In Part 1 of this series, we covered what an FTO analysis is, when it creates the most value, and what options companies have when a high-risk patent is identified. In this article, we turn to a question that is often underestimated: who should prepare the analysis — and why that choice matters.

Who should prepare an FTO analysis for the U.S. market?

Once a company decides it needs an FTO analysis, the next question is just as important: who should prepare it? In practice, this point is often underestimated. A weak or poorly structured analysis may create false comfort internally — and then prove much less helpful when a real dispute arises.

For U.S. patent risk, an FTO is generally best led by U.S. qualified patent counsel working closely with the company’s technical team. That is because an FTO is not simply a search exercise. It is a legal analysis built around claim construction, infringement assessment, and practical dispute risk.

Potential problems with internal-only analysis

Internal technical or legal teams can play an important role in gathering product information and helping identify relevant patents. But an internal analysis is not the same as an external legal opinion. In later disputes, internal materials may be harder to position as formal legal analysis, and they may not carry the same weight as advice from qualified outside counsel.

There is also a practical risk worth noting. If internal documents identify relevant patents but the company takes no clear follow-up action, those materials may look unfavorable in hindsight. This does not mean internal review should never happen. It means companies should be thoughtful about how internal work fits into the broader legal strategy.

Potential problems with mismatched technical expertise

Even a legally trained reviewer may reach unreliable conclusions if the technology is outside their real area of competence. FTO work depends on understanding both the claims and the product. If the relevant technical details are misunderstood, the infringement analysis can become unstable from the start.

This becomes more important in areas such as chemistry, biotech, software architecture, electronics, and complex mechanical systems, where small technical distinctions may matter a great deal. The stronger the fit between the reviewer’s technical background and the product at issue, the more reliable the final analysis is likely to be.

Potential problems with non-U.S. qualified opinions

For U.S. market entry, opinions prepared without relevant U.S. legal qualifications may not provide the same level of support in a later U.S. dispute. That is especially true where the analysis turns on U.S.-specific issues such as claim interpretation, infringement standards, or litigation posture.

This does not mean non-U.S. teams have no role. They can still contribute valuable technical knowledge, portfolio context, and commercial background. But where the question is U.S. freedom to operate, U.S. qualified legal analysis is usually the safer anchor for the overall work product.

Closing note

In the U.S. market, the quality of an FTO analysis depends not only on the patents reviewed, but also on who prepares the analysis and how the work is structured. In many cases, those choices become much more consequential once a warning letter, diligence request, or litigation threat appears. Getting the structure right from the start is not a formality — it is part of the analysis itself.

Authored by Qin Li, Managing Partner; Hanchen Liu, Patent Director; and Ying Zhou, Patent Bar No. 800161 (limited recognition)

Disclaimer: This article is for general informational purposes only and does not constitute legal advice or create an attorney-client relationship. Any FTO conclusion depends on the specific product, technical facts, and market assumptions involved.