Biosimilars Deals 2021

PI decision to be handed down 6 days after PI hearing. 

Justice Downes of the Federal Court of Australia is setting new records for expedition in a patent dispute between AstraZeneca and Pharmacor, relating to the latter’s generic dapagliflozin.  Following the hearing last Friday (6 February 2026) on the first week of the Court sitting in 2026, judgment on AstraZeneca’s PI application will be handed down next Monday (16 February), the 6^th working day after the hearing.  The hearing was 7 weeks from AstraZeneca’s application and the decision will be delivered 2 months from commencement despite the Court’s 6-week summer recess.  The substantive trial is likely to be scheduled to begin on 31 August 2026, 8 and a half months from commencement.

These timelines are unprecedented.  Justice Downes is demonstrating the Court’s sensitivity to commercial drivers where circumstances require it.

Assuming the matter proceeds to hearing in August, Justice Downes will be setting a new record for a substantive hearing in the Federal Court.  This will be faster even than Juno and Natco’s expedited hearing against Celgene before Justice Beach in 2021 regarding validity (and infringement) of a patent relating to blockbuster lenalidomide (in which Pearce IP acted for Juno and Natco).  That case went to hearing in 10 months (but without an interlocutory dispute) with his Honour promising judgement within 6 weeks (although the matter settled following the hearing).

The dispute between AstraZeneca and Pharmacor relates to infringement and validity of AU2003237886, AstraZeneca’s Australian patent to dapagliflozin, the active ingredient of its FORXIGA® type II diabetes treatment.  Pharmacor obtained ARTG registration of generic dapagliflozin products on 14 November 2025.

AstraZeneca filed infringement proceedings on 16 December 2025, with an application for a preliminary injunction restraining the launch of Pharmacor’s products.  Timetable orders were made by consent on the last sitting day of the year (19 December 2025), and the application for interlocutory injunction was heard on the first sitting week of the year.

At the beginning of the 6 February PI hearing, counsel for AstraZeneca informed the Court that the Department of Health’s position was if Pharmacor’s PBS listing application was to be withdrawn, it would need to do so by 18 February 2026.  AstraZeneca therefore sought a decision by this date.  The Court has met AstraZeneca’s request and will deliver a decision on 16 February, a record breaking 6 business days from the hearing, and 62 days from commencement, 44 of which were during the Court recess!

During the hearing, the parties discussed the possibility of a substantive trial, of five to seven days’ duration, commencing on 31 August 2026, i.e. only 258 days from commencement (including holidays).  The trial date is yet to be confirmed by Court orders.

Pearce IP maintains a close watch on all Australian patent proceedings and there has not been any first instance trial in a pharmaceutical patent dispute in less time than is proposed here in the last 30 years.

AstraZeneca has asserted four claims of one patent, which expires in 20 months.  Pharmacor is contesting validity of the asserted claims and is relying on one prior art publication, PCT/US0027187.  Pharmacor has also raised defences to infringement of a composition claim and a method of treatment claim under the term extension provisions of the Patents Act.

Generic pharmaceutical manufacturers setting strategies to enter the Australian market will already be aware of the current trend of the Courts to refuse PI.  It remains to be seen whether this proceeding will continue or buck this trend.  They should also take account of the potential for rapid resolution of both PI applications and substantive patent infringement/invalidity matters.

We will report further on Monday, once the interlocutory decision is issued.

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.

UON Pty Ltd v Hoascar (No 2) [2025] FCA 1608

Introduction

This decision highlights the difference between disclosure under patent law and disclosure of confidential information and confirms that, just because an invention has been made “publicly available”, this does not mean that the invention has lost its confidential nature.

Background

The interlocutory application considered in this matter arises from the infringement proceedings the subject of Allied Pumps Pty Ltd v LAA Industries Pty Ltd [2023] FCA 1457 (Allied Pumps (2023)) (see our case summary here).

By way of brief summary of the background and the cast of characters involved in this dispute, it is useful to know:

1. LAA Industries (LAA) was the proprietor of Australian innovation patent AU2020103197 (Patent) for an electric submersible pump used to lift water from underground, commonly used in mining.  The Patent was licensed to UON.  In Allied Pumps (2023), Allied Pumps Pty Ltd sought revocation of the Patent for lack of novelty, while LAA and its licensee, UON, filed a cross-claim asserting infringement.
2. In Allied Pumps (2023), Justice Downes found that the Patent lacked novelty because UON had supplied submersible pumps to another mining company, Roy Hill Iron Ore Pty Ltd (Roy Hill), before the priority date of the Patent, for the purposes of a trial period and that trial amounted to novelty-destroying prior use.  The Patent was therefore revoked.
3. Mr Hoascar was originally employed with UON Pty Ltd, the applicant in these proceedings, which were commenced in 2021.
4. During his employment with UON, Mr Hoascar obtained confidential information about UON’s submersible pumps.  Mr Hoascar’s next employer after UON was Taranis Power Group Pty Ltd (Taranis).
5. When these proceedings were commenced, UON claimed that Mr Hoascar disclosed the confidential information about UON’s pump to Taranis, breaching contractual and equitable obligations of confidence. UON also claimed that Taranis’ use of the information provided by Mr Hoascar amounted to patent infringement.
6. As a result of Allied Pumps (2023) and the Patent being revoked, LAA removed the patent infringement claim from its Statement of Claim in these Proceedings.
7. Mr Hoascar and Taranis subsequently brought an interlocutory application to strike out the remaining substantive aspects of LAA’s Statement of Claim for these Proceedings, namely:
   1. The breach of confidentiality obligations by Mr Hoascar;
   2. Related claims for misleading and deceptive conduct and breach of fiduciary duties by Mr Hoascar; and
   3. Breach of confidence claims against Taranis,

saying that it would be an abuse of process in light of the findings in Allied Pumps (2023) that the Patent was not novel at its priority date.

The current decision sets out Justice Jackson’s findings in relation to Mr Hoascar’s and Taranis’ interlocutory strike out application.

Key Issues

Justice Jackson held that whether the strike out application should succeed depended on whether the information passed from Mr Hoascar to Taranis and used to Taranis’ commercial advantage was, in fact, confidential and the subject of confidentiality obligations, given that the Patent had been revoked for lack of novelty at its priority date.

His Honour relied strongly on Justice Downes’ findings in Allied Pumps (2023) regarding whether the trial period of the submersible pumps with Roy Hill resulted in a destruction of the confidential nature of the relevant information.  Justice Downes had found that:

• Roy Hill had not been subject to any confidentiality obligations during the trial period;
• A UON support technician had made information publicly available during their support of Roy Hill employees during the trial period;
• A Roy Hill employee involved in the trial of UON’s submersible pumps “considered himself free in law and equity to tell the world about what he did and observed” (Allied Pumps (2023) at [326]); and
• These factors had contributed to the novelty-destroying prior use.

However, Justice Jackson was clear that patent validity and misuse of confidential information are different concepts at law and the two most not be conflated.

Consideration

When considering whether the disclosures during the Roy Hill trial period resulted in the destruction of the confidential nature of certain information, Justice Jackson stated that “it does not follow…that unfettered disclosure to a small group of persons results in the loss of the necessary quality of confidence…” (at [68]).  His Honour held that:

• demonstration of the submersible pumps to a small number of employees at Roy Hill, even without any confidentiality restraints, did not amount to a loss of confidentiality as a whole (at [71]);
• even though there were prior art documents that also destroyed the novelty of UON’s Patent, it was necessary to take into account that UON relied on express contractual terms to maintain confidentiality of certain information. The presence of a prior art document that destroys novelty does not necessarily destroy confidentiality ([73]-[74]); and
• in line with Justice Downes’ comments in Allied Pumps (2023), the Roy Hill trial period did not necessarily mean that confidentiality of the information had been destroyed.  Whether the disclosure of certain information to a limited number of people constituted a public disclosure destroying confidentiality is “a question of fact, a question of degree, and so a question for trial” (at [82]).

Outcome

For these reasons, Justice Jackson held that the findings in Allied Pumps (2023) did not necessarily prevent UON from pursuing its claims against Mr Hoascar and Taranis in relation to breach of confidentiality obligations.  The strike out application was dismissed with costs.  The proceedings remain on foot, with the parties now preparing the case for a final hearing.  We will update you when and if there is a final judgment on the allegation of breach of confidentiality obligations.

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.

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.

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