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

Figures & data

Table 1. Orange Book-listed patents for top-selling 2013–2017 drugs, with patent claim types.

	All Orange Book-listed patents	Percent of all patents with given claim type
Method of use patents	666	57.9%
Drug product patents	677	58.8%
Drug substance patents	335	29.1%
Total Orange Book patents	1,151	N/A*

*Patent claim types do not sum to total; individual patents may include multiple claim types.

Notes: Method of use (MOU), drug product (DP), and drug substance (DS) patent claim types are as recorded in FDA Orange Book.

Source: Author’s analysis of FDA Orange Book, US PTO data (see Notes 11, 15, and 17).

Table 2. Orange Book-listed patents for top-selling 2013–2017 drugs, by patent claim type and government-interest patent disclosure.

	All Orange Book-listed patents	Patents with government-interest patent disclosure	Percent with government-interest patent disclosure
Method of use patents	666	21	3.2%
Drug product patents	677	11	1.6%
Drug substance patents	335	12	3.6%
Total Orange Book patents	1,151	30	2.6%

Notes: Method of use (MOU), drug product (DP), and drug substance (DS) patent claim types are as recorded in FDA Orange Book. Patent claim types do not sum to total; individual patents may include multiple claim types. Government-interest patent disclosure is either: government-interest statement patent disclosure; or US government patent assignee (or both).

Source: Author’s analysis of FDA Orange Book, US PTO data (see Notes 11, 15, and 17).

Table 3. Average number of Orange Book-listed patents per drug, by type of patent.

	Drug substance patents	Drug product patents	Method of use patents	Total Orange Book patents
All drugs reviewed	2.2 (2.1)	3.9 (4.4)	3.8 (4.0)	6.0 (6.2)
Drugs with at least one government-interest patent disclosure	2.0 (3.2)	3.2 (3.6)	3.4 (3.4)	5.7 (5.1)

Notes: Method of use (MOU), drug product (DP), and drug substance (DS) patent claim types are as recorded in FDA Orange Book. Calculations exclude drugs without a patent of the specified type; individual patents may include multiple claim types. Government-interest patent disclosure is either: government-interest statement patent disclosure; or US government patent assignee (or both). Averages exclude drugs with no unexpired patents in any Orange Book edition data. Figures in parentheses are standard deviations.

Source: Author’s analysis of FDA Orange Book, US PTO data (see Notes 11, 15, and 17).

Table 4. Top-selling 2013–2017 drugs with at least one government-interest patent disclosure.

	Percent with at least one patent with government-interest statement	Percent with at least one patent with government patent assignee	Percent with either government-interest patent disclosure measure
Number of drugs reviewed	8.6% (17 of 197)	1.5% (3 of 197)	10.2% (20 of 197)

Notes: Government-interest patent disclosure is either: government-interest statement patent disclosure; or US government patent assignee (or both).

Source: Author’s analysis of FDA Orange Book, US PTO data (see Notes 11, 15, and 17).