ANDA disputes drop in 2016, says report

The number of Abbreviated New Drug Application (ANDA) disputes filed in 2016 represented a drop for the first time in three years, the newly published “Hatch-Waxman ANDA Litigation Report 2017” has said.

However, the report, which was published by legal analytics company Lex Machina, revealed that the 2016 figure of 316 was still higher than the average of around 269 cases per year from 2009-2013.

In 2015, the number of ANDA cases was 468.

The report looked into the last seven years of patent litigation related to ANDA, focusing on cases filed from the beginning of 2009 through to the end of March 2017.

“ANDA litigation is heavily concentrated in the top districts: the District of Delaware (1,114 cases since 2009) and the District of New Jersey (850 cases) each easily have more cases than all the other districts combined (total of 220 cases),” said the report.

According to the report, the antipsychotic drug Abilify (aripiprazole) is the most litigated trade name, overtaking Oxycontin (oxycodone), a pain relief medication.

The report also revealed that very few ANDA cases reach a finding of damages. In cases filed since 2000, only six have reached a ruling on compensatory damages.

“Three were jury verdicts, one a summary judgment, one a consent judgment, and the last a mixture of consent and bench trial,” said the report.

The report can be found here.

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