP, GTP or GTP plus GDP in the case of the claimed invention, in a greater concentration than at least one of the other NTPs with two or more other NTPs being equimolar.

While product purity was not certain with deviation from the alpha and GDP alpha reactions, given the expert evidence, the Delegate was prepared to accept that AU423 provided sufficient disclosure to enable a person skilled in the art to perform the invention of claims 9 and 10. However, the alpha and GDP alpha reactions did not extend to a general principle where the concentration of the GTP or GTP plus GDP need only be greater than one or more of the other NTPs with two or more of the other NTPs being in equimolar concentrations. Accordingly, there was insufficient disclosure to enable a person skilled in the art to perform the inventions of claims 1-8 and 11-20, and these claims lacked support as they extended beyond the applicant’s contribution to the art as disclosed in the description.

Outcome and Implications

These two decisions provide two recent examples of the power of strong prior art to knock out a patent application on the ground of lack of inventive step, as well as the power of the support and sufficiency grounds post the “Raising the Bar” amendments to the Australian Patents Act. While Moderna applied to amend AU553 to cure the identified deficiencies, IP Australia considered that the proposed amendments did not overcome these deficiencies. Moderna subsequently withdrew AU553 in December 2025, leaving one live divisional application in the same patent family. As no amendments were filed on AU423, the Commissioner of Patents refused AU423 on 24 September 2025, again leaving one live divisional application in the same patent family.

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

IPTA and MA seek to intervene in Otsuka’s Application for Leave to appeal to Australia’s High Court 

On 30 January 2026, two industry organisations – the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) and Medicines Australia (MA) – filed applications with the High Court of Australia to intervene as amici curiae in Otsuka’s application for special leave to appeal from the decision of the Full Federal Court finding that pharmaceutical formulations are not eligible for a patent term extension (PTE).

IPTA is the peak industry body representing Australian patent and trade mark attorneys. MA is the peak industry body representing originator pharmaceutical companies in Australia.

The Full Court decision has significant ramifications for originator companies as now:

• patentees cannot extend the term of pharmaceutical formulation patents; and
• PTEs for such patents are both unenforceable and vulnerable to challenge via a low cost rectification process in the patent office.

Given this seismic re-calibration in law and practice in Australia, it was inevitable that Otsuka would seek special leave to appeal to the High Court, and that industry bodies such as IPTA and MA would wish to be heard on the special leave application and any subsequent High Court appeal.  It remains to be seen whether others will apply to intervene.

We will provide a further update as soon as the High Court announces the date on which Otsuka’s special leave application is to be heard and determined.

Read more about the Australian patent extension regime in our free PTE eBook which can be downloaded Pharmaceutical Patent Term Extensions in Australia.

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

Zuru v Lego [2025] NZCA 650 (10 December 2025)

Introduction

The New Zealand Court of Appeal has allowed an appeal by New Zealand toy manufacturer, Zuru, holding that it was not trade mark infringement for Zuru to use the phrase “LEGO® BRICK COMPATIBLE” on the packaging of its plastic bricks.  It also upheld the lower court’s decision that this conduct was not likely to mislead or deceive contrary to the Fair Trading Act 1986, nor did it amount to the tort of passing off.

The Court of Appeal was unanimous in its conclusions, however the judges split 2:1 on the reasoning underlying the decision on trade mark infringement.  The majority judgment (given by Ellis J) provides useful clarity on the use of competitors’ trade marks in compatibility statements and comparative advertising.  However, the minority judgment does highlight some ambiguity in the Trade Marks Act 2002.  The case may still be subject to a further appeal to the Supreme Court.  If not, or if the Supreme Court proves unable to bring compete clarity, future legislative amendment could be useful.

On the consumer law issues, the Court of Appeal has applied a robust and realistic approach.  It preferred to draw its own conclusions on what message consumers would take from the packaging in question, noting that “consumers are not stupid.”  The decision adds to the already weighty body of case law establishing that evidence from marketing experts is usually not considered to be helpful in determining how consumers view the marketing of ordinary retail goods.

Background

Lego is world famous for its plastic blocks.  Zuru has positioned itself as a “disruptor” in the toy industry.  In 2018, Zuru launched its MAX BUILD MORE brand of plastic bricks, which are similar to, and compatible with, the more famous bricks made by Lego.  Zuru included on the front of its packaging a compatibility statement: “LEGO® BRICK COMPATIBLE” as shown below.

Zuru included on the front of its packaging a compatibility statement: “LEGO® BRICK COMPATIBLE”

Lego objected and served cease and desist letters on both Zuru and its principal New Zealand stockist, The Warehouse (a major general retail chain that also stocks Lego’s products).  (Ellis J astutely noted at the outset of the majority judgment[1] that Lego’s copyright and patent protection for its basic products has long since expired but its LEGO® trade mark remains.[2])  The Warehouse withdrew Zuru’s bricks from sale until Zuru could resolve the issue with Lego.  Zuru altered its compatibility statement to “COMPATIBLE WITH MAJOR BRANDS”, placating The Warehouse.  Zuru sought, but could not reach, an agreement with Lego on wording for a compatibility statement that included the LEGO trade mark.

In order to be able to use such a statement while remaining stocked by The Warehouse, Zuru applied to the High Court for a declaration that its use of its previous “LEGO® BRICK COMPATIBLE” statement, and a series of proposed similar statements, would not infringe Lego’s registered trade marks, breach the Fair Trading Act or amount to passing off.  Lego counterclaimed alleging all three of these forms of unlawful conduct.[3]

Interestingly, Zuru initially also claimed that Lego had itself breached the Fair Trading Act by falsely and misleadingly stating to The Warehouse that Zuru was infringing Lego’s intellectual property rights.  It is not clear whether Zuru has any intention of reviving that claim, now that its non‑infringement position is clear (pending any further appeal to the Supreme Court).

Trade mark issues

Ellis J traversed at length and in detail the history of statutory trade mark infringement provisions and case law in New Zealand, including where these sources draw from foreign jurisprudence, providing an excellent, if lengthy, summary.[4]

Relevantly, the current legislation includes the following:

There was no doubt that Zuru’s conduct fell within section 89(1), so the questions for the Court were:

1. Was Zuru’s use of “LEGO” was “in such a manner as to render the use of [“LEGO”] as likely to be taken as being use as a trade mark” i.e. was there prima facie infringement under s89?

Majority answer: no

Minority answer: yes

2. Did s94 apply and, if so, did it operate merely as a defence to infringement under s89, or does the passage “…must be treated as infringing…” operate as an independent ground of infringement?

Majority answer: s94 is a mere defence provision, and that defence would apply in this case

Minority answer: s94 is an independent ground of infringement but the requirements for infringement are not met

3. Did the defences in either 95(c) or 95(d) apply?

Not answered given the conclusions above

Section 89(2)

The orthodox interpretation of this section is that it is a prerequisite to a finding of infringement under s89(1).  That prerequisite is met if the sign in question, here “LEGO”, is being used as an indication of the trade origin of the goods on which it is being used, i.e. that Zuru’s own bricks were LEGO brand goods.  This was clearly not the case given the express statement that the bricks in question were “compatible” with LEGO bricks, thus implying that they were not themselves LEGO bricks.

The majority of the Court of Appeal applied this interpretation in favour of Lego’s submission, which it summarised as being that “use as a trade mark” encompasses:

a wider concept of a trade mark’s function, namely to act as “a guarantee that all the goods or services bearing it have been manufactured or supplied under the control of a single undertaking which is responsible for their quality” meaning the mere inclusion of the Lego mark on Zuru’s products will always constitute infringement.

The majority held that Lego’s argument failed to properly distinguish between use of a trade mark and use as a trade mark.  Under the majority interpretation, as s89(2) was not met, Zuru did not infringe.

Justice Cooke, in his minority judgment, summarised Lego’s position differently, being that s89(2) is satisfied when there is “use of the mark to identify the trade mark owner’s goods or services, but there is no requirement that there be…misappropriation. So, here the word “LEGO” is plainly used to identify [Lego’s] goods, but not in a way that involves any claim of association. That is, there is no misappropriation of intellectual property.”

The fact that the Court could not even agree on exactly what position Lego was taking perhaps indicates the difficulties it faced with this argument.

Justice Cooke took the view that as LEGO has no meaning other than as a trade mark, any use of it must be use “as a trade mark.”  If this interpretation was correct, then section 89(2) would not exclude from infringement any use of a third party’s mark to honestly refer to that third party’s goods whether by way of express comparison, compatibility statement or other descriptive purpose.  Any allegation of infringement in those circumstances would need to be met by showing that the infringement provisions in s89(1) did not apply, or that a defence in ss92 – 98A did apply.  Section 89(2) would still exclude from infringement use of another’s trade mark where that mark had an independent, descriptive meaning other than as a trade mark, and it was used in that sense.  As an invented word, LEGO could never be used in such a way.

Justice Cooke also observed, with some justification, that if the majority interpretation was correct, then no use of a trade mark in a comparative advertisement could ever infringe under s89, so there would be no need for section 94.

Section 94

The court identified a peculiarity with section 94.  The Trade Marks Act has s89 under the heading “Acts amounting to infringement” and s94 under the heading “Acts not amounting to infringement”.  One would therefore expect sections under the first of those headings to codify all conduct that amounts to trade mark infringement, and for sections under the second heading to identify various circumstances in which an alleged infringer has a defence despite their conduct being one of the “Acts amounting to infringement.”  This Court held that this expectation is met for all sections under the second heading other than sections 94 and 95.  That is, that the conduct described in sections 92, 93, and 96 to 98A would otherwise be infringing under s89.  (However, one could argue that the conduct described in section 93 – use of another registered trade mark – would not otherwise be infringement due to the positive right to use a trade mark conferred on an owner by section 10(1)(a) of the Act.)

Section 94 on the other hand deals with comparative advertising which, under the majority interpretation, would not otherwise infringe.  Section 94 also provides what appears to be a further infringement provision, saying that that use for comparative advertising “must be treated as infringing” if that use, “without due cause, takes unfair advantage of, or is detrimental to, the distinctive character or the repute of the trade mark.”  So the section, on one view, provides that certain use in comparative advertising will be infringing even though s89(2) is not satisfied.  This appears to have come about from the “cut & paste” drafting of the Trade Marks Act drawing on Australian, UK, and Singaporean provisions, plus some further amendment by a parliamentary committee.  The alternative view is that s94 is largely a “belt and braces” approach to ensure the enactment of clear legislative intention to permit comparative advertising.  This approach was favoured by the majority, who somewhat unconvincingly said that “Whether or not that [approach] would render [section 94] largely otiose is an open question, although we do not accept that would automatically follow.”

Justice Cooke, on the other hand, stated expressly that “on the majority approach, [section 94] is rendered redundant.”  He preferred the interpretation that section 94 alone regulated when comparative advertising would infringe, and that s89 was not relevant.  Arguably, this approach does less violence to the words of the statute, giving s94 some real work to do, at the cost of rendering a heading arguably inaccurate.  On the other hand, in the 23 years since the passage of the Trade Marks Act, it has never before been suggested that any section other than s 89 defines when trade mark infringement occurs.

Section 95

Neither the majority nor Justice Cooke found it necessary to reach any firm conclusions about the applicability of section 95.

Impact of trade mark findings

In summary, the majority decision is effectively that:

• Section 89(1) is the only provision defining infringement i.e. s94 is only a defence provision.
• Section 89(2) is a “gateway” to the application of section 89(1).
• Section 89(2) is not satisfied where the allegedly infringed trade mark is used only to refer to the trade mark owner’s goods or services (as in comparative advertising), so such use can never infringe.
• Nevertheless, section 94 is not to be automatically regarded as otiose, meaning it still has some function.

Lego has applied for leave for a further appeal to the Supreme Court which is likely to be decided in April or May 2026.  If the leave application, or any appeal, is unsuccessful, the findings on the meanings of section 89(2) will remain binding on the High Court (the lower court with first instance jurisdiction in trade mark matters) and likely to be followed by the Court of Appeal in the future.  The findings on s94 are obiter only and therefore not strictly binding.

If matters remain as they are, the High Court may find it very difficult to square the circle should it need to address a case where the alleged infringement both:

a. is comparative advertising, and thus cannot not infringe as it does not pass the s89(2) gateway; but

b. is also not “in accordance with honest practices in industrial or commercial matters” and “without due cause, takes unfair advantage of, or is detrimental to, the distinctive character or the repute of the trade mark.”

In those circumstances, the High Court would be faced with conduct that parliament has expressly legislated “must be treated as infringing [a] registered trade mark” but which the majority of the Court of Appeal has said can never infringe.

One possible route to resolving this conundrum would be for the High Court to reject the obiter view of the Court of Appeal majority and hold that in fact s94 does amount to an infringement provision wholly independent of section 89.  A less-brave High Court may prefer to use a finding of dishonesty to primarily decide the case under the Fair Trading Act.  (New Zealand trade mark infringement cases almost invariably include claims of breach of the Fair Trading Act by conduct in trade that is likely to mislead or deceive).

Fair Trading Act and passing off

Lego cross-appealed the High Court’s finding that Zuru’s conduct did not amount to conduct likely to confuse, deceive or mislead contrary to the Fair Trading Act, and did not amount to the tort of passing off.

In the High Court, Lego did not adduce any evidence of actual confusion but instead relied on expert evidence that use of the famous LEGO trade mark would be likely to confuse consumers.  The High Court judge also visited a store and was shown photographs of the Zuru and Lego products as presented on the shelf to customers.  The Court of Appeal noted that this gave the High Court judge an advantage.  The Court of Appeal held that

• The issues of deception and misleading conduct here were not ones on which expert evidence was likely to be substantially helpful;
• Zuru’s compatibility statements themselves were not false; and
• “a touch of reality is called for…Consumers are not stupid”.

Viewing the presentation of Zuru’s products as a whole, the Court of Appeal upheld the High Court judge’s decision to largely reject Lego’s expert evidence and upheld the finding that “Consumers in the 21st century are not easily fooled, are brand-aware, and would not reasonably think Zuru’s products were made by or associated with Lego”.  Because consumers would apply ‘at least a moderate level of involvement’ and would ‘take some care in choosing’, consumers ‘will recognise that those displayed under the MAX BUILD MORE label are different products to those made by LEGO’”

Although this is an orthodox approach, it is a useful reminder that consumer law is a matter of commonsense, overall impression.  Where the products in question are marketed to the general public, expert evidence is unlikely to move matters beyond a judge’s own assessment of the facts.

Final note

Since the issuing of this decision, one of the counsel for Lego, Jack Oliver-Hood, has tragically passed away.  Mr Oliver-Hood was highly regarded as an emerging talent at the bar, including in intellectual property, and he will be sadly missed by the profession.  The authors personally, and Pearce IP, extend our condolences to Mr Oliver-Hood’s family and whanau.

[1] Judgment at [1]

[2] Lego holds a New Zealand trade mark registration for the three-dimensional shape of its “minifig” character, but not of its basic brick shapes.  It also has a registration of a two-dimensional representation of its classic 4×2 brick.

[3] See the decision the subject of this appeal, Zuru New Zealand Limited v Lego Juris A/S [2023] NZHC 1808 (12 July 2023) at [19] to [24]

[4] See [11] to [107]

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

Samsung Bioepis AU Pty Ltd v Janssen Biotech, Inc. [2025] APO 32 (3 October 2025)

Introduction

Samsung Bioepis (Samsung) has successfully opposed Janssen Biotech’s (Janssen) AU2019346134 patent application (AU134) for methods of treating ulcerative colitis (UC) with ustekinumab (Stelara®).  Samsung invalidated all of the AU134 claims on the grounds of lack of novelty and obviousness.  Samsung’s lack of support attack did not succeed.  This decision marks the end of the road for AU134, with Janssen choosing not to appeal the opposition decision to the Federal Court of Australia or to propose amendments aimed at overcoming the deficiencies in the claims.  The Australian Patent Office formally refused AU134 in January 2026, leaving one divisional application (AU2023201217) as the only surviving member of the AU134 patent family.

The IP Australia decision marks yet another success for Samsung in its Australian actions against Janssen regarding Janssen’s Australian ustekinumab patent portfolio for the treatment of UC.  On 9 June 2025, the Federal Court of Australia ordered the revocation of three Janssen Biotech innovation patents  (AU2024100006, AU2024100007 and AU2024100016).  In an earlier victory for Samsung Bioepis, Janssen surrendered two innovation patents (AU 2023100041 and 2023100042).

Background

The AU134 invention related to methods of providing a clinically proven safe and effective treatment of UC, particularly moderately to severely active UC in patients who had had an inadequate response to or were intolerant of a conventional or existing therapy, by intravenous and/or subcutaneous administration of an anti-IL-12/IL-23p40 antibody i.e. ustekinumab.

Claim 1 of AU134 claimed:

a)   A method of treating moderately to severely active UC in a subject in need thereof, comprising

b)   administering to the subject a pharmaceutical composition comprising an effective amount of an anti-IL-12/IL-23p40 antibody,

c)   wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising: a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:1; a CDRH2 amino acid sequence of SEQ ID NO:2; and a CDRH3 amino acid sequence of SEQ ID NO:3; and the light chain variable region comprising: a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:4; a CDRL2 amino acid sequence of SEQ ID NO:5; and a CDRL3 amino acid sequence of SEQ ID NO:6,

d)   wherein after treating with the antibody, the subject is a responder to treatment by at least one measure of response to treatment

e)   selected from the group consisting of: (i) clinical remission based on at least one of the global definition of clinical remission with Mayo score ≤ 2 points with no individual subscore > 1 and the US definition of clinical remission with absolute stool number ≤ 3, rectal bleeding subscore of 0 and Mayo endoscopy subscore of 0 or 1, (ii) endoscopic healing with a Mayo endoscopy subscore of 0 or 1, (iii) clinical response based on the Mayo endoscopy subscore, (iv) mucosal healing, and (v) clinical response as determined by a decrease from baseline in the Mayo score by ≥30% and ≥3 points and a decrease from baseline in the rectal bleeding subscore ≥1 points or a rectal bleeding subscore of 0 or 1.

Key Issues

Novelty

Samsung alleged that four prior art publications anticipated the AU134 claims, with the Delegate giving the greatest consideration to the following prior art:

1. The record of the clinical trial titled “A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI)”and identifiable by ClinicalTrials.gov identifier NCT02407236 published on the ClinicalTrials.gov website on 13 August 2018 (CTR 236); and

2. Ochsenkühn, T., et al(2018) “P759 Ustekinumab as rescue treatment in therapy-refractory or -intolerant ulcerative colitis”, Journal of Crohn’s and Colitis, Volume 12, Issue supplement 1, published on 16 January 2018 (Abstract P759).

The Delegate held that all claims of AU134 were anticipated by one or both of CTR 236 and Abstract P579.

The Delegate held that CTR 236 anticipated each of claims 1-3, 6-19 and 22-30, but did not anticipate claims 4, 5, 20 or 21.  In reaching this conclusion, the Delegate had to grapple with the nature of the clinical trial disclosure in CTR 236.

Janssen argued that CTR 236 did not anticipate AU134 because it was a Phase III clinical trial protocol that did not contain any results, nor did it provide any rationale for why ustekinumab would treat moderately to severely active UC.  Rather, Janssen argued:

• it was a study designed to evaluate the safety and efficacy of ustekinumab in participants with moderately to severely active UC, and was the first clinical trial of ustekinumab in this patient population; and
• there was no teaching in CTR 236 of a ‘reasoned hypothesis’; it was no more than a disclosure of a ‘hypothesis to be tested’.

The Delegate disagreed, holding that Janssen’s position was inconsistent with previous Federal Court of Australia authority, in particular the decision of the Full Court of the Federal Court of Australia in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd (Mylan).  In Mylan, the Full Court held that a clinical trial protocol which contained an hypothesis without scientific proof or substantiation could constitute an anticipatory disclosure (and did so in that case).  As it is not a requirement for patentability that an invention, as claimed, be based on scientific proof or substantiation, the Full Court in Mylan held that no greater requirement is imposed on a prior documentary disclosure in order for it to be anticipatory.

The Delegate considered that CTR 236 had disclosed the method of treatment, regardless of the proportion of participants in the CTR 236 Phase III clinical trials shown to demonstrate the defined primary and secondary outcome measures.  In addition, the Delegate considered that CTR 236 contained a clear direction, recommendation or suggestion to deliberately administer ustekinumab with an intended purpose of treating a subject with UC by achieving the defined primary and secondary outcome measures.

The Delegate then moved on to discuss Abstract P759.  Abstract P759 disclosed a small-scale study that aimed to “assess the clinical outcomes achieved with ustekinumab as rescue treatment in therapy-refractory or intolerant UC”.  The Delegate held that Abstract P579 anticipated claims 1-9, 17-28 and 30, but did not anticipate claims 10-16 or 29.

The Delegate considered that, even though ustekinumab was administered as an off-label treatment in Abstract P759 and to avoid surgery, it was apparent that ustekinumab was being used with the intended purpose to relieve or cure a patient with moderately to severely active UC.  The Delegate accepted that there might be limitations regarding the conclusions that could be drawn from retrospective studies, and that these studies were still important in the development of approaches to the treatment of inflammatory bowel disease.  However, even if there were limitations, these did not undermine the disclosure in Abstract P759.  As a result, the Delegate considered that the off-label use of ustekinumab disclosed in Abstract P759 was a method of treatment that was relevant for the purposes of assessing novelty.

The Delegate then went on to consider whether the specific clinical endpoints in the AU134 claims conferred novelty on the claims.  The Delegate answered this question in the negative.  While the specific clinical endpoints in the AU134 claims were new information that was not disclosed in Abstract P759, the Delegate held that these endpoints were not features that could provide a meaningful difference over what was disclosed in the prior art but were “merely supplementary information” about the measure of success which the method of administering ustekinumab was intended to achieve.

In contrast, the Delegate considered that the length of the maintenance treatment recited in claim 29 did specify the duration of the maintenance therapy and was therefore a limitation on the dosage regimen.  Consequently, the length of the maintenance treatment was a limitation on the claim and could confer novelty.

Obviousness

The Delegate considered the question of obviousness based on the common general knowledge (CGK) alone and in combination with the prior art relied on in the novelty case.

The Delegate held that Samsung had not established that, when considering the CGK alone, the skilled person would be directly led as a matter of course to select only ustekinumab to treat moderately to severely active UC in the expectation that doing so might well produce a useful alternative to the prior art.  The Delegate considered that the idiosyncrasies associated with Samsung’s expert’s experience as a practitioner in Australia led him to select ustekinumab and exclude other potential drug candidates for the hypothetical task which he addressed in his evidence.  The hypothetical task given to Samsung’s expert required him to propose a medication for the treatment or management of UC which would be a useful alternative to, or better than, the medications that were approved for use for the treatment and/or management of UC, based on information that was known and accepted and regarded to be widely known and generally accepted by other gastroenterologists (whether in Australia or overseas) working in the field of the diagnosis, treatment and management of inflammatory bowel disease before the priority date.

The Delegate, however, found that all of the AU134 claims were obvious in light of the CGK taken together with the prior art cited for lack of novelty.  The Delegate’s decision in this regard flowed directly from the Delegate’s decision that all of the AU134 claims were anticipated by one or more of the cited prior art.

Support

The Delegate applied the following three-step process in determining the issue of support:

1. Construction of the claims to determine the scope of the invention as claimed;
2. Construction of the description to determine the technical contribution to the art; and
3. Determination as to whether the claims were supported by the technical contribution to the art.

Ultimately, the Delegate held that the AU134 claims corresponded to the technical contribution to the art disclosed in the description, with the technical contribution to the art being the use of an anti-IL-12/IL-23p40 antibody having the six defined CDRs sequences (these being amino acid sequences SEQ ID NO: 1 to SEQ ID NO: 6) to bind to the common p40 subunit of IL-12 and IL-23 and thereby neutralise the cellular responses mediated by these cytokines.

Outcome and Implications

The Delgate’s decision illustrates the power of strong prior art to knock out a patent application on the grounds of lack novelty and obviousness, with all claims of the AU134 claims being held to be invalid on those grounds.  The Australian Patent Office has now formally refused AU134, as Janssen did not appeal the opposition decision to the Federal Court of Australia or propose amendments aimed at overcoming the deficiencies in the claims.

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

Adama Agan Ltd. v Kumiai Chemical Industry Co., Ltd. [2025] APO 41

Introduction

IP Australia has dismissed Adama Agan Ltd’s (Adama) opposition to the grant of Kumiai Chemical Industry Co., Ltd’s (Kumiai) Australian patent application directed to an industrial process for producing the herbicide pyroxasulfone, with Kumiai’s patent application proceeding to grant in early January 2026.

The decision provides a detailed and instructive analysis of inventive step in the context of chemical process claims, particularly where the individual reaction components are well known but their specific combination addresses a substrate-specific industrial problem.  It also reinforces the limited scope of Patents Regulation 5.23 as a mechanism for admitting late-filed evidence.

Background

The application (AU 2020300922) relates to a process for oxidising a sulfide precursor to a sulfone (pyroxasulfone) using hydrogen peroxide in the presence of selected metal catalysts (tungsten, molybdenum or niobium) in a mixed aqueous/organic solvent system.

Pyroxasulfone is a commercially valuable herbicide. The specification states that known oxidation methods for preparing pyroxasulfone, including peracid-based systems, are unsuitable for industrial use due to cost, safety concerns, poor yields, and persistent sulfoxide impurities that are difficult to remove and may adversely affect herbicidal performance.  The invention described in the specification relates to a process for producing pyroxasulfone which is claimed to be superior in yield, advantageous for production on an industrial scale and contains substantially no sulfoxide derivative which can cause crop injury and impact the quality of the herbicide.

The claims of the application are directed to a process of producing pyroxasulfone, and a product produced by the process.

Claim 1 is the only independent claim, and reads as follows:

A process for producing a compound of the formula (5), the process comprising the following step iii, wherein the reaction step iii is performed in the presence of organic solvent(s) having an acceptor number of 0 to 50 and a water solvent, wherein the organic solvent for the reaction step iii is one or more organic solvents selected from alcohols, nitriles, carboxylic acid esters and amides: (step iii) a step of reacting a compound of the formula (4) with hydrogen peroxide in the presence of a metal catalyst, wherein the metal catalyst is selected from a tungsten catalyst, a molybdenum catalyst and a niobium catalyst, to produce the compound of the formula (5):

wherein in the formula (4) and the formula (5), R1 is methyl, R2 is trifluoromethyl, R3 is difluoromethyl, and R4 and R5 are methyl.

Adama pleaded numerous grounds of opposition initially, however, only the grounds of inventive step and sufficiency were pursued at the hearing. Kumiai had filed post-acceptance amendments narrowing the claims, which were allowed prior to the hearing.

Key Issues

The delegate was required to determine the following issues:

1. 1. Inventive step
      Whether the claimed process would have been obvious to the person skilled in the art in light of the common general knowledge (CGK), given that hydrogen peroxide oxidations, metal catalysts, and aqueous/organic solvent systems were individually well known.
   2. Sufficiency
      Whether the specification enabled the skilled person to perform the invention across the full scope of the claims without undue burden.
   3. Procedural issue – Regulation 5.23
      Whether late-filed expert evidence submitted by Kumiai should be consulted under Patents Regulation 5.23.

Consideration

Procedural Issue – Patents Regulation 5.23

Kumiai did not file any evidence in answer to Adama’s evidence within the deadline.  Kumiai requested an extension of time but that was refused.  Some two months later Kumiai filed evidence.  The delegate refused to consult Kumiai’s late-filed evidence, finding that it was essentially evidence in answer filed out of time, that no exceptional circumstances existed, and that admission would unfairly prejudice Adama. Importantly, the delegate concluded that the material was not crucial to resolving the opposition.

Inventive Step

Expert evidence on inventive step was filed by Adama, consisting of a declaration by Professor James Hanley Clark, a Senior Professor at the University of York specialising in green and sustainable chemistry with over 45 years of experience working in the field of chemistry.   As noted above, the expert evidence filed by Kumiai, although considered relevant, was not consulted, due to it being filed out of time.

In assessing the CGK, the delegate was satisfied that the relevant CGK included the knowledge that hydrogen peroxide is one of (many) oxidants which may be used to oxidise sulfides to sulfones, optionally in the presence of a metal catalyst, and often in the presence of water and a co-solvent such as acetone or an alcohol.  The delegate considered that various suitable metal catalysts, including tungsten-based catalysts, would be known to the skilled person as would various other oxidants and associated conditions.

Professor Clark’s evidence was that, without hindsight, he arrived at a process falling within the scope of the claims, and on this basis Adama submitted that the claims lacked an inventive step in light of the common general knowledge alone.  However, the delegate, quoting AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23] noted that it is important to recall that the notional skilled person is not a reference to a specific person, it is a tool of analysis which guides the court in determining the issue of inventive step.  The delegate stated that, as such, evidence of Professor Clark’s approach is not an answer in itself to the question of obviousness. Idiosyncratic knowledge or preferences of a skilled person are relevant to the weight that can be attached to their evidence.  While it seemed reasonably clear that the components of the claimed reaction method, individually, were part of the CGK, the question was whether the notional skilled person would be directly led to their use, in combination, with an expectation of achieving an industrially useful process for the preparation of pyroxasulfone.  Kumiai identified several difficulties with Professor Clark’s evidence which led the delegate to conclude that overall, the evidence revealed a measure of unpredictability. Added to this, the specification itself revealed a significant difference in efficacy between the Comparative and Reference Examples, despite structural similarities.  The delegate did not consider the evidence to support a conclusion that a skilled person could a priori form an expectation that an industrially useful process would be achieved with any particular oxidant (and associated reaction conditions) and substrate combination.  The delegate agreed with Kumiai that, while the claimed reaction conditions might be included in an experimental program, this does not equate to an expectation that they will solve the relevant problem, or to a conclusion that they are a combination of conditions, out of many possibilities, to which the skilled person would be “directly led”.  On balance, the delegate was not satisfied that it had been established that the notional skilled person, in view of the CGK alone, would, when seeking an industrially useful process for the production of pyroxasulfone, be directly led to the claimed combination of reaction parameters.

Adama also relied on six prior art documents to establish a lack of inventive step.  However, the delegate was not satisfied that lack of inventive step in light of any of these documents was made out.

In summary, the delegate emphasised that although each element of the claimed process was known in isolation, the correct question was whether the combination of features would have been arrived at by the skilled person with a reasonable expectation of success, not whether it could be assembled with hindsight.

The key points underpinning the finding of inventiveness included:

• Substrate-specific unpredictability
  Oxidation of sulfides to sulfones is highly substrate dependent.  The prior art showed that similar reaction conditions could yield sulfoxides, sulfones, or mixtures depending on the substrate.  There was no evidence that the skilled person would expect the claimed conditions to successfully and reliably produce pyroxasulfone with low sulfoxide content.
• Departure from mainstream industrial practice
  The evidence indicated that conventional industrial processes favoured peracid/acetic acid systems, not aqueous hydrogen peroxide systems.  The delegate found that the skilled person would not be directly led away from established industrial practice absent a clear reason to do so.
• Non-routine selection of parameters
  The claimed selection of specific metal catalysts, solvent classes defined by acceptor number, and mixed aqueous/organic systems was not shown to be routine optimisation. Rather, it reflected an inventive selection that rejected other plausible alternatives.
• Unexpected technical effect
  The specification demonstrated that peroxide-based systems using certain catalysts could stall at the sulfoxide stage, and that the claimed solvent system unexpectedly enabled sufficient oxidation to the sulfone while suppressing impurities.  Comparative examples showing failures with closely related compounds were particularly persuasive.

The delegate also cautioned against equating an expert’s personal preferences with the hypothetical skilled person, noting that expert reasoning influenced by specialist interests (such as “green chemistry”) may not reflect mainstream industrial expectations.

Sufficiency

The sufficiency ground was pleaded only in relation to claims 14 – 18 which were dependent product-by-process claims defining the product produced by the process of any one of claims 1- 12, comprising specified low percentages of the sulfoxide derivative.

Adama submitted that it was not plausible that the claims could be worked across their breadth, having regard to the number of variables (such as, reaction conditions, catalysts and solvents) which may be used in the process claimed in claim 1.   Kumiai submitted that the examples provided broad support for the claims as they demonstrated a broad range of solvents and each of the metal catalysts, and there was no evidence to suggest that anything within the claims would not work.

The delegate found that Adama failed to establish insufficiency of these claims on the basis that:

• The claims were directed to a narrowly defined substrate.
• The specification contained multiple working examples across the claimed catalyst and solvent classes.
• A skilled person could perform the invention without undue experimentation.

The delegate noted that although not every embodiment within claim 1 achieved the very low sulfoxide impurity thresholds recited in the product-by-process claims, the relevant question was whether those claims could be worked across their full scope without undue burden.  Following post-acceptance narrowing of the claims to pyroxasulfone and to specific metal catalysts, the specification was found to provide a sufficient range of examples demonstrating that the claimed impurity levels could be achieved.  Any further optimisation of reaction conditions was considered routine experimentation for the skilled person, not an undue burden.

Outcome

The opposition was unsuccessful, with the patent application proceeding to grant in early January 2026.  Costs were awarded against Kumiai up to 4 April 2024 (pre-amendment), and against Adama from that date onward, reflecting the delegate’s view that Adama should not have persisted with the opposition after the claims were narrowed.

Implications

For IP Practitioners

• This decision reinforces that chemical process claims remain defensible where inventiveness lies in the selection and combination of known reaction parameters.
• Comparative data showing failures for close analogues is highly influential in defeating obviousness attacks.
• Expert evidence must demonstrate what the skilled person would expect to succeed, not merely what is “worth trying”.
• Patent Regulation 5.23 will be applied narrowly; procedural discipline in opposition evidence remains critical.
• Strategic post-acceptance amendments can materially affect both substantive outcomes and costs exposure.

For Applicants

• Improvements to known manufacturing processes can still attract robust patent protection where they solve real industrial problems such as impurity control, yield, safety, or scalability.
• Even in mature chemistry fields, unpredictable substrate behaviour can support an inventive step finding.
• Well-drafted specifications that explain the technical problem and provide comparative evidence significantly strengthen enforceability.

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

Commonwealth Scientific and Industrial Research Organisation v Urrbrae Foods Pty Ltd [2025] FCA 1591 (16 December 2025)

Introduction

Justice Beach of the Federal Court of Australia has granted an appeal by CSIRO overturning the APO decision that CSIRO’s patent application number AU 2017292900 (the Application) was invalid due to lack of support.  In the appeal, CSIRO adduced expert evidence not put before the APO Delegate which Justice Beach was satisfied demonstrated that the specification, in the eyes of a skilled person armed with the common general knowledge, did provide proper support for the claims.  CSIRO had been given an opportunity to amend the Application to narrow the claims commensurate with the APO’s decision on lack of support but chose instead to appeal.  The opponent, Urrbrae Foods, did not participate in the appeal, did not file any evidence, and did not challenge CSIRO’s new expert evidence.  The Commissioner of Patents was granted leave to appear but did not appear at the appeal.

Key issue

As noted in our previous report, the central issue was whether the claimed invention—wheat grains exhibiting high amylose and fibre content—was enabled and supported across the full scope of the claims, or whether the disclosure only enabled and supported claims to wheat grains from specific genetic backgrounds.  The Delegate held that while the specification enabled production of grains meeting the claimed parameters in Sunco and Westonia strains of wheat, it provided no guiding principle for extending those results to other genetic lines such as EGA-Hume. The Delegate further noted that, while the specification lists a number of possible genetic backgrounds into which the triple null mutation could be introduced, it did not provide any indication that success in achieving the claimed phenotype is likely in those strains.  Justice Beach noted, in particular, the Delegate’s statement that:

The specification does not show production of any wheat grain within the scope of the claims in the EGA-Hume line.  While it may be conceivable that this could be achieved upon further work, or even repetition of the experiment disclosed in the specification, the specification provides no basis to expect that it would be obtainable.

[Emphasis added]

That “basis to expect” that the Delegate considered was missing from the specification was subsequently proven to exist by the new evidence submitted on behalf of CSIRO from Professor Peter Sharp, an emeritus professor at the University of Sydney with a PhD in genetics and over 40 years’ experience working in the field of wheat breeding, including breeding varieties of wheat with particular nutritional properties.

Justice Beach summarised Professor Sharp’s evidence, saying:

“[T]the evidence now filed in the appeal before me establishes that to the person skilled in the art equipped with the common general knowledge, the patent application provides a proof of principle, such that it would appear reasonably likely to such a person that the claimed grain could be made in a range of different genetic backgrounds, including EGA Hume”

Beach J noted that as a matter of law:

“[A] patent applicant does not need to demonstrate in the patent application “that every embodiment within the scope of the claim has been tried, tested and proved to have been enabled to be made.”  Further and consistently, it was said in another context that the disclosure need not include specific instructions as to how all possible component variants within the relevant functional definition should be obtained”

[Citations omitted]

As part of his evidence, Professor Sharp explained that, while the specification described experiments with EGA Hume variety wheat which failed to produce grain with the claimed features, these experiments were limited in scale.  Given the probabilities involved in wheat breeding, and other natural variation, Professor Sharp would expect further larger scale experiments with EGA Hume to succeed in producing grain as described in the patent claims.

Outcome and implications

In the absence of any challenge to his evidence, Justice Beach accepted Professor Sharp’s evidence and allowed the appeal, overturning the APO decision and allowing the Application to proceed to grant with the claims as originally accepted.  No order was made on costs.

Although one must be cautious in drawing conclusions from uncontested cases, this decision reinforces that support does not require working examples across the entire breadth of the claim. What matters is whether, to the skilled person armed with common general knowledge, the specification provides a credible technical basis or proof of principle that the invention will work across the claimed scope.  It also highlights the value of providing expert evidence that assists in establishing such a principle of general application.  In this case, the appeal was a valuable opportunity to revisit this issue and submit further important evidence.

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

Southern Cross Industrial Group Pty Ltd v Mickala Mining Maintenance Pty Ltd (Liability Trial) [2025] FCA 1363.

Introduction

In Southern Cross Industrial Group Pty Ltd v Mickala Mining Maintenance Pty Ltd (Liability Trial) [2025] FCA 1363, Justice Downes of the Federal Court found an innovation patent for LED lighting towers invalid for lack of novelty and innovative step.  Mickala admitted infringement of claims 1 and 4 of Southern Cross’ innovation patent, but successfully cross-claimed for revocation on the basis of five pieces of prior art, including the patentee’s own prior publications.  The decision addressed claim construction, the limits of implicit disclosure in prior art, and the standard of evidence required to establish prior public use.

Background

Southern Cross Industrial Group Pty Ltd (Southern Cross) is the owner of Innovation Patent No. 2013100095 entitled ‘Lighting Tower’ (the Patent), which claims a priority date of 30 January 2013.  The Patent relates to portable LED lighting towers used for night construction and mining operations.

The claimed invention addresses inefficiencies in conventional lighting towers by combining a low-voltage alternator directly connected to the engine shaft with an LED lighting unit mounted on a manoeuvrable mast.  Claim 1 requires that the LED lighting unit comprise a plurality of arrays of LED elements arranged at an angle relative to each other.  Claim 4 adds that the LED lighting unit comprises at least one capacitor electrically connected in parallel to the alternator.

Claims 1 and 4 are as follows (with integers identified):

Claim 1

A lighting tower comprising [integer 1.1]:

an engine [integer 1.2];

an alternator mechanically connected to the engine [integer 1.3]; and

an LED lighting unit electrically connected to the alternator [integer 1.4];

the LED lighting unit being mounted on a manoeuvrable mast [integer 1.5];

wherein the alternator is a low voltage alternator [integer 1.6];

[the alternator] having a voltage output of less than 50V [integer 1.7];

[the alternator] connected directly to a shaft of the engine [integer 1.8];

wherein the LED lighting unit comprises a plurality of arrays of LED elements [integer 1.9]; and

at least some of the plurality of arrays being arranged at an angle relative to at least some of the other arrays [integer 1.10].

          Claim 4

The lighting tower of any one of the preceding claims, wherein the LED lighting unit comprises at least one capacitor electrically connected in parallel to the alternator [integer 4.1].

Mickala Mining Maintenance Pty Ltd (Mickala) admitted infringement of claims 1 and 4 but cross-claimed for revocation based on five pieces of prior art:

(i)   an advertisement published by Southern Cross in the Australasian Mine Safety Journal (AMSJ Article);

(ii)   a Southern Cross brochure;

(iii)  Innovation Patent No. 201110074 (the 774 Patent);

(iv)  Two “EcoTower” lighting towers sold in Papua New Guinea; and

(v)   Lighting Towers manufactured by Exsto Group Pty Ltd (the Exsto Towers).

Key Issues

The key issues for determination were:

(i) The proper construction of “manoeuvrable mast” in claim 1 and “electrically connected in parallel to the alternator” in claim 4;

(ii) Whether claims 1 and 4 were anticipated by any of the five prior art references;

(iii) Whether claims 1 and 4 lacked an innovative step; and

(iv) If the claims were valid, whether Mr Englebrecht (the Director for Mickala) was personally liable for authorising infringement or as a joint tortfeasor.

Construction

Two construction issues arose.  The first concerned “manoeuvrable mast” in claim 1.  Southern Cross’ expert, Mr Sizer, considered that, in the context of the Patent, “manoeuvrable” meant the mast would be “able to rotate relative to the light tower chassis”, relying on preferred embodiments set out in the specification the Patent.

Justice Downes rejected this narrow construction.  Her Honour considered that the ordinary meaning of “mast” encompassed poles, latticework towers, and tripods, while “manoeuvrable” simply meant “able to be manoeuvred” without importing any requirement to be manoeuvrable in a specific way.  The Patent itself used “manoeuvring” to describe different movements – along the ground, height adjustment, and upward movement of the mast. Her Honour noted that selecting preferred embodiments to alter the plain meaning was impermissible as it would impose a gloss on the meaning of the word as claimed.

The second issue related to the meaning of the phrase “electrically connected in parallel to alternator” in claim 4, which was disputed by the parties.  Her Honour resolved this issue by reference to the experts, both of whom agreed that this phrase referred to a component connected across each side of the device, providing an alternate path for electricity.

Novelty

AMSJ Article

The AMSJ Article was a Southern Cross advertisement published in 2011 which included the following critical sentence: “The revolutionary Linz direct drive alternator also minimises maintenance costs”.

Mickala’s expert, Mr Fogarty, gave evidence that “direct drive” discloses an alternator connected directly to the engine via a shaft, as opposed to a belt.  Mr Sizer accepted it was likely directly connected but considered it was not “definitively and explicitly disclosed”.  Her Honour preferred Mr Fogarty’s evidence and found that integer 1.8 – ‘[the alternator] connected directly to a shaft of the engine’ – was present.  As a result, the AMSJ Article anticipated claim 1, as Southern Cross conceded that all other integers were present. However, the AMSJ Article did not anticipate claim 4 because there was no disclosure of capacitors “electrically connected in parallel”.  Mr Sizer gave uncontradicted evidence that there were multiple possible configurations for capacitors.

Southern Cross brochure

Southern Cross published the Southern Cross Brochure in 2011. Justice Downes found that this brochure did not anticipate claims 1 and 4 based on the shared views of the experts that the brochure did not disclose a lighting tower that possessed an alternator connected directly to a shaft of the engine (integer 1.8) or a lighting tower that possessed an LED lighting unit comprising at least one capacitor electrically connected in parallel to the alternator (integer 4.1).

774 Patent

Mickala also relied on Innovation Patent No. 2011100774 (the 774 Patent) entitled “A Portable Lightning Tower”, which was granted in August 2011.  The 774 Patent disclosed a “manoeuvrable mast”, but Justice Downes did not find that it anticipated claims 1 or 4.

While the 774 Patent referred to Coolon CP96 LED lights, a commercial LED lighting product, as suitable for use with the invention, and those lights were capable of angled mounting and contained parallel capacitors, the 774 Patent did not identify these features as criteria of suitability.  The person skilled in the art would understand they could use “any suitable LED lamp” without those features being required.  Her Honour observed that implicit disclosure is confined to what the document actually discloses – common general knowledge cannot be used complementarily to arrive at a disclosure the document alone does not make.

The EcoTowers

Mr Torok, another expert witness for Mickala (also the inventor of the 774 Patent), gave evidence regarding two EcoTower lighting towers sold by his company to a client in Papua New Guinea in September 2012.  Mr Torok gave unchallenged evidence that the LED lights were “capable of being arranged at different angles” and photographs showed the lights splayed on rotatable bolts, leading to Justice Downes’s finding that the EcoTowers anticipated claim 1.

However, the evidence was insufficient to establish that the EcoTowers anticipated claim 4.  Mr Torok’s affidavit stated capacitors were present, but under cross-examination, resiled from this position, stating only that “potentially there could also be capacitors installed in the lights” but that he did not know.  No direct evidence established that the Magna Vision light installed contained parallel capacitors.

The Exsto Towers

Mr Tate, a former director of Exsto Group, whom Mickala also relied on as an expert witness, gave evidence that five Exsto Towers were sold to Rio Tinto in December 2012.  The critical issue was whether the ‘LP33’ Exsto Lighting Tower was delivered on 29 January 2013, one day before the priority date of the Patent.

Mr Tate’s evidence was that he personally delivered LP33 to Clermont Coal Mine on 29 January 2013, exchanging it for a trial tower (LP14) loaned pending delivery.  His evidence was supported by a build spreadsheet recording “Send to Site” on 29 January 2013.

Southern Cross challenged this evidence on multiple grounds, including that Cyclone Oswald flooding would have prevented the journey.  Mr Tate explained that the flooding was in Bundaberg, not North Bundaberg where Exsto’s premises were located, and that he departed via Childers.  Her Honour found Mr Tate’s “spontaneous responses” reinforced his own genuine recollection, which he was able to recall by reference to the unusual flooding event, and was corroborated by contemporaneous documents.

Southern Cross admitted LP33 possessed all integers of claims 1 and 4, including the ‘Coolon CP56’ LED lights which contained capacitors connected in parallel.  Both claims were therefore anticipated by LP33.

LP14 (the trial tower loaned to Rio Tinto) was found also to have anticipated both claims, based on Mr Tate’s unchallenged evidence that all Exsto Towers from LP11 onwards had uniform features including the Coolon CP56 lights.

Innovative Step

Justice Downes found that claims 1 and 4 also lacked innovative step, on the basis that the claim integers relevant to this issue were not different to the prior art.

Infringement

Although unnecessary given the invalidity findings, Justice Downes addressed whether Mr Engelbrecht would have been personally liable for infringement.

As Mr Englebrecht was the sole director, in effective control, and the “guiding mind” of the Mickala, her Honour found that she would have inferred personal knowledge, approval and power to prevent infringing conduct, and thus, would have found Mr Englebrecht liable for authorising infringement but for the invalidity finding.

However, Mr Englebrecht would not have been liable as a joint tortfeasor, which would require showing that he “directed or procured” the tort with “close personal involvement” beyond the proper role of director.  Mickala’s admissions only established that Mr Englebrecht was involved in day-to-day management and effective control, which was insufficient to establish joint tortfeasorship.

Outcome and Implications

Sothern Cross’ infringement claims were dismissed, with Southern Cross subsequently ordered to pay Mickala’s costs on a standard basis until March 2023, and on an indemnity basis thereafter.  This aligned with Mickala’s third and final offer of compromise made on 28 February 2023 which provided that all related proceedings be dismissed and that Southern Cross pay Mickala’s costs in a fixed amount of $300,000. Her Honour considered that this offer constituted a significant compromise, given Mickala had incurred nearly $700,000 in costs to that date.

Justice Downes’s decision covered familiar territory in patent validity disputes: claim construction, the boundaries of implicit disclosure in prior art, the evidentiary requirements for establishing prior public use, and the personal liability of directors for authorised infringement and joint tortfeasorship.  Notably, the decision serves as a reminder that a patentee’s own prior publication can prove fatal to validity.

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