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One possibility is that the public sector actually does the key work but does not patent it. But in such cases the private sector Orange Book listed patents should be vulnerable to validity challenges. Given strong incentives to challenge patents on important drugs (Hemphill and Sampat 2012, infra note 38) one would expect to see many active ingredient patents on drugs invalidated because of public sector prior art. To my knowledge, this is rare.Google Scholar

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In principal, the federal iEdison database ought to provide a full listing of all patents resulting from federal grants. The NIH is the only agency that provides iEdison patent data publicly, through its RePORTER system, available at <https://exporter.nih.gov/ExPORTER_Catalog.aspx?sid=0&index=3> (last visited December 18, 2020), but its listings appear to be incomplete. RePORTER notes “Patent information in RePORTER is incomplete. The patents in RePORTER come from the iEdison database. Not all recipients of NIH funding are compliant with the iEdison reporting requirements, particularly after their NIH support has ended.” Compliance appears to have improved over time, at least if we use RePORTER to gauge accuracy of government interest statements and vice versa. (In principle, the two sources should completely overlap.) However, we don’t know what patents were not reported in either source. A. K. Rai and B. N. Sampat, “Accountability in Patenting of Federally Funded Research”, Nature Biotechnology 30, no. 10 (2012): 953-956.+(last+visited+December+18,+2020),+but+its+listings+appear+to+be+incomplete.+RePORTER+notes+“Patent+information+in+RePORTER+is+incomplete.+The+patents+in+RePORTER+come+from+the+iEdison+database.+Not+all+recipients+of+NIH+funding+are+compliant+with+the+iEdison+reporting+requirements,+particularly+after+their+NIH+support+has+ended.”+Compliance+appears+to+have+improved+over+time,+at+least+if+we+use+RePORTER+to+gauge+accuracy+of+government+interest+statements+and+vice+versa.+(In+principle,+the+two+sources+should+completely+overlap.)+However,+we+don’t+know+what+patents+were+not+reported+in+either+source.+A.+K.+Rai+and+B.+N.+Sampat,+“Accountability+in+Patenting+of+Federally+Funded+Research”,+Nature+Biotechnology+30,+no.+10+(2012):+953-956.>Google Scholar

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