Key legal issues shaping life sciences and health care M&A

Life sciences M&A continues to accelerate as companies pursue innovation, navigate regulatory pressure, and respond to shifting market dynamics. Large pharmaceutical companies face mounting patent cliffs that threaten major revenue streams, prompting a renewed push to acquire innovative assets capable of replenishing pipelines through targeted acquisitions that deliver specific scientific capabilities, such as next generation biologics, cell and gene therapies, or AI-enabled discovery platforms. Unlike traditional M&A, value in life sciences transactions is often concentrated in future regulatory milestones and IP durability rather than current revenue, making legal diligence and risk allocation (including through contingent consideration) critical to deal success.

Unlike many other sectors, life sciences companies operate under intense regulatory oversight. Buyers must navigate a multilayered diligence process that spans clinical data integrity, IP protection, manufacturing compliance, and reimbursement pathways. Each of these areas carries material risk, and shortcomings can dramatically alter deal value or derail transactions entirely.

Globalization adds another layer of complexity. Divergent regulatory regimes across the U.S., EU, and China require companies to assess cross-border data requirements, export controls, and evolving rules governing sensitive technologies. These regimes are subject to change and are impacted by evolving geopolitical and economic factors. As a result, buyers in early 2025 adopted a "wait-and-see" approach. By the end of 2025 and into 2026, buyers returned to their acquisition strategies, but are increasingly relying on specialized regulatory, scientific, and legal expertise to validate assumptions and mitigate regulatory risk.

IP is often the crown jewel of a life sciences target, making its legal status central to any transaction. Sellers will often have various licensing arrangements with universities or large pharmaceutical companies that impact the value of the assets. In addition to diligence around ownership of patents, data, and know‑how and freedom‑to‑operate, buyers need to analyze any third‑party rights or encumbrances coming out of pre-existing licensing agreements, collaboration arrangements, and research partnerships. These types of arrangements can all impose restrictions that affect commercialization or future development, including through ongoing payment obligations, joint ownership and rights of first refusal or negotiation, or include provisions that reach into a buyer's broader portfolio, which can negatively impact the strategic case for the acquisition.

As life sciences companies navigate an environment defined by rapid innovation, heightened regulatory scrutiny, and unpredictable market conditions, M&A remains a vital tool for shaping long term growth and competitive advantage. Organizations that succeed will be those that balance scientific vision with disciplined execution – aligning deals to strategic priorities, conducting rigorous cross functional diligence, and structuring transactions that reflect today's valuation realities.

Authors

Jessica A. Bisignano

Partner Corporate & Finance Philadelphia

Gabrielle (Gabi) M. Witt

Partner Corporate & Finance Washington, D.C.

All M&A, Licensing and Commercial Transactions articles
Next article