The Case: Major Drug Manufacturer Sues to Stop Generic Release of Schizophrenia Drug

The plaintiffs, two major pharmaceutical companies, sued more than 10 generic drug manufacturers for infringing on a patent essential to the creation of their commercially successful schizophrenia medication. One of those manufacturers sought FDA approval for a generic version of the drug that plaintiffs claim directly infringes upon their IP because of language on the label regarding patient weight gain, which uses data directly referenced in their patent.

The Ask: A Testifying Expert with Experience Diagnosing and Treating Mental Health Disorders Using Medication

A defendant approached WIT to provide a testifying expert with experience prescribing atypical antipsychotics and managing patient weight. Their ideal expert currently or previously worked as a clinical psychiatrist to treat schizophrenia and had prescribed the drug in question, allowing them to opine on whether weight gain is in fact a problem associated with the medication.

Why WIT Was Best Suited to Meet the Expert Need

In anticipation of an influx of disputes regarding pharmaceutical patents and drug manufacturing, WIT has actively recruited and retained world-class academics, industry executives, and subject-matter experts to support clients in life sciences litigation. For this Hatch-Waxman case, WIT was able to recommend an expert who has worked in the area of psychiatry for more than 25 years and is an expert clinical trialist, providing them with extensive knowledge on how to treat mental health disorders. As head of psychiatry at a major university, this expert possessed a deep understanding of the effects that various antipsychotics can have on the system.

The case was settled during trial, and our expert provided insights essential to the resolution of the dispute.

The Legal Landscape: ANDA Cases on the Rise

As the pharmaceutical industry continues to experience a rapid evolution on account of federal regulations, patent cliffs, and expanded generic manufacturing capabilities, pharma cases have been hitting the courts at an increased rate based on data reported by Lex Machina. Last year, there were 265 ANDA cases that went to trial, which is up from 218 cases in 2021. But interestingly, only 158 unique drugs were at issue in 2021, compared to 178 in 2022; the number only increased about 14% YOY while case numbers rose close to 22%.

How Experts Can Assist in ANDA Cases

When it comes to ANDA cases and Hatch-Waxman litigation, these disputes can become increasingly complex depending on the patent at issue, as well as its enforceability and validity. Further, ANDAs that involve generics are often filed with Paragraph IV certification, which can lead to even more litigation. The stakes in these cases can have far-reaching consequences that could alter the industry as it stands concerning the pharma market as a whole, drug prices, and patient access to medications.

Engaging with experienced experts can help those in the industry prepare for potential litigation risk as the pharmaceutical industry continues to evolve. By collaborating with experts now, pharma players can stay ahead of the curve when it comes to FDA regulations and guidance related to ANDA disputes, and mitigate potential pitfalls associated with drug submissions and approvals. Further, industry professionals can offer insights into competitor filings, previous ANDA cases, patent analysis, and generic manufacturing to help form a proactive litigation strategy for market players.

At WIT, we understand that ANDA litigation can be highly specialized and have engaged with experts who possess a deep understanding of pharmaceutical laws and regulations. Our diverse team of pharmaceutical testifying experts features prominent academics, scientists, former regulators, and industry veterans who can opine on the science, research & development, and clinical trial protocols of new or generic drugs; explain industry practices and policies; or discuss patent validation processes.

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, contact us to discuss your expert witness needs. Follow us on LinkedIn and Twitter to stay up-to-date on our latest insights.

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