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WIT Legal's Annual Report on Hatch-Waxman Litigation Trends

WIT Legal, a prominent agency in the legal domain, has recently published its second annual report analyzing trends in Hatch-Waxman litigation. Their comprehensive report, titled '2024 in Review: Analyzing Hatch-Waxman Litigation Trends,' delivers an in-depth evaluation of Abbreviated New Drug Application (ANDA) cases and the significant factors influencing them during 2024.

Key Findings from the 2024 Report

In 2024, ANDA litigation witnessed a striking 27% increase, reaching a total of 304 cases compared to 239 in 2023. This upward trend not only reflects the growing complexity of pharmaceutical disputes but also emphasizes the increasing significance of expert testimonies in legal processes.

Furthermore, the report highlighted notable shifts in venue patterns, particularly in New Jersey, which experienced an impressive 100% increase in ANDA filings, doubling from 85 cases in 2023 to 170 in 2024. On the other hand, Delaware saw a decrease of 18%, dropping from 142 cases to 116.

With respect to the drugs involved, the report identified that medications treating endocrinological conditions attracted the most litigation, contrasting last year’s focus on rare diseases. The active involvement of key players was evident, with Multrys/Tralement and Caplyta generating notable activity, a shift from the previous year’s emphasis on Xarelto and Orilissa/Oriahnn litigations.

Noteworthy judicial developments were also documented, as Judge Martinotti and Judge Shipp took over from their counterparts, Judges Andrews and Williams, who had dominated the previous year’s docket. This rotation may signal fresh legal interpretations and strategies in handling ANDA cases moving forward.

Corporate Patterns and Market Dynamics

WIT's report goes beyond mere case statistics; it delves into the corporate families driving ANDA litigation. It brings to light the significant role of American Regent, identified as the top New Drug Application (NDA) Holder involved in 43 cases, while Aurobindo Pharma was noted for being the leading ANDA filer, represented in 25 cases. These insights provide a comprehensive understanding of the corporate landscape influencing current litigation trends.

Michael Connelly, the president of WIT, emphasized the purpose of these reports, stating, 'With these annual reports, our goal remains to deliver the most in-depth analysis of true ANDA litigation in the industry.' This thorough examination of the complaints filed over the past year enables the firm to forecast the types of pharmaceutical experts that will be in demand.

Importance of Legal Expertise

WIT Legal remains dedicated to supporting parties engaged in ANDA litigation. According to Michael Crowe, WIT's Hatch-Waxman Chair, 'Our team has worked with hundreds of testifying experts in cases before district courts and the U.S. Patent and Trademark Office. Attorneys representing life sciences clients count on us to provide the most qualified and experienced experts for their pharmaceutical disputes.'

This commitment highlights the agency’s role in ensuring that clients have access to the best possible guidance within the complex world of pharmaceutical regulations and litigation.

To access more details and download the full report, interested parties can visit WIT Legal’s Hatch-Waxman Practice page.

The release of this report positions WIT Legal as a leader in the examination and analysis of Hatch-Waxman litigation, making it an essential resource for legal professionals and pharmaceutical companies involved in this intricate sector of law.