We have a lot of experience of carrying out Freedom to operate (FTO) analysis. In this article we explain a typical process for carrying out an FTO analysis.

What is patent freedom to operate analysis?

Freedom to operate analysis is the process of finding and reviewing existing patents and patent applications belonging to others to assess whether a proposed new product or process is at risk of infringing the patent rights of others. It is a completely different process to finding out whether a new idea is patentable (see our article comparing patentability and freedom to operate searching). Although there is considerable variation from one project to the next, this article sets out a typical process for an FTO search and analysis for patents.

When should freedom to operate analysis be carried out?

Freedom to operate analysis should be carried out before the launch of new products and processes, or the expansion of products and processes into new geographies. That being said, there can be challenges in deciding when to carry out an analysis. If you carry out the analysis too late, for example just before launch, you may find out about problems after you have already committed to manufacturing your product, when it would be costly to make changes or lead to delays. On the other hand, if you carry it out too early, while you are in an R&D phase, you might not be able to specify the product accurately enough to carry out a reliable search, and you may find that product changes later in development are not covered. It is not meaningful to carry out a search of all potential FTO risks in a general field - you would usually find hundreds or thousands of patents protecting specific parts of that field. In that case, it may be better to carry out a state of the art search for information purposes and to look at FTO analysis later.

Step 1 - specifying the product or process

The first step of our procedure is to agree a specification of the product or process that is to be searched with our client. This requires care and experience. The search specification needs to be sufficiently detailed to include features which might infringe patents, but if there is too much information then either the searching will be very expensive, or it can be difficult for the searcher to understand what features are important and they will lose focus.

Step 2 - considering the relevant geography

It is necessary to consider in which countries the product will be sold, and often manufacturing location etc., to thereby work out the geographic scope of searching that would ideally be carried out. Some countries have many active granted patents and can be costly to search, others have relatively few. There are practical commercial considerations to take into account.

Step 3 - obtaining cost estimates

We use specialist external searchers to find relevant documents, and so the next step is obtaining cost estimates from our searchers for searches of different levels of depth, in different geographies. Costs do vary a lot from one industry to another and from one country to another, and depend how thorough you wish to be. Computer software and biotechnology inventions are often the most expensive, whereas mechanical and electrical inventions, medical devices, specific chemicals and so forth are often easier to search. There can be a discussion whether to include pending applications which could come into force in the future or not, and whether to include utility models.

Step 4 - starting the search

Once the scope of the search is agreed, our external search firm carry out their work. This usually takes a few weeks, although again this depends how thorough the search is to be.

Step 5 - initial review of results

Once we have the search results back, we review the patent families which are uncovered and make an initial assessment as to their potential relevance. This includes checking their status and reviewing the claims. Usually, the majority of search results can be quickly ruled out, leaving a list of rights of potential concern. Usually, we do not reach final conclusions without speaking with our client first, and we initially issue a draft report.

Step 6 - discussion

We then arrange a discussion with our client about the rights of potential concern, looking for ways in which our clients' plans can be distinguished from what is covered by the relevant patents. There is frequently a need to discuss details of a proposed product or process which were not originally thought to be of particular importance.

Step 7 - issue report

Thereafter, we can issue a report highlighting which rights may be of concern and which are not. There may be rights for which a conclusion cannot be reached without detailed further work, set out below.

Step 8 - follow-up actions

It is common for a freedom-to-operate searches to require follow-up work. For example, there may be patents which require more detailed analysis and opinions, including written opinions from foreign attorneys, which we can arrange where required. There may be a decision to monitor potentially relevant pending patent applications that are not yet granted. Sometimes we will find patents which are thought to be invalid, and a decision is required as to how to address that. This may include searching for prior art and sometimes challenging the validity of third-party rights. Sometimes a decision is made to contact a patentee, for example to request a licence. Sometimes the follow-up actions become much more involved than the search itself - it depends what is found. It may be important to search for other types of intellectual property right, for example registered designs (known as design patents in some countries).

Step 9 - top-up searching

Freedom to operate searches can be topped up from time to time. This can be important to find new risks, and also to identify patent applications which were still unpublished when the initial search was carried out. Patent applications are usually published 18 months after their priority date, and so there can be significant numbers of pending rights that cannot be uncovered when a search is first carried out.

Timescales and costs

The duration and cost of freedom to operate searching and analysis vary dramatically depending on the thoroughness and scope of the project. A typical project might cost £10 - £20k + VAT and take 6 - 8 weeks, but thorough analyses in complex fields can be a good deal more expensive and time-consuming.

If you would like to speak to us about our freedom to operate searching services, please get in touch.

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