The Cost of Going to Market Without FTO Coverage
Medical device companies with in-house IP teams of five to fifteen attorneys have learned, sometimes expensively, that an undiscovered infringement risk is worst when it surfaces post-launch. At that point, design-around is constrained by manufacturing commitments, licensing negotiations happen from weakness, and injunctive relief is a real commercial threat. The fourteen third-party patents in a preliminary landscape aren't all equal risks — some have claim scope that clearly doesn't read on your device features; others require careful element-by-element analysis. The problem is that without the mapping, the IP team doesn't know which is which.
Feature-by-Claim Mapping at Scale, Integrated With Outside Counsel
An AI Labor Company agent works through the fourteen identified patents in Westlaw Edge and Lexis+, conducting feature-by-claim element-by-element mapping against the device's technical specification. Each claim element is assessed for correspondence to device features, with citations to the patent specification. Where mapping identifies potential reads, the agent flags design-around opportunities for IP team consideration. The written FTO analysis structure is assembled in iManage in a format that outside counsel can finalize and sign off on — the agent does the analytical scaffolding; counsel does the legal conclusion. Anaqua carries the portfolio context throughout.
The Business Case: Protecting a Commercial Launch
The revenue case here is straightforward: an unaddressed infringement risk can stop a commercial launch or force costly post-clearance redesign. FTO work through outside counsel alone on fourteen patents typically runs $50,000–$180,000 and takes more time than a six-month window comfortably allows when discovery, mapping, and drafting are sequential. An agent can handle 45–65% of the research and mapping effort, compressing the timeline and allowing outside counsel to focus on legal conclusions rather than claim charting from scratch. The agent is typically producing a complete draft FTO package in about seven weeks — material time savings against a fixed FDA clearance date.
Can the agent's FTO analysis be used directly in regulatory or litigation contexts?
The agent produces the analytical foundation — claim charts, element mapping, design-around identification — for outside counsel review and finalization. The signed FTO opinion comes from licensed patent counsel; the agent accelerates how counsel gets there.
What if additional patents are identified during the landscape beyond the initial fourteen?
The agent's process can be extended to additional references. The initial scope covers the fourteen identified patents; incremental patents can be added to the analysis during the engagement.