The Pharmaceutical Intellectual Property and Competition Law Review: Editor's Preface

The pharmaceutical business is truly one of the most global industries, with many companies operating in dozens of countries with differing legal regimes and healthcare systems. In certain respects, the rules governing industry activities have largely become harmonised, such as in drug manufacturing and the conduct of clinical trials. However, in other areas the legal frameworks differ, and those nuances can require significant efforts to both optimise strategies and comply with requirements in local jurisdictions. In the areas of focus of this book – pharmaceutical intellectual property, including patent linkage and exclusivities, and related competition concerns –it can be critically important to tailor approaches to the local legal environment despite general concepts that may be shared across jurisdictions.

Maximising the value of intellectual property can make the difference in deciding to pursue the development of an important new treatment, and in determining its sustained success in the marketplace. Similarly, a failure to carefully manage risks in dealings with competitors, such as generic and biosimilar companies, can result in huge civil and criminal liabilities. This is an area of significant enforcement activity around the world, with large fines being imposed and transactions thwarted if applicable legal constraints are not heeded. Moreover, the links between intellectual property, such as exclusivities, and drug pricing and affordability have been a constant source of political scrutiny, as well as patient and physician concern.

The ongoing global response to the covid-19 pandemic has re-emphasised the importance of rapid drug and biologic product development to public health around the world, and the critical need to maintain incentives to enable such innovations. However, the stakes in demonstrating the need to maintain such protections for innovation have grown even higher as the pandemic has spurred an intense focus on intellectual property and pricing issues associated with vaccines and other needed treatments.

Our objective in framing this updated volume is to give practitioners in the field a one-volume introduction to these critical issues in an array of jurisdictions. I would like to thank the authors for their renewed contributions to this edition of The Pharmaceutical Intellectual Property and Competition Law Review. They have produced what we believe is a very useful tool for managing global risks in this area.

Daniel A Kracov
Arnold & Porter
Washington, DC
August 2021

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