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Introduction
Freedom to operate or an FTO search is known by many different names. These commonly include “clearance search”, “right to use search” or “freedom to practice search”. The objective of an FTO search is to determine whether an entity’s product or process is infringing the claims of an enforceable patent or pending patent application in geographies of interest. Specifically, whether an entity has a clearance to make, use or sell a product or service. Freedom to operate is established when no active patent is being infringed or it is otherwise not in-force. An FTO search is accompanied by a legal opinion that predicts the potential of infringement of an issued and active patent claim or those of a pending patent application. The following article explores what an FTO entails when and why you need to do it?
The FTO search involves searching of In-force patents, active pending applications as well as lapsed patents in jurisdictions of interest to determine where the technology may be used freely without allegations of infringement or need of licensing. A thorough comparison or mapping of features of the technology under study against claims of the relevant patent documents is performed. The latest legal status of those relevant patent documents is also studied and based on these parameters, a legal opinion regarding clearance in chosen geographies is provided.
Common Practices while doing an FTO Search
- Geographic restriction – Patent rights are territorial. A technology protected in some markets may not be protected in others. In such a scenario, no approval is needed for commercialization in those markets. Typically, for an FTO search, patents should be searched only in those markets where the entity wants to practice its product or process. For example, if the entity is clear about using/developing the product or process in Indian or US markets then the patent search should be restricted to only those jurisdictions. However, it is judicious to search for PCT or Convention patent applications that may potentially enter target jurisdictions.
- Date restriction – Ordinarily, a period of 20 years is used for patent searching for an FTO search. To account for patent term extension given to drugs, veterinary products, and medical devices in some jurisdictions the date range can be adjusted beyond 20 years by 2-5 years accordingly.
- Document type restriction – The main focus of an FTO search is active issued patents and pending applications. The pending patent applications are relevant to the assessment since they represent future hurdles for clearance when enforced/granted. The objective is to determine what is in the public domain and therefore free to use. However, the importance of lapsed patents cannot be ignored. Some jurisdictions may have the provision of restoration of patent. For example, in India, there is a provision to restore a patent that has lapsed (inactive/dead) due to non-payment of maintenance fees within 18 months of such a lapse. In an FTO search, non-patent literature is not included.
- Additional considerations – For an FTO search, all relevant patent documents need to be found and missing even a single relevant document can be detrimental to the clearance opinion. Regular monitoring of latest legal status of the relevant patents and pending patent applications to alert for any changes in the status of the FTO is necessary.
When to Conduct an FTO Search
- Early in the product/process development cycle performing an FTO search early in the product or process cycle is important in the following ways –
- Helps decide the allocation of resources and avoids financial implications during the early stage of product/process development.
- Reduces the risk of time-consuming and expensive future litigation and point out any potential licensing opportunities.
- Allows designing around any enforceable patent technology early on in the product/process development cycle.
- Before bringing a product to the market or continuance of a product in a market
A favourable FTO search conducted before launching a product into the market or its continuance in the market gives an entity an added assurance to support its business decisions and reassure existing investors and shareholders. It may reveal a potentially unexploited market where the entity can make, use, sell or license the invention. In case an FTO is unfavourable with a high probability of litigation, the organisation then has the option to –- Approaching the entity whose active patent is covering the invention to be operated for licensing or buying.
- Apply for opposition or invalidation of the relevant patent.
- Modifying the product so that the infringement objection can be overcome.
- Not to proceed with bringing the product into the market.
- After receiving a granted patent
Patent prosecution takes time and the state of the art can change during that duration. It is important to know for a patent holder what other organisations have done with the invention since the disclosure (publication after 18 months of filing) of that technology. An FTO may help him/her locate potential competition or infringement so that they can defend their right. It may help the entity find suitable business partners or attracting investors especially, if it is a start-up.FTO search is thus an essential tool to assess your risk of potential infringement and identify barriers that can be removed by licensing, invalidation, or opposition before product launch or continuance. It helps assert your patent right and, bring in new business opportunities. An FTO search can also serve as a guide to invent around your product during early product or process development.
Using a global patent database such as PatSeer helps achieve a higher accuracy on your FTO searches. PatSeer has many features that allow geographic, date, document type restrictions, for easy FTO-specific patent searches. It also provides up-to-date legal status and remaining lifetime (after factoring term extensions in many countries) of relevant patents for your FTO search.
