In its new book, Empirical Challenges in Pharma Litigation*, OnPoint’s pharmaceuticals team distills a deep well of pharmaceutical industry knowledge down to its most useful and interesting elements.
For 14 years, OnPoint has provided expert analysis and testimony for some of the most complex and groundbreaking pharmaceuticals lawsuits. These cases run the gamut from antitrust, to patent infringement, to breach of contractual commitments, to alleged fraud on the market. OnPoint’s success in this field depends on a deep knowledge of pharmaceutical markets, the laws and regulations that shape them, and the complex universe of data sources that can be used to analyze them.
The first chapter describes the many sources of pharmaceutical data. It includes sections on proprietary data collected by drug manufacturers, pharmacies, and prescription drug plans, as well as data collected by the FDA. It also includes a section on the myriad offerings of third-party data vendors, including data on sales, prices, drug uses by diagnosis, pharmaceutical promotion, and formulary status. The chapter compares the pros and cons of different data sources and highlights special considerations for working with particular datasets.
Chapter 2 explores the two major laws regulating the FDA’s approval of new drugs: Hatch-Waxman, which covers brand and generic small-molecule drugs, and the Biologics Price Competition and Innovation Act (BPCIA), which covers biologics and biosimilars. This chapter summarizes the provisions of the two acts and compares the ways that each law facilitates price competition while protecting patent rights and rewarding innovation.
Chapter 3 discusses a common dispute in pharmaceutical patent litigation: whether the claimed invention was “obvious,” and therefore not patentable. This chapter summarizes the “objective considerations” used to evaluate obviousness, with special attention given to two of those considerations that are commonly litigated using the types of pharmaceutical data detailed in Chapter 1 of this book: commercial success and long-felt need.
Chapter 4 reviews the case law related to the calculation of damages in pharmaceutical patent litigation, including the two major approaches: lost profits and reasonable royalties. It explains the Panduit Factors, the Georgia-Pacific Factors, and key legal concepts such as the “entire market rule.”
Chapters 5, 6, and 7 constitute a nuts-and-bolts handbook providing practical examples of the use of particular types of pharmaceutical data to address specific litigation challenges. Chapter 5 explores the use of third-party-supplied data, Chapter 6 explores the use of proprietary data, and Chapter 7 illustrates the use of pharmaceutical data in antitrust litigation.
Finally, Chapter 8 places the U.S. pharmaceutical market in the context of the rest of the world. It offers a geographic overview of the global pharmaceutical industry, mapping out the spatial distribution of pharmaceutical consumption and production and tracing the networks created by exports, imports, outsourcing, and offshoring. It also draws country-by-country comparisons of intellectual property protections, marketing approval processes, and pricing regulations.
This richly informative book is a source of invaluable background knowledge for attorneys and others working in the pharmaceutical space. And it is a clear map of the complicated terrain of empirical analysis for pharmaceutical litigation.
* Empirical Challenges in Pharma Litigation, by Laura Craft, Marty Kovach, Chandra Wallace, and Claudia Cortez (OnPoint Analytics 2017). For copies contact OnPoint at firstname.lastname@example.org.