Pharmaceutical Patent Litigation Filings Have Declined for the First Time in Three Years According to Lex Machina’s Hatch-Waxman/ANDA Litigation Report

Abilify overtakes OxyContin as the most litigated trade name, but Actavis holds the record for participating in the most ANDA cases since 2009

Pharma-centric Delaware and New Jersey continue to receive the highest number of ANDA filings, while Southern District of New York filings plummet

Menlo Park, CA — April 27, 2017 — Lex Machina, a LexisNexis company and creator of the award-winning Legal Analytics® platform, today announced the release of its third annual Hatch-Waxman/ ANDA Litigation Report. The report, which focuses on patent litigation related to Abbreviated New Drug Applications (ANDAs) submitted to the FDA under the Hatch-Waxman Act, provides litigators with trends and data-driven insights from 2,646 ANDA cases filed in U.S. district courts between January 1, 2009 and March 31, 2017.

Among the report’s key findings is that ANDA patent litigation has declined for the first time in three years – from a high of 468 cases in 2015 to 316 cases in 2016 – which represents a nearly 32.5% decline. However, ANDA litigation in 2016 remained higher than the average number of filings from 2009 through 2013 – about 269 cases per year.

The two U.S. districts that have received an overwhelming majority of ANDA filings are 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 (only one case, down from a high of 41 in 2011). Both Delaware and New Jersey have seen more ANDA cases filed since 2009 than all other jurisdictions combined (682 cases).

“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, Chief Evangelist and 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. Together with traditional research and intuition gained from experience, the report’s insights can provide readers with a distinct advantage over their competition.

Other facts and report findings:

  • 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.

The report also explores data-driven trends and insights pertaining to case timing and outcomes, as well as top ANDA judges and law firms, which can help litigators prepare legal strategies and help corporations select the best outside counsel and forecast litigation costs.

For additional insights into Lex Machina’s Hatch-Waxman/ANDA Litigation Report, the company will be hosting a live webcast on April 27, 2017 at 11:00 PDT. Brian Howard, legal data scientist at Lex Machina and author of the report, will discuss the report’s findings and answer participant questions. Legal practitioners and other interested parties are welcome to register here for the event:

To request a copy of the full report please register here:

About Lex Machina
Lex Machina’s award-winning Legal Analytics® platform is a new category of legal technology that fundamentally changes how companies and law firms compete in the business and practice of law. Delivered as Software-as a-Service, Lex Machina provides strategic insights on judges, lawyers, parties, and more, mined from millions of pages of legal information. This allows law firms and companies to predict the behaviors and outcomes that different legal strategies will produce, enabling them to win cases and close business.

Lex Machina was named “Best Legal Analytics” by readers of The Recorder in 2014, 2015 and 2016, and received the “Best New Product of the Year” award in 2015 from the American Association of Law Libraries.

Based in Silicon Valley, Lex Machina is part of LexisNexis, a leading information provider and a pioneer in delivering trusted legal content and insights through innovative research and productivity solutions, supporting the needs of legal professionals at every step of their workflow. By harnessing the power of Big Data, LexisNexis provides legal professionals with essential information and insights derived from an unmatched collection of legal and news content—fueling productivity, confidence, and better outcomes. For more information, please visit