The landscape of patent litigation related to Abbreviated New Drug Applications (ANDAs) submitted to the Food and Drug Administration under the Hatch-Waxman Act is reviewed by Lex Machina, a LexisNexis company, its second Hatch-Waxman/ANDA Report.
The report focuses on trends and insights from 2,249 ANDA cases filed in US district courts between January 1, 2009 and December 31, 2015.
Among the report's key findings is that ANDA patent litigation has risen sharply since Lex Machina's initial ANDA report in 2014. Between 2009 and 2013, the average number of ANDA cases filed each year was 269, but over the last two years the average number of filings rose to 451 - a 68% increase.
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