AT WIT, we understand the parties, opportunities, and risks associated with ANDA proceedings and are familiar with the intricacies of the Hatch-Waxman Act. In building industry-specific teams to address the unique needs of those litigating ANDA disputes, WIT’s Hatch-Waxman Practice Team monitors the needs and challenges of our clients to identify the industry, regulatory, and technical experts needed in these proceedings to address the underlying issues that make related cases so complex.
Recently, we spoke to our Hatch-Waxman Practice Chair, Michael Crowe, to gain insights into Hatch-Waxman litigation trends in 2024. Crowe and the WIT Team are working diligently to provide clients with experienced industry professionals with diverse backgrounds in pharmaceutical sciences who can explain complex drug formulations, manufacturing processes, and the science behind the drug’s action. Here’s what he had to say about filings and possible trends in the year ahead.
Q: Given the volume of litigation filed in 2023, how did 2024’s case volume compare? Did you observe an upward or downward trend in ANDA filings?
Crowe: As we documented in our 2023 report, the number of ANDAs filed has generally declined since 2017 with a noticeable dip after COVID-19. It looks like that trend continued in 2024 with an estimated 801 original ANDAs submitted in 2024.
Q: What trends emerged in 2024 in terms of the products most frequently involved in Hach-Waxman litigation? Have there been notable high-profile cases in these areas?
Crowe: Xarelto has been at the center of much of the year’s Hatch-Waxman litigation, reflecting a broader focus on high-value, widely used pharmaceutical products. A particularly notable opinion was issued in October: Teva Pharmaceuticals USA, Inc. v. Amneal Pharmaceuticals LLC. In this case, Judge Chesley ruled that five patents asserted by Teva were improperly listed in the Orange Book. This decision has sparked increased scrutiny of Orange Book listings, drawing attention not only from litigators but also from the FTC, which is intensifying its oversight of how patents are listed and the competitive implications for generic drug manufacturers.
Cases like this highlight a growing trend where courts and regulators are taking a closer look at the intersection of intellectual property and competition, with significant implications for Hatch-Waxman disputes going forward.
Q: In your experience, how significant is the role of expert testimony in Hatch-Waxman cases, and what qualities make an expert particularly effective?
Crowe: Expert testimony is critical in Hatch-Waxman cases due to their inherently scientific nature. These disputes often hinge on an expert’s ability to provide clear, concise explanations of complex topics like pharmacology or bioequivalence. An effective expert not only conveys technical mastery but also communicates persuasively, making dense scientific details accessible to judges and maintaining credibility under scrutiny. Their ability to simplify and articulate these concepts can make the difference between success and failure in a case.
That is why it is important to ensure that the experts selected are going to be the most relevant and qualified for each case. With amendments to Rule 702 causing increased scrutiny around expert’s testimony, methodology, and background, working with an expert agency that has experience in the sector can help ensure that attorneys engage with experts who can communicate their testimony effectively and are adequately equipped to address issues at the center of their dispute.
Q: Where can practitioners find comprehensive updates and insights on the latest developments on the Hatch-Waxman Act and ANDA litigation?
Crowe: There are many resources that provide updates and insights on Hatch-Waxman and ANDA litigation, and we utilize a variety of resources to inform our practice activity. For example, WIT publishes a yearly ANDA report and individual judge reports that offer in-depth analyses and trends in this space utilizing data from Docket Navigator and Lex Machina. Recently, we published a new judge report covering Judge Michael Shipp’s activity at the District Court of the District of New Jersey, and the 100 ANDA cases he has presided over since being appointed in 2012. Additionally, the ACI Paragraph IV Disputes Conference is an invaluable resource. We sponsored the event last year, gaining insights from top ANDA litigators and in-house counsel from leading pharmaceutical companies. Following these developments allows us to better anticipate client needs and efficiently source expert testimony.
At WIT, we know that information on ANDA litigation trends is often fractured across multiple resources. To address this, our Hatch-Waxman Practice Team gathers data from various sources, with our team reviewing each matter to offer clients exclusive insights into case trends, judicial preferences, and regulatory updates.
Q: What unique advantages does WIT’s Hatch-Waxman Practice offer to companies involved in ANDA litigation?
Crowe: I believe we have an unparalleled understanding of ANDA/Hatch-Waxman litigation compared to any other expert provider, as we track both individual cases and broader trends in the pharmaceutical industry. This allows us to accurately identify the types of experts our clients need to navigate the complexities of this specialized area of litigation. Our team includes attorneys who have practiced in Hatch-Waxman cases, providing us with an insider’s perspective on the nuances and demands of Paragraph IV disputes, which is crucial for selecting and preparing the right experts.
We also leverage our network of world-class experts across scientific, regulatory, and commercial disciplines, ensuring that our clients receive testimony from individuals who are not only highly knowledgeable but also effective communicators. These experts excel at breaking down complex scientific and technical information into clear, compelling narratives for judges and juries. This combination of deep venue expertise, experienced legal professionals, and top-tier experts uniquely positions WIT to deliver exceptional support to companies engaged in ANDA/Hatch-Waxman litigation, maximizing their chances of a favorable outcome.
How WIT’s Experts Can Assist in Hatch-Waxman Litigation
At WIT, we understand that ANDA proceedings can be highly nuanced; therefore, we have engaged with experts who possess a deep understanding of the industry, drug development, and the regulatory framework in the life sciences sector.
Our Hatch-Waxman Practice features a diverse group of world-class academics, industry executives, and former government regulators who are dedicated to supporting our clients in these complex matters. As the leading agency representing testifying experts for disputes involving life sciences and advanced technologies, our experience in providing experts for pharmaceutical-related cases is unmatched. Backed by our deep understanding of Hatch-Waxman litigation, we offer unparalleled support for our clients navigating this intricate legal landscape.
Contact us for more information about our experts and to learn more about our expert teams in our areas of focus within life sciences.