Intellectual property rights (IPRs) play an important and controversial role in respect to the protection and promotion of human health. On one hand, certain forms of IP, most specifically the “patent” and regulatory data exclusivity, are intended to stimulate investment in innovation and the introduction of new and improved therapeutic products. On the other hand, those same IP protections may reward their owners with exclusive rights that may significantly restrict access to the products. The tension produces stress on public policy makers that must determine the appropriate balance for encouraging innovation while providing necessary access. This chapter describes the complex web of international IP-related rules that are relevant to health products, and reflects on areas of continuing controversy regarding the characteristics of those rules and their enforcement.
Frederick M. Abbott
Patents are, in essence, a private right to tax. There is a fundamental question regarding the allocation of a monopolistic private tax to large industrial and post-industrial organizations: that is, does the power to collect a monopoly tax entail public responsibilities? The ‘genius’ of the industrialists that promoted the Paris Convention in the late 1800s was to bring the terminology of industrial ‘property’ into wide usage. The transition from ‘industrial property’ to ‘intellectual property’ is also significant from a linguistic standpoint. ‘Industrial’ conveys the sense of business orientation or commercial activity. ‘Intellectual’ conveys the sense of ideation or creativity. Consider the difference in public discourse if patents were referred to as ‘private monopolies’ or ‘private taxes’ instead of ‘intellectual property’. The Chairman of PharmaCo would seem a much less sympathetic figure when stating ‘the government has no right to interfere with my “private monopoly” or “private taxation scheme”’ than when stating ‘the government has no right to interfere with my “intellectual property”’. Terminology does matter. Scientists are feeding into a vast corporate and financial apparatus dedicated to maximizing financial returns, accompanied by gigantic payouts to corporate executives, and engaged in aggressive marketing campaigns. No level of patent-based rent extraction or private taxation is too high. There is no public or social responsibility other than that which may be imposed by class-action tort lawyers. We have watched the industry long enough to know that social responsibility must be legislated and enforced. Patents are not ‘intellectual property’. They are ‘private monopolies’ established by legislatures. As such, they should be subject to regulation in the nature of public utilities.