WIT Legal Releases New Report on 2023 Activities and Trends in Hatch-Waxman Litigation

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Mar 20, 2024, 11:00 ET

NEW YORK, March 20, 2024 /PRNewswire/ -- WIT Legal ("WIT"), the leading agency representing testifying experts for high-stakes, complex legal matters, today released a new report that evaluates 2023 Hatch-Waxman Litigation. The report, 2023 in Review: Analyzing Hatch-Waxman Litigation Trends, provides a comprehensive look at 2023's ANDA cases, including the drugs at issue, the key players involved in disputes, and the judges overseeing cases.

In examining ANDA activity from last year, WIT's analysis identified a total of 239 Hatch-Waxman cases filed in 2023 that involved active ANDA filings. We further grouped these matters based on the unique sets of Orange Book products involved, resulting in 118 unique cases by product group.

When examining total cases by unique Orange Book product groupings, the separation of D.Del. and D.N.J. shrinks significantly. Note that the unique case count is determined by looking at each district court in isolation.

"Our intent is to provide the most comprehensive review of true ANDA litigation available," said Michael Connelly, WIT President. "By meticulously reviewing complaints filed over the past year, we can predict the types of pharmaceutical experts that will be in highest demand and most useful to our clients."

Some key findings in the report include:

ANDA cases peaked at 239 during the year.
These cases involved only 118 unique Orange Book-listed drug groups.
Xarelto and Orilissa/Oriahnn generated the most activity, with double-digit case filings spanning multiple jurisdictions.
Drugs targeting rare diseases/conditions were the most frequently litigated among top Orange Book-listed products.
While the District of Delaware remains the busiest court, the District of New Jersey handles a proportionally greater number of cases when considering the diversity of unique drug groups involved.

Additionally, the report goes beyond the specific companies involved to provide insight into the corporate families driving ANDA litigation to highlight potential market dynamics and litigation trends. In our findings, Johnson & Johnson (J&J) emerged as the top New Drug Application (NDA) Holder represented in 31 cases, while Lupin was the top ANDA filer represented in 25 cases.

"We routinely support parties involved in ANDA litigation," WIT Director Jeremy Scholem said. "We have represented many testifying experts in cases in district courts and the U.S. Patent and Trademark Office (USPTO). Lawyers representing life sciences clients trust us to provide only the best experts for their pharmaceutical matters."

To learn more about WIT's Hatch-Waxman Practice or to download the report, visit https://www.witlegal.com/hatch-waxman-litigation/.

About WIT Legal, LLC.

WIT is the leading agency representing testifying experts in legal disputes involving advanced technologies and life sciences. We focus on industries with increased risk of litigation and build expert teams comprised of world-class academics, industry executives, and former government regulators. Partnering with WIT assures that you engage with testifying experts who have been selected for their knowledge, experience, and ability to communicate effectively.

For more information about WIT, visit WITlegal.com and follow us at @WITexperts.

Media Inquiries:

Cindy Siegel
Vice President of Marketing, WIT Legal, LLC
[email protected]

SOURCE WIT Legal, LLC