Freedom-to-Operate Analysis

The legal framework

A freedom-to-operate (FTO) analysis asks whether you can make, use, sell or import a product or process in certain countries without infringing valid patents of others. There is no formal clearance certificate in patent law and no authority that confirms freedom to operate. An FTO analysis is a reasoned legal opinion on risk.

Patents are territorial and claims decide

A patent has effect only in the states where it is in force. A European patent has to be validated in each country, or granted unitary effect, and the same invention may therefore be protected in Germany and free in Spain. An FTO analysis is run per territory, and it starts by establishing the legal status of each candidate: whether it was granted, validated, is still renewed, or has lapsed or been revoked.

The scope of protection is determined by the claims. The description and drawings are used to interpret them (Art. 69 EPC and its Protocol), and due account is taken of equivalents. A product infringes only if it falls within a claim, meaning that it contains every feature of at least one claim, literally or by equivalent. If one feature is missing, there is no infringement of that claim.

What counts as infringement

Making, offering, placing on the market, using, importing or storing a patented product for those purposes, and using a patented process, are acts reserved to the proprietor (see Art. 25 UPCA and the national patent law of each country concerned). Suppliers, importers and distributors can be liable as well as the manufacturer, so the question applies throughout the chain.

Pending applications and special rights

Patent applications that have not yet been granted do not give enforceable rights, but they may be granted later with claims that cover your product. Pending applications in your field therefore have to be watched. Supplementary protection certificates can extend protection for medicinal and plant protection products. A prior-use right or a licence can also affect the answer.

Effect of the UPC

Where the Unified Patent Court is competent, an injunction can cover many states in one decision. That raises the stakes of an FTO analysis for a launch in several UPC states. See the Unified Patent Court.

In practice

An FTO analysis normally follows these steps.

1. Define the product or process as precisely as possible, with its technical features, and the countries of manufacture and sale.
2. Search for potentially relevant patents and applications, with strategies based on classification, keywords and the names of competitors, supported by our patent analysis and research function.
3. Establish legal status per country and discard patents that are not in force there.
4. Read the claims of the remaining patents and compare them feature by feature with the product. A claim chart records the comparison.
5. Assess the strength of the claims that may apply: could they be invalid in view of the prior art? Prior art and how to search for it explains the tests.
6. Report the result by patent and by risk level, with options.

Take a company that builds a battery-management module and plans to sell in Germany, France and the Netherlands. The analysis finds 40 candidate patent families. After legal status checks, 12 are in force in at least one of the three states. Reading the claims shows that 10 require a feature the module does not have, one is probably invalid in view of a published standard, and one is a genuine risk. The company can design around the feature, seek a licence, or prepare an invalidity case, instead of discovering the problem through a cease-and-desist letter after launch.

Owning your own patent does not give freedom to operate. Your patent gives you a right to exclude others; it does not authorise you to use an invention that improves on someone else's earlier patent.

FTO results go out of date. A new grant or a change in your product can change the answer, which is why many companies combine the opinion with a patent watch.

Frequently asked questions

Is an FTO analysis a guarantee that I will not be sued?

No. It lowers risk by identifying relevant patents, assessing infringement and validity, and giving you options. A third party can still sue on a claim that was interpreted differently, or on a patent that was not found.

What can I do if the analysis finds a blocking patent?

Common options are to design around the claims, to take a licence, to buy the patent, to challenge its validity, for example through opposition at the EPO within nine months of grant or in revocation proceedings, or to accept a known risk with a fallback plan.

Do I need an FTO analysis for each country?

It is made for the countries that matter commercially, namely those of manufacture, sale and import. Scope and cost increase with each country, so the list should be set early.

When should I do it?

Before significant investment in a product or before a launch, early enough to still change the design. A later update on a few key patents is much cheaper than a full new analysis.

How this connects

FTO analysis is one of the main services in patent research. The technology behind it is described in patent analysis and research and patent watch.