Life Sciences and Pharma IP Litigation 2025

Definitive global law guides offering comparative analysis from top-ranked lawyers

CHAMBERS GLOBAL PRACTICE GUIDES

Life Sciences & Pharma IP Litigation 2025

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

2025

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. GPG Director Katie Burrington Content Management Director Claire Oxborrow Content Manager Jonathan Mendelowitz Senior Content Reviewers Sally McGonigal, Ethne Withers, Deborah Sinclair and Stephen Dinkeldein Content Reviewers Vivienne Button, Lawrence Garrett, Sean Marshall, Marianne Page, Heather Palomino and Adrian Ciechacki Content Coordination Manager Nancy Laidler Senior Content Coordinators Carla Cagnina and Delicia Tasinda Content Coordinator Hannah Leinmüller 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

Contents

INTRODUCTION Contributed by Nicola Dagg, Daniel Lim, Jin Ooi and Alex Magnusdottir, Kirkland & Ellis International LLP p.4

MEXICO Trends and Developments p.189 Contributed by Calderón & De La Sierra

AUSTRALIA Trends and Developments p.9 Contributed by Maddocks

NORWAY Law and Practice p.194 Contributed by Wikborg Rein Advokatfirma AS Trends and Developments p.209 Contributed by Advokatfirmaet Thommessen AS POLAND Law and Practice p.217 Contributed by A&O Shearman, A. Pedzich Sp. k. Trends and Developments p.240 Contributed by A&O Shearman, A. Pedzich Sp. k. SAUDI ARABIA Law and Practice p.247 Contributed by Mohammed Al Dhabaan & Partners Eversheds Sutherland Trends and Developments p.268 Contributed by Mohammed Al Dhabaan & Partners Eversheds Sutherland

BRAZIL Law and Practice p.17 Contributed by Montaury Pimenta, Machado & Vieira de Mello

Trends and Developments p.41 Contributed by Licks Attorneys

CHINA Law and Practice p.50

Contributed by Fangda Partners Trends and Developments p.71 Contributed by LeanWill Law Firm GERMANY Law and Practice p.81 Contributed by Hoffmann Eitle Trends and Developments p.103 Contributed by Hoffmann Eitle

SINGAPORE Law and Practice p.275 Contributed by Drew & Napier LLC

INDIA Trends and Developments p.112 Contributed by Anand and Anand Advocates ISRAEL Law and Practice p.120 Contributed by Gilat, Bareket & Co, Reinhold Cohn Group

SOUTH AFRICA Law and Practice p.302 Contributed by Adams & Adams Attorneys

SWITZERLAND Law and Practice p.318 Contributed by Wenger Plattner USA Law and Practice p.337 Contributed by Kirkland & Ellis Trends and Developments p.360 Contributed by Haug Partners LLP

ITALY Law and Practice p.143 Contributed by Trevisan & Cuonzo

JAPAN Law and Practice p.167

Contributed by Ohno & Partners Trends and Developments p.181 Contributed by Nagashima Ohno & Tsunematsu

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INTRODUCTION

Contributed by: Nicola Dagg, Daniel Lim, Jin Ooi and Alex Magnusdottir, Kirkland & Ellis International LLP

Kirkland & Ellis International LLP has a patent litigation practice comprised of approximately 230 attorneys in London, Austin, Boston, Chi- cago, Houston, Los Angeles, New York, Palo Alto, Salt Lake City, San Francisco and Wash - ington, DC. More than 75% of Kirkland’s pat - ent litigation attorneys are engineers and scien - tists, trained in a variety of technical disciplines. Kirkland’s experienced IP litigation attorneys achieve extraordinary results in patent, copy - right, trade mark, trade secret misappropriation and advertising matters. They represent clients across a broad range of industries, including

life sciences, technology, consumer products manufacturing, financial services, automotive, and food and beverage. Other areas of prac - tice are pharmaceutical and biologics patent litigation, co-ordinating global IP enforcement/ 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 Su - preme Court.

Contributing Editor

Co-Authors

Nicola Dagg is a partner and leader of Kirkland’s IP litigation practice in London. She draws upon experience of more than 25 years at the forefront of IP litigation, particularly in relation

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

to trade secrets and patents. Her practice includes pharmaceutical and biologics patent litigation; strategic life sciences patent and product life cycle advice; co-ordinating global IP enforcement/defence cases; hi-tech, digital and telecommunications litigation; and SEP and FRAND disputes. Nicola, who also has an MA in natural sciences, is renowned for her strategic and creative approach to solving difficult and commercially critical IP issues and regularly represents her clients in ground- breaking cases in the Court of Appeal and UK Supreme Court.

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.

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INTRODUCTION Contributed by: Nicola Dagg, Daniel Lim, Jin Ooi and Alex Magnusdottir, Kirkland & Ellis International LLP

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/

Alex Magnusdottir is an associate in Kirkland & Ellis International LLP’s IP litigation practice in London. Alex has trial and advisory experience across the IP spectrum with a particular

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.

focus on pharmaceutical, biotechnology and medical device patents, and product life cycle advice. Her case experience includes oncology, molecular biology, antibodies, medical devices, and SPCs and medical devices. She works on high value, cross- border disputes dealing with complex technical and patent issues. Alex holds a PhD in neuroscience which gives her particular insight into the challenges facing IP clients.

Kirkland & Ellis International LLP 30 St Mary Axe London EC3A 8AF United Kingdom

Tel: +44 20 7469 2150 Fax: +44 20 7469 2001 Email: nicola.dagg@kirkland.com Web: www.kirkland.com

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INTRODUCTION Contributed by: Nicola Dagg, Daniel Lim, Jin Ooi and Alex Magnusdottir, Kirkland & Ellis International LLP

A Global Overview of Life Sciences & Pharma IP Litigation We are delighted to introduce the Life Sciences & Pharma IP Litigation 2025 edition of Cham - bers’ Global Practice Guides, 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 developments expected in the coming year by leading lawyers in each jurisdiction. Litigation in the life sciences and pharmaceu - tical industries continues to be prolific across all jurisdictions. With increasing complexity of the technologies involved, innovators have ever more avenues to consider when protecting their inventions. However, the socio-political environ - ment companies are operating in is ever more challenging – governments in key manufac - turing jurisdictions, including China and India, have been taking steps to make their countries more attractive for innovators. If manufacturing countries become more patentee friendly, we could see changes in global life-cycle manage - ment and enforcement strategies and litigation dynamics in this sector, with an increased focus on enforcement against manufacturers of active pharmaceutical ingredients (API) and finished products in jurisdictions where enforcement of patent rights had previously been regarded as challenging. Biologics (and biosimilar versions of originator biologics) are now firmly established at the fore - front of pharmaceutical litigation, and comprise the vast majority of the current generation of blockbuster medicines. Whilst small molecule generic litigation continues, the rise of biolog - ics/biosimilars has had and continues to have an impact in terms of the dynamics of, and key regular players in, large-scale pharmaceutical patent litigation. Overall, the number of patent

disputes in the sector has remained steady but the disputes are increasingly complex and high- stakes and are often fought in parallel across multiple forums. Other industry trends include the continued rise in the frequency of “innova - tor-on-innovator” disputes. At the tail end of the year, the US Court of Appeals for the Federal Circuit released an opinion that Orange Book patents must claim at least the active ingredi - ent of a patent. It also addressed device pat - ents specifically, holding that patents which only claim device components do not meet the listing requirement. Parties in the pharmaceutical space will also have a particular eye out for develop - ments in the coming year regarding implications of the European Commission’s decision about the alleged misuse of divisional patents, where an innovator’s conduct of filing divisional patents to extend exclusivity on the market was found to be anti-competitive. This decision could have wide-ranging implications for life-cycle manage - ment throughout Europe. New technologies on the rise The focus on mRNA-based vaccines and treat - ment continues. The litigation related to the COVID-19 vaccines persists in some jurisdic - tions, while the parties have settled in others. Next generation technologies such as CRISPR gene editing and base editing remain on the forefront, and approvals of new CRISPR-based therapies are bound to lead to litigation in the area, including around licensing arrangements by the many players involved with the founda - tional CRISPR technology. With the rapid expan - sion of AI-based tools and technology, there has been continued focus on AI-based inventions. The UK courts continued to grapple with AI- based technology, and the UK Supreme Court is set to hear an appeal on the patentability of AI-based inventions in the coming year. The UK Court of Appeal had previously said obiter

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INTRODUCTION Contributed by: Nicola Dagg, Daniel Lim, Jin Ooi and Alex Magnusdottir, Kirkland & Ellis International LLP

that AI-based inventions were not categori - cally unpatentable. Similarly, the US Patent and Trademark Office issued guidance stating that while AI-based inventions are not categorically unpatentable, the inventorship analysis should focus on human contributions. Increased sophistication of AI-systems may lead to more prevalent use in drug discovery and platform technologies, and arguments about the patentability of such inventions are bound to arise before the courts and patent offices. Given the rapid uptake of AI-based inventions in areas such as healthcare and medical devices, we expect to see litigation in this area evolve in the coming year. Approaches to enforcement The ability to obtain a preliminary injunction to prevent the launch of a generic or biosimilar medicine is an all-important consideration in any business/legal strategy to protect the exclusiv - ity of an originator product. However, there has been a recent trend in traditionally more prelimi - nary injunction-friendly jurisdictions like the UK and Australia towards fewer injunctions being granted and greater scrutiny of claimants’ asser - tions of irreparable harm if the injunction they seek is denied. Perhaps relatedly, and with an increased awareness of the impact of public interest factors in the proportionality calculus, recently we have also seen greater forbearance on the part of claimants in seeking preliminary or final injunctive relief where critical medicines are concerned, although this continues to vary extensively from jurisdiction to jurisdiction, even across the EU where a single enforcement direc - tive is in place. Each country guide includes an update on the steps required to obtain a pre - liminary injunction and the considerations for applicants.

The emergence of the Unified Patent Court (UPC) has also changed the injunction situation in Europe, with the Court granting a number of preliminary injunctions in the last year, but pro - cedural requirements such as acceptable delay before bringing a request for an injunction have not quite crystallised between the different divi - sions. Given the wide-ranging scope of such injunctions, we expect to see increased interest in seeking them in parallel with other enforce - ment approaches. Changing landscape in European litigation with the UPC The UPC completed its first year of operation in June 2024, and has shaken up the patent litiga - tion landscape in Europe, including the interplay with both national actions and the European Pat - ent Office (EPO). As the Court matures, increas - ing numbers of unitary patents have been added to the register. The Court has seen a range of cases filed with it, with the number of pharma - ceutical, medical devices and life sciences cas - es on the rise. Given the international nature of many disputes before the Court and the preva - lence of UK-based firms co-ordinating the litiga - tion, English has now become the most preva - lent language in proceedings before the Court. With the Court’s many local and central divi - sions and their different approaches and time - lines, parties have, to a certain extent, been able to forum shop to achieve desired forum and outcomes. Given the Court’s infancy, many substantive and procedural issues are arising for the first time, and practitioners will eagerly await decisions from the UPC Court of Appeal regarding the proper approach to jurisdiction, bifurcated cases, and other procedural issues. These tactical opportunities also complicate considerations for both patentees and imple - menters, as the interplay between the UPC, the

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INTRODUCTION Contributed by: Nicola Dagg, Daniel Lim, Jin Ooi and Alex Magnusdottir, Kirkland & Ellis International LLP

Conclusion Litigation in the pharmaceutical and life sciences industries is often highly complex and involves concurrent cross-border litigation in numerous jurisdictions. As the snapshot of issues pro - vided by this brief overview illustrates, the law and practice in the area is constantly developing and continues to evolve, such that, in navigat - ing life sciences and pharmaceutical patent dis - putes, 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 contributing jurisdictions.

EPO and national rights and actions must all be taken into account in product life-cycle planning. Litigation funding In the medical devices, product liability and related fields, litigation funding has globally become an increasingly important factor in litiga - tion strategies. While litigation funding has a long history in the USA, over the last year we have increasingly seen it utilised in the UK, where a proposal for reform of third-party litigation fund - ing is expected this year. This enables parties that might historically not have been litigious, or able to undertake large scale litigation, to enter the litigation arena. While not prevalent in the medical devices or product liability space in the UK and EU as of yet, it is likely only a mat - ter of time until the first funder-backed actions emerge.

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AUSTRALIA

Australia

Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong Maddocks Maddocks has extensive experience across the life sciences, pharmaceutical, biotech and digital health sectors, in both litigious and com - mercial matters. Maddocks’ specialist teams provide strategic advice, freedom to operate advice, litigation, IP licensing and commer - cialisation services across the full spectrum of IP matters, in particular for patents and trade marks. The firm combines its IP expertise with market-leading healthcare and TMT practices in Australia to realise opportunities for its clients in biologics, digital health, rapid diagnostics,

Sydney

Tasmania

personalised medicine and clinical genomics. Based in offices in Sydney, Melbourne and Canberra, many of Maddocks’ patent litigation team are dual qualified with degrees in a num - ber of scientific and technical disciplines. The partners and senior lawyers have strong track records of success in some of the leading re - cent cases in Australia before the Federal Court and High Court of Australia, including regarding biosimilars, pharmaceuticals, chemistry, bio - technology, second medical uses and medical devices.

Authors

Ben Miller is widely recognised as one of Australia’s leading patent litigators and leads Maddocks’ patent litigation team. With a degree in biochemistry, he draws on over

Stephen Rohl is an IP litigation special counsel at Maddocks with more than ten years’ experience in complex multi- jurisdictional patent litigation, in particular for the biotechnology

27 years’ experience leading IP disputes and transactions to develop effective litigation strategies with incisive technical and commercial focus. Ben has led clients to success in recent years in some of Australia’s leading patent cases, including Novartis v Pharmacor, Mylan Health v Sun Pharma, Pfizer v Samsung Bioepis, Servier v Apotex, Lundbeck v Alphapharm, Apotex v Sanofi Aventis, Pfizer v Commissioner of Patents, and Fresenius Medical Care v Gambro.

and pharmaceutical, medical devices and veterinary medicines industries. Stephen specialises in life sciences patent cases before the Federal Court and High Court of Australia, as well as disputes in the Australian Patent Office, for which he draws upon his degree in applied chemistry. He also advises on IP transactions and therapeutic goods regulation.

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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks

Katie Pryor is a senior associate in Maddocks’ IP team, with expertise in sectors including medtech, pharmaceuticals and engineering. With a degree in science (majoring in

Jenny Wong is an IP litigation senior associate at Maddocks with experience in complex multi-jurisdictional patent disputes involving clients in the life sciences and engineering

pharmacology), she has a particular focus on matters relating to highly complex technical subject matter. Katie has advised various multinational clients on IP commercialisation, transactions, enforcement and freedom to operate. She has acted in a number of global patent disputes, involving proceedings before the Federal Court of Australia, the High Court of Australia, the UK High Court and Court of Appeal, and the European Patent Office.

sectors. She has a PhD in biochemistry with specialist training in molecular biology. She specialises in life sciences patent cases before the Federal Court of Australia and has acted for clients in patent disputes relating to human vaccines, small molecules, biosimilar monoclonal antibodies, transgenic mice and gene editing technology. Jenny also advises clients on issues relating to freedom to operate and pricing, and reimbursement of prescription pharmaceutical products in Australia.

Maddocks Angel Place Level 27 123 Pitt Street Sydney NSW 2000 Australia Tel: +61 2 9291 6100

Email: info@maddocks.com.au Web: www.maddocks.com.au

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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks

Overview The year 2024 brought several significant intel - lectual property judgments in the life sciences and pharmaceuticals sector, particularly in the context of patents and consumer law. In Invis - align v SmileDirectClub, the Full Federal Court found that SmileDirectClub’s comparative advertising contravened the Australian Con - sumer Law, emphasising the need for accuracy and fairness in health and efficacy claims in comparative advertising. The Full Federal Court also handed down a seminal judgment in San - doz v Bayer, holding that in the context of the pharmaceutical development process, taking a drug candidate forward in a generally high-risk area is not enough to overcome an obviousness challenge. The same case also provided valu - able guidance on the question of ascertainment of prior art documents under the pre-Raising the Bar Patents Act. Meanwhile, the ToolGen v Fisher decision high - lighted the scope for correcting obvious mis - takes in patent claims, reinforcing that while the error and its correction must be apparent to a skilled person, the skilled person will be taken to bring all their knowledge to that question. Aus - tralia’s highly contentious patent term extension regime was again tested in Novartis v Pharma - cor, where the court ruled that Novartis’ term extension should be removed. The Australian Market The life sciences sector continued to see sig - nificant growth in Australia in 2024, with close to 1,600 biotechnology and medical technol - ogy companies now operating there. This year, the federal government announced its Strategic Examination of Research and Development, the first review into R&D in nearly 20 years, aimed at growing Australia’s science and innovation capabilities. The Strategic Examination coin -

cides with an increased push by the industry for policy reforms to strengthen Australia’s capac - ity for life sciences research, development and commercialisation, with the first National Bio - tech and Medtech Development and Commer - cialisation Summit occurring in November 2024. The year 2024 also saw the government expand on its commitment to ensuring affordable and accessible medication. The government intro - duced significant new funding (AUD4.3 billion) to the Pharmaceutical Benefits Scheme (PBS), which included AUD3.4 billion allocated for new and amended listings to the PBS, and deliv - ered a funding boost to community pharmacies of AUD3 billion per the commencement of the eighth Community Pharmacy Agreement. Inherently risky business – the Full Court finds rivaroxaban patents obvious The Full Federal Court has reversed a decision of Justice Rofe at first instance to invalidate Bayer’s patents for a particular formulation of rivaroxaban and a once-a-day dosing regimen. The decision held that general risks in the rou - tine drug development process should be under - stood as part of the background against which the person skilled in the art operates, and are not sufficient, on their own, to defeat an obvi - ousness challenge to formulation patents and dosage regimen patents which would have been arrived at in the course of phase I, II and III clini - cal trials. Rivaroxaban is in a class of factor Xa inhibitors, and is the active ingredient in Bayer’s block- buster drug XARELTO. XARELTO is used as a treatment for deep-vein thrombosis and pulmo - nary embolism. XARELTO is Bayer’s best-selling drug globally, earning around AUD140 million under the PBS in 2024. Internationally, Bayer

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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks

and Sandoz have been involved in a number of disputes regarding rivaroxaban, including in the UK, where the UK High Court revoked Bayer’s patents. The case concerned Australian Patent No 2004305226 (the “226 Patent”) for a formula - tion, and Australian Patent No 2006208613 (the “613 Patent”) for a once-a-day dosing regimen. At first instance, Justice Rofe rejected an obvi - ousness challenge based on the common gen - eral knowledge (CGK) together with WO 919, the compound patent which disclosed rivaroxaban as a particularly promising candidate. In her reasoning, Justice Rofe accepted that WO 919 would be of interest to a drug development team seeking to develop a new antithrombotic drug, and that the skilled reader would likely focus on rivaroxaban when selecting lead can - didates to take into further drug development work. Justice Rofe then went on to apply the “reformulated Cripps question”, finding that: • the well-known standard series of steps of drug development were not routine steps; and • Bayer’s drug development journey was more akin to a “voyage of discovery” than “working towards the invention with an expectation of success”. On appeal, the Full Court found that Justice Rofe had placed too much emphasis on “the risk of failure to gain regulatory approval which is inherent in any drug development project”, and what would have been undertaken as a matter of course following the selection of rivaroxaban as a lead candidate. Further, the Full Court confirmed that the “rel - evant expectation” should be measured against

the ordinary level of expectation and risk inher - ent in routine work in the field. It is not necessary to know a particular outcome at the outset of the hypothetical task. Rather, the Full Court stated the question as whether a person skilled in the art with the relevant CGK, would have been directly led, as a matter of course, to develop rivaroxaban in the expectation that it might pro - duce a useful alternative (or better drug than) the existing compounds for the treatment of throm - boembolic disorders. In the absence of any evidence of any particu - lar problem or difficulty overcome in arriving at a suitable formulation (using a standard wet granulation process) or an (obviously desirable) once-a-day dosing regimen, the Full Court found that these matters would have been arrived at in the course of conventional clinical trials. Bayer has applied to the High Court of Australia for special leave to appeal. Ascertaining prior art for pre-Raising the Bar patents In the same case, the Full Court addressed the standard to be applied in determining whether the person skilled in the art could be reason - ably expected to have “ascertained” a prior art document, which is a prerequisite for consider - ing obviousness in light of the prior art. At first instance, Justice Rofe had accepted that a person skilled in the art would have conduct - ed searches on patent databases using search terms including factor Xa inhibitors, and that the search would have returned results that included WO 919. She accepted that Sandoz’s expert, Professor Roberts, had reviewed the search of the patent database, identified WO 919 as a top priority, and had done so without the benefit of hindsight. However, Justice Rofe found that

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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks

Sandoz’s evidence on ascertainment involved a “short cut” because: • it involved a hypothetical literature search that was limited to one search term (factor Xa inhibitors) and one database; and • Professor Roberts had been provided with a spreadsheet of search results from which he selected WO 919 as a top priority, but had not been provided with copies of the other documents. Justice Rofe was critical of the form of this evi - dence, and found that Professor Roberts had not been provided with “the full suite of results from searches undertaken across all his sug - gested databases”. Her Honour therefore held that the evidence did not establish that it would be reasonable for the person skilled in the art undertaking a search of the kind described by Professor Roberts, but not restricted to factor Xa inhibitors, to have found WO 919. On appeal, the Full Court found that, once Jus - tice Rofe accepted that the search results were a subset of the searches that a skilled person would have done, it was not to the point that additional searches might have been performed, or that the skilled person would have been required to review these additional documents or information. It was not, therefore, necessary for evidence to be adduced that the skilled per - son would select WO 919 over all other informa - tion that they would reasonably be expected to have discovered or found out. Invisalign appeal against SmileDirectClub In 2024, the Full Court of the Federal Court also weighed in on comparative advertising in pro - ceedings brought by Invisalign against SmileDi - rectClub.

Invisalign Australia Pty Ltd (“Invisalign”) and SmileDirectClub LLC (SDC) are competitors in the market of clear aligner teeth-straightening products in Australia. Invisalign alleged that SDC made false, misleading or deceptive rep - resentations in contravention of ss 18 and 29 of the Australian Consumer Law (ACL) in rela - tion to certain material promoting its clear align - ers, which are a type of orthodontic appliance that induces mechanical movement of the teeth (“SDC Aligner Treatment”). On appeal in Invisalign Australia Pty Ltd v Smil - eDirectClub LLC [2024] FCAFC 46, the Full Court reversed the first-instance decision of Justice Anderson, finding that SDC had engaged in con - duct which contravened the ACL. Invisalign relied on five groups of representations made by SDC, each of which was considered by the Full Court. These representations and the Full Court’s holdings are summarised below: 1. The comparable treatment representations – the SDC Aligner Treatment was of compara - ble efficacy to, and would achieve the same or similar clinical outcomes to, traditional braces or Invisalign aligners. The Full Court did not agree with the primary judge and held that by making the comparable treatment representations, SDC had contra - vened the ACL, as the dominant impression cre - ated by the promotional material was to convey to a consumer that they would end up with the same smile, irrespective of whether they chose braces or SDC Aligner Treatment; that consum - ers would achieve the same or a similar clinical outcome from SDC Aligner Treatment as they would achieve with Invisalign treatment; and that SDC Aligner Treatment was of comparable

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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks

efficacy to Invisalign treatment and traditional braces treatment. 2. The price comparison representations – the SDC Aligner Treatment was less expensive in all instances, or was “60% less” or “up to 60% less” expensive for equivalent treatments obtained from an orthodontist or dentist, such as braces or Invisalign. 3. The lower cost representations the SDC Aligner Treatment provided a comprehensive solution to orthodontic issues, or alternatively all non-severe orthodontic issues, at significantly less cost than that of equivalent treatments with braces or Invisalign. Again, the Full Court did not agree with the pri - mary judge and held that by making the price comparison representations and the lower cost representations, SDC had contravened the ACL, as the dominant message of the advertisements was that the products were interchangeable or equivalent or had an equivalent effect on con - sumers’ teeth, but that SDC Aligner Treatment cost “60% less”. This message was not quali - fied by reference to the severity of the problems with the consumers’ teeth. Further, even though this message did not include express claims that SDC cost 60% less than Invisalign, their Hon - ours held that the ordinary reasonable consum - er interested in undertaking treatment for teeth straightening would understand that SDC could only be referring to its competitors. 4. The less than AUD4-a-day representation – the total cost associated with SDC Aligner Treat - ment was “less than $4 a day” for the duration of treatment. SDC admitted that it made the representation in its advertising material but that the representa -

tion was not referring to the treatment time of an average of four-to-six months as contended by Invisalign, but rather to the 24-month period over which instalments for SDC Aligner Treat - ment were paid. The primary judge held that the placement of a footnote above the full stop was sufficiently prominent to alert the ordinary and reasonable consumer to the manner in which the represen - tation had been calculated. Their Honours con - sidered the primary judge had made no error. 5. The total-cost representation – the total cost associated with the SDC Aligner Treatment was either AUD2,825 for upfront payment or AUD3,155 by instalments. Invisalign alleged that the total-cost repre - sentation was misleading as it did not refer to the ongoing costs associated with purchasing retainers at six-monthly intervals after the SDC Aligner Treatment was completed, which was required to keep a consumer’s teeth in their new position. The Full Court agreed with the primary judge that it was clear that the ongoing costs were outside the cost of the SDC Aligner Treat - ment and therefore that the total-cost represen - tation did not contravene the ACL. Notably, the only representations which were made by Invisalign were those concerning comparative advertising. This is an important reminder that when engaging in comparative advertising, context is key. It is always prudent to ensure that comparative advertisements have accurate comparisons that compare like prod - ucts and/or services fairly.

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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks

Saved by an obvious mistake – ToolGen’s patent amendments The decision in ToolGen Incorporated v Fisher (No 3) [2024] FCA 539 serves as a useful remind - er of the ability to amend patent claims to correct an “obvious mistake”, even where the effect is to broaden the claims. Justice Nicholas had previously held that each of the claims of ToolGen’s patent application would, if granted, be invalid. ToolGen sought leave to amend the claims of the patent appli - cation pursuant to s 105(1A) of the Patents Act 1990 (Cth) (the “Patents Act”). ToolGen sought solace in s 102(3)(a) of the Pat - ents Act, arguing that claims 10 and 19 when read together contain an “obvious mistake”. Section 102(3)(a) provides that where an amend - ment is to correct a clerical error or an obvious mistake, the requirements in s 102 regarding the allowability of amendments do not apply. The claims of a patent serve to give the public notice of the limits of the monopoly. Because amendments are retrospective, amendments which broaden the claims are not allowed – they would turn earlier non-infringing activities into acts of infringement. The narrow exceptions to this rule are amendments for the purpose of cor - recting a clerical error or obvious mistake. The theory is that an obvious mistake cannot have misled a person skilled in the art. Justice Nicholas considered the principles rel - evant to what constitutes an obvious mistake, including: • both the error itself and the necessary correc - tion must be obvious to the person skilled in the art;

• “mistake” is a failure to express the real inten - tion of the writer of the specification; • the correction required does not cease to be “obvious” because there is more than one way of expressing it; and • it is not an obvious mistake if extraneous evidence, beyond what is required to put the court in the position of a person skilled in the art, is needed to show the mistake. Justice Nicholas considered that the skilled per - son would understand there to be a mistake in the “composite claim” (ie, claim 10 when read with claim 19) and that the relevant correction of the mistake was one which would be obvious to the person skilled in the art. His Honour consid - ered that the skilled person would clearly under - stand from reading the specification that the various embodiments of the system described included embodiments in which the guide RNA was created in vitro before introduction into the cell, as well as embodiments in which nucleic acid encoding the guide RNA was introduced into the cell where the guide RNA was subse - quently transcribed. His Honour further consid - ered that the skilled person would understand that claim 10 was directed at embodiments in which the guide RNA was produced in vivo and that claim 19 was directed at embodiments in which the guide RNA was an in vitro-transcribed RNA. The relevant correction would, therefore, involve re-writing the composite claim to eliminate the inconsistency in language between claims 10 and 19 so that, rather than referring to nucleic acid encoding a guide RNA, the composite claim instead referred to an in vitro-transcribed guide RNA. The result was that claim 10 would con - tinue to include use of a guide RNA produced in vivo and the composite claim would include use of a guide RNA produced in vitro.

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AUSTRALIA Trends and Developments Contributed by: Ben Miller, Stephen Rohl, Katie Pryor and Jenny Wong, Maddocks

Amendments to correct obvious mistakes are an exception to the rule in s 102 of the Patents Act that amendments must not broaden the scope of the claims. Although amendments to cor - rect mistakes can be allowed, even in a manner which broadens the claims, both the mistake and its correction must be obvious. Term extensions remain in the firing line As we reported in the 2024 Trends & Develop - ments report in this guide, the patent term exten - sion (PTE) regime continues to be a contentious battleground in Australian litigation. A patentee may apply for a PTE if certain condi - tions are met, including that a “pharmaceutical substance per se” is “in substance disclosed” in the specification and “in substance fall[s] within the scope” of the claims. In Novartis AG v Pharmacor Pty Limited (No 3) [2024] FCA 1307, Novartis sought a PTE in rela - tion to goods containing, or consisting of, the pharmaceutical substance included in the ARTG as: “ENTRESTO sacubitril/valsartan (combined as a sodium salt hydrate complex)”. Novartis obtained the PTE in relation to its patent titled “Pharmaceutical compositions comprising val - sartan and NEP inhibitors”, of which claim 1 is to pharmaceutical compositions comprising an NEP inhibitor, such as sacubitril, and an AT 1-antagonist, such as valsartan, and salts there - of.

Pharmacor challenged the validity of the PTE on the basis that Entresto contains “TSVH”, a single crystalline complex of the anionic forms of sacubitril and valsartan. Pharmacor argued that because the claims related to two separate salts of sacubitril and valsartan, TSVH was not disclosed and claimed in the patent. Novartis responded that the two distinct mol - ecules had not lost their identities in forming the complex, pointing to the ARTG certificate which refers to Entresto as “sacubitril/valsartan (com - bined as a sodium salt hydrate complex)”. Justice Yates agreed with Pharmacor, finding that two pharmaceutical substances per se were disclosed and fell within the scope of claim 1, of which Entresto comprised neither. His Honour found that TSVH was a different compound with a unique set of physiochemical properties, and was not disclosed “or even envisaged” in the patent. Novartis v Pharmacor is yet another decision highlighting the nuances of Australia’s PTE provi - sions. While the Australian regime has historical - ly been considered a relatively patentee-friendly one, more recent Federal Court judgments have tested its limits.

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BRAZIL

Colombia

Ecuador

Brazil

Peru

Brasilia

Bolivia

Law and Practice Contributed by: Ana Paula Affonso Brito and Maria Eduarda de O Borrelli Junqueira Montaury Pimenta, Machado & Vieira de Mello

Rio de Janeiro São Paulo

Paraguay

Chile

Argentina

Contents 1. Life Sciences and Pharma/Biopharma Patent Litigation p.20 1.1 Claimants/Plaintiffs to an Action p.20

1.2 Defendants/Other Parties to an Action p.21 1.3 Preliminary Injunction Proceedings p.22

1.4 Structure of Main Proceedings on Infringement/Validity p.23 1.5 Timing for Main Proceedings on Infringement/Validity p.24 1.6 Requirements to Bring Infringement Action p.25 1.7 Pre-Action Discovery/Disclosure p.25 1.8 Search and Seizure Orders p.25 1.9 Declaratory Relief p.26 1.10 Doctrine of Equivalents p.26 1.11 Clearing the Way p.26 1.12 Experts p.26

1.13 Use of Experiments p.26 1.14 Discovery/Disclosure p.27

1.15 Defences and Exceptions to Patent Infringement p.27 1.16 Stays and Relevance of Parallel Proceedings p.27 1.17 Patent Amendment p.27 1.18 Court Arbiter p.27 2. Generic Market Entry p.27 2.1 Infringing Acts p.27 2.2 Regulatory Data and Market Exclusivity p.28 2.3 Acceptable Pre-Launch Preparations p.28 2.4 Publicly Available Drug and Patent Information p.29 2.5 Reimbursement and Pricing/Linkage Markets p.30 3. Biosimilar Market Entry p.30 3.1 Infringing Acts p.30 3.2 Data and Regulatory Exclusivity p.30 3.3 Acceptable Pre-Launch Preparations p.30 3.4 Publicly Available Drug and Patent Information p.30 3.5 Reimbursement and Pricing/Linkage Markets p.30

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BRAZIL CONTENTS

4. Patent Term Extensions for Pharmaceutical Products p.31 4.1 Supplementary Protection Certificates p.31 4.2 Paediatric Extensions p.32 4.3 Paediatric-Use Marketing Authorisations p.32 4.4 Orphan Medicines Extensions p.32 5. Relief Available for Patent Infringement p.32 5.1 Preliminary Injunctive Relief p.32 5.2 Final Injunctive Relief p.33 5.3 Discretion to Award Injunctive Relief (Final or Preliminary) p.34 5.4 Damages p.34 5.5 Legal Costs p.36 5.6 Relevance of Claimant/Plaintiff Conduct to Relief p.36 6. Other IP Rights p.36 6.1 Trade Marks p.36 6.2 Copyright p.37 6.3 Trade Secrets p.37 7. Appeal p.37 7.1 Timeframe to Appeal Decision p.37 7.2 Appeal Court(s) Arbiter p.38 7.3 Special Provisions p.38 8. Other Relevant Forums/Procedures p.38 8.1 The UPC or Other Forums p.38 9. Alternative Dispute Resolution p.38 9.1 ADR Options p.38 10. Settlement/Antitrust p.39 10.1 Considerations and Scrutiny p.39 11. Collective Redress p.39 11.1 Group Claims p.39

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BRAZIL Law and Practice Contributed by: Ana Paula Affonso Brito and Maria Eduarda de O Borrelli Junqueira, Montaury Pimenta, Machado & Vieira de Mello

Montaury Pimenta, Machado & Vieira de Mello is a leading IP law firm, renowned for resolving disputes before the Brazilian IP courts. With over 150 professionals located in Rio de Janeiro and São Paulo, the firm has experienced remarkable growth and holds an important position at the forefront of the market, especially in the patents and life sciences fields. The firm’s experienced patent lawyers have a successful track record in handling disputes in the areas of patent in - fringement, patent invalidation and pharmaceu - tical patents, and the team includes engineers

with chemistry and biotech backgrounds, as well as leading patent and life sciences litiga - tors who have been involved in some of the most high-profile cases in Brazil. These cases include representing clients from the pharma - ceutical, healthcare, biotech and chemistry in - dustries in high-stakes patent cases before the Brazilian courts. The firm’s integrated team of legal and technical professionals is able to offer a cutting-edge blend of capabilities, and handle complex deals and cases of any size. Maria Eduarda de O Borrelli Junqueira joined Montaury Pimenta, Machado & Vieira de Mello as a paralegal in 2017, became a lawyer in 2019, and a partner in 2020. She studied industrial property law at the Nova University of Lisbon in 2016 as part of a graduate exchange programme, obtained her law degree from PUC-Rio in January 2020, and a post-graduate degree in IP law at the same university. She has been working in IP litigation since 2016 and her experience includes complex cases related to patents in the pharmaceutical and life sciences fields, dealing with copyright and unfair competition issues, as well as assisting clients with judicial and extrajudicial matters in the area.

Authors

Ana Paula Affonso Brito has extensive expertise in IP

litigation matters before the Brazilian federal and state courts, acting for both domestic and international clients of Montaury Pimenta, Machado & Vieira de Mello. She has a master’s degree in IP from the Brazilian Patent and Trademark Office Academy and a post-graduate degree in IP from the Rio de Janeiro State University School of Law, where she graduated in 2000. Ana Paula’s practice includes the evaluation of litigation risks, collaborating with corporate departments, and developing mitigation solutions and litigation strategies. She assists clients across different fields of activity and technologies, such as pharmaceuticals, crop science and cosmetics.

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BRAZIL Law and Practice Contributed by: Ana Paula Affonso Brito and Maria Eduarda de O Borrelli Junqueira, Montaury Pimenta, Machado & Vieira de Mello

Montaury Pimenta, Machado & Vieira de Mello Av. Almirante Barroso, 139-7th Floor

Rio de Janeiro ZIP 20.031-005 Brazil Tel: +55 21 2524 0510 Email: montaury@montaury.com.br Web: www.montaury.com.br

1. Life Sciences and Pharma/ Biopharma Patent Litigation 1.1 Claimants/Plaintiffs to an Action The Brazilian Code of Civil Procedure Article 17 of the Brazilian Code of Civil Proce - dure (the “Brazilian Civil Code” or the “Code”) provides that in order to file a lawsuit, it is nec - essary to demonstrate legal interest and legiti - macy. Thus, an action for patent infringement must be filed by the patentee and in the case of co-ownership, the provisions of the Civil Code will apply. Since Brazilian law does not provide further details for the co-ownership of patents, other than defining that a patent application may be filed by a group of inventors, most of the rules established between the co-owners are guided by the Brazilian Civil Code. What is not statuto - rily required, may be required by contract. Con - tractual dispositions are therefore strongly rec - ommended in Brazil, due to the lack of detailed provisions in the Industrial Property Act. The Brazilian Civil Code is applied subsidiarily, as the law on co-ownership of a patent is analo - gous to the law onco-ownership of real estate/

property, which sets forth that if two or more people own an undivided thing, each may exer - cise possessory acts over it, as long as they do not exclude the other co-owners. Not all joint owners therefore have to join as plaintiffs in patent enforcement actions, and each owner has the right to enforce its prop - erty independently. Such provision may not be changed by contract, since this would be an ownership limitation rule. However, other provi - sions may be altered by contract. The Brazilian Industrial Property Act As to licensees, the Brazilian Industrial Property Act (Law #9.279/96) foresees in Articles 61 and 62 that patentees can celebrate exploitation licensing agreements with third parties, and, in this case, the licensee may be invested with all powers to act in defence of the patent. This includes the extraordinary right to figure as a plaintiff in an infringement action, even without joining the patentee as a co-plaintiff. In the specific scenario in which the patentee does not figure as a co-plaintiff, it will not be nec - essary to figure as a defendant either – as this position will be solely occupied by the alleged

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BRAZIL Law and Practice Contributed by: Ana Paula Affonso Brito and Maria Eduarda de O Borrelli Junqueira, Montaury Pimenta, Machado & Vieira de Mello

infringer(s). It is important to highlight, however, that the licence agreement must be recorded with the Brazilian Patent and Trademark Office (BPTO) to have an effect on third parties. Patent nullity actions As to patent nullity actions, Article 56 of the Brazilian Industrial Property Act foresees that these can be filed before a federal court by the BPTO or by any legitimately interested party, at any time during the patent validity term. Nullity actions are usually filed by those who have been sued in a state court for patent infringement or who have received a cease-and-desist letter from the patentee, to refrain from using the pro - tected technology. This is because an invalidity declaration by the court will have retroactive (ex tunc) effects from the date of the patent applica - tion’s filing with the BPTO – which means that should a patent be declared invalid, it will be as if it has never existed, and no infringement con - demnation may be declared on a parallel ongo - ing infringement action. There are also technologies where protection by patent may put a segment of society at risk, such as pharmaceutical patents, generating greater flexibility for the judge in gauging the legitimate interest of the plaintiff in the nullity action. In a recent case (REsp No 1332417/RS decision issued on 20 June 2024), the Brazilian Superior Court of Justice ( Superior Tribunal de Justiça , or STJ) confirmed its understanding that it is possible to argue the nullity of a patent or of a design as a defence against an infringement lawsuit before the state court in Brazil. The issue had already been analysed by the court in 2020, when the Third Panel of the STJ decided, within the scope of lawsuit REsp No 1.843.507/SP, that although the invalidity claim

of a patent has to be addressed to a federal court, the Brazilian IP Act would expressly allow the defendant the possibility to invoke nullity in an infringement action, as a matter of defence, without the need for the BPTO to participate in the lawsuit (Article 56, § 1º of the LPI). The decision issued on 20 June 2024 standard - ises the case law and explicitly states that the consequence of a declaration of invalidity of an industrial design or patent as a defence strategy against an infringement lawsuit is limited to par - ties involved in the lawsuit. This means that the state court’s ruling is con - fined to the infringement case in which it arises, dealing solely with disputes between private parties without the participation of the BPTO. Thus, such decision does not constitute the formal revocation of the patent or utility model involved and will not cause general effects (erga omnes) or impact on its validity before third par - ties. 1.2 Defendants/Other Parties to an Action In life science/pharma cases, the manufacturer is generally sued for infringement, as the supplier of the whole chain, although in the case of phar - maceuticals produced outside Brazil (generally generics), the importer is generally the one who will be sued. Thus, it is seen as more efficient to target the person that started the infringement or the one who has launched the product and given rise to it, as the patentee will be able to seek to cease the infringement at the “roots”. While the infringement action takes place between private parties in the state court, the nullity action may be filed by anyone with a legitimate interest against the patentee and the BPTO, in the federal courts, in accordance with

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