Personal View
Will longer antimicrobial patents improve global public health?

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Summary

The problem of antimicrobial resistance has led some infectious disease experts and their professional societies to propose the use of transferable intellectual property rights (wildcard patents) and patent term extensions as methods to encourage antimicrobial research and development. We evaluate recent approvals of new antimicrobial classes and find that the number of new introductions is higher than previously suggested. More importantly, creating new patent rights is shown to be an inefficient and possibly counterproductive response to antimicrobial resistance. Wildcard patents would operate as a more than US$40 billion annual tax on heart disease, hypertension, chronic obstructive pulmonary disease, asthma, and depression to inefficiently cross-subsidise antimicrobial research and development. Patent term extensions would likewise cost more than $5 billion per year, hinder access, and allocate resources inefficiently. Alternative uses for these funds are proposed, with greater potential positive effects on global public health. Additional public funding of antimicrobial research could be a more effective use of these funds. Conservation efforts to encourage the prudent use of antimicrobial drugs should be directly reimbursed. Patent owners should be compensated for both conservation efforts and valuable innovation.

Introduction

Antimicrobial agents are valuable resources for global public health. As microbial resistance progresses, each new pharmaceutical molecule represents a potentially exhaustible innovation, similar in some ways to natural resources such as fossil fuels.1 Society could respond to antimicrobial exhaustion in two ways: (1) production of novel antimicrobial drugs through research and development (the supply-side production response), and (2) conservation of existing antimicrobial drugs through research, development, and implementation of prudent techniques of antimicrobial therapy to maximise effectiveness, delay resistance, and conserve resources (the demand-side conservation response). In recent publications, leading academic groups have evaluated the medical need for additional antimicrobial drugs. These groups include the Infectious Diseases Society of America (IDSA),2, 3 the European Society of Clinical Microbiology and Infectious Diseases (ESCMID),4 a European Union (EU) Intergovernmental Conference,5 the US Institute of Medicine,6 the UK Commission on Macroeconomics and Health,7 and others.8, 9 The groups find the research and development pipeline to be insufficient. Among a host of recommendations, several of these reports propose supply-side strategies such as extending patent terms for antimicrobial drugs and creating patent rights that can be transferred to other drugs, a “transferable intellectual property right” (TIPR) or “wildcard” patent.2, 3, 4, 5, 8 Wildcard patents have been proposed in two prominent bills in the US Congress, supported in part by such reports.10, 11

The case for wildcards and patent extensions is founded upon two claims. First, that we face an unprecedented drought in the discovery of novel antimicrobial classes, and second, that changes to the patent system are therefore indicated. In this Personal View, we examine both propositions. We review the claim that drug companies are failing to deliver new antimicrobial classes, but most importantly we highlight how patent extension will operate as a global tax on treatments for common diseases while inefficiently cross-subsidising antimicrobial research.

Section snippets

Is the antimicrobial research and development pipeline empty?

The following discussion is a Sisyphean task, an attempt to characterise the glass as half full rather than half empty. We recognise that resistance drives the clinical need for additional antimicrobial drugs, the importance of prudent use of antimicrobial drugs,12, 13 and that every physician would prefer to have better weapons against infectious disease. Our purpose in this section is quite limited; we seek only to question certain elements of the claims by IDSA,2, 3 ESCMID,4 and others,5, 6,

Will longer patents improve global public health?

We will now evaluate the claim that wildcards and patent extensions are the correct mechanisms to stimulate antimicrobial innovation and therefore improve global public health. The existing published work emphasises that the patent system entails both costs and benefits to patients and society.50, 51, 52, 53 Bad Bugs, No Drugs,2 and similar reports3, 4, 5, 8 did not adequately examine the potential costs of wildcards and patent extensions.

Alternatives to longer patents

We suggest that funds earmarked by the patent-based drug industry for wildcards and patent extensions could be more thoughtfully applied to other approaches with greater positive effect on global public health.

Conclusion

Health-care providers seek effective clinical options for patients with serious infections. Whereas the patent-based pharmaceutical industry seeks wildcard patents and patent term extensions, the public's health might be better served by increasing direct public funding for antimicrobial research, reimbursing providers for infection control, creating innovative diagnostic tests and antimicrobial drugs, and otherwise investing in conservation.

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