When Cheaper Medicines Meet Patent Law: Regeneron v Sandoz

A Federal Court decision has just reshaped the battlefield for biosimilars in Australia.

In Regeneron v Sandoz [2025] FCA 1067, Justice Rofe refused an interlocutory injunction that would have blocked the launch of Sandoz’s aflibercept biosimilar. The case isn’t just about patents — it’s about the balance between innovation, public health, and billions in PBS spending.

The dispute

• Regeneron and Bayer own patents over aflibercept (marketed as EYLEA®).

• Sandoz sought to launch a competing biosimilar.

• The Court was asked to stop the launch pending trial.

The ruling

• No injunction: Justice Rofe refused to grant interlocutory relief.

• Key reasons:

  • Public interest: cheaper biosimilars mean lower PBS prices, better access for patients.

  • Commercial realities: Regeneron had already launched an 8mg product (EYLEA HD), while uptake of Roche’s VABYSMO® was rising.

  • Patent merits: while Regeneron had arguable claims, they weren’t strong enough to outweigh the public health case.

Why it matters

• For innovators: You can’t assume automatic injunctions — public interest now weighs heavily.

• For biosimilar entrants: The Court is more receptive to arguments about affordability and patient access.

• For the PBS: This case signals a judicial awareness of pricing impacts, not just patent rights.

Takeaway
This is one of the clearest recent examples of the Federal Court weighing patent exclusivity against healthcare economics.

Expect more disputes like this as Australia’s biosimilar pipeline grows.

Where in the World Is Patent Infringement?

Scidera v MLA and the Offshore Method Problem

What happens when half your invention lives in the cloud — or, worse, on another continent?

That’s the question Rofe J has just (on 10 October 2025) refused to shut down in Scidera, Inc v Meat and Livestock Australia Ltd (No 2) [2025] FCA 1236.

The decision keeps alive a fascinating issue: can you infringe an Australian method patent when some of the steps happen overseas?

---

The background: cows, code and cross-border science

Scidera holds a patent for a method of identifying genetic traits in cattle by analysing single-nucleotide polymorphisms (SNPs) — essentially, genetic markers associated with desirable characteristics like feed efficiency or milk yield.

Zoetis, a major player in animal genetics, collects biological samples from Australian cattle but ships them to its US affiliate for lab testing on Illumina “SNP Chips”. The raw genetic data are then transmitted back to Australia, where they’re integrated into local systems to produce breeding-value reports for Australian farmers.

Scidera sued, alleging that this end-to-end process uses its patented method in Australia, even though the “wet-lab” work is performed offshore.

---

Zoetis’s strike-out strategy

Zoetis sought summary dismissal of all infringement claims, arguing that:

1. All essential integers of the claimed method occur in the US — specifically the physical SNP testing — so nothing is “used” in the patent area as required by s 13 of the Patents Act 1990 (Cth); and

2. Allowing an “in-substance” or “partial” use theory would contradict the territorial limits of Australian patents.

If one step happens in Missouri, they said, there’s simply no infringement in Mudgee.

---

Scidera’s reply: the trait inference matters

Scidera countered that the patent is not limited to laboratory steps. The act of identifying or inferring the trait — which occurs when Australian data are processed into EBV and ABV reports — is part of the claimed method itself.

On that view, the relevant exploitation occurs in Australia, even if some earlier testing work is done abroad. Scidera also invoked UK authority such as Menashe v William Hill and Illumina v Premaitha, where courts adopted an “in-substance” approach to cross-border method claims.

---

The Court: too novel for summary execution

Rofe J agreed that Zoetis’s application raised a novel question of law never before determined in Australia:

“Whether all the essential integers of a claimed method or process must be performed within the patent area for there to be infringement of said method or process claim that does not result in a product.”

Her Honour wasn’t persuaded that Zoetis’s narrow, “all-steps-in-Australia” construction was obviously correct. Citing Beach J’s earlier reasoning in Meat & Livestock Australia v Cargill Inc (2018) 129 IPR 278, Rofe J noted that the patent claimed “a method for identifying (or inferring) a trait” — not merely the physical act of testing DNA.

Because the alleged infringing process also included domestic analysis and reporting steps, and because claim construction and common-general-knowledge issues required expert evidence, summary dismissal was inappropriate.

Zoetis’s application was dismissed with costs.

---

The legal heartbeat: territoriality vs technology

Section 13 of the Patents Act grants the patentee the exclusive right to “exploit the invention” within the patent area — Australia. For product claims, that’s simple: you make or sell a thing here.

But for method claims, exploitation means using the method. When the method’s steps span jurisdictions — as in distributed computing, AI pipelines, or biotech testing — where exactly does “use” occur?

Zoetis urged a hard territorial rule: unless every essential step happens in Australia, there’s no infringement.

Scidera urged a functional test: if, in substance, the method is put into effect here, that’s enough.

Rofe J didn’t decide between them — but by letting the case proceed, she signalled that Australian law may yet evolve beyond the rigid “all integers here” rule.

---

Why it matters

This skirmish goes far beyond cattle genotyping. It has implications for:

• Cloud computing and AI – where model training or data processing occurs overseas.

• Medical diagnostics – where patient samples are analysed offshore, but reports are issued locally.

• Software as a Service – where code execution crosses borders invisibly.

If the Court ultimately accepts Scidera’s reasoning, offshoring one step won’t guarantee safety from infringement — especially where the commercial benefit and control remain in Australia.

---

💡 IP Mojo Take

Cross-border collaboration is the new normal, but patent boundaries still cling to old-world geography.

Scidera v MLA may become Australia’s test case for digital and distributed inventions, forcing courts to define where a “method” actually happens when its neurons fire on different sides of the planet.

The takeaway for innovators and counsel:

• Map your process flow against territorial rights, not just claim language.

• Offshoring may reduce cost but not always risk.

• And when a patent claim uses the word “comprising”, expect the court to look at the whole method, not just the bit that happens in the lab.

IP Australia Knocks Canva to the Canvas

How many patents could a patent combatant patent if a patent combatant could patent patents?  It turns out possibly none, if they’re IT-based patents …

It’s not often that a legal decision about slide deck formatting gets a 230-page appendix and a judicial tone verging on exasperation. But that’s exactly what happened in April when IP Australia handed down the Delegate’s ruling on two Canva patent applications. And for tech lawyers, it’s a masterclass in where the edges of software patentability still lie in Australia.

What Canva Sought to Patent

Canva — Australia’s SaaS design darling — had sought patent protection for two computer-implemented inventions. One described how to take content from a document and reflow it into a deck format automatically. The other focused on the math behind mapping design “fills” into limited layout “frames.”

The applications were meticulous. Detailed. Full of flowcharts, hierarchy data, bounding boxes, fills, and pagination logic. They read like a design engineer’s epic poem – a love letter to structured templates.

But in the eyes of IP Australia, they weren’t inventions. Not in the legal sense, anyway.

The Legal Lesson: “Manner of Manufacture” Still Matters

Australia’s test for whether a computer-implemented invention is patentable remains the “manner of manufacture” test — essentially asking whether the claimed invention involves more than just abstract ideas, business rules, or well-known computer functions.

And here, the Delegate of the Commissioner of Patents said: nope.

Despite Canva’s argument that their invention transformed how users generate designs and templates, IP Australia saw it differently: the claims described a process for applying “rules” to content in order to lay it out aesthetically — something a human designer could do, and something that didn’t, in substance, solve a technical problem or enhance the functioning of a computer. It was more scheme than science.

More Than Just a Canva Problem

Why should the rest of us care?

Because this is yet another signal — after decisions like Research Affiliates and Rokt — that Australia continues to draw a relatively narrow line on software patents. If you’re advising a client on patent strategy in the digital design, AI, or UX tooling space, the key takeaway is this: just because something’s hard to code doesn’t mean it’s patentable.

The software has to do more than automate — it must yield a technical effect or improvement that isn’t just the automation itself.

So, What’s Next?

For Canva, it’s back to the drawing board — or perhaps, back to their formidable brand and copyright moat. And they still have six months to reframe the claims in a way that may survive scrutiny.

For the rest of us, it’s another sharp reminder that patenting in the tech sector remains as much an art as a science. Don’t just ask “Is it clever?” Ask, “Is it a manner of manufacture?”

Because in Australian patent law, not all clicks are created equal.