“Freedom to operate”, abbreviated “FTO”, is usually used to mean determining whether a particular action, such as testing or commercialising a product, can be done without infringing valid intellectual property rights of others.
Since IP rights are specific to different jurisdictions, a “freedom to operate” analysis should relate to particular countries or regions where you want to operate. If you want to commercialise a new variety of lentil seed in your own country, for example, you might have complete freedom to operate if there are no patents, plant variety rights, trademarks or other IP rights covering the seed, the process used to make it or the way you wish to market it or in your country.
However, you might not have the same freedom to operate if you want to export the seed to another country, where patents or other IP rights may have been issued covering the plant genotype, methods, etc.
Determining whether there is freedom to operate in any particular jurisdiction is a major reason why patent databases are so important, and why the Patent Tools on this website are so useful! We hope to make them even more useful, and so we are glad to have suggestions and questions from the user community such as yourself.
If you discover a patent application or patent in the database that seems to relate to the action for which you are seeking FTO, you can’t immediately conclude that there isn’t FTO, because for a variety of reasons the matter claimed in the patent could be available to use.
- Patents may not have been applied for in many countries; the claimed matter is protected only where there is a patent.
- Patents may not have been granted in some of the countries where applications were made; laws about what is patentable vary between countries.
- Patents that were issued may not still be in force if the patentee has not made regular payments due.
- Patents are a limited monopoly and they do expire (check expiration dates!).
- Some countries have exemptions for certain actions (for example, Germany is enacting a research exemption, and New Zealand has an exemption for certain types of clinical trials).
- Patents that were issued in different countries may have broader or narrower claims—so it is really important to look at the claims to see what they read on.
If you ask an attorney to render an FTO opinion, that might consist of finding such IP rights, issue jurisdictions, expiry dates and so on, and also assessing how the issued claims are to be construed and whether or not the issued claims might be invalid.
Most commonly, claims in a particular patent could be invalid because there is prior art, perhaps a publication or a public presentation about the matter claimed in the patent, that the patent examination process didn’t find. In some countries a patent could be vulnerable to challenge because an inventor wasn’t properly named.
Claims may be construed to cover some actions and not others, for example, because of definitions in the body of the patent specification, or admissions made by the patentee while the patent application was being examined.
If there are valid intellectual property rights of others that would be infringed by the action you want to take, you may be able to obtain freedom to operate with respect to any one of those rights by negotiating for a license with the owner of the IP rights.
That doesn’t give you rights with respect to any other IP, though. You might find that to obtain FTO in a country with many valid patents covering the action you want to pursue, you need to obtain many licenses from many different parties. Some have referred to such a situation as a patent “thicket”, where a lot of care is needed to proceed!