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77 Food & Drug L.J. 51 (2022-2023)
An Orange Book Landscape: Drugs, Patents, and Generic Competition

handle is hein.journals/foodlj77 and id is 55 raw text is: An Orange Book Landscape: Drugs, Patents, and Generic Competition JONATHAN J. DARROW* & DANIEL T.C. MALt ABSTRACT Patents are widely considered to be a critical incentive for drug development because they allow manufacturers to recoup investments in research and development activities. However, patents are also criticized for preventing competition and contributing to higher prices. To better understand the patent landscape for approved drug products and the relationship between patents, other exclusivities, and generic competition, we examined all prescription drug products listed in the Orange Book as of February 2021. Surprisingly, only 31% to 39% of drug products had any remaining patent protection as of this date, meaning the majority of approved drug products are unencumbered by patents. This finding remained true even when regulatory exclusivities were considered. We also found that generic drug approval occurred despite the presence of patent protection in 28% of cases, and that patent expiration was not followed by generic drug approval in 32% of cases. These findings suggest that even valid patents do not necessarily block competition, as is commonly believed, and that dramatic price decreases often cannot be expected when patents expire. As scholars and policymakers craft policies aimed at controlling drug prices, they should seek to better understand how factors other than patents and regulatory exclusivities affect generic competition and patient health. I. INTRODUCTION Since the signing of the Constitution, the United States has embraced a philosophy of granting exclusive rights to inventors to promote technological advance, including in the field of medicine.1 Patents are intended to achieve this goal by giving inventors the ability to temporarily exclude direct competition and last for twenty years from the Assistant Professor of Medicine, Harvard Medical School; Associate Professor of Law, Bentley University; Associate Scientist, Brigham & Women's Hospital, at time of acceptance for publication. Darrow has received research support from Arnold Ventures, the Commonwealth Fund, the Greenwall Foundation, the Harvard-MIT Center for Regulatory Science, Health Action International's ACCISS program, the Kaiser Permanente Institute for Health Policy, West Health, and under a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme (grant NNF17SA0027784). The funders had no role in the conception, drafting, editing, or submission of this manuscript. The authors thank Jerry Avorn and fellow members of the Program on Regulation, Therapeutics, and Law at Brigham & Women's Hospital and Harvard Medical School for offering feedback that helped improve the manuscript. Yale University School of Management. 1 U.S. CONST. Art. I, § 8, cl. 8. For an example of an early medicine patent, see U.S. Pat. No. 4848 (Nov. 12, 1846) (patent on ether as an anesthetic). 51

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