In the two-year period ending December 31, 2017, there were 741 Abbreviated New Drug Application (ANDA) patent litigation cases and 196 Patent Trial and Appeal Board (PTAB) pharmaceutical petitions filed, according to a new report issued by Lex Machina, a LexisNexis company.
The fourth annual Hatch-Waxman/ANDA Litigation Report also showed that 843 ANDA cases and 246 PTAB pharmaceutical trials were completed during the period.
The report, which focuses on FDA Paragraph IV pharmaceutical patent litigation related to ANDAs filed in U.S. district courts under the Hatch-Waxman Act and PTAB cases involving FDA Orange Book patents, found that district court ANDA case filings rebounded nearly 30 percent, from 324 cases in 2016 to 417 cases in 2017, but remained below the 2015 record high of 475 cases.
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