What does “Freedom to Operate” mean?
- “Freedom to operate”, abbreviated “FTO”, is usually used to determining whether a particular action, such as Testing or commercializing a product, can be done without infringing valid intellectual property rights of others.
- A freedom to operate search involves searching the claims language of third-party in-force patents to determine if the claims of the any prior art read on aspects of the technology that is to enter the marketplace.
- Freedom to Operate research is typically conducted as a due diligence effort to prevent potential infringement.
- 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.
When can I have freedom-To-Operate?
- If you want to commercialize a new variety of lentil seed in your own country, for example, you might have complete freedom to operate if there are:
- No patents (product or process)
- No plant variety rights,
- No trademarks or other IP rights covering the seed
How to determine FTO?
Determining whether there is freedom to operate in any particular jurisdiction is a major reason why patent databases are so important.
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. For example:
- 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.
What if there isn’t any FTO possibility?
- Option 1: Invalidate
- 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
Which could have possibly been missed during patent examination process. In some countries a patent could be vulnerable to challenge because an inventor wasn’t properly named.
- Option 2: Design around
- Claims may be construed to cover some actions and not others,
- Narrowing down the claims
- Option 3: Licensing
- 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.
To ensure that the company or individual is free from any threat of infringement of third party rights a freedom to operate (or infringement clearance) study needs to be undertaken on each and every aspect of the
- Its formulation and
- Its use
These studies need to be carried out early in development of any product/process/use, etc.
If patents are identified which may affect freedom to operate strategies one can
- Challenge the patents i.e. Invalidate
- Obtain licenses
- Design or work around the patents to devise non-infringing processes & formulation of product which are free from potential infringement problems
- Avoid wasted investment