Biosimilars Deals 2021

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, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand 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, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand 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, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand 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.

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

Abbey Laboratories Pty Ltd v Virbac (Australia) Pty Ltd (No 3) [2025] FCA 1179

Introduction

Justice Jackman of the Federal Court has handed down judgment in proceedings between Abbey Laboratories Pty Ltd. (Abbey) and Virbac Australia Pty Ltd (Virbac), in a dispute concerning Virbac’s patent for a veterinary topical pour-on formulation for cattle containing macrocyclic lactone and levamisole.  Justice Jackman found that the majority of the patent’s claims were valid and infringed by Abbey, while three claims concerning viscosity modifiers were found invalid for lack of inventive step.

Background

The patent, AU2012227241 entitled “Veterinary Topical Formulation” with a priority date of 23 September 2011 (the 241 Patent), relates to anthelmintic formulations for treating parasitic infections in cattle.  Anthelmintics are products used to treat parasites in livestock, an important aspect of modern livestock farming.

The specification identifies five major classes of broad spectrum anthelmintic.  Of these, macrocyclic lactones, introduced in the 1980s, are described as the most potent killers of worms with a unique quality of also killing external parasites such as lice, mites and ticks.  The 241 Patent addresses the challenge of formulating a stable combination of macrocyclic lactones and levamisole in a pour-on formulation, which is ordinarily difficult given their different physicochemical properties.  The invention claimed stable formulations using specific non-aqueous solvents, namely dimethyl acetamide (DMA), dimethyl isosorbide (DMI), diethyl phthalate (DEP) and dimethyl phthalate (DMP).

Abbey commenced revocation proceedings in May 2024 and subsequently launched its competing product, Levamox Duo, in January 2025,  after an interlocutory injunction was refused in December 2024 on balance of convenience grounds.  Virbac cross-claimed for infringement.  There was no dispute that if the Patent was valid, Abbey had infringed by offering to sell and supplying Levamox Duo in Australia.

Key Issues and Consideration

Inventive Step

Abbey challenged claims 1-10, 13, 15, 16, 18-21 on lack of inventive step.  Claim 1 is as follows (with integers identified):

1.1    A stable formulation including

1.1(a)   a levamisole active ingredient and

1.1(b)   at least one active selected from the group known as macrocyclic lactones

1.2    with both of said actives being dissolved in a non-aqueous system, including solvents selected from DMA, DMI, DEP and DMP

1.3    wherein the formulation is a topical formulation for administration

1.4    to cattle

Abbey had initially also challenged claims 11 and 12 (relating to additional anthelmintics such as triclabendazole), but abandoned that challenge.

Abbey’s inventive step challenge focused on two key propositions: that a person skilled in the art (PSA), would obviously adopt a non-aqueous solvent system, and that the PSA would select one of the four specified solvents.  Both these challenges failed.

Abbey’s expert, Dr Alawi (a pharmaceutical formulator with extensive experience in the animal health industry, including as co-inventor on competing patents), gave evidence that using a non-aqueous system was “the usual approach” for dissolving lipophilic molecules and that including water would be “unusual and a waste of time”.  However, Justice Jackman found that Dr Alawi’s evidence was based on his own specialised research experience rather than the common general knowledge.  Critically, Dr Alawi’s position was contradicted by his own prior conduct.  In developing the invention the subject of New Zealand patent NZ 20060552040 (the 040 Patent), Dr Alawi had tested twelve aqueous formulations combining abamectin and levamisole.  More significantly, for another patent in the same field filed just three months before the 241 Patent’s priority date, Dr Alawi had trialled over forty formulations with eleven out of thirteen test formulations using water and various salt forms of levamisole.

Justice Jackman accepted evidence from Virbac’s expert, Professor Bunt, that a PSA would not exclude water from consideration without first testing.  Professor Bunt explained that water and water-based solvents are generally safer on animals, easier to formulate and less expensive than organic solvents.  Professor Bunt considered that he would have begun testing levamisole’s solubility in water across different pH values, prioritising the salt form of levamisole as salts are the most water-soluble form of a compound.  Dr Alawi admitted in cross-examination that someone who had not conducted his research program would say: “Okay. Let’s try the water” and “let’s try the levamisole … hydrochloride format”.

The Court also considered whether the PSA would have selected any of the four solvents specified in claim 1 (namely, DMA, DMI, DEP and DMP).  Database search evidence relied upon by Virbac showed that DMI, DEP and DMP were not used in any veterinary product at the priority date, and DMA appeared in only one product.

Professor Bunt gave evidence that DMA would have been an unlikely choice due to its known skin irritancy, distinct unpleasant odour, being water-miscible and quite fluid, causing run-off concerns, links to reproductive and developmental toxicity, flammability concerns, and potential regulatory difficulties given its limited prior use in veterinary products.

As to DMI, Professor Bunt had never used it, did not keep it in his ‘library’ of solvents, was not aware of others using it for veterinary formulations, and noted concerns about regulatory approval and cost.  Dr Alawi had not used DMI in any of his prior research work for various patents, explaining he included it in his solvent list as a “back up”.  The Court rejected this explanation, finding the most plausible explanation was that Dr Alawi’s awareness of Virbac’s Cydectin Platinum product led him to include DMI in his list.

As to the phthalates (DEP and DMP), Dr Alawi had not used them in his work for the 040 Patent but listed them as a “back up”.  Neither Dr Alawi, Dr Agnew nor the database search evidence identified any veterinary products using phthalates.  Professor Bunt said it had never been his preference to consider a phthalate when other materials could function just as well.

Justice Jackman accepted Professor Bunt’s list of preferred solvents for the hypothetical task, which in order of preference were: water, PEGs; propylene glycol; glycerol formal; ethanol; benzyl alcohol; methyl ethyl ketone; and NMP – none of which were the solvents listed in claim 1.

Accordingly, his Honour held that it was not obvious that the PSA would adopt a non-aqueous solvent system, nor would the PSA select any of the four solvents listed in claim 1.  Abbey’s inventive step challenge to claim 1 and its dependent claims (claims 2-10, 13, 15) therefore failed.

As to the independent claim 16 (a method of preparation claim requiring dissolving actives in at least one of DMI, DMA, DEP or DMP), as the selection of those solvents was not obvious, his Honour also found this claim to be inventive.

However, claim 19 (a solvent-based topical formulation containing a macrocyclic lactone and levamisole in organic solvents with a viscosity modifier) did not require the use of DMI, DMA, DEP or DMP, but merely the use of one or more organic solvents together with a viscosity modifier.  Professor Bunt’s choice of potential solvents included a number of organic solvents, and his Honour considered that there was nothing inventive about the use of organic solvents in this kind of formulation.  The addition of viscosity modifiers was also common practice within the industry as at the priority date of the 241 Patent – 23 September 2011.  Justice Jackman consequently found claim 19 lacked an inventive step and was invalid.  Claims 20 and 21, being dependant on claim 19, and merely stipulating the concentration and type of viscosity modifier, were also invalid.

Abbey also relied on three pieces of prior art information in its inventive step challenge.  However, his Honour found these documents did not indicate that the development of an anthelmintic combination formulation for cattle should only use a non-aqueous system, nor did they identify any of the solvents specifically nominated in the 241 Patent for pour-on formulations.

Novelty

Abbey relied on a “whole of contents” novelty objection based on Australian patent AU2011234984 (the 984 Patent), directed to compositions comprising four different active agents (1–arylpyrazole, a macrocyclic lactone, an insect growth regulator, and an anthelmintic) for treating parasites.

A preliminary issue arose as to whether Abbey needed to formulate a set of “notional claims” to establish anticipation.  Since EI Du Pont de Nemours and Co v ICI Chemicals & Polymers Ltd [2005] FCA 892; (2005) 66 IPR 462 (Du Pont), it had been understood that a “whole of contents” objection required formulating notional claims that would be fairly based on the prior disclosure.

Justice Jackman declined to follow Du Pont, stating that its reasoning was “wrong”.  The statutory language – “if the information … were to be, the subject of a claim” – does not require information to actually be drafted as a claim.  The legislative history showed the “whole of contents” approach was introduced in response to the Industrial Property Advisory Committee’s recommendation to replace the “unsatisfactory” and “too narrow” prior claiming approach with a “simpler mechanism”.  Requiring notional claims would “re-re-route Australian patent law back towards something resembling prior claiming … but in an even more obscure form”.

His Honour also observed that, when considering whether to depart from earlier single judge decisions, a Judge should not approach such a task through the lens of “judicial comity”, a term which “creates the unfortunate impression that judges should give priority to questions of courtesy and politeness to each other over their duty to apply the law as properly understood”.  Instead, the question is whether there is a “compelling reason” to depart, rather than whether the earlier decision was “plainly” or “clearly” wrong.

Comparison with the 984 Patent

Turning to the comparison between the 241 Patent and the 984 Patent, Justice Jackman found there was no “clear and unmistakable direction” in the 984 Patent to make any formulation within the claims of the 241 Patent.  The 984 Patent required four active ingredients (whereas the Patent required two); listed levamisole as merely one of sixteen possible anthelmintic options; expressly encompassed aqueous formulations (the 241 Patent required non-aqueous); and listed DMA and DMI among over 25 solvents without preference or specific combination with levamisole.  Abbey’s approach of finding isolated references to individual claim features in different parts of the 984 Patent was rejected as failing to anticipate the specific combinations claimed.

Ferrocom Inferences

Abbey submitted that adverse inferences should be drawn under Commercial Union Assurance Company of Australia Ltd v Ferrcom Pty Ltd (1991) 22 NSWLR 389 (Ferrcom) from matters Virbac’s expert, Professor Bunt, had not addressed in evidence in chief – specifically, the obviousness of the solvent concentration ranges in claim 2.  Justice Jackman rejected this as “misplaced” as Professor Bunt had already explained that he would not have selected the relevant solvents in the first place, so there was no need for him to address the concentration ranges of solvents he would not have chosen.

More fundamentally, his Honour held that there would “rarely (if ever)” be scope for such an inference in contemporary expert evidence practice, given the requirement for expert conferences, joint reports, and declarations that all appropriate inquiries have been made.  These safeguards mean “contemporary practice thus does not leave any effective room for a party tactically to seek to ensure that certain subject matter is avoided by an expert witness”.

Outcome and Implications

Justice Jackman found that Abbey had infringed claims 1-10, 13, 15, 16 and 18, and granted an injunction preventing the sale of Levamox Duo, with an inquiry on costs to follow.  His Honour found claims 19-21 invalid.  Abbey has subsequently appealed the decision.

Justice Jackson’s decision demonstrates the importance of ensuring that an expert’s opinion on the issue of inventive step is based on the CGK and not knowledge specific to that particular expert which is not representative of the CGK. His Honour’s judgment also illustrates the power of prior patents and publications to corroborate or dispute the approach which PSAs would have taken to research around the time of the priority date.

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.