Overview

The life sciences and pharma IP litigation landscape is rapidly evolving in Australia, propelled by innovation, a dynamic regulatory environment and shifting market forces. Key legal battles – including increased scrutiny of patent term extensions, important interlocutory injunction decisions and significant biologic/biosimilar disputes – have shaped strategies for market access and patent protection. 

Recent regulatory changes – including amendments to the Pharmaceutical Benefits Scheme (PBS) and reduced prescription co-payments, along with Therapeutic Goods Administration (TGA) actions underscoring a more proactive approach to enforcement – have also influenced the pharma IP litigation landscape.

There has been a noticeable increase in trade mark filings within the life sciences sector, likely driven by brand owners placing greater emphasis on securing robust and more diverse trade mark protection.

These developments highlight Australia’s growing role in the international life sciences sector and in strategic IP litigation (often as part of a multi-jurisdictional strategy), as policy reforms, commercial opportunities and judicial precedent intersect to set the stage for the sector’s future direction.

The Australian Market

The Australian life sciences sector continues on an upward trajectory, employing approximately 350,000 people across 3,000 organisations, underscoring the sector’s growing economic footprint.

Australia’s innovation performance also strengthened in 2025. Australia ranked 22nd in the Global Innovation Index, up one place from 2024, reflecting improvements in innovation inputs and outputs and aligning with a sustained uplift in commercialisation activity and patenting quality. Within the World Intellectual Property Organization’s (WIPO) global top 100 innovation clusters, Sydney ranked 36 for medical technology (by patent filings) and engineering (by academia), while Melbourne ranked 52 for pharmaceuticals (by patent filings) and engineering, highlighting the complementary strengths of Australia’s largest life sciences hubs.

The Pharmaceutical Benefits Scheme (PBS) has seen several changes, including expanding access for certain indications and dropping the PBS general co-payment to AUD25 per prescription (from AUD31.60), as part of measures to increase affordability of medicines.

Interlocutory Injunctions – the Balance of Convenience Starts to Favour Biosimilars: Regeneron v Sandoz

In June 2025, Regeneron and Bayer sued Sandoz in the Federal Court, seeking injunctive relief to prevent the launch of Australia’s first biosimilar competitors to aflibercept (EYLEA). However, in a decision handed down on 3 September 2025, Justice Rofe declined to grant an interlocutory injunction (Regeneron Pharmaceuticals, Inc v Sandoz Pty Ltd [2025] FCA 1067). 

Until recently, the Federal Court had been inclined to grant interlocutory injunctions to preserve the status quo on the basis that generic/biosimilar entry would disrupt the market and cause lasting price effects that would be difficult to remedy with damages alone. However, there has been a notable evolution in how the Court assesses the balance of convenience in pharmaceutical patent disputes, particularly in the context of first generic/biosimilar launches and PBS price dynamics. The Court’s decision in Regeneron shows just how far the balance has shifted in favour of generic and biosimilar companies.

Pricing

Historically, Australian courts viewed the 25% mandatory statutory price reduction applied to an originator product when the first generic/biosimilar is listed on the PBS as a significant factor weighing in favour of an interlocutory injunction because it would change the status quo, with no guarantee that it would be reversed, even if the generic/biosimilar were later removed by a final injunction. However, reflecting the turning tide of legal sentiment, Justice Rofe found that, while a 25% price drop would occur, Regeneron and Bayer’s loss as a result of this price drop could be quantified and damages would be an adequate remedy.

Regeneron and Bayer also argued that there might be additional price reductions for EYLEA, including further price disclosure-related reductions or if Sandoz entered pricing negotiations with the government and offered a further reduced approved ex-manufacturer price (AEMP). Justice Rofe did not, however, accept that this was a significant factor. Her Honour found that, as biological drugs, further price discounts were expected to be minimal compared to typical small molecule generics due to limited biosimilar competition, restricted pharmacist substitution options, and little incentive for ophthalmologists to switch products.

Justice Rofe also rejected an argument that, once EYLEA moved PBS Formulary (from F1 to F2), certain special agreements between Regeneron/Bayer and the government would cease, meaning the effective price (reduced by 25%) would become publicly available and could be used by international pricing regimes (eg, in the USA or Taiwan) to reduce the price for EYLEA in other countries. Her Honour said that there was a lack of corroborating evidence of sufficient certainty to prove the risk of this, or the extent of any asserted reduction.

First mover advantage

Sandoz argued that being the first biosimilar to enter the market would give it a significant and lasting advantage, greater than for small molecule generics, as prescribers are relatively unlikely to switch patients to a second biosimilar once initiated on treatment with the first biosimilar. Sandoz also argued that biosimilars take much longer to develop and obtain regulatory approval, and that launching the Sandoz products immediately would give Sandoz a significant competitive edge over other biosimilar contenders, who might otherwise be able to launch at the same time as Sandoz if Sandoz were restrained.

Finally, Sandoz noted that Regeneron/Bayer could themselves launch an “authorised biosimilar”, which would change the status quo, rob Sandoz of its first mover advantage, and make the calculation of relief difficult. Justice Rofe agreed, holding that the first mover advantage could have a major impact on Sandoz’s market share and was a relevant factor in assessing the balance of convenience.

Overall, Justice Rofe held that the balance of convenience did not support granting an interlocutory injunction, a conclusion bolstered by her Honour’s assessment of Regeneron/Bayer’s prima facie infringement case as relatively weak. Factors such as the unique characteristics of the biosimilar market, prolonged development timelines, regulatory approval processes, the importance of encouraging biosimilar uptake, and the significance of the first-mover advantage were all influential in persuading the Court that the balance of convenience favoured Sandoz’s launch. Following an appeal by Regeneron and Bayer to the Full Court, the proceeding was resolved commercially. 

No PTEs for Formulations: Sun Pharma v Otsuka

In December 2025, the Full Court of the Federal Court of Australia delivered one of the most notable patent decisions of the year in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161, clarifying the scope of the patent term extension (PTE) provisions of the Patents Act 1990 (Cth). 

The Full Court concluded that the definition of “pharmaceutical substance” refers only to active ingredients, and does not include formulations. The decision will have major implications in Australia, preventing originators from obtaining extended protection for secondary patents such as those claiming new formulations of known drugs, and offering new opportunities for earlier generic market access for a host of products that may be covered by invalid PTEs.

Otsuka’s patent covered certain controlled-release injectable and freeze-dried formulations of aripiprazole. The patent’s standard term expired in October 2024, but Otsuka obtained a PTE based on ARTG-listed products (ABILIFY MAINTENA kits). Sun Pharma challenged the validity of the PTE, arguing that the claims of the patent did not meet statutory requirements for an extension.

At first instance, the primary judge found that eight of Otsuka’s ten asserted pharmaceutical substances did not fall within the scope of any of the claims as they did not take all of the essential integers of those claims, and the claims were invalid because they failed to define the invention and lacked clarity.

The Full Court dismissed Otsuka’s appeal from that decision but upheld the primary judge’s finding that the PTE was invalid on different grounds.

The central issue was whether a formulation (ie, a mixture of an active pharmaceutical ingredient (API) and excipients) falls within the definition of a “pharmaceutical substance” eligible for a PTE. Prior to this decision, three decisions of single judges at first instance had held that the definition of “pharmaceutical substance” could include a formulation, but none of these decisions was appealed.

The Full Court found that, against the legislative context, the natural and ordinary wording of the definition of pharmaceutical substance “immediately and naturally puts the focus on the substance which itself produces the therapeutic effect”, and does not extend to new formulations, delivery methods or dosage forms containing known substances. The Full Court considered that the legislative history and policy rationale for the current PTE regime was always intended to compensate for regulatory delays in bringing new APIs to market, not for improvements in delivery or formulation of known substances. The Court found that the reasoning in earlier first-instance decisions (such as Pharmacia, Spirit and Cipla), finding that formulations could qualify, were incorrect, and preferred the construction given in the Full Court authorities of Alphapharm and Boehringer, which focused on the API. 

As a result, the patent was not eligible for a PTE. This decision narrows the scope for extending the term of patent protection in Australia, and aligns with a policy of rewarding primary research in new and inventive pharmaceutical substances, rather than allowing extensions on secondary patents or incremental improvements.

The Centrality of Claim Construction for PTEs: Novartis v Pharmacor

Another significant appeal decision concerned an ENTRESTO (sacubitril/valsartan) product (Novartis AG v Pharmacor Limited [2025] FCAFC 33). The Full Court upheld Justice Yates’ decision at first instance that Pharmacor’s product, in which two APIs were combined as a complex, did not infringe Novartis’s patent claiming a composition comprising each of the two APIs, and Novartis’s PTE had been wrongly granted. Key aspects of the Full Court’s reasons included the following.

• Claim 1 is to a pharmaceutical composition comprising the “AT 1-antagonist” valsartan and the “NEP inhibitor” sacubitril, whose descriptions provided “adjectival clarity” to what followed. A person skilled in the art would, therefore, understand that the first integer could not be satisfied by something that also satisfies the second integer.
• There was no ambiguity in claim 1 suggesting that it might cover a complex formed from valsartan and sacubitril, or a pharmaceutically acceptable salt of the complex, and to read the claim otherwise would ignore its clear terms. The claim required both valsartan or a pharmaceutical salt thereof and sacubitril or a pharmaceutical salt thereof to be present, and to be distinct and separate components in the pharmaceutical composition claimed.
• Justice Yates did not err in considering the specification of the patent, nor in observing that particular passages of the specification supported his reasons. The Full Court was satisfied that the relevant passages did not determine or drive the primary judge’s construction of claim 1, which would have been contrary to a key principle of claim construction. 
• A construction requiring both salts to be present, and separate, was consistent with not only the plain English meaning of the claim but with the meaning accepted by the expert witnesses, who had agreed that the composition of claim 1 included two APIs and their pharmaceutically acceptable salts. A complex, on the other hand, is a singular entity that cannot be divided into its constituent parts, including its anions and cations in the solid. As a result, a salt of the complex would not fall within the scope of claim 1, as it represents one salt (not two distinct and separate salts). 
• Claim 1 is a product claim, which on its proper construction relates to the state of components and in the pharmaceutical composition prepared. Claim 1 is not a claim to the use of valsartan and sacubitril in the preparation of a pharmaceutical composition, or a claim to “something that happens” to the composition after administration.

By upholding the primary judge’s construction, the Full Court concluded that VALTRESTO was not within the scope of claim 1, and Pharmacor had not, therefore, threatened infringement of the patent. Similarly, ENTRESTO was held not to be within the scope of claim 1, meaning that the PTE was wrongly granted.

The High Court of Australia subsequently refused Novartis’s application for special leave to appeal.

Sanofi v Amgen: Evolocumab (Repatha) Litigation

Another case in 2025 that turned on claim construction was Sanofi v Amgen Inc (No 3) [2025] FCA 387, where Justice Nicholas dismissed Sanofi’s appeal to overturn the Patent Office’s decision allowing Amgen’s patent applications relating to evolocumab (Repatha). This appeal was decided under provisions of the Patents Act 1990 (Cth) as they existed prior to the enactment of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, meaning that a lower standard applied to some validity grounds than those in the current version of the Patents Act.

The case involved five patent applications relating to antibodies that inhibit PCSK9. Sanofi argued that Amgen’s claims failed to define the invention, lacked fair basis, were not fully described and lacked inventive step. Central to these arguments was Sanofi’s assertion that the claims failed to include any structural features to define the antibodies of the invention.

Sanofi argued that the patents failed to define the invention because the claims did not specify the amino acid sequences of the antibodies, such that others could not know in advance whether a MAb they proposed to make would fall within the claims. Justice Nicholas disagreed, finding that it was not necessary to define an invention so that others know whether a product would infringe before making it, and that defining the physical characteristics of the antibodies was impractical. His Honour held that describing functional outcomes (limitations by result) was sufficient, even if experimentation is then required to assess whether a product falls within the claims. 

As to fair basis, Sanofi claimed that, by describing antibody function by amino acid residues in the specification, but by epitopes in the consistory clauses, the specification lacked fair basis. Justice Nicholas disagreed, stating that scientific proof of the relationship between residues and epitopes included in the specification was sufficient. His Honour also held that a claim may be fairly based even where it omits some elements described in the specification, unless those omissions cause the claim to cover a fundamentally different invention. Justice Nicholas also found that the specification need not exemplify all antibodies falling within the claims and no impermissible extrapolation was required by the person skilled in the art.

With regards to inventive step, Justice Nicholas rejected Sanofi’s expert evidence that developing a PCSK9 inhibiting antibody would be straightforward, owing to the expert’s opinion being “heavily influenced by hindsight”. His Honour determined that the skilled person would not have been naturally led to antibodies targeting the PCSK9-LDLR interaction, due to uncertainty in the common general knowledge about whether PCSK9 acted extracellularly or intracellularly on LDLR.

Sanofi also argued that the claims were unclear as they did not define a numerical threshold for the word “competes”. While there was evidence showing discrepancy between results of various assays and that choices would need to be made in the assay procedure, his Honour found that this would have been known to a person skilled in the art. His Honour held that “competes” is a binary concept whereby the antibody either does or does not compete, and that testing to identify competition would have been well known based on the specification.

This decision highlights the significant changes between the pre- and post-RTB versions of the Patents Act, which should reduce the number of lower-quality patents granted and held to be valid in Australia. It seems likely the Section 40 grounds in particular would have been decided differently under the current version of the Act.

Janssen Biotech v Samsung Bioepis – Ustekinumab (Stelara) Litigation

This year also saw Samsung Bioepis win challenges to Janssen Biotech’s patents relating to the use of ustekinumab (Stelara) in the treatment of ulcerative colitis (one of the top five PBS drugs) on multiple fronts.

In August 2024, after eight months of litigation in Samsung Bioepis’s revocation proceedings in the Federal Court, Janssen surrendered two innovation patents a few months before trial, only to obtain three more (amended) innovation patents and commence fresh proceedings for infringement. Samsung Bioepis duly cross-claimed for revocation, and the litigation continued to trial in June 2025. Four days into a two-week trial, Janssen volunteered orders revoking all three of its patents. 

In October 2025, the Patent Office then handed down its decision upholding Samsung Bioepis’s opposition to Janssen’s patent application relating to the use of ustekinumab for ulcerative colitis, finding all claims invalid. Janssen has not appealed the decision nor sought to amend its patent application, signalling an end to the dispute, and heralding the first biosimilar competition in a highly lucrative market. 

Regulatory Enforcement

The TGA has responded to ongoing compliance and consumer protection concerns with robust enforcement throughout 2025 and stepped up its regulatory focus on digital and direct-to-consumer promotion practices. In June, the TGA initiated Federal Court proceedings targeting AG Therapeutics and Mamamia.com.au over allegedly unlawful advertising of medicinal cannabis products. This action follows almost AUD280,000 in infringement notices being issued for unlawful advertising of medicinal cannabis in the year prior, and a trend of higher penalties ordered by courts for violations of the Therapeutic Goods Act 1989 (Cth), especially where misleading or non-compliant advertising is involved.

Recent regulatory action also reflects a broader policy shift towards tighter risk-based control of emerging therapeutic markets, with vapes, medicinal cannabis and GLP‑1 receptor agonists all subject to heightened regulatory scrutiny and enforcement. In the vaping space, the TGA has moved from a relatively permissive import framework to a tightly controlled, “therapeutic use only” model, including a ban on the importation of disposable vapes, staged prohibitions on non‑therapeutic and disposable products, and strengthened product standards and notification requirements for therapeutic vapes (covering ingredients, nicotine concentration, packaging, labelling and flavour restrictions). These reforms are coupled with an aggressive compliance programme, involving joint operations with states and territories, takedowns of thousands of unlawful online advertisements, and blocking of non‑compliant websites, underscoring the TGA’s increasing willingness to use its civil and criminal enforcement toolkit.

Over the past year, the TGA has also demonstrated readiness to intervene in the compounding sector on safety grounds, particularly when it comes to medical weight loss, such as GLP‑1 receptor agonists. Following consultation and high‑profile safety concerns about “replica” semaglutide and tirzepatide products, amendments to the Therapeutic Goods Regulations 1990 (Cth) removed GLP‑1 receptor agonists from the pharmacy compounding exemption; as such, pharmacists have been unable to compound or supply such preparations, with civil and criminal penalties for unlawful manufacture and associated advertising. 

In addition to TGA regulations, Australia is also served by the Medicines Australia Code of Conduct Committee, which is empowered to impose financial penalties for Code breaches. In December 2025, the Code Committee fined Amgen for breaches relating to misleading promotional material concerning Repatha, including comparative statements concerning Novartis’s Leqvio. The complaint centred on information provided by Amgen in a product information table for Repatha, with the Code Committee finding that Amgen had failed to supply adequate evidence to justify the comparison.

Protective Trade Marks

“Protective” trade mark strategies are especially important in the pharmaceutical and life sciences sector, where brand equity often outlasts individual product patents and sits alongside complex regulatory naming rules. Protective/defensive marks are effectively available for well‑known brands that have been used so extensively that consumers would assume a connection if the mark appeared on unrelated goods – and, unlike ordinary marks, they are not vulnerable to non‑use removal, making them attractive for “block out” protection of blockbuster medicines and corporate house brands in a crowded marketplace, where product promotion is restricted and highly regulated.

In August 2025, the Trade Mark Office delivered its decision in Sandoz AG v Actor Pharmaceuticals Pty Ltd [2025] ATMO 152, which concerned Actor’s application for the word mark “ACC”. Sandoz markets a cough suppressant containing acetylcysteine under the ACC brand. Actor is a local licensee and distributor of Sinupret, a product described as being in “direct competition” with the Sandoz product.

Sandoz opposed the registration on several grounds, including Section 60 of the Trade Marks Act 1995 (Cth), arguing that the mark was similar to one that had acquired a reputation in Australia. Notably, Sandoz was only able to present evidence of its product’s reputation in Germany and South Africa, relying on the concept of “spill-over” reputation extending to Australia. The Delegate found that Sandoz had not adequately demonstrated how use of the Actor trade mark in Australia would lead consumers to be confused or deceived into thinking there was an association with the Sandoz product, and the application was permitted to proceed to registration. 

Recent trends in trade mark filings indicate a renewed focus on defensive and other “protective” trade mark strategies in Australia, especially within the pharmaceutical and life sciences sectors. This is supported by findings in IP Australia’s IP Report, which noted an increase in trade mark applications in the medical and veterinary service categories by domestic applicants for 2024/2025.