Federal government-interest patent disclosures for recent top-selling drugs

Abstract

Objective: To provide updated evidence on government-interest patent disclosures in US patents for top-selling small-molecule drugs.Methods: IQVIA National Sales Perspectives data identified 300 top-selling drugs, defined by peak 2013–2017 US sales. For the 197 approved through New Drug Applications (NDAs), data were collected from a recently-released dataset of all patents listed in 1985–2016 Annual Editions of the FDA Orange Book. Data on patent assignees and Government Interest Statements (if any) were collected from the US Patent and Trademark Office online database. The percentage of drugs with at least one government-interest patent disclosure was calculated, as was the percentage of patents with a disclosure, by type (drug product, drug substance, or method of use). Government-interest patent disclosures were defined as those for which: the patent application contained a Government Interest Statement; and/or any of the patent assignees was a US government agency.Results: Few patents for the top-selling drugs had a government-interest patent disclosure, 2.6% on average. By patent type, figures ranged between 1.6% (for patents with drug product claims) and 3.6% (for patents with drug substance claims). Accounting for multiple patents per drug, 8.6% of top-selling drugs analyzed had at least one patent with a Government Interest Statement; 1.5% had at least one with a US government agency assignee; and 10.2% met either criterion (none met both).Limitations: Analyses were limited to top-selling NDA-approved drugs (generally excluding biologics) and Orange Book-listed patents. Patents with government-interest patent disclosures could also have relied on non-government funding. Patents were not characterized by relative economic investments, importance in the discovery and development process, or contribution to clinical value.Conclusion: Results were generally comparable to a prior analysis that found that 9.0% of new drugs approved between 1988 and 2005 had either a Government Interest Statement disclosure or a government agency first-listed patent assignee.