Rethinking Patent Dispute Strategy: Mediation in Life SciencesSeptember 10, 2025

Patent disputes at the intersection of science and law, such as in agriculture and health care, have always carried unique weight. They involve inventions that impact food security, patient outcomes, regulatory timelines, and billion-dollar markets. Litigation is a main option for resolution, but increasingly companies are turning to structured settlement processes designed specifically for complex intellectual property conflicts. These methods emphasize preparation, people, confidentiality, timing, and creative business-oriented solutions.

The most successful outcomes to dispute resolution start with mapping the business interests and timing of biological and regulatory milestones alongside the legal positions. For agricultural companies, that can mean understanding the growing season(s), stewardship duties tied to a seed trait, and/or obligations to downstream growers and the processing and supply chain. For health care companies it may include clinical endpoints and regulatory submissions. When disputes are framed through those business realities, solutions emerge that courts are not equipped to impose.

Another key factor to success is people. This begins with alignment to proceed with mediation, and the choice of an objective mediator. Mediators with technical and industry literacy keep discussions anchored in risk and settlement, rather than time spent providing tutorials on the science or general industry background for the life sciences, which often involve not only intellectual property but also regulatory considerations. Choice of participants is equally important. Company representatives who can explain scientific, regulatory, and business context in plain language bring credibility that is invaluable in the room. This credibility fosters trust and often determines whether settlement proposals gain traction.

In considering which people should be involved, authority to settle is indispensable. The process stalls when the people at the table cannot commit. Identify who has authority to settle, how far that authority extends, and what approvals may be needed afterward to increase efficiency of discussions and chances of success. Where boards or public partners must review terms, planning the pathway to that approval before the mediation begins avoids wasted sessions that end with only memoranda rather than signatures.

Confidentiality is a key differentiator from litigation for the mediation process. It creates a safe space for selective disclosure of information that may not be shared in litigation. A well-structured confidentiality agreement allows the exchange of field trial results, clinical data, or manufacturing protocols without exposure to later discovery or patent invalidity proceedings. This not only builds trust but enables each side to assign value to concessions and weigh risk with better accuracy. Most importantly, a confidentiality agreement and the use of mediation vs. litigation ensures there are no publicly available motions, discovery, or rulings which may be precedential or negatively impact other facets of a party’s intellectual property or business activities.

Timing is another important factor. Structured settlement processes work best in awareness of natural inflection points to the business. A harvest window, a trial completion, or an FDA filing date are all moments that create leverage and urgency. A mediator works with parties to explicitly identify events relevant to the dispute in advance. If development of settlement options recognizes milestones that both parties recognize as critical, the discussions will maintain momentum toward alignment of solutions.

Mediation allows for creative options other than those limited by jury instructions or specific legal claims. Settlements may include field-of-use or geography carve-outs, milestone royalties, validation studies, or joint steering committees that govern ongoing collaboration. These business solutions may be beyond the reach of a court order, but well within the reach of a negotiated settlement. And again, all of the terms of the settlement remain confidential and will not set legally binding precedent for any future disputes related to that same intellectual property.

Practical lessons for heading into mediation include entering the process with context that connects not only law but the science and business goals; and ensuring that the people at the table understand the technology, the industry, and the commercial stakes. Ensure that the mediation agreement covers confidentiality and the parties’ intentions to reach a voluntary and mutually beneficial binding settlement. Stage the process around genuine business deadlines, and confirm authority to settle and draft solutions toward a term sheet that can be signed on the spot. These are fundamental conditions to set the stage for a successful mediation.

Patent conflict in agriculture and health care is likely to continue as foundational biotechnology ownership disputes such as those around gene editing, and related licenses and collaborations remain breeding grounds for disagreements. While litigation remains the standard approach to force parties to the table to address the underlying issues, it is not always the most appropriate solution to proceed through discovery and trial/appeals.

By choosing mediation, bringing the right participants to the table, and structuring the process around business realities, companies can transform disputes into agreements that preserve innovation and value. Utilizing mediation for biotechnology disputes gives parties agency and autonomy, fosters development of mutually beneficial affiliative and appreciative solutions and preserve IP assets in a way that keeps innovation, business goals, and relationships moving forward.

Cassie J. Edgar is a Partner, Patent Attorney, and trained mediator. She is Chair of the Licensing and Regulatory Law practice groups. She advises clients in IP, regulatory law, and licensing including matters with USDA, FDA, and EPA. Cassie is also Co-Chair of the Data Privacy and Cybersecurity practice group. For additional information, please contact Cassie directly via e-mail at cassie.edgar@ipmvs.com. Please seek consultation for specific inquiries as this publication provides overview data only and does not provide legal advice.

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