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27 April 2016Americas

ANDA litigation ‘up 68%’ since 2014, says report

Patent litigation related to Abbreviated New Drug Applications (ANDAs) has increased by nearly 70% in the last two years, a report has claimed.

According to legal analytics company Lex Machina’s second Hatch-Waxman/ANDA report, cases of ANDA-related litigation have risen sharply since 2014.

Between 2009 and 2013, the average number of patent infringement cases filed at US district courts in response to ANDA applications each year was 269, but over the last two years the number of filings rose to 451—a 68% increase.

The report focuses on trends and insights from 2,249 ANDA cases filed between January 1, 2009 and December 31, 2015.

The report uses a combination of litigation data from Lex Machina’s legal analytics platform and information published by the US Food and Drug Administration on ANDA applications.

Delaware has received “an overwhelming majority” of ANDA filings, with 911 cases filed since 2009, the report said.

Owen Byrd, general counsel at Lex Machina, said: “Although ANDA filings constitute only about 10% of all patent litigation in US district courts in recent years, growth rates for those filings have been steadier than filing rates for other patent litigation.”

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