ANDA patent litigation ‘falls for first time in three years’

Lex Machina said its third annual Hatch-Waxman/ANDA Litigation Report showed that Abbreviated New Drug Applications (ANDA) patent litigation declined for the first time in three years – from a high of 468 cases in 2015 to 316 cases in 2016.

However, ANDA litigation in 2016 remained higher than the average number of filings from 2009 through 2013 – about 269 cases per year.

The report provides litigators with insights from 2,646 ANDA cases filed in US district courts between January 1, 2009 and March 31, 2017.

The report said the two US districts that received an overwhelming majority of ANDA filings were Delaware with 1,114 cases filed since 2009 (up nearly 22.3% since 2015), and New Jersey with 850 cases (up more than 17.2% since 2015).

The third largest ANDA district – Southern District of New York (159 cases filed since 2009) – saw a dramatic decline in ANDA filings over the last five quarters.

Both Delaware and New Jersey have seen more ANDA cases filed since 2009 than all other jurisdictions combined.

“Lex Machina’s 2017 Hatch-Waxman/ANDA Litigation Report provides valuable insights into current trends in ANDA litigation, and illuminates the ways in which ANDA litigation differs significantly from other, non-ANDA patent litigation,” said Owen Byrd, General Counsel, Lex Machina.

“Understanding where to file a case, one’s exposure to damage awards, and average case timing for key legal milestones is key to helping practitioners make more informed decisions, which leads to better litigation strategy.”

Lex Machina’s third annual Hatch-Waxman/ANDA Report draws on a combination of litigation data from the company’s Legal Analytics platform and Orange Book data published by the FDA on ANDA applications and related patents.

Other report findings were:

  • Abilify (an antipsychotic, 63 cases since 2009) has overtaken Oxycontin (a pain relief medication, 59 cases) as the most litigated trade name by number of cases. Vascepa (a cholesterol medication) leads by the number of asserted patents.
  • Actavis (including Allergan and Watson Laboratories) has participated in the most ANDA cases since 2009 (427 cases), followed by Mylan (290 cases), and Teva Pharmaceutical Industries (232 cases).
  • Among the top parties since 2009, AstraZeneca (156 cases), Pfizer (143 cases) and Novartis (144 cases) have the largest number of cases as claimant (the party that is asserting the patent, as opposed to claim defendant). Other top claimants include Takeda, Cephalon, Roche, Abbott Labs, Genzyme and Wyeth.
  • Only six ANDA cases filed since 2000 have resulted in actual damages, including one case in 2016 (Brigham and Women’s Hospital, Inc. et al v. Perrigo Company et al. for more than $10.2 million).
  • ANDA cases are less likely to end in a settlement (57.9%) than other patent litigation (77.8%), and more likely to be won by the claimant (15.9% in ANDA cases vs. 4.4% in other litigation).
  • The median time to a Markman hearing was 453 days (about a year and three months) from the case filing date.