This chapter discusses the pharmaceutical industry, with specific attention given to the role of intellectual property and R&D. The chapter also explains (broadly) the process by which a new drug is approved by the Food and Drug Administration. The key concept in the chapter is the tradeoff inherent in intellectual property protections: stronger protections spur more innovation but at the cost of higher prices for a longer period of time. On the other hand, weaker protections allow for more affordable products more quickly, but at the cost of reduced innovation. The end of chapter supplement explores the role of international trade agreements in solving research and development coordination problems.

Chapter 5 commences by discussing how intellectual property rights and patents affect the rate and direction of progress. The idea behind intellectual property rights in general is to incentivize innovation by allowing the holders of the patents to capture a larger share of the returns on these research investments. On the face of it, this seems like a fair bargain. The person who discovers something should be compensated with the ability to get a higher return on investment on it than the rest of the population. But can patents actually stifle modern day medical innovation? These concerns, and the extent to which they hold true, are the main focus of Chapter 6. Later in the chapter, the role of regulation more generally in influencing the trajectory is discussed. The chapter explores how regulation can act both as a deterrent and as a stimulator of medical progress, using the regulation of MDMA in the United States and Orphan Drug Designations as case examples to explore this dynamic.

Focusing on firm-level behavior in the US pharmaceutical and agrochemical industries, Chapter 4 provides evidence that companies do indeed seek stricter standards on their own, out-of-patent products in order to boost sales of newer, patented substitutes, even providing negative information about their own products in pursuit of this goal. In order to show this, the chapter leverages petitions submitted by pharmaceutical and agrochemical companies to the US FDA and EPA, respectively, requesting that the agencies place stricter standards or all out bans on products that these companies themselves developed. In the case of the pharmaceutical petitions, the chapter provides evidence that all but one of the requests for a product ban has targeted a drug that is about to lose or has already lost patent protection and for which the company had a more recently patented substitute. This suggests that such requests are not publicly minded attempts to ensure dangerous products remain off the market but, instead, are strategic gambits to boost profits of exclusively produced alternatives. In addition, the chapter provides a statistical analysis of petitions submitted by agrochemical companies and farm groups to show that, whereas farmers are no more likely to seek stricter standards on out-of-patent pesticides, agrochemical companies systematically request stricter standards on these products while requesting more lenient standards on products still enjoying patent protection.

This chapter considers how intangible assets that businesses develop, such as inventions, designs and brands, as well as business ideas and information, can be protected pursuant to Australian intellectual property (IP) laws. It identifies that various IP rights are protected by statute, while others are protected pursuant to common law. It explains that some forms of intellectual property require businesses to apply and register for protection before an IP right can be claimed, such as designs, patents and trade marks, while others, such as copyright, dont require any application or registration. The chapter highlights that an array of IP rights can be used to protect different aspects of a business’s goods and/or services. For example, a business’s product might have a patent that attaches to it regarding how it works, a registered trade mark protecting its brand name, and a design for its appearance. The more IP rights that can be used to protect a particular good or service, the more defiant the good or service will be to imitation and competition.

We find that most Asian economies are not very innovative by international standards, though in line with their level of development. Asian economies mostly obtain their technologies from abroad through FDI or via technological diffusion. However, FDI to Asia has been modest and entrepreneurship limited, largely as a consequence of the connections world. Politicians and business groups have been mutually supportive in erecting barriers to entry. As a result, most innovation has been within business groups or by new firms entering new sectors where existing business groups were absent or had not managed to erect unscalable entry barriers. However, three countries have developed some base for innovation: China, India and South Korea. In each, efforts to construct a supportive ecosystem, including policies for education, science and technology, as well as encouraging returning migrants with knowledge, are reaping dividends. Each has adopted a rather different model which we discuss in detail. Despite these achievements, the power and influence of the connections world in these three countries also remains a serious brake on their ability to innovate in the future.

Meccano Ltd promoted a particular type of subjectivity: the ‘Meccano Boy’. This construction toy schooled the child in scientific education, social participation, civic roles, life within a profession and in building the material infrastructure of modernity. Playing with Meccano encouraged translation of an intangible idea represented in two dimensions into material forms through the production of three-dimensional compositions of machinery or models. We compare the legal interpretation of this form of play with its broader cultural significance in creating a base of socially connected consumers, orchestrated to extract commercial value from educational play. Meccano did not involve free play or simply making educational models. A toy for making toys, Meccano was marketed as training for adulthood. Through the establishment of Meccano guilds and the relevance of the Meccano Magazine, children, their fathers and a wider brotherhood were interpellated as active developers of Meccano. It was a brand and activity that Meccano designed for international appeal and where the child was happily engaged in play that supported a later life that contributed to international industrialisation.

The regulation of patent enforcement in Europe is characterized by the typical multi-layered EU law system of primary EU law, secondary EU law, i.e. unification and harmonization of member states’ laws by way of regulations and directives, and member states’ laws which in particular implement the EU directives into national law.1 Primary EU law, insofar as it is similar to written constitutional law, establishes the competence and baseline for all EU legal actions. Secondary legislation is based on the competences of the EU established in primary law and unifies certain areas of law (by way of directly applicable unitary regulations) or harmonizes member states’ laws by way of directives that are not directly applicable but addressed to the member states and that typically leave the member states certain leeway for manoeuvre when they implement such directives in their national law systems. Both EU primary and secondary legislation take primacy over national law; this so-called principle of primacy of EU law has been developed by the Court of Justice of the European Union (CJEU) in its case law2 and is meanwhile also laid down in a declaration concerning primacy,3 which is part of the Treaty of Lisbon.4

All patent cases are heard by the specialized IP chamber of the District Court of the Hague. Appeals (which are de novo) are heard by the specialized chamber of the Court of Appeal of the Hague. Thereafter an appeal (on points of law) is possible without the necessity of leave to the Supreme Court. The specialized chamber in first instance issues between about fifty and seventy decisions each year. The Court of Appeal issues about twenty and the Supreme Court around five. Of course, numbers vary from year to year. The courts have a good reputation in patent matters. The UK, German and Dutch courts take into consideration each other’s decisions in cases invoking the same European Patent and normally give reasons if they do not follow each other’s decision (which is more the exception than the rule). The Netherlands does not have a bifurcated system for patent cases: validity and infringement are always dealt with in the same proceedings. Thus, if an infringer challenges the validity of the patent, the court will normally first decide on the validity of the patent and only turn to infringement if the validity of the patent is upheld. In other words, a Dutch court will not order an injunction unless it has first established that the patent is valid, and the only way that an injunction can be granted on the basis of a patent that is later invalidated is if the decision on validity is overturned on appeal.1 This is true in proceedings on the merits, where the court will always rule on the validity of the patent if it is challenged, but also in interim relief proceedings, where the court will make a preliminary assessment of the patent's validity before imposing interim relief, denying it if there is a reasonable, not-to-be-ignored chance that the patent will be revoked or invalidated.

Israeli law, in general, is based on the principles of English common law, in which an injunction is perceived as a form of equitable, discretionary relief.1 Historically, injunctive relief was granted based on discretionary criteria, including the irreparable injury rule (in the absence of an injunction, the plaintiff would be caused an irreparable injury, which could not be compensated for by monetary relief); the balance of hardships between the plaintiff and defendant (known also as the “balance of convenience”); and the clean hands rule (equitable relief is only granted if the plaintiff acted in a decent and moral manner, disclosing the relevant facts).2 Another important criterion was the public interest.3

Despite their outward differences, all modern legal systems share a number of fundamental features. One of these features is the availability of remedies for injuries that are proven to an adequate legal standard. As explained by Douglas Laycock, one of the preeminent scholars of common law remedies: “The choice of remedy and the measure and administration of the remedy chosen pose a distinctive set of questions – logically separate from the liability determination and usually considered subsequent to that determination – focused on what the court will do to correct or prevent the violation of legal rights that gives rise to liability.”1

Canada is a federal system with jurisdiction shared between the federal government and the provinces. Patent law is a matter of exclusive federal jurisdiction and is based on the federal Patent Act. The federal nature of Canada is reflected in a bifurcated judicial system. The Federal Courts of Canada, a statutory court system with defined jurisdiction,1 and the provincial superior courts, courts of inherent jurisdiction, corresponding to the traditional English common law courts, both have jurisdiction over patent infringement.2 However, the Federal Court has exclusive jurisdiction to declare a patent invalid,3 and the very substantial majority of patent cases are decided by the Federal Court. Consequently, it is largely the case law of the Federal Courts which governs the grant of injunctive relief in patent cases, subject to the guidance of the Supreme Court of Canada.4

For patent litigation, Germany is among the most frequented venues in Europe.1 Both large, international law firms and highly specialized boutique firms are active before German courts. Not only the Federal Supreme Court (Bundesgerichtshof – BGH) but also a handful of major first- and second-instance venues, such as Düsseldorf, Hamburg, Mannheim and München, play an important role in shaping German patent law. Stakeholders, such as patentees, licensees, inhouse and outside counsel, scholars and non-German courts or lawmakers, therefore have a strong interest not only in the established legal framework for patent litigation in Germany, but also in shifts this framework is, of late, undergoing. At the same time, the language barrier complicates insights on these matters, not least for Anglo-American stakeholders, although a slowly increasing part of scholarship, and even of case law, is available in English. Against that background, this chapter sets out to explain basic structures and recent developments in German patent injunction law. It covers the main types of and requirements for such injunctions under German law (Section A), the injunction’s scope as claimed and granted (Section B), bifurcation and stays (Section C), defences and limitations (Section D), as well as alternatives to injunctive relief (Section E), before a conclusion and an outlook (Section G) round off the chapter.

United States courts take a context-sensitive approach to the grant of injunctive relief for US patent infringement. Such context-sensitivity is consistent with the US Patent Act, which indicates that courts “may grant injunctions in accordance with the principles of equity to prevent the violation of any right secured by patent, on such terms as the court deems reasonable.”1 In common law jurisdictions, “equity” is generally viewed as resistant to strict rules and willing to make exceptions in light of particular circumstances.2 In accordance with this vision of equity, the generalist trial judges of US district courts3 consider various factors in determining whether injunctive relief is justified and have great discretion to tailor injunctions in a particular case.4 On the other hand, US courts have continued to grant injunctive relief in most infringement cases in which a patent owner prevails, particularly when the patent owner is in direct competition with the adjudged infringer.5 In contrast, US courts commonly deny injunctive relief for patent owners who are “nonpracticing entities” or “patent trolls” – forms of patent-owning entities that do not engage in substantial commercialization or use of the patented invention or variants of it.6 Further, the US Court of Appeals for the Federal Circuit has held that the US Patent Act does not authorize injunctions to correct past patent infringement.7 Instead, injunctions are to be granted only as a means to prevent future infringement.8

Most UK patent litigation takes place in England and Wales, where it is heard by either the Patents Court (larger, more complex and/or more valuable cases) or the Intellectual Property Enterprise Court (smaller, less complex and/or less valuable cases). These are both specialised courts. It is normal in both courts for issues of infringement and validity of the patent to be heard together. The intellectual property bar in England and Wales consists of a considerable number of highly specialised and skilful advocates, most of whom have a Science, Technology, Engineering and Mathematics (STEM) degree as well as a legal qualification. They are instructed by both large multinational firms and small boutique firms of lawyers, and they are well known for being innovative, particularly with regard to procedural questions. Although there is a reasonable volume of UK patent litigation, disputes concerning injunctions are relatively infrequent.

In France, the question of injunctive relief for infringement of patents has only given rise to a very limited number of academic studies.1 Although there are quite a lot of court decisions dealing with this topic, the courts generally do not explain their reasoning on this particular point. In France, patent injunctions can only be handled2 by the specialized IP chambers3 of the general jurisdictions of Paris, which are the Tribunal Judiciaire (formerly known as the Tribunal de Grande Instance) de Paris on first instance, where the judgment is generally delivered within eighteen months, and, on appeal, the Cour d’appel de Paris, where the cases are generally adjudicated within twelve months. The highest court, the Cour de cassation only deals with matters of law, and not fact.4 On average, 170 court decisions on patent litigation were delivered per year in France between 2015 and 2019.

Injunctive relief can be found in all Polish patent statutes in the twentieth and twenty-first centuries.1 The Industrial Property Law2 (IPL) that currently regulates industrial property rights including patents also envisages this form of relief. Article 287 section 1 of the IPL provides that a patentee whose patent has been infringed, as well as exclusive licensees, may – apart from other remedies – demand injunctive relief. Generally, injunctions are perceived as a necessary corollary to patents. Patents, as exclusive rights, provide patentees with exclusivity to use an invention within limits provided in the law. The availability of injunctive relief allows patentees to protect that exclusivity.

Traditionally, intellectual property’s right to exclude has implied that injunctive relief should always be available at the conclusion of a successful infringement action.1 However, in recent years that view has evolved. As discussed in Chapter 14, in the United States, the 2006 Supreme Court decision in eBay Inc. v. MercExchange imposed a four-part test requiring the plaintiff in a patent case seeking a permanent injunction to demonstrate “(1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction.”2 While this standard appears to impose quite a restrictive test, several members of the court emphasized that even under this discretionary standard, injunctive relief should remain available in the vast majority of cases.3