As ANDA Litigation Hits an Eleven-Year Low, Other Operating Company Filings Have Leveled Out

Operating companies added 1,179 defendants to patent litigation campaigns in 2021, a 7.9% decrease from the prior year—continuing a general downward trend that began around 2010. However, these data are influenced somewhat by the inclusion of litigation alleging infringement through the filing of Abbreviated New Drug Applications (ANDAs).

ANDA litigation (i.e., patent infringement litigation filed under the Hatch-Waxman Act) had already been trending downward since 2017, but a more substantial drop began in March 2020, around the time the COVID-19 pandemic was picking up steam. The decline began to level out around the middle of last year, but 2021 still saw the slowest pace of ANDA litigation seen since 2010 (with 153 defendants added in 2021, compared to 162 in 2010).

Excluding these ANDA disputes—which are distinct from “typical” operating company litigation in that plaintiffs mainly seek injunctions and the delay of generic drug products, rather than monetary damages—somewhat dampens the overall downward trend in recent years. As seen below, operating company filings —excluding ANDA activity—have declined by roughly half since 2010, but have been largely flat at 1,000 to 1,100 disputes per year since 2017.

See RPX’s review of the fourth quarter and 2021 for more on ANDA litigation, as well as a deep dive on other trends impacting patent litigation and the patent marketplace.