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Preliminary Injunctions in Patent Litigation

Alternative Approaches to Provide Effective Justice under Uncertainty

by Arthur von Martels (Author)
©2019 Thesis 332 Pages

Summary

This academic work investigates various approaches for deciding on the grant of preliminary injunctions in patent litigation. These can be a highly effective remedy, but a decision to grant a preliminary injunction is taken early in the course of litigation and often under a cloud of uncertainty. If granted too easily or erroneously, preliminary injunctions can have negative consequences on competition and innovation. The author looks at (judicial) standards that have been developed in various national jurisdictions, Legal theory and Law and Economics. The lessons learned here can be of particular relevance for the future Unified Patent Court.

Table Of Contents

  • Cover
  • Title
  • Copyright
  • About the author
  • About the book
  • This eBook can be cited
  • Table of Contents
  • Frequently used Abbrevations
  • Acknowledgments
  • Preface
  • §1. Introduction
  • §2. The main research question
  • §3. Scientific contribution
  • §4. A concise overview of the chapters
  • §5. Limitations
  • §6. Terminology
  • Part I: The Theoretical Underpinning
  • Chapter 1: Setting the Scene: Preliminary Injunctions, Patents and Uncertainty
  • §1.1. Introduction
  • §1.2. Justifications for patent protection
  • §1.3. Uncertainty in litigation
  • §1.3.1. (Technical) complexity in patent litigation
  • §1.3.2. Legal and economic uncertainties
  • §1.3.2.1. Legal uncertainties
  • §1.3.2.2. Economic uncertainties: assessing the economic harms that may occur to the plaintiff and to the defendant
  • §1.4. The property and liability rules framework and preliminary injunctions
  • §1.4.1. The framework itself
  • §1.4.2. The role of preliminary injunctions in (the application of) the framework
  • §1.5. Chapter conclusion
  • Chapter 2: Independent Economic and Doctrinal Reasons in Favour of the Availability of the Remedy of Preliminary Injunctions
  • §2.1. Introduction
  • §2.2. To preserve the status quo between the parties: more than an effect?
  • §2.3. To prevent irreparable harm: the inadequacy of damages to make whole
  • §2.3.1. Is ‘to prevent irreparable harm’ a distinct justification?
  • §2.3.2. The main sources of irreparable harm
  • A) An irreplaceable loss
  • B) The difficulty to calculate damages
  • C) The inability to pay and insolvent defendants
  • §2.4. To prevent delay rendering rights meaningless (periculum in mora)
  • §2.5. To protect rights given: the need for enforcement
  • §2.6. To preserve the ability for the court to do judgment later
  • §2.7. Possible positive effects on innovation
  • §2.8. Providing temporary clarity
  • §2.9. Chapter conclusion
  • Chapter 3: Potential Risks with the Grant of Preliminary Injunctions in Patent Litigation
  • §3.1. Introduction
  • §3.2. Possible lock-in effect leading to biased decisionmaking
  • §3.3. The subsequent trial on the merits is a legal fiction
  • §3.4. Negative effects on competition and innovation
  • §3.4.1. ‘Working around’ the contested patent and the preliminary injunction: a waste of resources?
  • §3.4.2. Hold-up problems
  • §3.4.3. Settlements and (the threat of) preliminary injunctions
  • §3.5. An erroneous decision and the question of compensation
  • §3.5.1. Potentially reparable harms – harms due to an undeserved wealth transfer
  • §3.5.2. Deadweight losses and practically irreparable harm
  • §3.5.3. An insufficient remedy to compensate and further effects
  • §3.6. Chapter conclusion
  • Chapter 4: A Case Study of the role of Preliminary Injunctions in Practice: Generic Entry in the Pharmaceutical Market
  • §4.1. Introduction
  • §4.2. Preliminary injunctions and the (generic) pharmaceutical market
  • §4.3. Characteristics of the pharmaceutical market regarding supply and demand
  • §4.4. Generic entry and regulatory approval
  • §4.5. Preventing generic entry versus First Mover Advantage
  • §4.6. Main findings and data from the EU Pharmaceutical Sector Inquiry with respect to preliminary injunctions
  • §4.7. Analysis of the findings of the Pharmaceutical Sector Inquiry
  • Chapter 5: How Courts Can Deal with Preliminary Injunctions from the Perspective of Law & Economics Theory
  • §5.1. Introduction
  • §5.2. Tight judicial control in decisionmaking under uncertainty
  • §5.2.1. The Leubsdorf-Posner approach
  • §5.2.2. A refinement of Leubsdorf’s formula: Davis’ Modified Framework
  • §5.3. Alternatives to tight judicial control in decisionmaking under uncertainty
  • §5.3.1. The PI liability rule
  • §5.3.2. Romeu’s dual standard
  • §5.3.3. The relative consequences model of Norrgård
  • §5.4. Chapter conclusion
  • §5.5. A schematic overview of different Law & Economics theories
  • Part II: International and National Law
  • Chapter 6: International and European Obligations and Preliminary Injunctions
  • §6.1. Introduction
  • §6.2. The international level: the TRIPS Agreement
  • §6.3. The (supranational) European level
  • §6.3.1. Introduction
  • §6.3.2. The EU Enforcement Directive (2004/48/EC)
  • §6.3.3. Further comments on the EU Enforcement Directive
  • §6.3.4. Art. 6 of the European Convention on Human Rights and Art. 47 of the Charter of Fundamental Rights of the EU
  • §6.3.5. The Brussels I Regulation
  • §6.4. Chapter conclusion
  • Chapter 7: An Overview of National Legal Frameworks and the Practices and Issues Courts Encounter
  • §7.1. The Netherlands
  • §7.1.1. Introduction
  • §7.1.2. Legal basis
  • §7.1.3. Urgency
  • §7.1.4. Suitability
  • §7.1.5. Balancing
  • §7.1.6. Security and compensation
  • §7.1.7. Intermediate conclusion
  • §7.2. Germany
  • §7.2.1. Introduction
  • §7.2.2. The legal basis
  • §7.2.3. Verfügungsanspruch
  • §7.2.4. Verfügungsgrund
  • §7.2.5. Interessenabwägung
  • §7.2.5.1. The issue of patent validity
  • §7.2.5.2. The balancing of interests as part of the Interessenabwägung
  • §7.2.6. Sicherheitsleistung and damages
  • §7.2.7. Intermediate conclusion
  • §7.3. England
  • §7.3.1. Introduction
  • §7.3.2. The legal basis and guiding principles: Equity and American Cyanamid
  • §7.3.2.1. Is there a serious question to be tried?
  • §7.3.2.2. Are damages an adequate remedy?
  • §7.3.2.3. If damages are not adequate, taking into account the position of both the plaintiff and the defendant, does the balance of convenience favour the injunction?
  • §7.3.2.3.1. Balancing – ‘clearing the way’
  • §7.3.2.3.2. Balancing – other factors
  • §7.3.3. Previous decisions on patent validity
  • §7.3.4. Cross-undertaking in damages
  • §7.3.5. Intermediate conclusion
  • §7.4. The United States
  • §7.4.1. Introduction
  • §7.4.2. The legal basis and test
  • §7.4.3. Likelihood of success
  • §7.4.4. Irreparable harm
  • §7.4.5. Balance of convenience
  • §7.4.6. Public interest
  • §7.4.7. Bond and damages
  • §7.4.8. Intermediate conclusion
  • §7.5. Concluding discussion, thereby relating to earlier findings
  • §7.5.1. Key commonalities
  • §7.5.2. Key differences
  • §7.5.3. How do national practices tie in with preceding chapters?
  • §7.5.4. Improving the court’s information position
  • Part III: A Look into the Future
  • Chapter 8: Preliminary Injunctions under the Unified Patent Court; What is known and to be Expected
  • §8.1. Introduction
  • §8.2. Background
  • §8.3. Legislative basis for preliminary injunctions and the legal test
  • §8.4. The UPC and an adequate security against an erroneous decision
  • §8.5. The transitional period
  • §8.6. Risk of differences between local courts and forum shopping
  • §8.7. Patent trolls and the UPC
  • §8.8. Competition law and preliminary injunctions under the UPC
  • §8.9. Intermediate conclusion
  • §8.10. De Lege Ferenda – Recommended best Practices for the Unified Patent Court to Deal with Preliminary Injunctions
  • §8.10.1. Introduction
  • §8.10.2. Urgency (temporal and necessity)
  • §8.10.2.1. Urgency (temporal)
  • §8.10.2.2. Urgency (necessity)
  • §8.10.2.3. Imminent infringement
  • §8.10.3. Validity
  • §8.10.3.1. A patent’s likelihood of validity – the role of presumptions
  • §8.10.3.2. An evident error on validity from within the court system
  • §8.10.3.3. The extent of the validity analysis itself
  • §8.10.4. Infringement and/or harm
  • §8.10.4.1. Likelihood of infringement analysis
  • §8.10.4.2. An explicit requirement to demonstrate irreparable harm?
  • §8.10.5. Balancing of hardships and the public interest
  • §8.10.6. Bond and damages
  • §8.10.7. Concluding proposal
  • Literature and Case Law
  • Cited legislation
  • List of cited cases
  • List of cited literature
  • Deutsche Zusammenfassung

← 12 | 13 →

Frequently used Abbrevations

← 14 | 15 →

Acknowledgments

In front of the reader lays a work that is the fruit of the research during my time in Munich in 2013–2016. It has been an enriching but challenging experience and it would not be finished without the encouragement, advice and companionship of many.

My first word of thanks of course goes to my Doktorvater, Prof. Dr. Ansgar Ohly, who has been most helpful, patient and inspiring in guiding me on this academic journey. I have always very much appreciated our conversations and have got particular good memories of the interesting and enriching Doctoral Seminars and workshops we had in Munich, Schloß Ringberg at the Tegernsee, Tutzing, Bayreuth and Bressanone. I would also like to thank Prof. Dr. Thomas Ackermann for being the Second Reading Professor of this dissertation.

Furthermore, I’m also highly grateful to the Max Planck Institute for Innovation and Competition in Munich that not only granted me funding, but also a fantastic place to work. The expertise and resources of the Institute located at the Marstallplatz are the best in the world when it comes to Intellectual Property and it has been a joy to be part of that community. I would therefore like to thank Professors Hilty, Drexl and Kur for offering me a place in the IMPRS-CI programme at the Institute, and for all the interesting academic interactions afterwards. A special word of thanks is for Dr. Sylvie Nerisson who worked at the Max Planck Institute, for managing the programme and providing advice.

Gratitude is also due to the many colleagues and friends, from all corners of the world, which I saw on a day-to-day basis in Munich and that made my time in Bavaria unforgettable. The list of names of these people is too long to provide here, but they know who they are. Thanks is equally due to my Dutch friends and family that have visited me in Munich. They too know who they are. Nevertheless, there are a few people I would like to single out at this page: Martin and his wife Lucia for their warm and loyal friendship (both in Germany and in The Netherlands) as well as for their encouragement to me in writing this dissertation. To Henri, for all the dinners and running during our time that we shared a house. A special word of thanks also goes out to Manon and Reinder, your house was always open for me and I truly cherish all the great moments we had. And finally a grazie mille, to Sebastian, who encouraged me during the the final evenings of edits to be made.

I would like to dedicate this work to my parents and my fiancé. To my parents, Zweder and Margreet who have always lovingly supported me in every single way and at every single moment of my life. This is something I will always be grateful for and I hope to raise my children in the same way that they have done ← 15 | 16 → with me, Julius and Eduard. And to my fiancé, Simona, who I met during my years in Munich: she has not only introduced me to the wonders of Italy but also proved to be the love of my life and the person con cui voglio percorrere il sentiero della vita.

Arthur von Martels, Amsterdam, July 2017.

← 16 | 17 →

Preface

§1.  Introduction

In intellectual property disputes in general – and in patent disputes in particular – injunctions are amongst the most effective and powerful legal measures that can be provided for by a legal system. An injunction is a legal order, given by a court of law, specifically prescribing a particular conduct to be followed or to stop a certain activity. Traditionally, injunctions are granted by a court when monetary remedies do not provide an adequate form of relief. Sometimes, an injunction is combined with a monetary remedy such as damages or restitution of profits. Together, both injunctions and monetary rewards are remedies that can greatly stop, reduce and prevent (the further) infringement of intellectual property rights.1

With respect to injunctive relief specifically in patent disputes, the focus of literature and research tends to be on injunctive relief with a permanent character. These permanent injunctions are granted after the case has been through the normal judicial civil proceedings of a legal system. The case is thus assessed on the merits with ample scope for both the plaintiff (usually the patentee)2 and the defendant (the alleged infringer) to fully present their arguments in the case at hand. Regardless whether appeal at a higher court is still possible and the initial verdict can still be overturned, these injunctions are, at the very least,3 characterised by a significantly higher degree of legal scrutiny than the injunctions that will be at the heart of this research; namely that of preliminary injunctions.

Known under various names,4 and required by obligations of International Law and in European Union (EU) jurisdictions by European Union Law,5 the decision to grant or deny a preliminary injunction is determined early in the course of the legal ← 17 | 18 → dispute. It is also often taken after merely a rudimentary hearing has taken place. This means that the court, when asked to adjudicate, should decide on the request for a preliminary injunction after a relatively limited judicial investigation – as opposed to a decision after normal proceedings on the merits. These proceedings are limited in terms of time, the available evidence that is presented, and the possibility to call in third-party expertise.

This obviously has profound consequences and can result in a certain tension. On the one hand, a preliminary injunction can offer a rights holder speedy, effective and timely relief in preventing or stopping infringement, before a final determination of the legal rights. This relief is (supposedly) temporary of nature, namely, as longs as the proceedings on the merits take. In complex (patent) litigation, this time can range from a few months to even a few years. Nevertheless, on the other hand, a preliminary injunction can have far-reaching consequences. These consequences do not only affect the parties involved but also the wider society, including affecting competitors.

With patents in particular, due to their (often) complex and technical nature, as well as their relationship with other patents and the state of the art, the assessment of a request for a preliminary injunction can be a challenging task for the preliminary injunction court. The abovementioned tension is then often high. Despite this however, preliminary injunctions are generally seen as an often necessary and effective tool in stopping the infringement of patent rights, should the circumstances of a case ask for this.

§2.  The main research question

The main research question underpinning this thesis is:

Should the Unified Patent Court provide preliminary injunctions in actual practice, and what can be learned from the different approaches national courts currently have in deciding whether or not to grant this remedy?

It is argued that this research, resulting in the question as formulated above, is of interest for several reasons. Apart from the intellectually appealing tension that underlies the preliminary injunction doctrine – as written above this is the need to provide swift and effective justice versus the challenge to decide on difficult (technical) subject matter in which both granting and denying the request can have profound consequences – there are also at least two more practical reasons. Both these practical reasons are connected to the future establishment of the Unified Patent Court (UPC). The first reason is to find out how preliminary injunctions are currently dealt with in various countries, in order to see whether common principles exist for the UPC to draw upon. The second reason is that the ← 18 | 19 → start of the UPC is a moment for a new practice regarding the grant of preliminary injunctions. Therefore too, a better understanding of the issues and applicable criteria when granting preliminary injunctions, as well as the consequences of interim relief, may be helpful.

The UPC will likely start to function in 2018, and at the moment of writing the final preparatory efforts are being made in its anticipation.6 These include the recruitment of judges and staff. As will be seen in the last chapter of this work which is dedicated to the UPC, under the new Court rules, the grant of preliminary injunctions by the UPC is a given statutory possibility. However the judges under this regime are left significant discretion and little guidance on how and when to use this (hence also the phrase ‘in actual practice’ has been chosen in the wording of the main research question). This means that current national principles and practices will likely be very important sources to draw on, especially in the early years. When these principles and practices are far apart from each other, this may become problematic and lead to a less uniform policy. It may also prove to be quite the contrary: differences between the national courts may exist, but common principles should and could facilitate the transition into a single UPC approach. More research on how courts decide on preliminary injunctions can firstly thus lead to a better understanding of what is likely to happen, and point out some key issues.

Secondly, unburdened by prior decisions and legal tradition, the enactment of the UPC is also an excellent opportunity to develop the preliminary injunction practice into a certain direction and shape it into a bespoke mould. This research therefore tries to look at strengths and weaknesses of current approaches. Which direction should the UPC follow and which elements should the Court ideally incorporate in its own substantive legal test when deciding on a request for interim relief in a patent dispute?

These questions will inter alia be answered by looking at three key countries in EU patent litigation: Germany, England and The Netherlands. All three countries attract not only a significant proportion of European patent litigation, but they also offer alternative ways of deciding on whether to grant preliminary injunctive relief. To enrichen the analysis, a look will also be taken at the United States as the American practice is characterised by various elements that may be of interest for the UPC to consider. Additionally, more theoretical insights stemming from the literature will be taken along. ← 19 | 20 →

§3.  Scientific contribution

Whilst works specifically on interim relief of course exist,7 these works have a different focus and approach to the topic than this work purports to do. Many of these works do not focus on preliminary injunctions as such, but more on provisional measures in a wider sense – sometimes also outside the immediate realm of intellectual property.

A first example is the book written by Schneider in which she has focussed on comparatively analysing most aspects of German-Dutch preliminary relief.8 This book is rather procedural of nature, focussing much on issues of procedural law and jurisdiction. The authors Berneke and Schüttpelz have written a comprehensive and practically very useful book on the topic, however this only focusses on German law regarding preliminary injunctions, and is not specifically on patents.9 The same goes for the older work of Leipold, written in 1971, about interim relief in German (general) litigation proceedings.10 Another German scholar, Heinze, has written an impressive and doctrinally valuable work on interim measures in the context of intellectual property law. However, that work differs from this thesis as it covers more than preliminary injunctions alone and is not on patents specifically. The book also mainly zooms in on how such relief is regulated on a European (Union) level, instead of looking at national practices.11 A work that does go into national legal practices of various countries is the work of Ehrenzeller. Her manuscript however puts a strong emphasis on human rights aspects, and again is not specifically on intellectual property.12 Very notable too is the Swedish work of Norrgård, who has mainly looked into the Finnish and United States doctrine.13 Also stemming from Scandinavia is the Danish language work of Petersen.14 Yet another author, Kramer, has written her book in Dutch. She provides a comparative work going into ← 20 | 21 → national practices of interim relief of various European countries.15 However, the core of her work is on international private law aspects. Somewhat similar to this, is the German book written by Pansch, he looks at various cross-border aspects of preliminary injunctions.16

Finally, interim relief is a topic that is of course covered in works on remedies or enforcement that are of a more general nature. These works thus cover more than interim measures alone. Examples are the books by Rademacher17 and Cotter.18 Furthermore, apart from being found in dedicated works on the enforcement of patents or intellectual property, the subject of preliminary injunctions is sometimes also covered in individual articles or book chapters. Many of these works are cited in this dissertation.

What sets this thesis apart from the literature that has been cited above? Apart from its dedicated focus on patents and prohibitory preliminary injunctions – as supposed to interim relief in wider sense – and from being a recent and English-written work on the interesting issues this topic entails, this contribution is novel as it attempts to provide a more holistic view. In this thesis, preliminary injunctions are viewed from five different angles. Whilst other works may cover some issues that are addressed in this thesis, here an attempt is made to look at several issues at the same time and in relation to each other;

(1) By extensively covering the justifications and risks of granting preliminary injunctions.

(2) By virtue of a legal-comparative analysis of international and national law: a selection of national European jurisdictions, at EU and European law, at TRIPS and at the US approach.

(3) In giving a short overview of how legal theory has approached the decisionmaking process taken by the preliminary injunction court.

(4) By looking beyond formal, statutory and procedural aspects, and trying to map which issues are important in decisionmaking in practice. Since the reasoning of the courts is very important to look at here, there will be various cases to illustrate the relevant issues. Although legal cases (and preliminary injunction proceedings are of course no exception to this) to a large extent hinge on the specific facts and circumstances which are central to the proceeding, it is submitted that the issues raised in cases in this thesis are rather exemplary. The selected cases thus give a good overview of how the courts deal with issues that they encounter. ← 21 | 22 →

(5) The last angle is on preliminary injunctive relief in the nearby future. This work attempts to forecast the issues that will play a role when the UPC comes into force, its likely approach and it will finally make a proposal for UPC judges to be followed, based on all what is learned in preceding chapters.

§4.  A concise overview of the chapters

At this point, in order to offer a better understanding of the issues this dissertation covers, a brief overview of the upcoming chapters in this thesis will follow.

Part I – The theoretical underpinning

In the first chapter of this work the scene will be set by describing various fundamental issues that surround preliminary injunctions in patent litigation. What are the main arguments for the enforcement of patent rights in the first place? Why is interim litigation uncertain? And what is the property and liability rules framework and the place of preliminary injunctions therein?

The second and third chapter look at the ‘pros and cons’ of preliminary injunctions in patent litigation. Chapter two starts by taking a critical look at the independent economic and doctrinal justifications for prohibitory preliminary injunctions. Why, apart from being legally prescribed, should society have and grant the remedy? The third chapter looks at the potential risks the remedy entails.

After these two chapters, in chapter four, a case-study follows, looking at a key example of preliminary injunctions in practice. This is on preliminary injunctions with respect to generic competition in the pharmaceutical industry. This is largely based on the data and findings from the European Commission. This chapter offers an excellent example of the role the remedy can have, and the issues that can occur. It also demonstrates that preliminary injunctions can be beneficial for society, but are not without risk.

In chapter five, a review is made of various approaches stemming from the field of Law & Economics: what insights can be learned from this discipline about the court’s decisionmaking process on whether or not to grant preliminary injunctions and what exactly from these models can be extracted and used in practice?

Part II – International and national law

In chapter six and seven, we will look at the current legal framework. Firstly, in the sixth chapter, this will happen regarding the international (TRIPS) and European level. The latter will of course specifically address the EU Enforcement Directive, but it will also shortly cover cross-border enforcement and the influence of the ECHR. Chapter seven looks at the national legal frameworks and practices of the four selected national jurisdictions. It will be seen that across the board there are many similarities, but that there are also a number of interesting differences, when it comes to how courts deal with preliminary injunctions in patent litigation. ← 22 | 23 →

Part III – A look into the future

Chapter eight looks at upcoming changes that will transform the patent litigation landscape in Europe when the UPC starts with its work. It will be examined which changes and challenges the UPC will likely bring end encounter when it comes to preliminary injunctions. Subsequently, an attempt will be made to – within the framework of the UPC Agreement and Rules of Procedure – to provide suggestions for the newly to be formed Court. This will happen in the form of a recommended practices.

§5.  Limitations

This work is mainly based on research during my time in Munich in 2013–2016. As is apparent from above, quite some ground will be covered in this thesis: both in terms of the number of issues as regarding the multitude of jurisdictions that are dealt with. At the same time, the length of this dissertation is of course limited. It is thus important to stress therefore, that by no means this work attempts to give an exhaustive analysis of the remedy in all its aspects. Nor does it attempt to provide a review of cases as handed down by national courts. Rather it attempts to illustrate the main and most interesting issues and developments. It also attempts to highlight the different ways and approaches courts have to decide on a request for this type of interim relief.

Details

Pages
332
Year
2019
ISBN (PDF)
9783631793695
ISBN (ePUB)
9783631793701
ISBN (MOBI)
9783631793718
ISBN (Softcover)
9783631786987
DOI
10.3726/b15798
Language
English
Publication date
2019 (June)
Keywords
Justifications Balance of convenience Public interest Risk Remedies Patent validity
Published
Berlin, Bern, Bruxelles, New York, Oxford, Warszawa, Wien, 2019. 331 pp., 2 tables, 9 graphs

Biographical notes

Arthur von Martels (Author)

Arthur von Martels studied International Relations and European Law at the University of Groningen, The Netherlands, and subsequently ‘Innovation, Technology and the Law’ at the University of Edinburgh. He then moved to Munich for doctoral research at the International Max Planck Research School for Competition and Innovation (IMPRS-CI) and the University of Munich. He currently lives in Amsterdam and works for a major legal services provider.

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Title: Preliminary Injunctions in Patent Litigation
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