Earlier this month, the USPTO released a special report on litigation under the America Invents Act (AIA) involving U.S. Food and Drug Administration (FDA)-approved drugs (also known as Orange Book patents) and biologic patents. Three-party public comments or related litigation.
The report shows that the proportion of third-party public comments or litigation on patent applications listed in the Orange Book has dropped from 7.5% in fiscal year 2016 to less than 2% this fiscal year. The proportion of biological patents challenged under the AIA has remained stable over the past six years, accounting for an average of approximately 2% of all applications. In fiscal year 2017, this proportion once reached nearly 4%.
The report shows that the rate at which disputed claims in biological patents are reviewed by the Patent Review Board (PTAB) is lower than for patents listed in the Orange Book. However, patents listed in the Orange Book were more likely to be upheld by the PTAB in final decisions.
Readers who need this report can obtain this report by contacting the code on the page.
