Pharmaceutical Patent Litigation Filings Have Risen Significantly since 2014, According to Lex Machina’s 2015 Hatch-Waxman/ANDA Report

OxyContin remains the most litigated trade name, while Sandoz has participated in the most ANDA cases
Pharma-centric Delaware and New Jersey overwhelmingly receive the highest number of ANDA filings

Menlo Park, CA — April 26, 2016 — Lex Machina, a LexisNexis company and creator of Legal Analytics®, today announced the release of its second Hatch-Waxman/ANDA Report, which surveys the landscape of patent litigation related to Abbreviated New Drug Applications (ANDAs) submitted to the FDA under the Hatch-Waxman Act. The report focuses on trends and insights from 2,249 ANDA cases filed in U.S. district courts between January 1, 2009 and December 31, 2015.

Among the report’s key findings is that ANDA patent litigation has risen sharply since Lex Machina’s initial ANDA report in 2014. Between 2009 and 2013, the average number of ANDA cases filed each year was 269, but over the last two years the average number of filings rose to 451 — a 68% increase.

The two U.S. districts that have received an overwhelming majority of ANDA filings are Delaware, with 911 cases filed since 2009 (up nearly 35% since 2014), and New Jersey, with 725 cases (up nearly 51% since 2014). The combined total of ANDA cases that have been filed outside of Delaware and New Jersey since 2009 is only 613.

“Although ANDA filings constitute only about 10% of all patent litigation in U.S. district courts in recent years, growth rates for those filings have been steadier than filing rates for other patent litigation. With the abundance of new filings, it is critical for corporate legal teams and outside counsel to have the most accurate data on opposing parties, counsel, judges and judicial outcomes in order to develop winning legal strategies,” said Owen Byrd, Chief Evangelist and General Counsel, Lex Machina.

The Hatch-Waxman/ANDA Report draws on a combination of litigation data from Lex Machina’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 users with a distinct advantage over their competition.

Jeffrey Gargano, Partner at McDermott Will & Emery said, “Lex Machina’s analytics and use of boxplots to understand trends and the historical timing of significant case events (e.g., claim construction, summary judgment) is extremely useful in proposing realistic case schedules within the 30-month regulatory time frame. I also find the judge-specific data invaluable in preparing meaningful case budgets, which clients always appreciate.”

Other facts and report findings:

  • Sandoz has participated in the most ANDA cases since 2009 (426), followed by Actavis (including Allergan and Watson Laboratories; 359 cases), and Teva Pharmaceutical Industries (188 cases)
  • Among the top parties, AstraZeneca (139 cases), Novartis (133 cases), and Pfizer (130 cases) have the largest number of cases as claimant
  • OxyContin remains the most litigated trade name
  • The vast majority (97%) of applications are for prescription drugs; over-the-counter and discontinued drugs are a tiny minority
  • The median time to a Markman hearing was 475 days from the case filing date
  • Only 25% of temporary restraining order motions are granted in ANDA cases, while the success rate for preliminary injunctions is 50%
  • ANDA cases are less likely to end in a settlement (57.9%) than other patent litigation (77.1%), and more likely to be won by the claimant (14.6% in ANDA cases vs. 4.4% in other litigation)
  • Only five ANDA cases filed since 2000 have resulted in actual damages

For additional insights into Lex Machina’s 2015 Hatch-Waxman ANDA Litigation Report, the company will be hosting a live webcast on April 28, 2016 at 11:00 PDT. Speakers will include Jeffry Gargano, Partner, McDermott Will & Emery; Mark Rachlin, Senior Patent Counsel at Glaxo Smith Kline; and Owen Byrd, Chief Evangelist and General Counsel at Lex Machina, who will review the report findings and answer participant questions. Legal practitioners and other interested parties are welcome to register here for the event:

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 IP, 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 is used by established companies such as Microsoft, IBM, Nike, and eBay, and prominent law firms like Wilson Sonsini, Fish & Richardson and Fenwick & West. Lex Machina was named one of the “Best New Legal Services” by readers of The Recorder in 2014 and 2015, 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.