Biosimilars Deals 2021

Urrbrae Foods Pty Ltd v Commonwealth Scientific and Industrial Research Organisation [2025] APO 12

Introduction

The Australian Patent Office (APO) upheld an opposition by Urrbrae Foods Pty Ltd against CSIRO’s patent application number AU2017292900 (the Application) directed to high amylose wheat.  While grounds of manner of manufacture and entitlement failed, the Delegate found the claims lacked support and the opposition was successful on that ground.  CSIRO was given two months to amend, and costs were awarded against it.  No amendments have been filed.  Instead, CSIRO has filed an appeal of the decision in the Federal Court.

Background

The application, entitled “High amylose wheat – III” relates to high amylose wheat plants and methods of producing them.  The invention concerns wheat grains having null mutations in all three SSIIa genes (A, B and D genomes), leading to increased amylose content (≥45%) and higher dietary fibre fractions such as β-glucan, arabinoxylan, cellulose and fructan.  These traits are purported to improve nutritional value and human health outcomes.

The application contained 28 claims at acceptance.  Claim 1, as the only independent claim, reads as follows:

Wheat grain of the species Triticum aestivum, the grain comprising

i.       mutations in each of its SSIIa genes such that the grain is homozygous for a null mutation in its SSIIa-A gene, homozygous for a null mutation in its SSIIa-B gene and homozygous for a null mutation in its SSIIa-D gene,

ii.       a total starch content comprising an amylose content and an amylopectin content,

iii.    a fructan content which is increased relative to wild-type wheat grain on a weight basis, preferably between 3% and 12% of the grain weight,

iv.      a β-glucan content,

v.       an arabinoxylan content,

vi.      a cellulose content,

the grain having a grain weight of between 25mg and 60mg, wherein the amylose content is between 45% and 70% on a weight basis of the total starch content of the grain as determined by iodine binding assay, wherein the amylopectin content on a weight basis is reduced relative to the wild-type wheat grain, wherein each of the β-glucan content, arabinoxylan content and cellulose content are increased relative to the wild-type grain on a weight basis, such that the sum of the fructan content, β-glucan content, arabinoxylan content and cellulose content is between 15% and 30% of the grain weight.

Dependent claims are directed to flour, food products, methods of producing the wheat, and uses in human nutrition.

Urrbrae initially opposed the application on the grounds of entitlement, manner of manufacture, novelty, inventive step, utility and support.  At the hearing, however, Urrbrae pressed only the grounds of manner of manufacture, support and entitlement.

Key Issues

Lack of Support

The central issue in the case concerned 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.

Urrbrae argued that the CSIRO’s technical contribution was confined to grains developed from the Sunco genetic background.  The specification itself, via the worked examples, highlighted Sunco as uniquely successful in achieving the claimed characteristics of the wheat, while grains from other genetic backgrounds such as EGA-Hume and Westonia lines either failed to achieve the claimed characteristics or achieved inconsistent results.  Urrbrae submitted that this demonstrated that the invention could not be performed across its full breadth, and that the claims therefore extended beyond what was enabled or supported by the specification.

In contrast, the CSIRO argued that the invention lay not simply in the generation of the claimed grain lines from one genetic background, but in the method of generating, screening, and selecting suitable lines.  CSIRO maintained that the specification provided sufficient guidance to enable the skilled person to reproduce the invention across different wheat cultivars, without undue experimentation, and that it was unnecessary to exemplify every possible genetic background.  CSIRO characterised Urrbae’s objection as being that, a priori, it is not possible to generate only wheat grain with the required characteristics.

The Delegate agreed in part with Urrbrae, finding that while the specification clearly enabled production of grains meeting the claimed parameters in Sunco and Westonia backgrounds, it provided no guiding principle for extending those results to other genetic lines such as EGA-Hume.  The Delegate noted that, while the specification lists a number of possible genetic backgrounds into which the triple null mutation could be introduced, it does not provide any indication that success in achieving the claimed phenotype is likely in those strains.  The Delegate referred to the comments of Lord Hoffman in Biogen to the effect that where a patentee provides a new product with a beneficial effect but cannot demonstrate a common principle by which a beneficial effect will be shared by other products of the class, they will not be entitled to a claim to the entire class, as being apt in this case.  The Delegate found that the specification recognises that the genetic background of the wheat is important to achieving the claimed results, but there is no further elucidation of any associated principle that would support a technical contribution to the art of the scope claimed.  Determination of whether wheat grains from any particular genetic background will afford the claimed results effectively left the skilled person to conduct a trial-and-error research project where the outcome is uncertain.  As such, the Delegate found that the technical contribution was limited to the success demonstrated in the Sunco and Westonia genetic lines, and the broader claims were not supported to the extent that they encompassed other wheat grains from other genetic backgrounds.

Manner of Manufacture

Urrbrae argued that the invention did not constitute a manner of manufacture under s 18(1)(a) of the Patents Act 1990, contending that (i) the claims lacked inventive character on the face of the specification, and (ii) not everything within the claims was the result of human action.

Lack of Inventive Character

Urrbrae submitted that there is no inventiveness in developing triple null grain with the intention of producing high amylose wheat plants, particularly where there is a need for improving high amylose wheat plants.  Urrbrae argued that the invention was no more than the use of a known property (increased amylose content) of a known article (triple null wheat) for a new use for which that property makes it suitable, and the serendipitous discovery of other properties or characteristics of that wheat do not take it outside of this category.

CSIRO responded that the prior art incorporated into the specification does not state that grain with the defined characteristics could be produced and that admissions that it was known that triple null wheat had a higher amylose content than wild type do not amount to an admission that grain with the combined claimed characteristics was known. CSIRO also pointed to the specification’s reference to the SBEIIa gene as a more obvious target if seeking to produce wheat with at least 50% amylose.

The Delegate was not persuaded that the specification on its face reveals an absence of the requisite quality of inventiveness, stating that while it may have been obvious to generate triple null wheat with an objective of increased amylose content, the specification makes no clear admission that a grain having an amylose content of 45% and the other parameters defined in the present claims was known or a desired result.  To the contrary, that is presented as the invention.  The Delegate stated that it was not apparent on the face of the specification that the claimed invention would be arrived at without invention.

Result of Human Action

Urrbrae argued that the claimed wheat plants were not the result of human action, since the specification allowed for the possibility of naturally occurring mutations and natural crossing or self-fertilisation of grain lines.  On that basis, Urrbrae submitted that the claims could capture plants arising without human intervention.

CSIRO responded that there was no evidence that triple-null wheat plants—those with mutations in all three SSIIa genes and exhibiting the claimed composition—occur naturally.  The specification, particularly Example 4 and its breeding schematics, demonstrated extensive human involvement through controlled crossing, backcrossing, and selection to achieve the desired phenotype.

The Delegate noted that even if natural mutations are theoretically possible, that does not mean they exist in practice.  There was no evidence that any naturally occurring plants fell within the scope of the claims.

The Delegate held that the claimed invention was clearly the product of deliberate human breeding and selection, not a spontaneous natural occurrence.  A mere possibility of natural existence does not meet the balance of probabilities threshold.  Accordingly, the ground that the claims were not the result of human action was not made out.

Lack of Entitlement

Urrbrae alleged the invention was first made by Dr Colin Jenner, whose ‘Cross III’ wheat achieved amylose contents of up to 55%.  However, the Delegate found that there was no persuasive evidence that CSIRO derived its invention from Dr Jenner.  Whilst no evidence was filed by the named inventor, which the Delegate noted would have been the best evidence, internal CSIRO documentation showed the inventive concept was developed independently of Dr Jenner.  The entitlement ground therefore failed.

Outcome

The opposition succeeded on the ground of lack of support.  The grounds of manner of manufacture and entitlement were rejected.  CSIRO was given two months to file amendments to narrow the claims to align with its demonstrated contribution to the art. Costs were awarded against CSIRO.  CSIRO has not filed any amendments.  Instead, CSIRO has filed an appeal with the Federal Court.

Implications

This decision demonstrates the APO’s strict application of post-Raising the Bar support requirements in the agricultural biotech space.  Broad claims encompassing wheat grains from all genetic lines were not allowed due to a lack of consistent experimental evidence that established a principle of general application.  This finding emphasises the importance, in biotechnology and plant breeding cases, of articulating a clear principle or rationale for why an invention should be expected to work across its claimed scope, particularly when results vary across genetic backgrounds.  Without this, patent applicants risk having their monopoly confined to specific examples rather than the broader class of products they intended to protect.

The decision also confirms that plant breeding inventions remain patentable in Australia where they involve deliberate human intervention, even if some mutations could theoretically occur in nature.  However, patentees should ensure their specifications clearly describe the inventive human contribution, particularly where the invention builds on naturally occurring traits or known breeding systems.

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.

Seqirus, Inc. v Translate Bio, Inc. [2025] APO 5 (18 February 2025)

Background

Seqirus, Inc. opposed Translate Bio, Inc.’s patent application (AU2020202755) concerning the in vivo delivery of mRNA for augmenting proteins and enzymes in genetic diseases.  The invention’s contribution lay in specific liposome-forming lipid combinations (and ratios) which encapsulate the mRNA to facilitate delivery into a cell.  Whilst the specification exemplified liposomes with specific combinations and ratios of various lipids, the claims defined the combinations more broadly than what was exemplified.

Seqirus opposed the application on several grounds, including novelty, inventive step, utility, clarity, sufficiency and support.  The fate of the opposition ultimately turned on the questions of sufficiency (clear enough and complete enough disclosure) and support.

Key Issues and Consideration

Novelty and Inventive Step

The novelty and inventive step debates were straightforward.

Seqirus raised a series of prior art documents on the question of novelty.  The Delegate, however, was not persuaded that any of this prior art provided a clear and unmistakable direction for the claimed liposome composition having the required combination of lipid components, encapsulating within its interior mRNA having the required structure, and a size of less than about 150 nm.

The Delegate then considered inventive step based on the common general knowledge alone and taken together with a series of prior art documents.  When considered in light of the common general knowledge alone, the Delegate stated that, at best, the evidence suggested that a person skilled in the art would have contemplated formulating mRNA with liposomes.  However, it remained unanswered whether the liposome would have encapsulated or merely formed complexes with the mRNA, and what liposome formulation would have been used or what structural modifications may have been carried out on the mRNA.  Ultimately, the Delegate found that, while each feature of the claims was individually known in the art, the combination of those features was not obvious.  The Delegate also did not accept that a person skilled in the art faced with the problem of formulating mRNA for delivery, transfection and protein expression, and armed with any one of the prior art documents would arrive at the claimed invention as a matter of routine.

Utility

On the question of utility, both sides agreed that the specification showed that the scope of the claims included something that was capable of delivering mRNA to a cell and expressing the encoded protein in vivo.  Seqirus argued that a therapeutic effect was also required (but not demonstrated).  However, the Delegate, agreeing with Translate Bio, held that the ‘promise’ of the invention was delivery, transfection, and expression only, and that no therapeutic effect was required.  Consequently, this ground of opposition failed.

Sufficiency (clear enough and complete enough)

This was the decisive issue (together with that of support).

Australia’s law on sufficiency requires the specification to disclose the claimed invention in a manner that is clear enough and complete enough to enable a skilled person to perform the invention across the full width of the claims without undue burden or further invention.

In the present case, the claims covered broad ranges of lipid ratios (e.g., 20–70% cationic lipid, 5%–90% non-cationic lipid (cholesterol and either DSPC or DOPE) and 1 %–15% PEG-modified lipids, but the specification only exemplified narrow ranges (e.g., 25–30% cationic lipid, ~40% cholesterol, 4% PEG-lipid).  The question at hand, was whether Translate Bio’s contribution to the art extends to the general principle of encapsulating mRNA within the full breadth of the claimed liposomes and whether this has been sufficiently enabled.  Experts on both sides agreed that small deviations in lipid content could collapse formulation stability of the essential liposome.  In accepting the evidence presented, the Delegate concluded that each component in the liposome had structural and functional features, and that, if these components were not properly balanced, the successful formation of the liposome which was essential for delivery of the mRNA to the cell could be disrupted.  Thus, the Delegate concluded that the specification did not provide a general principle for broader application beyond what was illustrated in the examples.  As such the claims were said to be overly broad and not enabled across the full scope of the claims.

Support

For similar reasons, the broad monopoly claimed was not commensurate with the technical contribution.  Translate Bio’s demonstrated contribution lay in identifying certain four-component lipid mixtures suitable for encapsulating and delivering mRNA, not a general principle covering all the broadly claimed ranges.

Outcome

The opposition succeeded on grounds of insufficiency and lack of support.  All claims were found invalid in their current form.  Translate Bio was given two months to propose amendments to overcome these deficiencies, but no amendments were proposed before the deadline.  The application was formally refused on 12 May 2025, and costs were awarded to Seqirus.

Implications

Patent applicants should be careful to:

• describe the invention thoroughly in the specification and include multiple different embodiments and variations traversing the full scope of the claims;
• exercise caution when drafting claims which go beyond what is exemplified;
• avoid overly broad generalisations which are not supported by a clear and detailed description; and
• provide a clear and logical progression from the worked examples to the broader embodiments, including a detailed outline of any claimed principle of general application.

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.

Highlight

This decision concerns the apportionment of costs arising from the substantive decision in Miele & Cie KG v Bruckbauer [2025] FCA 537 (27 May 2025) (Substantive Decision). Justice Rofe considered the appropriate apportionment of costs where Bruckbauer had rejected a Calderbank offer from Miele but ultimately failed in its infringement case, and where Miele had made certain strategic choices which resulted in higher evidence costs being incurred by both parties but with no effect on the overall result of the case.

Background

In the Substantive Decision in May 2025, Miele succeeded in revoking relevant claims of Bruckbauer’s patent AU2012247900 entitled “Hob with central removal of cooking vapours by suction-extraction in the downward direction” (the Patent), which Bruckbauer claimed were infringed by Miele’s cook-top hobs. The revocation of the relevant claims meant that Miele’s cook-top hobs did not infringe Bruckbauer’s Patent.

In the course of the infringement proceedings, and after the close of evidence, Miele served Bruckbauer with a Notice of Offer to Compromise together with a Calderbank offer. The Notice and Calderbank offer together proposed resolution of the proceedings, including that Bruckbauer would pay Miele’s costs in the sum of AUD $250,000, and that the parties would take all necessary steps to facilitate suitable orders being made by the Court to support the resolution of the matter and the payment of costs to Miele. Bruckbauer rejected the offer but subsequently failed in its infringement case.

Key Issues and Consideration

Since Miele succeeded in the Substantive Decision, Miele was entitled to costs. As a result of the Notice and Calderbank offer, Miele argued that it was entitled to indemnity costs. The parties disagreed on two issues affecting the apportionment of costs, namely whether:

1. Miele’s recoverable costs should be discounted due to Miele’s lack of success in relation to certain issues argued in the case (the Chinese Amendments); and

2. Miele should be awarded a portion of its costs on an indemnity basis due to the rejected Calderbank.

In relation to the first point, Miele had argued in the substantive proceedings that the Chinese Amendments (which were amendments made by Bruckbauer to one of its Chinese patent applications) were publicly available in 2015 and disclosed the invention claimed in the Patent, therefore making the relevant claims of the Patent invalid. This argument was ultimately unsuccessful but resulted in a substantial amount of evidence being dedicated to the Chinese Amendments, including unscheduled evidence from Miele which was served days before the start of the trial. Justice Rofe found that a significant portion of the trial was devoted to the issue of the public availability of the Chinese Amendments and the trial was extended due to issues with interpreter-related delays (i.e. lengthening of cross examination due to translation of questions and answers) and uncooperative conduct from witnesses on both sides. Justice Rofe found that it was appropriate to reduce Miele’s costs by 15%, as Miele had initiated the Chinese Amendments issue and the related line of evidence, which ultimately did not add any value to Miele’s invalidity case against the Patent. Accordingly, her Honour considered that the costs would not have been incurred had the issue of the Chinese Amendments not been raised.

In relation to the second point, Justice Rofe considered whether Miele was entitled to indemnity costs under Rule 25.14(3) of the Federal Court Rules 2011 (Cth), which provides:

(3) If an offer is made by an applicant and not accepted by a respondent, and the applicant obtains a judgment that is more favourable than the terms of the offer, the applicant is entitled to an order that the respondent pay the applicant’s costs:

(a) before 11.00 am on the second business day after the offer was served–on a party and party basis; and

(b) after the time mentioned in paragraph (a)–on an indemnity basis.

Bruckbauer argued that, the Substantive Decision was not more favourable to Miele than what was proposed by Miele under the offer, that the offer was not a genuine compromise and, for those reasons it was reasonable for Bruckbauer to reject the offer. Justice Rofe disagreed, saying that Miele had achieved a more favourable judgment than what was proposed in the offer. Her Honour also considered that no exceptional circumstances existed which would justify an order inconsistent with the Federal Court Rules. Justice Rofe was of the view that the Calderbank offer, which explained why Miele believed it would succeed at trial, constituted a genuine offer of compromise as there was little else that Miele could offer to Bruckbauer by way of compromise and that, by the time Miele extended the offer, Bruckbauer should have been aware that its infringement case was weak. As a result, no exceptional circumstances were established.

Outcome and Implications

Bruckbauer was ordered to pay 85% of Miele’s costs on an indemnity basis from the second business day after the offer was served on Bruckbauer. Miele’s overall costs were discounted by 15% because it had chosen to pursue the Chinese Amendments issue and the associated line of evidence which ultimately had no impact on the outcome of the case.

Justice Rofe’s decision highlights the impact that evidentiary decisions and offers of compromise can have on the extent of the ultimate costs orders. This is of great significance given the high cost of patent litigation 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.

Oxford Nanopore Technologies Plc v MGI Australia Pty Ltd (No 2) [2025] FCA 869

Highlight

Justice Jackman has confirmed that, in the context of a preliminary discovery application, where a prospective applicant vacates a hearing date and the prospective respondent has incurred costs in preparing for the vacated hearing, the question of costs should be determined later, either in the course of disposing of the preliminary discovery proceedings or in any substantive patent infringement proceedings that are later commenced. As a result, MGI Australia failed in its application for costs incurred in preparing for the vacated preliminary discovery hearing.

Background

In March 2025, Oxford Nanopore Technology (ONT) commenced an application for preliminary discovery from MGI Australia (MGI) in order to decide whether to commence patent infringement proceedings against MGI. Since December 2024, MGI had refused to provide samples of its nanopore sequencing devices to ONT so that ONT could determine whether ONT’s patents were infringed by those devices. In the course of these proceedings, the hearing of the application for preliminary discovery was listed for 24 July 2025 and MGI had filed evidence in answer to the application on 28 May 2025.

In late June 2025, ONT informed MGI that it had been able to independently acquire some, but not all, of the materials the subject of the application and that ONT expected to have sufficient basis to commence substantive proceedings for patent infringement. On 4 July 2025, the parties proposed that, among other things, the hearing listed for 24 July 2025 be vacated and that the current proceedings be stayed for three (3) months so that ONT could decide whether to file substantive proceedings within that three (3) month period. In addition to those proposed orders, MGI proposed that ONT pay MGI’s costs incurred in preparing for the vacated hearing. ONT opposed this order, so Justice Jackman indicated that he would decide the matter on the papers, with parties to make suitable submissions.

Key Issues

The key issue under consideration was whether ONT should be responsible for MGI’s costs in preparing for the hearing that was vacated. MGI’s position was that ONT would ordinarily be required to pay costs thrown away by its application and vacated hearing, while ONT’s position was that MGI’s costs were reasonably incurred as the work done would be useful for the purpose of a hearing if substantive proceedings were commenced. ONT argued that any order for costs would be premature and should be deferred until ONT commenced substantive proceedings as ONT expected to rely on MGI’s behaviour in refusing to provide samples of the allegedly infringing devices when requested. If substantive proceedings were not commenced in due course, the costs of the preliminary discovery application would be determined as part of the disposal of the application.

Outcome

Justice Jackman accepted ONT’s submission that an order for costs would be premature as, at the time the hearing was scheduled, MGI had resisted ONT’s requests to produce relevant material, thereby necessitating the preliminary discovery application. His Honour ordered that the question of costs should be reserved for later determination, either in the course of disposing of the current proceedings or in any substantive proceedings that ONT commenced, given that MGI’s conduct between December 2024 and June 2025 in refusing to provide samples had played a part in ONT commencing the application for preliminary discovery.

Implications

This decision turns on the fairly specific circumstances of a hearing for an application for preliminary discovery being vacated because the patentee had been able to independently obtain evidence that would allow it to determine whether substantive proceedings should be commenced. Parties to patent proceedings are required to act with an overarching purpose of facilitating the just resolution of a dispute as quickly, inexpensively and efficiently as possible, and often this assessment cannot be made until all of the relevant circumstances have been revealed.

Subsequent developments

The application for preliminary discovery was withdrawn on 18 September 2025, with ONT commencing patent infringement proceedings against MGI on 6 August 2025.

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

Newron Pharmaceuticals S.p.A. (Newron) and Zambon S.p.A (Zambon) have succeeded in their preliminary discovery application against Arrotex Pharmaceuticals Pty Ltd (Arrotex) in the Federal Court of Australia.  Newron and Zambon sought production of documents from Arrotex, for the purpose of deciding whether to commence court proceedings for actual or threatened infringement of two patents relating to the product and the process of producing high purity safinamide (which contains two particular impurities at a level less than 0.03% by weight).  Safinamide is the active ingredient in Xadago®, which is used in the treatment for moderate-to-late-stage Parkinson’s disease.

Justice Needham’s decision illustrates the ease with which patentees are able to obtain preliminary discovery in the Federal Court of Australia given the low bar set by rule 7.23 of the Federal Court Rules 2011 (Cth).

Background

In their preliminary discovery application, Newron and Zambon sought production of documents from Arrotex, for the purpose of deciding whether to commence court proceedings for actual or threatened infringement of two patents relating to the product and the process of producing high purity safinamide.  Arrotex had four Australian Register of Therapeutic Goods (ARTG) registrations for safinamide products which had been approved as generic versions of Xadago®.  Arrotex expected to start supply in the near future, following the listing of its products on the PBS.

Rule 7.23 provides that a party may apply to the Court for a preliminary discovery order if that party:

a) reasonably believes that it may have the right to obtain relief in the Court from another person or entity whose description has been ascertained;

b) after making reasonable inquiries, does not have sufficient information to decide whether to start a proceeding in the Court to obtain that relief; and

c) reasonably believes that:

i. the other person or entity has or is likely to have or has had or is likely to have had in their control documents directly relevant to the question whether the first party has a right to obtain the relief; and

ii. inspection of the documents by the first party would assist in making the decision.

In interpreting rule 7.23, the Full Court (Allsop CJ, Perram and Nicholas JJ) in Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd (2017) 257 FCR 62 (Pfizer) stated that:

• rule 7.23 is a beneficial provision, which enables a person who believes they may have a right to seek relief to obtain information to make a responsible decision as to whether to start court proceedings;
• the party seeking preliminary discovery must prove that it has a belief that it may (not does) have a right to relief, and must demonstrate that the belief is reasonable, either by reference to material known to the person holding the belief or by other material subsequently placed before the Court;
• the question of whether the belief is reasonable requires one to ask whether a person, in light of all of the material before the person holding the belief (or subsequently the Court), could reasonably believe that they may have a right to obtain relief; and
• to defeat a claim for preliminary discovery, the party from who discovery is sought will need to show, either that the subjectively held belief does not exist, or, if it does, that there is no reasonable basis for thinking that there may be (not is) such a case. That may be done by demonstrating that no reasonable person, faced with the evidence relied on by the prospective applicant, would think that a right to relief might exist.

Newron and Zambon relied on the evidence of Zambon’s General Counsel, Ms De Dominicis, who was the person “primarily responsible for making legal decisions on Zambon’s behalf relating to its concerns” about the possible infringement of the patents.  Ms De Dominicis stated in her evidence that she inferred that the Arrotex products must have been approved on the basis of bioequivalence with Xadago®, and that there was nothing in the material available to her which would lead her to believe that the Arrotex products differed from Xadago® in terms of efficacy and safety.  Accordingly, she believed, but did not know, that the Arrotex products might contain high purity safinamide, and/or might be made using the patented processes.

Arrotex principally relied on the expert evidence of Professor Michael Roberts, an Emeritus Professor of Clinical Pharmacology and Therapeutics at the University of Queensland, and Emeritus Professor of Therapeutics and Pharmaceutical Science at UniSA Clinical and Health Science.  Professor Roberts stated, in his evidence (amongst other things), that determination of bioequivalence did not require determination of whether two drug products have the same or similar levels of impurities, and that there was no reason to believe the percentage of the impurity in the Arrotex products might be below the claimed threshold, because even amounts of the impurity far above that threshold would still result in blood plasma concentrations so low as to be therapeutically meaningless.

Key Issues

The key issue for Justice Needham’s determination was whether Newron’s and Zambon’s belief that they may have a right to relief against Arrotex was reasonable.

In short, her Honour found that Newron’s and Zambon’s belief was reasonable, or, in other words, was not a belief based on “unreasonable, untenable, irrational or baseless” considerations or views.  In reaching this view, Justice Needham noted that rule 7.23 must be applied in a way which gives full weight to its purpose, which is to allow a person to make up their mind whether to commence proceedings.  Her Honour further noted that Newron and Zambon did not need to establish a prima facie case of patent infringement, and that the relevant question was not whether one scientific view was more or less persuasive than another.

Her Honour considered that, giving the views of Professor Roberts the appropriate weight, in the context of the preliminary discovery application, Newron’s and Zambon’s evidence did not demonstrate affirmatively that the safety level of impurities in safinamide was lower than 0.03%, nor did it demonstrate affirmatively that the bioequivalence of the Arrotex products meant that they were the same high purity formulation as Xadago®.  However, her Honour did not consider that she needed to be persuaded to that level.  Instead, her Honour considered that, given the range of scientific views expressed in the patents and Newron’s and Zambon’s evidence, and that given that the Arrotex products did contain safinamide, there was a reasonable basis for the belief that Newron and Zambon might have a right to relief.

Justice Needham did not find persuasive Arrotex’s argument that, as the Therapeutic Goods Administration did not recognise the 0.03% impurity level as a safety threshold, Ms De Dominicis’ belief was unreasonable.  Nor did her Honour accept Arrotex’s submission that bioequivalence of the prospective parties’ products, and reliance on the same testing for each products’ Product Information, did not give rise to a belief that the impurity factor may be present.  Neither ruled out the possibility that the claimed impurity level might be present.

Her Honour also considered Professor Roberts’ reasoning to be circular when he stated that, as his calculations were that safinamide with higher impurity levels were not toxic, then there was no reason to believe that the Arrotex products were high purity products.  To the contrary, her Honour considered that it was equally open to believe that they might be high purity products.  Her Honour also noted that Professor Roberts’ analysis was based on his calculations of toxicity by reason of blood plasma concentrations in vivo, and that in the context of the preliminary discovery application, her Honour had not been able to accept that the calculations on the various assumptions were unassailable.

Accordingly, her Honour held that, when all of the evidence was considered, including the expert evidence of Professor Roberts, a belief that Newron and Zambon might be entitled to relief appeared to be reasonable; that is, it is not a view that could not be held by any reasonable person.

Outcome and Implications

Her Honour ordered Arrotex to provide preliminary discovery, with her Honour then ruling on the access regime for the production of documents by Arrotex and on the issue of costs in a short subsequent judgment.  On the issue of costs, her Honour ordered that the costs of the preliminary discovery application be costs in the cause of any infringement proceedings, but should no infringement proceedings be commenced, then there be no order for the costs of the preliminary discovery application, with the intent that each party bear their own costs.

Justice Needham’s decision applies the principles set out by the Full Court in the Pfizer decision as to the factors relevant to a preliminary discovery application.  Her Honour’s decision illustrates the ease with which patentees are able to obtain preliminary discovery in the Federal Court of Australia given the low bar set by rule 7.23 of the Federal Court Rules 2011 (Cth).

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.

Scidera, Inc. v Meat and Livestock Australia Limited (No 2) [2025] FCA 1236

Introduction

Justice Rofe has handed down an interlocutory judgment dismissing Zoetis Australia Pty Ltd’s (Zoetis) application for summary dismissal of Scidera, Inc.’s (Scidera) patent infringement claims.  The decision addresses a novel question of Australian patent law: whether all essential integers of a claimed method must be performed domestically for infringement to occur where the method does not produce a product.

Background

Scidera is the patentee of patent AU2010202253 (the Patent) which broadly relates to methods for identifying traits in cattle through genetic testing using single nucleotide polymorphisms (SNPs) in nucleic acid samples.  Scidera alleged that MLA, along with the Agricultural Business Research Institute (ABRI), Zoetis Australia Pty Ltd, DataGene Limited and Genotyping Australia Pty Ltd (together, the Respondents), directly infringed or authorised infringement of the Patent through the provision of genomic selection services in Australia.

This decision follows an earlier interlocutory judgment by Justice Rofe in Scidera, Inc. v Meat and Livestock Australia Limited [2025] FCA 308, in which her Honour dismissed the Respondents’ applications to strike out Scidera’s statement of claim.  Following that decision, Scidera was permitted to file an amended statement of claim.

The dispute the subject of her Honour’s decision centres on Zoetis’ business model for genetic testing of Australian cattle.  According to evidence submitted by Zoetis Inc., this testing involved the following steps:

1. Biological samples from Australian cattle are collected and sent to Zoetis’ Queensland premises.
2. Zoetis sends these samples to its US-based related entity, Zoetis Inc., for testing.
3. Zoetis Inc. performs SNP Testing in the US using specialised SNP Chips that detect 50,000+ SNPs through a process involving DNA amplification, hybridisation, and fluorescent imaging.
4. The testing generates a SNP text file containing genetic data (the Genotype Files), which is transmitted back to Australia.
5. In Australia, the Genotype Files are analysed by associations or institutes representing breeders to produce reports such as Estimated Breeding Values (EBVs) and Australian Breeding Values (ABVs).  In the case of beef cattle, breeders received EBVs in Australia via ABRI.

Critically, Zoetis’ evidence stated that all SNP testing has been conducted by Zoetis Inc. in the US since Zoetis commenced business in Australia in 2012, and that Zoetis has never had the capacity to perform SNP Testing in Australia.

Zoetis’ application for summary dismissal raised an issue not previously determined in Australia: whether all essential integers of a claimed method must be performed domestically for infringement to occur where the method does not result in a product.  Broadly, Zoetis contended that as a matter of statutory construction, the act of exploitation must occur within the patent area (Australia), and where their SNP testing is performed in the US, there can be no infringement in Australia.

Consideration

Claim Construction

Despite extensive consideration of the Patent’s claims by Beach J in the appeal from the opposition decision in Meat and Live stock Australia v Cargill, Inc (2018) 129 IPR 278 (Cargill), and subsequently in the amendment application in Meat and Livestock Australia Ltd v Cargill, Inc (No 2) (2019) 139 IPR 47 (Cargill (No 2)), the parties still disagreed on the construction of claim 1, which provides:

A method for identifying a trait of a bovine subject from a nucleic acid sample of the bovine subject, comprising identifying in the nucleic acid sample an occurrence of at least three single nucleotide polymorphisms (SNPs) wherein each of the at least three SNPs are significantly associated with the trait, with the degree of statistical significance being p≤0.05, and wherein the at least three SNPs occur in more than one gene; and wherein (a) at least one of the SNPs [meets the limb (a) requirement], or (b) the SNP [meets the limb (b) requirement].

(Emphasis added)

Zoetis argued that the phrase “identifying in the nucleic acid sample an occurrence of at least three SNPs” refers to the step performed by Zoetis Inc. in the United States.  Zoetis characterised the phrase “method for identifying a trait” as a “purpose constraint”, whereby the physical act of conducting the genetic testing must be done with the purpose of resulting in the ability to identify or infer a trait.  According to Zoetis, the claim is met by the mere ability to identify or infer, regardless of whether an identification or inference is actually drawn.  At [73], Justice Rofe observed that:

In recasting the underlined integer as a purpose constraint rather than an essential integer, Zoetis seeks to dismiss Scidera’s contention that the identifying or the drawing of an inference of a trait is an essential integer of the claim that, when performed or used by Zoetis in Australia, satisfies the territorial nexus required by the acts of exploitation and infringement as contemplated by the Patents Act.

So on Zoetis’ construction, the claim is met by carrying out the genetic testing in the US with the mere purpose of being able to infer, and because nothing further is required, the integers of the claim are entirely carried outside the protected jurisdiction.

Scidera rejected this characterisation, contending that its own construction correctly adopts that of Beach J in Cargill, such that “the claim is infringed by a method which takes all the integers, including the actual identification or inference of a trait”.  Scidera referred to the Amended Statement of Claim which particularises that “[…] [t]he identification of the trait occurs upon the provision of the EBV reports”.

Justice Rofe’s “provisional view” favoured Scidera’s construction.  Her Honour rejected Zoetis’ “purpose constraint” characterisation, noting Beach J’s references to “purpose” in Cargill were made in the context of an anticipation analysis, not claim construction.  Beach J had held that for method claims, construing “for” as merely requiring that a disclosure of something that could be used for that purpose is “misconceived” and “inapposite” as it “involves disregarding what is an important limiting and characterising feature of the claim”.  Justice Rofe found that claim 1 requires both identification of SNPs through physical testing and a separate step of identifying or inferring traits, the latter of which appeared to be undertaken in Australia on the evidence available to her Honour.

Justice Rofe identified two flaws in Zoetis’ approach.  First, Zoetis impermissibly disaggregated the integers of the claimed method, focusing solely on the physical testing integer while relegating the identification or inference of traits to a mere purpose.  Her Honour cited Ariosa Diagnostics, Inc v Sequenom, Inc (2021) 159 IPR 371 (Ariosa Diagnostics) and National Resource Development Corporation v Commissioner of Patents (1959) 102 CLR 252 for the principle that the invention is a “unitary concept” and “it is the whole process that must be considered”.  Second, Zoetis’ submission that the invention is not a manner of manufacture contradicted Beach J’s findings in Cargill, where his Honour held the claim 1 was a manner of manufacture because the method “involves drawing an inference about the potential for the trait of interest to exist in the bovine subject” and creates “an artificially created state of affairs of economic significance”.

Territorial Question

Justice Rofe noted that the case raises “a novel and important question of law: whether all the essential integers of a claimed method or process must be performed within the patent area for there to be infringement of a claim to said method or process that does not produce a product”.

Her Honour considered the inclusion of an object clause under s 2A of the Patents Act 1990 (Cth) (the Patents Act), introduced by the Intellectual Property Laws Amendment (Productivity Commission Response Part 2 and Other Measures) Act 2019 (Cth), which states that the object of the Patents Act is “to provide a patent system in Australia that promotes economic wellbeing through technological innovation”.  The Explanatory Memorandum to the amending bill further stated that the object clause would “assist courts in interpreting the Patents Act in cases where the text of the legislation is uncertain or ambiguous”, ensuring “that the patent system remains adaptable and fit-for-purpose”.  Justice Rofe noted that neither party addressed the object clause and how it might influence the question of whether potential infringers may circumvent a patentee’s exclusive rights to exploit its invention through divided performance of a method overseas.

Australian courts have previously considered infringement of method claims involving overseas use, but each involved the extended definition of “exploit”, wherein a product resulting from use of a method overseas was imported into Australia.[1]  Justice Rofe also referred to Ariosa Diagnostics, in which samples were taken from Australian patients and sent to the US for genetic testing and analysis, with the Full Court finding that the Harmony Test results did not constitute a “product” for the purpose of the definition of “exploit” in the Patents Act.  However, unlike the present matter, the method of detecting was carried out in its entirety in the US.  Thereafter, no further steps of the method remained to be performed in Australia – only the results of the test had to be electronically transmitted to the relevant medical practitioner in Australia, who would inform the patient of those results.  As those constituted mere information (and not a product), the Full Court held that no infringement occurred.

Justice Rofe noted that there is no fundamental requirement that all essential integers of a method claim that does not result in a product must be performed in the patent area.  Her Honour observed that there seems to be little basis in the Patents Act to distinguish methods which produce products (where offshore steps are considered), and those that do not.  Justice Rofe considered that such an “arbitrary distinction” would be inconsistent with UK authorities[2] which have demonstrated the UK court’s disinclination to enable infringers to avoid infringement by performing an integer of a claimed method offshore.

In reaching this view, Justice Rofe considered two modern UK cases.  Menashe Business Mercantile Ltd v William Hill Organisation Ltd [2003] 1 All ER 279 concerned a gaming system patent where the host computer processing customer bets was located in Antigua but accessed by UK customers placing bets from the UK.  In that case, Aldous LJ held that the UK punter “will in substance use the host computer in the United Kingdom, it being irrelevant to the punter where it is situated”.  Illumina, Inc v Premaitha Health Plc [2017] EWHC 2930 concerned a prenatal diagnosis patent where DNA sample preparation and sequencing occurred in the UK, but the data analysis and processing to generate diagnostic results occurred in Taiwan.  In that matter, Carr J held that the crucial question was whether, in substance, the process was used in the UK, accepting that any other result would make it “far too easy to avoid infringement of patents of this nature ‘given the ease of digital transmission and the ability to offshore computer processing’”.

Justice Rofe observed that these UK authorities demonstrate that the question of divided-performance of a method overseas is “not a simple one”, and that at this stage, “there may be an arguable case that the policy-based approach taken by the United Kingdom courts in Menashe and Illumina may align with a construction of ‘exploit’ which gives effect to the object clause of the Patents Act”.  Her Honour added that in each UK case, the question of law was “inextricably tethered to the factual circumstances”.

Outcome

Justice Rofe concluded that the matter was “not a straightforward case that is appropriate to be summarily dismissed”.  Her Honour noted that the “relevance and applicability of the United Kingdom case law in light of the object clause and differing statutory language” has not been the subject of argument and warrants full consideration at trial, further stating:

Whether the introduction of the object clause under s 2A of the Patents Act is consistent with a legislative intention towards a construction of infringement that patentees are entitled to enjoy the full benefit of their statutory right that ought not be set at naught by offshoring a step of a claimed method, is a question that merits fulsome argument and consideration on the facts of the case.

Consequently, Justice Rofe dismissed Zoetis’ application and ordered it to pay Scidera’s costs of the interlocutory application.

Implications

Should the matter proceed to trial, the proceedings are positioned to produce the first Australian decision addressing whether all essential integers of a method claim must be performed in the patent area (domestically) for infringement to occur where the method does not produce a product.  Justice Rofe’s decision signals that her Honour may adopt an “in substance” approach similar to UK jurisprudence, preventing circumvention of patented methods through the offshoring of essential steps.

[1] See Apotex Pty Ltd v Warner-Lambert Co LLC (No 2) (2017) 123 IPR 30 at [296]–[298] (per Nicholas J), endorsed in Warner-Lambert Co LLC v Apotex Pty Ltd (No 2) (2018) 129 IPR 205 at [167] (per Jagot, Yates and Burley JJ).

[2] See Von Heyden v Neustadt (1880) 14 Ch D 230, Saccharin Corp Ltd v Anglo-Continental Chemical Works Ltd [1901] 1 Ch 414 and Beecham Group Ltd v Bristol Laboratories Ltd [1978] 95 RPC 15.

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.