This chapter considers the scope of contemporary patent rights. In so doing, it considers whether the patent right is a form of property right (the conceptual question).

In recent years, there have been many accounts of extreme prescription drug prices that have raised issues of equity, price gouging, social conscience, and demands for relief. In part, these prices arise due to the inelastic demand for lifesaving drugs and the patents that create short-term legal monopolies. The economic rationale for patent protection flows from the fact that the investment made by inventors necessarily precedes any financial benefits received from the discovery of new products or more efficient production processes. Patent law prevents copiers from free riding so that innovators can reap the reward of monopoly profits for their innovation. Thus, there is a trade-off between innovation and affordability. Antitrust law cannot be used to disrupt legal monopolies, so the US government has turned to congressional proposals that would mitigate extreme drug pricing. We also review the policies of other countries that are aimed at reducing pharmaceutical drug prices and consider whether such policies would work in the US market.

In the preceding chapters of this book, we have seen a variety of national approaches to the issuance and tailoring of injunctive relief, characterized by a range of similarities and differences among jurisdictions. In this chapter, we synthesize the principal features of these different legal systems, provide an analytical framework for comparing them, and offer our observations about trends and the outlook for the future.

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

So far, the book has explored different problems in the life cycle of a vaccine. First, it surveyed the pathways to bring new vaccines to market against a backdrop of lacking incentives to R&D, in spite of the recognized public health value of vaccines and the widespread use of intellectual property rights as an incentive to vaccine R&D. Second, it examined the allocative disparities that result from the commodification of vaccines, especially in situations of product scarcity, in which lower-income populations often face considerable hurdles in obtaining access to vaccines. This section examines possible solutions to alleviate these problems. It considers proposals that would take effect at the incentives level, by increasing funding for vaccine-related R&D work; proposals that would operate at transactional level, facilitating the transfer of vaccine technology through the use of patent pools and patent pledges; and proposals to expand and fine-tune the role of vaccine-dedicated public–private partnerships as instruments for the promotion of equitable access to vaccines by populations irrespective of their socioeconomic status.

How should IP be reformed to incorporate a negligence liability rule? This chapter considers the various implementation options. It argues that, rather than return to a nineteenth-century reliance on formal rules, IP law should change infringement doctrine to incorporate a reasonable person standard. It then applies this proposed regime to a range of contemporary problems in IP law (i.e. orphan works, independent invention, strategic behaviour, IP triangles).

This chapter examines the debate over the right and ability of countries to grant compulsory licenses on patented pharmaceutical products, including biologic drugs produced in living organisms, as a means of ensuring access to medicines. Opponents of such measures sometimes label them as “theft.” This chapter contemplates the validity of such theft rhetoric from an unconventional perspective: that of biblical teachings on what it means to steal. After an introduction to the issue, Part II describes the use of theft rhetoric in relation to intellectual property infringement broadly and drug patent compulsory licenses in particular. Part III challenges the contention, suggested by theft rhetoric, that compulsory licenses are morally wrong as a form of stealing, by considering the meaning of theft in the context of its Judeo-Christian origins. Part IV considers the cogency of the accusation that the issuance of compulsory licenses in developing countries destroys pharmaceutical company innovation incentives. Part V concludes that expanding the definition of theft to include, as the Bible does, the possibility that a property owner may be stealing from the poor, can help us to properly evaluate the morality of drug patent compulsory licenses.