Characteristics Of Key Patents Covering Recent FDA-Approved Drugs.

Abstract

New drugs are protected by patents that block generic competition and allow manufacturers to charge high prices. To examine the breadth and characteristics of the key patents covering recently approved brand-name drugs, we extracted patents from the list maintained by the Food and Drug Administration (FDA) and evaluated the timing of patent filings, features of the drugs covered by patents, and whether similar patents were sought in other countries. Among seventy-eight qualifying drug approvals in 2019 and 2020, ten had zero patents, and the remaining sixty-eight drugs listed 322 different patents (the median number was 4). The most common category of patents, based on the nature of the invention being protected, was chemical compound (201; 62percent), followed by method of use (195; 61percent). The median time from originator drug approval to the expiration date of the final patent listed on our date of data collection was 10.3years. About one in five patents had no counterparts in other major jurisdictions around the world, suggesting either a different manufacturer strategy or a differing application of patent standards in the US than in other comparable settings. Patents covering newly approved drugs largely protect the product and its uses; this shows that patent reform, rather than changes to nonpatent exclusivities, is the key to ensuring timely generic entry.