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Federal Court of Australia · [2025] FCA 1236

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Scidera, Inc. v Meat and Livestock Australia Limited (No 2)

In <i>Scidera, Inc. v Meat and Livestock Australia Limited (No 2)</i> [2025] FCA 1236, the Federal Court refused Zoetis Australia's attempt to summarily dismiss patent infringement claims arising from a cattle genomics workflow split between Australia and the United States. The Court treated the issue as a novel question of law in a highly specialised biotechnology field and held that the case should continue rather than be shut down early. For businesses, the decision is a reminder that offshore testing arrangements do not automatically remove Australian patent risk.

Federal Court of AustraliaNot recorded

These are plain-English explainers, not legal advice. They are a good starting point, but check the linked official source before you rely on a specific section, and get advice for your situation.

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Decision snapshot

Facts

The dispute

Scidera, Inc. brought Federal Court patent infringement proceedings concerning a patent directed broadly to a method or system for identifying or inferring a trait of a bovine subject from a nucleic acid sample, including by identifying the occurrence of at least three SNPs meeting requirements stated in the claims. The respondents included Meat and Livestock Australia Limited, Agricultural Business Research Institute, Zoetis Australia Pty Ltd and others. This particular judgment, titled "No 2", did not determine infringement at trial. It dealt with an interlocutory application by Zoetis Australia for summary dismissal of all infringement claims against it under s 31A(2) of the Federal Court of Australia Act 1976 (Cth) or alternatively r 26.01 of the Federal Court Rules 2011 (Cth). The extract shows that the dispute arose in the commercial setting of genomic testing services for beef and dairy cattle in Australia. Evidence from Zoetis described a workflow in which biological material such as hair, semen, blood or ear notches was received by Zoetis at its Queensland premises with customer request forms. A Zoetis employee counted and checked the samples, entered information into electronic systems, and arranged shipment to Zoetis Inc. in the United States. In the US, Zoetis Inc. was said to conduct SNP testing on DNA samples using Illumina SNP chips, related equipment and software. The process described in the extract included amplification and fragmentation of DNA, hybridisation to SNP chips, fluorescent labelling, imaging through the Illumina iScan system, and generation of a SNP text file through GenomeStudio software. The results were reviewed in the US, and depending on the service ordered, further processing could produce reports for some genetic conditions or qualitative traits. A modified SNP text file, called the Genotype File in the extract, could then be provided to customers. The extract also records evidence about what happened after that. For beef cattle, breeders ultimately received Estimated Breeding Values in Australia via the relevant breed association or ABRI. For dairy cattle, Dr Piper's evidence was that DataGene prepared Australian Breeding Values, which were then received by GeneSys and made available to breeders through Zoetis' online reporting application, SearchPoint. Professor Taylor's evidence described how a service provider could use genotype files together with phenotype data, SNP data and sometimes legacy pedigree and trait data to identify or infer traits and generate reports such as EBVs or ABVs. Zoetis argued that a step in the claimed method, described in the extract as the genetic analysis of a bovine sample, was performed in the US, with the results sent back to Australia, and therefore the claims against it had no reasonable prospect of success. Scidera argued that the Patents Act did not necessarily require all essential integers of a claimed method to be performed within the patent area, and that claim construction and technical issues should not be resolved on a summary application without expert evidence.

Issue

The legal question

The legal issue on the interlocutory application was whether infringement of an Australian patent for a claimed method or process that does not result in a product requires all essential integers of the method to be performed within the Australian patent area. Zoetis argued that because a step in the claimed method, described in the extract as the genetic analysis of a bovine sample, was performed in the United States, the infringement claims against it had no reasonable prospect of success. Scidera argued that the Patents Act did not necessarily impose that requirement and that claim construction and technical questions should not be resolved summarily without expert evidence.

Outcome

Decision

The Federal Court dismissed Zoetis Australia Pty Ltd's interlocutory application for summary dismissal of all infringement claims against it. The Court also ordered, subject to further costs orders, that Zoetis pay Scidera's costs of and incidental to the application, and directed the parties to arrange a case management hearing in November 2025. On the available extract, the Court's reasoning was procedural and cautious. The application raised a novel question of law, the dispute sat in a highly specialised biotechnology field, and the proceeding was still at an early stage with no discovery and no substantive evidence for the main case yet filed. In those circumstances, the Court was not satisfied that Scidera had no reasonable prospect of success.

Practical impact

Commercial note

Do not assume that moving one technical step offshore removes Australian patent exposure. In this case, samples were received in Australia, testing was said to occur in the United States, and genotype information and downstream reports were then used in Australian cattle breeding workflows. The Court did not finally decide infringement, but it did decide that the issue was too novel and fact-sensitive to be shut down summarily. If your business uses overseas labs, software platforms or related entities, map the whole service chain carefully. Identify who receives samples, who performs each step, where data are generated, who sends results back, and how Australian customers receive and use the output. Review marketing materials, service descriptions and contracts alongside the technical workflow. If there is a relevant Australian patent landscape, get targeted patent advice before launch, before changing providers, and before relying on an offshore step as your main risk answer.

The story

This case sits inside a larger patent dispute about cattle genomics and breeding-related testing services. Scidera says its patent covers a method or system for identifying or inferring a trait of a bovine subject from a nucleic acid sample. The respondents include several participants in the Australian livestock and genetics ecosystem, including Meat and Livestock Australia Limited, Agricultural Business Research Institute, Zoetis Australia Pty Ltd and others.

The decision reported as Scidera, Inc. v Meat and Livestock Australia Limited (No 2) [2025] FCA 1236 is not the final trial. It is an interlocutory ruling on an early procedural application. Zoetis Australia asked the Federal Court to summarily dismiss all infringement claims against it. In practical terms, Zoetis wanted the Court to stop the case against it before trial.

The commercial setting is important. The alleged service chain was split across countries. Samples from cattle in Australia were received and processed administratively in Australia, then sent to Zoetis Inc. in the United States for SNP testing. Information generated from that testing was then used in ways that connected back to Australian customers and Australian breeding-value workflows. That cross-border structure is what made the legal issue commercially significant.

How the service workflow was said to operate

The extract gives a detailed picture of the workflow relied on for the application. Biological material from beef and dairy cattle, including hair, semen, blood or ear notches, was received by Zoetis at its Queensland premises. The samples came with customer request forms. A Zoetis employee counted the samples, checked that each matched the request form, entered the information into electronic systems, and arranged shipment to Zoetis Inc. in the US.

In the United States, Zoetis Inc. was said to perform SNP testing on DNA samples using Illumina SNP chips and associated equipment and software. The extract describes a technical process involving DNA amplification and fragmentation, hybridisation to SNP chips, fluorescent labelling, imaging through the Illumina iScan system, and generation of a SNP text file through GenomeStudio software. The results were then reviewed in the US.

The extract says the next steps depended on the service ordered. GeneSys or NGP could calculate results for markers associated with some genetic conditions and qualitative traits, such as coat colour and horn development. Depending on the order, Zoetis Inc. could provide a Genotype File only, or a Genotype File plus a report in PDF, Excel or text format for some results.

The evidence also pointed to downstream use in Australia. For beef cattle, breeders ultimately received Estimated Breeding Values through the relevant breed association or ABRI. For dairy cattle, Dr Piper's evidence was that DataGene prepared Australian Breeding Values, which were then received by GeneSys and made available to breeders through SearchPoint. Professor Taylor's evidence described how genotype files could be combined with phenotype data, SNP data and legacy data to identify or infer traits and generate reports.

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What the Court decided

Rofe J dismissed Zoetis Australia Pty Ltd's interlocutory application for summary dismissal. The orders in the extract are clear. First, the application was dismissed. Second, subject to further orders as to costs, Zoetis was ordered to pay Scidera's costs of and incidental to the application. Third, the parties were directed to confer and provide a mutually available date for a case management hearing between 11 and 13 November 2025.

Just as important as the orders is the procedural posture. The extract says the matter remained at an early stage. Pleadings had closed, but no discovery and no evidence corresponding to the substantive proceeding had been filed. The Court also noted that the patent specification related to a highly specialised field of biotechnology and referred to earlier Full Court comments recognising the important role of expert evidence in understanding the nature and scope of inventions in that field.

On the available material, the Court's refusal to summarily dismiss the claims was driven by two linked points. First, the issue was novel. Second, the technical and legal questions were not suitable for final determination on a summary application in a specialised biotechnology dispute without fuller evidence. The Court was therefore not satisfied that Scidera had no reasonable prospect of success.

How businesses should read it

Businesses should read this case as a warning against overconfidence in cross-border service design. A common assumption is that if the most technical step happens overseas, Australian patent risk falls away. This decision does not support that assumption as a safe early answer. The Court did not finally decide the infringement issue, but it did decide that the issue was arguable enough, and complex enough, to require the case to continue.

That matters well beyond cattle genomics. Many businesses now operate through distributed workflows. Samples may be collected in Australia, testing may occur overseas, software processing may happen on foreign servers, and reports may be delivered back to Australian customers. Some businesses also split functions across related entities, with one company handling customer intake and another handling technical processing. This case shows that those arrangements can still raise difficult Australian patent questions.

For a business owner, the practical reading is this: patent risk may depend on the whole commercial arrangement, not just the location of one laboratory or software step. Claim wording matters. The identity of the entities involved matters. The role of Australian-facing intake, coordination, reporting and downstream use may matter. Public brochures, service descriptions and agreements may also matter, especially where they describe the service as an integrated offering.

The extract also shows that expert evidence can be central in technical patent disputes. That means a business should be cautious about making broad legal assumptions from a simplified operational view of its service. If your sector has active patent owners, competitors or licensing practices, a proper freedom-to-operate review is usually more reliable than relying on a rough offshore-structure argument.

Documents and conduct to review in practice

If your business offers testing, analytics or decision-support services, review both the technical workflow and the documents that describe it. In the extract, the evidence included affidavits about how samples were handled, where testing occurred, what files were generated, and how outputs were delivered. The extract also refers to documents such as a services and limited licence agreement and Zoetis brochures. That is a reminder that courts may look at both conduct and documents when understanding what a business actually does.

For practical risk management, map the service chain from start to finish. Identify where samples or data are received, where each technical step occurs, which entity performs it, what software is used, what files are generated, who receives them, and what reports are ultimately delivered in Australia. Then compare that map against your customer contracts, intercompany arrangements, marketing materials and technical brochures. If those materials overstate or simplify the role of your Australian entity, they may create avoidable risk.

Also review whether downstream Australian partners or customers use your outputs to generate further reports or recommendations. In this case, the extract refers to breed associations, ABRI and DataGene using genotype information in breeding-value workflows. Even where your business does not control every downstream step, the overall arrangement may still matter to how a patent claim is argued.

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Dates and status

The judgment is dated 10 October 2025. The hearing date shown in the extract is 28 July 2025, with the date of last submissions recorded as 25 July 2025. The orders required the parties to confer and provide a mutually available date for a case management hearing between 11 and 13 November 2025.

The status point is critical. This is an interlocutory decision on summary dismissal. It does not finally determine infringement, validity, relief or the ultimate rights of the parties in the substantive patent proceeding.

Source notes

This page is based on the published Federal Court judgment for Scidera, Inc. v Meat and Livestock Australia Limited (No 2) [2025] FCA 1236. The extract clearly supports the procedural posture, the orders, the identified novel legal question, the broad factual workflow, and the Court's refusal to grant summary dismissal.

Because the available judgment material is truncated, this page should be read as an explanation of the interlocutory ruling on the material presently visible. The complete reasons should be checked before relying on the case for wider propositions about cross-border patent infringement, acting-in-concert allegations, or the final merits of the underlying dispute.

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