The Case: A Generic Manufacturer Defends Itself Amid Claims of Patent Infringement

The plaintiff, a multinational pharmaceutical corporation, sued a generic manufacturer for filing an Abbreviated New Drug Application (ANDA) that sought approval to engage in the manufacturing, use, and sale of a generic kidney cancer treatment drug before the expiration of the plaintiff’s patents. 

The Ask: A Testifying Expert with Knowledge of Renal Cell Carcinoma

The defendant approached WIT to provide an expert who could help bring their drug to market and invalidate the claims of the plaintiff. This ANDA dispute called for an expert who possessed a deep understanding of renal cell carcinoma (kidney cancer) and had experience working as a clinical oncologist or medical urologist. The expert also needed to be familiar with mTOR inhibitors and be adverse towards the plaintiff.

Why WIT Was Best Suited to Meet the Expert Need

In anticipation of an influx of disputes regarding pharmaceutical patents and drug manufacturing, WIT actively recruited a diverse group of world-class academics, industry executives, and former government regulators who are dedicated to supporting our clients in life sciences litigation. For this Hatch-Waxman case, WIT was able to recommend an expert who led the urology division of a major US University. He (or she) also acted as the president of several urology-related associations, including the Society of University Urologists and the Society for Urologic Chairpersons and Program Directors.

Additionally, we provided a second expert to further support the case. This expert was well-versed in all areas of urology, holding clinical appointments in several well-regarded medical centers throughout the West Coast. During his time as a medical professional, this expert has served as a Kidney Cancer Abstract Reviewer for several hospital and university committees, illustrating his deep understanding of the field.

The Legal Landscape: Generic ANDA Disputes Increase in Complexity

As pharmaceutical companies continue to rapidly bring drugs to market, cases involving active ANDA filings have been hitting the courts at a high rate. In building our life sciences teams to address the unique needs of these complex disputes, WIT closely monitors ANDA cases and the Orange Book-listed products at issue. In doing so, we created a new report to provide key insights from our research which we think will be of interest to our clients, presenting the most comprehensive review of ANDA litigation available.

In the report, 2023 in Review: Analyzing Hatch-Waxman Litigation Trends, we evaluated these disputes to find that a total of 239 Hatch-Waxman cases filed in 2023 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. 

Understanding ANDA statistics can offer insights into competitor filings, previous ANDA cases, patent analysis, and generic manufacturing to help form a proactive litigation strategy for market players, enabling them to anticipate potential legal challenges and navigate the intricate regulatory landscape more effectively.

How WIT’s Experts Can Assist in ANDA Disputes

At WIT, we understand that ANDA litigation can be highly specialized and have engaged with experts who possess a deep understanding of pharmaceutical operations, drugs, and regulations. Our Hatch-Waxman Practice features experienced professionals with diverse backgrounds in pharmaceutical sciences who can explain complex drug formulations, manufacturing processes, and the science behind the drug’s action.

Contact us for more information about how WIT’s pharmaceutical experts can help inform your litigation strategy and to learn more about our expert teams in other areas of focus within life sciences.

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