Definitive global law guides offering comparative analysis from top-ranked lawyers
CHAMBERS GLOBAL PRACTICE GUIDES
Life Sciences & Pharma IP Litigation 2026
Definitive global law guides offering comparative analysis from top-ranked lawyers
Contributing Editor Nicola Dagg Kirkland & Ellis LLP
Global Practice Guides
Life Sciences & Pharma IP Litigation
Contributing Editor Nicola Dagg Kirkland & Ellis International LLP
2026
Chambers Global Practice Guides For more than 20 years, Chambers Global Guides have ranked lawyers and law firms across the world. Chambers now offer clients a new series of Global Practice Guides, which contain practical guidance on doing legal business in key jurisdictions. We use our knowledge of the world’s best lawyers to select leading law firms in each jurisdiction to write the ‘Law & Practice’ sections. In addition, the ‘Trends & Developments’ sections analyse trends and developments in local legal markets. Disclaimer: The information in this guide is provided for general reference only, not as specific legal advice. Views expressed by the authors are not necessarily the views of the law firms in which they practise. For specific legal advice, a lawyer should be consulted. Content Management Director Claire Oxborrow Content Manager Jonathan Mendelowitz Senior Content Reviewers Sally McGonigal, Ethne Withers, Deborah Sinclair, Stephen Dinkeldein, Vivienne Button and Sean Marshall Content Reviewers Lawrence Garrett, Marianne Page, Heather Palomino, Alison Moore, Adrian Ciechacki and Michael Irvine Content Coordination Manager Nancy Tsang Senior Content Coordinators Carla Cagnina and Delicia Tasinda Content Coordinator Joanna Chivers Head of Production Jasper John Production Coordinator Genevieve Sibayan
Published by Chambers and Partners 165 Fleet Street London EC4A 2AE Tel +44 20 7606 8844 Fax +44 20 7831 5662 Web www.chambers.com
Copyright © 2026 Chambers and Partners
Contents
INTRODUCTION Contributed by Daniel Lim, Steven Baldwin and Jin Ooi, Kirkland & Ellis International LLP p.4
NORWAY Law and Practice p.145 Contributed by Wikborg Rein Advokatfirma AS
AUSTRALIA Trends and Developments p.9 Contributed by Maddocks
PHILIPPINES Law and Practice p.157 Contributed by Villaraza & Angangco POLAND Law and Practice p.174 Contributed by A&O Shearman
BRAZIL Law and Practice p.16
Contributed by Licks Attorneys Trends and Developments p.32 Contributed by Licks Attorneys CHINA Law and Practice p.38 Contributed by LeanWill Law Firm Contributed by HOFFMANN EITLE Trends and Developments p.74 Contributed by HOFFMANN EITLE INDIA Trends and Developments p.81 Contributed by Anand and Anand GERMANY Law and Practice p.57
SAUDI ARABIA Law and Practice p.193 Contributed by Mohammed AlDhabaan & Partners Eversheds Sutherland Trends and Developments p.209 Contributed by Mohammed AlDhabaan & Partners Eversheds Sutherland
SINGAPORE Law and Practice p.214 Contributed by Drew & Napier LLC
SOUTH KOREA Law and Practice p.234
Contributed by Bae, Kim & Lee LLC Trends and Developments p.246 Contributed by Bae, Kim & Lee LLC
ISRAEL Law and Practice p.89 Contributed by Gilat, Bareket & Co, Reinhold Cohn Group
USA Law and Practice p.253
Contributed by Gemini Law LLP Trends and Developments p.270 Contributed by Tensegrity Law Group LLP
JAPAN Law and Practice p.108
Contributed by Ohno & Partners Trends and Developments p.119 Contributed by Nagashima Ohno & Tsunematsu
MEXICO Law and Practice p.126 Contributed by Arochi & Lindner
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INTRODUCTION
Contributed by: Daniel Lim, Steven Baldwin and Jin Ooi, Kirkland & Ellis International LLP
Kirkland & Ellis International LLP has a patent litiga ‑ tion practice comprising approximately 230 attorneys in London, Austin, Boston, Chicago, Dallas, Houston, Los Angeles, Miami, New York, Salt Lake City, San Francisco and Washington, DC. More than 70% of Kirkland’s patent litigation attorneys are engineers and scientists, trained in a variety of technical disci ‑ plines. Kirkland’s experienced IP litigation attorneys achieve extraordinary results in patent, copyright, trade mark, trade secret misappropriation and adver ‑ tising matters. They represent clients across a broad range of industries, including life sciences, technol ‑
ogy, consumer products manufacturing, financial services, automotive, and food and beverage. Other areas of practice are pharmaceutical and biologics patent litigation, co-ordinating global IP enforce ‑ ment/defence cases, SEPs and FRAND disputes, post-grant proceedings before the US Patent and Trademark Office’s Patent Trial and Appeal Board, and appeals of high-stakes cases in the US Court of Appeals for the Federal Circuit and the US Supreme Court, as well as the Court of Appeal of England and Wales and the UK Supreme Court. farm” cases and has a strategic approach to litigation, finding novel solutions to complex problems facing his clients. Steven’s case experience covers a broad range of technical fields, including mobile telecommunications technologies, algorithmic trading, biological and chemical product development and screening platforms, next- generation cancer treatments and e-cigarette/vaping technologies.
Authors
Daniel Lim is a partner in Kirkland & Ellis International LLP’s IP litigation practice in London, where he focuses on high-stakes life sciences patent litigation – particularly with regard to diagnostics, precision medicine, cell
and gene therapy, and the pharmaceutical industry. His case experience includes oncology, molecular biology, diagnostics, antibody engineering and biostatistics, and often involves issues at the cutting edge of the law – notably in relation to second medical-use patents. He is active as a member of the International Association for the Protection of Intellectual Property (AIPPI) and the European Patent Lawyers Association (EPLAW), including as vice- chair of AIPPI’s standing committee on biotechnology.
Jin Ooi is a patent litigator at Kirkland & Ellis. He has worked on matters in the pharmaceutical, chemistry, biotech and life sciences fields (second medical use, biologics/ biosimilars, small molecules, DNA
sequencing, vaccines, and transgenic animal platforms for antibody discovery), in the medical device space (cochlear implants, and bone cements), and in the FMCG and consumer products sector (reduced-risk products including tobacco heating products and e-cigarettes, shaving razors, dishwashing tablets, and coffee pods and capsules). Jin’s cases are often multi-jurisdictional, requiring significant cross-border co-ordination across multiple forums. His dual qualifications in law and pharmacology give him a special insight into, and understanding of, his clients’ legal needs and commercial and regulatory imperatives.
Steven Baldwin is a partner in Kirkland & Ellis International LLP’s IP litigation team in London, with significant experience representing clients in trade secrets, patent, life sciences regulatory, copyright and
trade mark matters. Focusing on former employee trade secrets cases and complex cross-border life sciences and telecommunications patent disputes, Steven’s trade secrets experience includes high- value disputes in the life sciences and financial industries. He is routinely instructed on “bet-the-
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INTRODUCTION Contributed by: Daniel Lim, Steven Baldwin and Jin Ooi, Kirkland & Ellis International LLP
Kirkland & Ellis International LLP 40 Leadenhall Street London EC3A 2AA United Kingdom Tel: +44 20 7469 2000 Email: daniel.lim@kirkland.com Web: www.kirkland.com
A Global Overview of Life Sciences and Pharma IP Litigation We are delighted to introduce the Life Sciences & Pharma IP Litigation Chambers Global Practice Guide, which provides an overview of litigation in the life sciences and pharmaceutical sectors in a number of countries, and an update to the trends and devel ‑ opments expected in the coming year by leading law ‑ yers in each jurisdiction. Technological developments continue at pace in the life sciences and pharmaceutical sectors, driving liti ‑ gation across all jurisdictions. The great commercial and social importance of healthcare products, along with the increasing costs of developing and marketing them, puts pressure on innovators to extend exclu ‑ sivity to the maximum extent possible. At the same time, health systems across the world remain more financially challenged than ever, making generic and biosimilar alternatives a compelling and cost-effective proposition. Striking the right balance is a difficult and ongoing task for governments, regulators and courts, contributing to a dynamically changing global IP land ‑ scape. Such challenges are likely to remain for the foreseeable future, making it as important as ever to stay on top of the latest developments. Large-scale, cross-jurisdictional patent litigation remains a key part of this space. In addition to more traditional small-molecule generic pharmaceutical litigation, biosimilar litigation continues to increase in prominence and to throw up new and complex factual and legal issues. This reflects both the dominance of biologics amongst the current crop of blockbuster
drug products and their greater complexity compared to small-molecules. Additionally, increasingly ubiq ‑ uitous consumer-facing wearable medical technol ‑ ogy including watches and glucose monitors have emerged over recent years, joining more typical medi ‑ cal devices as an important battleground for patent, trade mark and other IP disputes. A key development has been the emergence of cross-jurisdictional injunctions both inside the EU and beyond its borders, following the CJEU’s deci ‑ sion in BSH Hausgeräte v Electrolux in early 2025. This has further tied in with the contentious question of infringement of formulation patents under the doc ‑ trine of equivalents by biosimilars in litigation concern ‑ ing blockbuster drug Aflibercept, which is likely to become an increasingly important issue as more basic patents for biologics expire over the coming years. Meanwhile, the EU General Court has clarified the limits of extended market exclusivity for re-purposed pharmaceuticals, while the European Commission issued fines after it found that an innovator’s conduct of filing divisional patents to extend exclusivity was anti-competitive. In Australia, patent term extension was held to no longer cover pharmaceutical formu ‑ lation patents, whilst in Brazil there was an abortive attempt to introduce new guidelines requiring results of in vivo tests to be included in any patent application in respect of second medical-use claims. Additionally, the EU’s long-awaited “pharma package” appears to be nearing completion, including reforms to regula ‑ tory data protection and market exclusivity periods. All these developments may indicate increasing desire
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INTRODUCTION Contributed by: Daniel Lim, Steven Baldwin and Jin Ooi, Kirkland & Ellis International LLP
from authorities to push back against some of the practices employed to increase exclusivity periods, while continuing to reward “true” innovation. This in turn highlights the continuing importance of well- considered product life cycle management across the globe. Enforcement and cross-jurisdictional injunctions Enforcement considerations remain an essential piece of any commercial IP strategy, with patent rights usu ‑ ally being backed by the ability to obtain a preliminary injunction preventing launch of an infringing generic, biosimilar or other product within the jurisdiction. We are now seeing a potentially major shift in this area following BSH Hausgeräte v Electrolux , which opened the gates for new cross-border “long-arm” injunctions provided an anchor defendant is domiciled in the juris ‑ diction of the court which is being asked to exercise this power. Both the Unified Patent Court (UPC) and some EU national courts have already exercised this power and issued injunctions to restrain infringing product launches not just within the court’s own juris ‑ diction but also in other countries. In addition to examples of injunctions covering several EU countries (both within and outside the UPC con ‑ tracting states), there have been decisions affecting products in jurisdictions which are members of the European Patent Convention (EPC) but not the EU, such as the UK. This has been the case notwithstand ‑ ing that the defendant sought to raise the defence that the relevant patent is invalid – prior to the BSH Hausgeräte v Electrolux decision, this would have pre ‑ cluded a cross-border injunction being granted. It will be important to follow how this area evolves over the coming year, with some speculating that such cross- border jurisdictions could even extend to patents of countries outside EPC countries, including to the US (a matter that is already presently before the European courts, albeit not in a life sciences context). Notably, to date the courts which have been pre ‑ pared to grant such cross-border “long-arm” injunc ‑ tions have generally applied their own local laws and procedures in their decision-making, adopting the rebuttable presumption that the outcome would be the same under the law of each of the other jurisdic ‑ tions to which the injunction is proposed to extend
and placing the onus on the defendant to convince the court otherwise. Arguably, that is a significant shift in the burden of proof from claimant to defendant, with major implications for litigants. It remains to be seen, as the jurisprudence develops, whether or not this will remain the position, and in practice what standard of evidence will be required to rebut the presumption to the satisfaction of the court. Given the extensive scope, along with the procedural and evidential economy, of such injunctions, we would expect to see these features increasing prominently in the litigation strategy of patentees across all indus ‑ tries, including life sciences. These tactics also raise accompanying considerations of forum shopping between the UPC and different EU national courts. Conversely, we may also begin to see a response from the courts of countries whose patents are subject to cross-border injunctions, particularly where patent validity is in dispute. In that regard, the recent uptick in anti-suit injunctions and jurisdiction challenges in the SEP/FRAND arena may be a precursor of what is to come in life sciences and pharmaceutical cross- border disputes. Continuing evolution of the UPC The UPC turned two years old in June 2025 and con ‑ tinues to shift the European patent litigation land ‑ scape, across the 18 contracting EU member states and beyond. In addition to extending its jurisdiction beyond the contracting states (as discussed above), the UPC’s influence has continued to grow as it gains more experience of dealing with cases and patentees gain more confidence in its practice and procedures. The number of infringement and revocation actions filed at the UPC continues to grow steadily, including an increasing number of pharmaceutical companies choosing to opt-in and use the court. As a result, we have had the first preliminary injunction to restrain sales of a generic pharmaceutical across the UPC states. On the other hand, innovator-against-innovator actions continue to be filed, including in relation to COVID-19 treatments, highlighting the wide range of potential court users. The UPC has been busy over the past year, dealing with a variety of procedural and substantive issues as they have fallen to be considered at first instance and
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INTRODUCTION Contributed by: Daniel Lim, Steven Baldwin and Jin Ooi, Kirkland & Ellis International LLP
at appeal level for the first time. Significant questions being considered have included claim construction, infringement (including under the doctrine of equiva ‑ lents and in relation to second medical-use patents), declarations of non-infringement, the requirements for granting preliminary injunctions, and various aspects of patent validity including two appeals in life scienc ‑ es disputes which have resulted in the UPC Court of Appeals’ latest decisions on inventive step (in which they adopted a “holistic” approach rather than the “problem–solution” approach, and emphasised that, for an inventive step attack to succeed, it had to be established that the skilled person would, not just could, have arrived at the claimed invention as the next step from the prior stage). Given the decentral ‑ ised nature of UPC first-instance decisions, some inconsistencies are still appearing between differ ‑ ent Local Divisions, with the associated risk of forum shopping by parties. Practitioners will be keen to fol ‑ low how these and other issues are ultimately resolved by the Court of Appeals. Further, the somewhat uncer ‑ tain extent of the UPC’s jurisdiction in relation to the European Patent Office (EPO) and national rights in both contracting and non-contracting states, remains an important consideration for parties developing and Following the decision of the Enlarged Board of Appeal of the EPO in G2/21 (handed down in March 2023), European jurisdictions have started to diverge some ‑ what in relation to the idea that a technical contribu ‑ tion should be plausible for there to be an inventive step as required for patentability. Several decisions over the past year have largely entrenched these dif ‑ ferences, with the UK Court of Appeal in the Dapa ‑ gliflozin proceedings following its own prior decision in the Apixaban proceedings which relied on the UK Supreme Court’s 2018 decision in Warner-Lambert . Thus, it appears that a technical contribution in the UK must be plausible ab initio, and post-filed evidence can be brought in only to confirm or reject an effect which is already rendered plausible by the patent. Meanwhile, several other European jurisdictions have followed the lead of the Dutch Court of Appeal in interpreting G2/21 to mean that a threshold closer to ab initio implausibility is correct. This lower threshold updating their product IP strategies. Diverging views on patent plausibility
for plausibility would make it easier for post-filed evi ‑ dence of a technical effect to be brought in. Meanwhile, the US approach continues to differ wide ‑ ly from both the UK and the rest of the EPC states. Rather than considering plausibility in relation to inventive step, the US primarily focuses on sufficiency in relation to enablement, as considered by the US Supreme Court more recently in Amgen . Though all agree that “armchair” inventions should be guarded against, these differing approaches emphasise the dif ‑ ficult balancing exercise for patent applicants when deciding whether to file early with limited data or wait for more evidence supporting an invention but with the risk of being scooped by keen competitors. It will be interesting to see to what extent these approaches will converge over the coming years. Product life cycle management and exclusivity While basic patents covering new products are incred ‑ ibly important, complementing them with a suite of other secondary patents and regulatory exclusivities is a critical element of every life cycle management strategy for an important and commercially successful product. Plenty of cases over recent years demon ‑ strate the powerful effect of a portfolio of patents con ‑ sisting of dosing, formulation, second medical use, and other additional patents in protecting originator medicines from generic or biosimilar entry. Likewise, additional rights such as supplementary protection certificates (SPCs) and regulatory data exclusivity are critical tools for innovators in life cycle manage ‑ ment. However, these additional protections are cur ‑ rently under the microscope in jurisdictions around the world, as governments increasingly seek to ensure that exclusivity periods are aligned with the invest ‑ ment required to develop innovative products, crack ‑ ing down on perceived abusive practices and exces ‑ sive exclusivity terms. Further, the approaches to exclusivity may vary across different jurisdictions, as seen in recent cases con ‑ sidering the SPC manufacturing waiver notice pro ‑ visions. While German courts have interpreted the requirements strictly, a more pragmatic approach has been taken in the Netherlands and the UK. This high ‑ lights that while the commercial value of exclusivity extensions can be immense, it is essential to consider
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INTRODUCTION Contributed by: Daniel Lim, Steven Baldwin and Jin Ooi, Kirkland & Ellis International LLP
Conclusion Litigation in the pharmaceutical and life sciences industries is often highly complex and involves con ‑ current cross-border litigation in numerous jurisdic ‑ tions. As the snapshot of issues provided by this brief overview illustrates, the law and practice in the com ‑ bined area is constantly developing and continues to evolve, such that in navigating life sciences and pharmaceutical patent disputes it is essential to have up-to-date advice and information from experienced practitioners in the field. It is hoped that this Guide is helpful to readers in providing a high-level overview of some of the essential features of life sciences and pharmaceutical IP litigation across the range of con ‑ tributing jurisdictions.
carefully the optimal strategy associated with each relevant region and market over the life cycle of the product. Finally, we look forward to considering the impact of the new EU pharma package following agreement by the EU institutions towards the end of 2025 (with the final text still pending). As part of these changes, the period of regulatory data protection will change from the familiar “8+2(+1)” to an “8+1(+1)(+1)” formula. That is, innovative medicines will continue to benefit from the existing eight years of regulatory data pro ‑ tection, but the subsequent market exclusivity period is reduced from two years to one, with the possibility for up to two further one-year extensions if certain conditions are met. This has the objective of limiting the maximum 11-year exclusivity period to truly inno ‑ vative products which address unmet medical needs. It should also be noted that these requirements, and their application deadlines, may be interpreted very strictly as seen by the EU General Court’s recent deci ‑ sion denying an exclusivity extension for Tecfidera. Other parts of the package include changes to orphan drug exclusivity for products treating rare diseases, expansion of the Bolar Exemption allowing generics and biosimilars to obtain reimbursement and pric ‑ ing approval prior to expiry of patent exclusivity, and various measures to address medicine shortages and strengthen pharmaceutical supply chains.
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AUSTRALIA
Australia
Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke Maddocks Maddocks and its national IP team are recognised for market-leading expertise in strategic IP advice and dis ‑ putes. The firm acts on complex matters for major na ‑ tional and international corporations, particularly in life sciences and pharmaceuticals. The team has a strong track record in high-stakes patent litigation, recently acting in Samsung Bioepis v Janssen (ustekinumab); AUPharma v Mundipharma (controlled release oxyco ‑ done/naloxone); Cipla v BMS (apixaban); AstraZeneca v Pharmacor (ticagrelor); Samsung Bioepis v Formy ‑ con (aflibercept, ranibizumab); Fit-Bioceuticals v Arro ‑
Sydney
Tasmania
tex (colour trade marks); Cipla v Novo Nordisk (liraglu ‑ tide); CSIRO v Urrbrae Foods (high amylose wheat); Orthalign v Navbit (medical devices); and AstraZeneca v Pharmacor (dapagliflozin). With offices in Sydney, Melbourne and Canberra, many of the firm’s lawyers are dual-qualified in scientific and technical disci ‑ plines, and bring exceptional technical insight to solv ‑ ing challenges in the life sciences, pharmaceuticals, biotechnology, medical devices and chemicals indus ‑ tries. The firm combines its IP expertise with leading healthcare, regulatory and technology practices.
Authors
Ben Miller is recognised as one of Australia’s leading IP lawyers, with nearly 30 years of experience in leading IP disputes and transactions. Ben is renowned for his expertise in strategic IP advice, litigation and
Alexandra de Zwart has extensive experience as an IP and life sciences lawyer, and is recognised for her expertise in pharmaceutical patent litigation. As a senior associate in the Maddocks IP team, she delivers
dispute resolution, as well as IP licensing and commercialisation transactions. Ben has worked closely with clients in a wide range of industries, including pharmaceuticals, biopharmaceuticals, biotechnology, animal health, manufacturing and engineering, chemicals, medical devices, consumer goods, food, vitamin supplements and TMT. He has led clients to success in a number of Australia’s leading IP cases.
practical, commercially focused advice and guides clients through complex, multi-jurisdictional patent litigation and other IP disputes. Alexandra has acted in significant IP and life sciences regulatory disputes, including before the Federal Court, the Full Federal Court, the NSW Supreme Court and the Australian Patent Office, combining technical insight with strategic solutions. Her work spans diverse technologies including pharmaceuticals, biotechnology, medical devices, software, hardware, telecommunications, mining and consumer goods.
Fiona Deng is an IP lawyer with broad experience in both contentious and non-contentious matters. She advises clients on protecting, managing and enforcing IP rights across patents, trade marks and copyright, as well as
Emma Woelke is an IP lawyer with dual qualifications in science and law. She advises on both contentious and non-contentious IP matters, including
patents, trade marks, copyright, consumer law and designs. Emma has supported clients across a range of sectors, with particular experience in biotechnology, pharmaceuticals and engineering. Her combined technical and legal expertise enables her to deliver practical, commercially focused solutions for complex IP challenges.
handling disputes involving misleading or deceptive conduct, passing off and breach of contract. Fiona combines technical knowledge with practical, commercially focused strategies to help clients safeguard and maximise the value of their IP.
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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke, Maddocks
Maddocks Lawyers Level 10 33 Alfred Street Circular Quay, Sydney NSW 2000 Australia Tel: +61 292 916 100 Email: info@maddocks.com.au Web: www.maddocks.com.au
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 scru ‑ tiny 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 Thera ‑ peutic Goods Administration (TGA) actions underscor ‑ ing 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 strate ‑ gic 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
Australia’s innovation performance also strength ‑ ened 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 Intel ‑ lectual Property Organization’s (WIPO) global top 100 innovation clusters, Sydney ranked 36 for medical technology (by patent filings) and engineering (by aca ‑ demia), while Melbourne ranked 52 for pharmaceuti ‑ cals (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 cer ‑ tain indications and dropping the PBS general co- payment to AUD25 per prescription (from AUD31.60), as part of measures to increase affordability of medi ‑ cines. 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 Phar- maceuticals, 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
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.
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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke, Maddocks
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% manda ‑ tory 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 fur ‑ ther 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 competi ‑ tion, restricted pharmacist substitution options, and little incentive for ophthalmologists to switch prod ‑ ucts. 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 effec ‑ tive 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 suffi ‑
cient 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 com ‑ petitive 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 conveni ‑ ence did not support granting an interlocutory injunc ‑ tion, a conclusion bolstered by her Honour’s assess ‑ ment 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 process ‑ es, 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).
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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke, Maddocks
The Full Court concluded that the definition of “phar ‑ maceutical substance” refers only to active ingredi ‑ ents, 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 for ‑ mulations of known drugs, and offering new oppor ‑ tunities 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 aripipra ‑ zole. The patent’s standard term expired in October 2024, but Otsuka obtained a PTE based on ARTG-list ‑ ed products (ABILIFY MAINTENA kits). Sun Pharma challenged the validity of the PTE, arguing that the claims of the patent did not meet statutory require ‑ ments 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 mix ‑ ture of an active pharmaceutical ingredient (API) and excipients) falls within the definition of a “pharmaceu ‑ tical substance” eligible for a PTE. Prior to this deci ‑ sion, three decisions of single judges at first instance had held that the definition of “pharmaceutical sub ‑ stance” could include a formulation, but none of these decisions was appealed. The Full Court found that, against the legislative con ‑ text, the natural and ordinary wording of the definition of pharmaceutical substance “immediately and natu ‑ rally puts the focus on the substance which itself pro ‑ duces the therapeutic effect”, and does not extend to new formulations, delivery methods or dosage forms containing known substances. The Full Court consid ‑ ered that the legislative history and policy rationale for the current PTE regime was always intended to com ‑
pensate for regulatory delays in bringing new APIs to market, not for improvements in delivery or formula ‑ tion 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 con ‑ struction given in the Full Court authorities of Alphap- harm 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 pol ‑ icy of rewarding primary research in new and inven ‑ tive pharmaceutical substances, rather than allow ‑ ing 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 com ‑ bined 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 com ‑ prising the “AT 1-antagonist” valsartan and the “NEP inhibitor” sacubitril, whose descriptions pro ‑ vided “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 oth ‑ erwise 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 sepa ‑ rate components in the pharmaceutical composi ‑ tion claimed.
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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke, Maddocks
• Justice Yates did not err in considering the specifi ‑ cation of the patent, nor in observing that particular passages of the specification supported his rea ‑ sons. 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 construc ‑ tion. • 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 includ ‑ ed 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 hap ‑ pens” 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, there ‑ fore, 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 construc ‑ tion 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 (Repa ‑ tha). This appeal was decided under provisions of the Patents Act 1990 (Cth) as they existed prior to the enactment of the Intellectual Property Laws Amend ‑ ment (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 inven ‑ tive step. Central to these arguments was Sanofi’s assertion that the claims failed to include any struc ‑ tural 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 ami ‑ no acid sequences of the antibodies, such that oth ‑ ers 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 func ‑ tional 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 speci ‑ fication, but by epitopes in the consistory clauses, the specification lacked fair basis. Justice Nicholas disagreed, stating that scientific proof of the relation ‑ ship 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 fall ‑ ing within the claims and no impermissible extrapola ‑ tion was required by the person skilled in the art. With regards to inventive step, Justice Nicholas reject ‑ ed Sanofi’s expert evidence that developing a PCSK9 inhibiting antibody would be straightforward, owing to the expert’s opinion being “heavily influenced by hind ‑ sight”. His Honour determined that the skilled person would not have been naturally led to antibodies target ‑ ing the PCSK9-LDLR interaction, due to uncertainty
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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke, Maddocks
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 dis ‑ crepancy between results of various assays and that choices would need to be made in the assay pro ‑ cedure, 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 Pat ‑ ents Act, which should reduce the number of lower- quality patents granted and held to be valid in Austral ‑ ia. 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 Sam ‑ sung 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 contin ‑ ued 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 enforce ‑ ment 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 Mama ‑ mia.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 canna ‑ bis 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 height ‑ ened 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 prohi ‑ bitions on non‑therapeutic and disposable products, and strengthened product standards and notification requirements for therapeutic vapes (covering ingre ‑ dients, 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 crimi ‑ nal 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. Fol ‑ lowing 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
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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke, Maddocks
pharmacy compounding exemption; as such, phar ‑ macists 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 Com ‑ mittee, 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 Repa ‑ tha, including comparative statements concerning Novartis’s Leqvio. The complaint centred on infor ‑ mation provided by Amgen in a product information table for Repatha, with the Code Committee finding that Amgen had failed to supply adequate evidence “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 regulato ‑ ry naming rules. Protective/defensive marks are effec ‑ tively 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 corpo ‑ rate house brands in a crowded marketplace, where product promotion is restricted and highly regulated. to justify the comparison. Protective Trade Marks
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 appli ‑ cation for the word mark “ACC”. Sandoz markets a cough suppressant containing acetylcysteine under the ACC brand. Actor is a local licensee and distribu ‑ tor 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, San ‑ doz 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 con ‑ fused or deceived into thinking there was an associa ‑ tion 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 pharma ‑ ceutical 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.
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