Freedom to Operate

Assessing Patent Risk Before Commercial Launch

Before bringing products to market or implementing new processes, companies need to understand whether they risk infringing third-party patents. Freedom to operate analysis provides that understanding—identifying relevant patents, analyzing potential infringement, and developing strategies to address identified risks. This practice provides FTO analysis that enables confident business decisions while managing patent exposure appropriately.

FTO Process and Methodology

Thorough FTO analysis follows systematic methodology. Scope definition establishes what products, processes, or activities will be evaluated and in what geographic markets. Search strategy identifies relevant patents through keyword searching, classification analysis, and assignee identification. Search execution gathers potentially relevant patents and published applications that may issue before commercial launch. Analysis evaluates each identified reference for relevance and potential infringement. Reporting presents findings with clear recommendations. Rigorous methodology ensures comprehensive coverage while managing the volume of potentially relevant references.

Patent Search Strategy

Effective FTO begins with comprehensive searching. Search strategies must balance thoroughness against practicality—too narrow a search misses relevant patents while too broad a search creates unmanageable volume. Search approaches include keyword searching using technical terminology, classification searching using patent classification codes, citation searching following reference chains from known relevant patents, and assignee searching focusing on known competitors. Multiple search strategies often combine to ensure comprehensive coverage. Search scope should account for patent publication timelines—applications publish 18 months after priority and patents may issue years later.

Claim Analysis and Infringement Assessment

Patent claims define the legal scope of protection, and FTO analysis requires careful claim construction. Each claim element must be present in the accused product or process for literal infringement. Doctrine of equivalents extends infringement to insubstantial variations. Claim interpretation applies legal standards developed through case law. For each identified patent, analysis assesses whether the proposed activity likely infringes any claim, probability and severity of infringement findings, and validity considerations that might limit patent scope. Conclusions range from clear non-infringement through uncertain risk to high likelihood of infringement.

Risk Categorization and Reporting

FTO findings must be communicated in actionable terms. Risk categorization typically distinguishes patents posing high, medium, and low infringement risk. Categorization considers both likelihood of infringement findings and commercial significance of potentially infringed claims. Detailed analysis accompanies high-risk patents. Summary treatment suffices for lower-risk references. Clear reporting enables business decision-makers to understand patent risk exposure without requiring technical patent expertise.

Risk Mitigation Strategies

When FTO analysis identifies potentially problematic patents, various strategies can address the risk. Design-around modifications may eliminate infringement by changing product features that implicate patent claims. Licensing provides authorized use in exchange for payment. Validity challenges may narrow or eliminate threatening patents through inter partes review or litigation. Non-assertion agreements or covenants not to sue provide protection without full licenses. Risk acceptance may be appropriate for low-severity exposures. Strategy selection depends on risk level, design flexibility, licensing availability, and risk tolerance.

Ongoing Monitoring

Patent landscapes change constantly as new patents issue, existing patents expire, and claim scope is clarified through litigation. Initial FTO analysis captures a snapshot that becomes outdated. Ongoing monitoring tracks new patent issuances in relevant technology areas, claim construction developments in litigation, ownership changes affecting enforcement likelihood, and product evolution that may affect infringement analysis. Monitoring programs maintain current risk understanding and enable proactive response to emerging threats.

FTO Opinions and Willfulness

Formal FTO opinions can serve multiple purposes beyond business planning. Reliance on competent counsel's opinion can negate willfulness findings that trigger enhanced damages. Investor and board due diligence may require formal FTO analysis. Insurance and indemnification may reference FTO work. Opinions prepared for these purposes require particular rigor in methodology and documentation. Counsel provides opinion work meeting the standards necessary for the purposes clients require.

International FTO Considerations

Patent rights are territorial, and products sold internationally require FTO analysis for each relevant jurisdiction. Key international markets warrant thorough analysis. Different countries' patents may have different claim scope even when based on the same priority application. Foreign patent searching presents language and database challenges. Coordinating international FTO efficiently while achieving adequate coverage requires experience with global patent systems.