What is Freedom to Operate?

Key Facts

• Question asked: "Can we sell this here without infringing?" Not "can we patent this?", which is patentability
• Scope: In-force patents and pending applications in each country where the product will be made, sold, or imported
• Timing: Before design freeze, ideally, and always before launch; changes are cheap in design and expensive after shipping
• Deliverables: A search report, a risk-ranked list of patents of concern, and, where warranted, a written opinion of counsel
• Cost: A law-firm FTO search and opinion for one product in one jurisdiction commonly runs from the low to mid five figures; broader products and multiple countries multiply it
• Not required by law: But a documented FTO review is the main evidence against a willfulness finding and treble damages

The FTO Process

1. Define the product: Features, components, methods, and the countries of manufacture and sale
2. Search: Classification, keyword, and semantic searches for in-force patents and pending applications, plus known competitor portfolios
3. Screen: Discard expired, lapsed, and clearly irrelevant results; check legal status and term
4. Analyze claims: For each remaining patent, compare the independent claims to the product, building a claim chart for close cases
5. Assess risk: Likelihood of infringement, strength of the patent, and the owner's history of enforcement
6. Mitigate: Design around, seek a license, challenge validity, buy the patent, or accept the risk with documentation

FTO vs Patentability

Having a patent on your product does not mean you can sell it. Your patent excludes others from your invention; someone else's broader patent can still cover your product. A new drug formulation can be patentable and still infringe the compound patent. FTO and patentability are separate questions with separate searches, and the prior art that defeats patentability is often the same art that clears FTO by showing a feature is old.

Pending Applications

Published applications cannot be infringed, but they can issue with claims that cover the product, and provisional rights under 35 U.S.C. § 154(d) can reach back to the publication date. An FTO review therefore monitors relevant pending applications, and patent monitoring on competitor families is the usual way to keep the analysis current after launch.

Opinions of Counsel

A written opinion that the product does not infringe, or that the patent is invalid, is not a legal requirement, but since the 2016 Halo decision willfulness turns on the infringer's knowledge and conduct, and a competent opinion obtained before launch is strong evidence of good faith. ArcPrime's freedom to operate tooling handles the search and screening so counsel's time goes to the patents that need an opinion.