Key Points
- With class action, arbitration and patent cases on the rise, life sciences companies may want to be proactive in minimizing their exposure to litigation. That may involve thorough assessment of side effects and adverse event reporting, and following any recommendations for FDA labeling changes.
- Pharmaceutical companies also may want to pay close attention to manufacturing compliance and supply chain vulnerabilities.
- To protect IP, companies should consider aligning their legal strategies with research and development, and challenges to drug approval applications should be monitored for competitive intelligence and insights to guide the company’s IP strategy.
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In-house legal teams are encountering mounting pressure,1 especially as they balance cost control, risk mitigation and rising litigation of all types.
For life sciences companies, the current environment raises the stakes as they grapple with an unpredictable Food and Drug Administration (FDA), aggressive state attorneys general scrutinizing pricing and patents, artificial intelligence (AI) innovation in all aspects of their business and growing consumer protection concerns. These types of advancements, combined with regulatory uncertainty, create the perfect breeding ground for litigation.
Litigation Trends in the Life Sciences Sector
Litigation is generally on the rise. Class action filings jumped 4% in 2023, with hot-button areas like data privacy, ESG “greenwashing” and consumer fraud driving activity.2 Risks associated with these trends include the financial and reputational impact of large settlements and regulatory scrutiny, with significant payouts in cases involving defective products, deceptive marketing and data breaches.
These risks can be costly for companies, from both a financial and reputational standpoint. FDA’s increasing reliance on “regulation by voluntary compliance” only compounds the exposure, leaving life science companies more vulnerable to class actions springing from informal regulatory actions.3
From 2021 to 2023, $30.4 billion was paid out in settlements,4 and mass arbitrations are surging, with privacy and consumer matters driving the wave.5 This poses challenges for corporate defendants, as courts increasingly reject efforts to limit arbitration-related costs. The U.S. District Courts for the Southern District of New York and Central District of California are the most active venues for class action and consumer protection cases, respectively.
Patent litigation is on the rise. Life sciences companies are watching patent litigation accelerate again: While patent cases overall rose 22% in 2024,6 life science patent litigation is increasing, with generic manufacturers pushing harder and earlier for market entry, particularly when there are opportunities to launch generics of complex products.7
The U.S. District Court for the Eastern District of Texas has reestablished itself as a patent litigation hotbed, handling more than 20% of all cases nationwide.8 While the U.S. District Courts for the Western District of Texas and District of Delaware were previously the most popular venues for patent litigation, modifications to case assignment rules in the Western District of Texas aimed at reducing the concentration of cases before Judge Alan Albright contributed to the decline in filings there. Similarly, the District of Delaware saw a decrease in filings, partly due to heightened transparency requirements regarding third-party litigation funding.9
What Does This All Mean for In-House Teams?
This evolving legal landscape highlights the importance of strategic risk mitigation and litigation management. Companies must proactively address compliance risks, adapt to emerging legal standards and engage in effective litigation planning to manage potential liabilities. In-house teams are playing a shifting, high-pressure game where defense must be proactive, not reactive.
In the life sciences sector, success hinges on:
- Mitigation and compliance: Ensuring appropriate pharmacovigilance and adverse event reporting, keeping up with any recommendations for FDA labeling changes (especially those related to safety) and monitoring trends in the environment.
- Operational vigilance: Paying close attention to manufacturing compliance as well as responsible sourcing and supply chain vulnerabilities (especially related to China).
- IP strategy: Tightly aligning with research and development (R&D), monitoring for competitive intelligence and Abbreviated New Drug Application (ANDA) challenges early, and knowing when to defend IP — and when not to.
The rise of ANDA-related patent litigation is unlikely to abate, as generic manufacturers have identified a more profitable strategy in complex generics. This means that, for new chemical entities (NCEs) — even those that have a complex drug delivery system — we are likely to continue to see patent lawsuits filed to ensure the earliest possible entry date.
For life sciences legal teams, the uncertainty of the current environment can be challenging. But those who combine foresight with disciplined risk management can turn that uncertainty into resilience — and a long-term competitive advantage.
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1 UnitedLex, “Booster Shot: How Legal Departments Are Driving Value in Life Sciences” (July 2025).
2 Lex Machina, “Class Action Litigation Report 2024.”
3 The Wall Street Journal, “Cooperation Is the Key to MAHA” (July 22, 2025).
4 Lex Machina, “Class Action Litigation Report 2024.”
5 The National Law Review, “5 Trends To Watch: 2024 Class Actions” (February 6, 2024).
6 Chambers Global Practice Guides’ Patent Litigation Report 2025 states that patent litigation increased by 22% in 2024. Specifically, patent case filings rebounded in 2024, with plaintiffs filing 3,806 patent complaints in district courts compared to 3,115 in 2023, marking a 22.2% increase.
7 Chambers Global Practice Guides, Patent Litigation Report 2025.
8 Unified Patents, Patent Dispute Report: 2024 Mid-Year Report.
9 Lex Machina, Patent Litigation Report 2025.
This memorandum is provided by Skadden, Arps, Slate, Meagher & Flom LLP and its affiliates for educational and informational purposes only and is not intended and should not be construed as legal advice. This memorandum is considered advertising under applicable state laws.