A freedom to operate search (FTO search) checks whether a product or process can be made, used or sold in a particular country without infringing a patent that is in force there. It is usually carried out before a product launch, before entry into a new market, or when an investor or acquirer asks about patent risk.
The search differs from most patent searches in what it reads. It looks at the claims of a patent. It also looks only at patents that are still in force, or may still be granted, in the countries where the product will be made or sold.
This guide explains how a freedom to operate search is scoped, how it is carried out, what the report contains, where its limits are and what it costs.
What is a freedom to operate search?
A freedom to operate search is a patent search that identifies granted patents and pending applications whose claims may cover a specific product or process in a specific country. Each relevant claim is compared with the product, feature by feature. The result shows which patents could block the launch.
The same search is also called an FTO search, a clearance search, a right-to-use search or a patent infringement search. The wider exercise, which includes the attorney’s reading of the results, is usually called an FTO analysis.
Freedom to operate is a separate question from patentability, and holding a patent on a product does not answer it. The two searches are set side by side in this comparison of patentability and FTO searches.
When an FTO search is needed
The best time is as soon as the product is defined well enough for its features to be listed. A blocking patent found at the design stage can often be avoided with a design change. The same patent found after tooling or regulatory approval is far more expensive to deal with.
The common triggers are:
- a design freeze, before money is committed to tooling or scale-up;
- the launch of a new product, or a significant change to an existing one;
- entry into a new country;
- a funding round, a licence or an acquisition in which the other side asks about patent risk;
- a warning letter, or a newly granted patent held by a competitor.
A separate article covers when to do an FTO search during product development.
The scope of a freedom to operate search
Three decisions set the scope, and with it the cost: the features, the countries and the time window.
Product features
A freedom to operate search needs a defined product. The searcher works from a description of what the product is and how it works, with enough detail for its features to be listed. Most features of a typical product are old and standard, so the search concentrates on the features that are new, that differ from earlier versions, or that the company cannot easily change.
Components bought from a supplier are sometimes left out where the supply contract includes a patent indemnity. The company that sells the finished product can still be sued, so this is a decision for the company and its attorney. It should be recorded in the scope.
Countries
Patent rights are territorial. A US patent has no effect in Germany, and a product that is made and sold only in India can infringe only the patents in force in India. US law gives an example. While a patent is in force, anyone who, without authority, makes, uses, offers to sell or sells the invention in the US, or imports it into the US, infringes the patent (35 U.S.C. 271(a)).
A freedom to operate search therefore covers the countries where the product will be manufactured, sold or imported.
Time window and legal status
Only patents that can still be enforced are a risk. In most countries a patent lasts 20 years from its filing date, provided that the renewal fees are paid. The search window is about 20 years, with a margin for patents whose term has been extended.
| Document | In scope? | Reason |
|---|---|---|
| Granted patent in force in a country of interest | Yes | Its claims can be enforced now |
| Pending application | Yes | It may be granted, and its claims can still change |
| Utility model in force in a country of interest | Yes | It is usually registered without substantive examination and can be enforced like a patent |
| Patent that lapsed because fees were not paid | Usually not | It cannot be enforced, although some lapsed patents can be restored |
| Expired patent | No, but worth noting | It shows that the feature it describes is old |
| Patent in a country outside the scope | No | It has no effect where the product is made or sold |
Utility models exist in Germany, China and many other countries, and they last up to 10 years in both.
How a freedom to operate search is conducted
An FTO search by a specialist firm usually follows six steps. The work is done by a patent searcher with a background in the technology, to a scope that is agreed with the attorney.
Step 1: Break the product into features
The searcher reads the product description, the drawings and any specification, and writes a list of features. Each feature is then described in the way a patent claim would describe it. An engineer may call a part a “snap-fit clip”, while a claim calls the same part a “resilient retaining member”.
Step 2: Agree the search plan
The search plan lists the features, the countries, the time window and any competitors that are already known. It also names the databases, which are normally commercial ones such as Questel Orbit, PatSeer or Derwent Innovation. The attorney or the product team confirms the plan before the full search starts.
Step 3: Build the search strings
Search strings for a freedom to operate search are written around claim language. Claims are drafted in broad and often functional terms, so each feature needs its synonyms and its more general terms.
Small differences in spelling also matter, because one patent says “touchscreen”, another says “touch screen” and a third says “touch-sensitive display”. Truncation and proximity operators are used to pick up these variants. A simplified string for a bottle cap with a valve could read:
(cap OR closure OR lid) NEAR5 (valve OR seal* OR diaphragm)
The exact syntax depends on the database. Such a string is run first in the claims field and then in the full text.
Keywords are not enough alone, since a claim can describe a feature without using any of the expected words. The strings are therefore combined with patent classifications such as the Cooperative Patent Classification (CPC). The searcher also searches known competitors by name and follows the citations of the closest patents in both directions.
Step 4: Screen the results on the claims
A first search often returns far more patents than can be read in full. The searcher screens them on the claims and leaves the abstract and the description aside. A patent that describes a feature of the product, but whose claims do not cover the product, is not a risk.
The independent claims are read first, because a claim is infringed only when the product has every element of that claim. If the product lacks one element of an independent claim, the claims that depend on it are not infringed either.
Some cases are borderline, because a product may differ from a claim element only slightly and in many countries a claim can extend to equivalents. These patents are marked for the attorney.
Step 5: Check legal status and patent families
The searcher then checks whether each relevant patent is in force, in which countries, and when it expires.
The answer can differ from country to country. After grant, a classic European patent has the effect of a national patent in each designated country. It stays in force there only if the owner meets any national validation requirement and pays the renewal fees, so it can be in force in Germany and lapsed in Spain. A unitary patent, available since June 2023, is different, because it is maintained or lapses as a single right in the participating EU countries. The Federated Register in the European Patent Register and the national registers show the position.
In the US, maintenance fees on utility patents are due 3.5, 7.5 and 11.5 years after grant. A patent expires if a fee is still unpaid at the end of the 6-month grace period. The term of a US patent can also be longer than 20 years because of patent term adjustment (PTA), which compensates for delays at the patent office.
The patent family is checked as well, since a family with a pending continuation or divisional application can still produce new claims. Those claims may be closer to the product than the granted ones.
Step 6: Rank the risk and map the claims
The searcher ranks the remaining patents, usually as high, medium or low risk. For the high-risk patents, a claim chart compares each claim element with the matching product feature. The chart also states where an element is missing from the product or where the wording is unclear.
Example: an FTO search for a generic tablet
The following example is an illustration and does not describe a real project.
A company plans to sell a generic version of an oral tablet in the US and Germany. The patent on the active compound expires next year, and the company wants to launch as soon as it does.
Patents beyond the compound
The compound patent is only the first layer of protection. A successful drug is usually surrounded by later patents on:
- salts, polymorphs and other solid forms of the compound;
- the formulation, such as the excipients, the release profile or the particle size;
- the manufacturing process and its intermediates;
- the use of the drug for a particular disease, and the dosage regimen;
- combinations with other drugs.
Each of these layers can remain in force for years after the compound patent has expired. Protection for the compound may itself last longer than 20 years. The US allows a patent term extension (PTE) of up to 5 years for time lost in regulatory review. European countries grant supplementary protection certificates (SPCs) for the same reason, and an SPC takes effect when the patent expires.
How the search differs
A compound is often claimed by a generic chemical formula that covers thousands of molecules, and keywords will not find it. The search includes a Markush structure search for this reason.
For the US, the Orange Book of the Food and Drug Administration (FDA) lists the patents that the brand company has declared for the approved drug. It is a starting point, but it is not complete, and process patents, for example, are not listed there. Biologics are a separate case: their patents are not in the Orange Book, and the search includes a biological sequence search.
The report shows which layers are still in force on the planned launch date in each country. The company and its attorney can then choose between a different solid form, a changed formulation or a later launch in one of the two countries.
What an FTO search report contains
A complete freedom to operate search report usually contains:
- The scope: product features, countries, time window and databases.
- The relevant patents and applications, ranked by risk.
- The legal status and the expected expiry date of each patent, by country.
- Claim charts for the higher-risk patents.
- Patent family details, including pending family members.
- The search record: strings, classifications and hit counts.
Some reports also list the closest expired patents, which help to show that a feature has been public for a long time.
The search record shows the attorney exactly what was covered, and it allows the search to be updated later without starting again.
FTO search vs FTO opinion
The search is factual: it finds the patents, reports their status and maps their claims to the product. The opinion is a legal conclusion on whether the product infringes a claim and whether the patent is valid. It is given by a patent attorney, and a search firm does not provide it.
The difference matters most in the US. A court there can increase the damages for infringement up to three times (35 U.S.C. 284), and it generally does so only where the infringement was wilful. An opinion obtained from counsel before launch can help to show that the company acted in good faith. The law also states that the absence of an opinion cannot be used to prove wilful infringement (35 U.S.C. 298).
A search report can also become evidence, because in US litigation it may show that the company knew of a patent. Knowledge of the patent is one element of wilful infringement. FTO searches are often commissioned through the attorney for this reason, so that the work can be covered by legal privilege where the law allows. The attorney then decides which patents need a written opinion.
What an FTO search cannot show
No search can give an absolute guarantee, a point that the World Intellectual Property Organization (WIPO) makes in its article on freedom to operate. The main limits are:
- Unpublished applications. Most patent applications are published 18 months after their earliest filing date. An application whose earliest filing date falls within the last 18 months has usually not been published, so a search cannot find it. Some US applications are not published until grant.
- Claims that change. The claims of a pending application can be amended, and new claims can be filed in a continuation or divisional application.
- Interpretation. The meaning of a claim term is finally decided by a court, and courts in different countries can read the same claim differently.
- Other rights. A search of patents and utility models does not cover registered designs, trade marks or contractual restrictions. The shape of a product needs a separate design patent search.
- Time. The search is a snapshot, while products change during development and new patents are granted every week.
Because of the last point, a freedom to operate search is normally updated before launch. Between updates, legal status monitoring of the patents already identified shows when one of them lapses, is amended or is granted.
What happens when a blocking patent is found
A blocking patent does not always stop a product. The usual options are:
- Design around the claim. Removing a single claimed element, or changing it so that it falls outside the wording of the claim, avoids literal infringement. The attorney then checks whether the changed feature is still an equivalent.
- Take a licence, or agree a cross-licence if the company holds patents that the other side needs.
- Challenge the patent. A patent invalidity search looks for prior art that the examiner did not consider.
- Wait. If the patent expires soon, the launch in that country can be delayed.
- Leave out the country where the patent is in force.
The choice depends on how important the feature is and on what each option costs.
How much does a freedom to operate search cost?
The FTO search cost depends mainly on the scope. As a reference point, FTO searches at Synoptic IP cost USD 800–4,000. The table below shows the factors that move the price within a range like this.
| Factor | Lower price | Higher price |
|---|---|---|
| Features | 1 feature or component | Every feature of a complete product |
| Countries | 1 country | 4 or more, with searches in other languages |
| Technology | Mechanical or electrical product | Chemical or biotech product that needs structure or sequence searching |
| Deliverable | Ranked list with comments | Claim charts for every relevant patent |
These figures cover the freedom to operate search and its report, while an attorney’s FTO opinion is charged separately by the law firm.
How long an FTO search takes
The turnaround time follows the same factors. A search on 1 feature in 1 country is the quickest, and a complete product in several countries with claim charts takes considerably longer. The delivery date is normally fixed in the proposal, before the search starts.
Commission a freedom to operate search
Synoptic IP conducts freedom to operate searches for law firms and in-house IP teams, including structure and sequence searches for pharmaceutical and biotech products. To receive a proposal with a fixed price and a delivery date, send us the product description and the countries of interest through our FTO search service page.
This guide is general information and is not legal advice. Whether a product infringes a patent is a question for a patent attorney.
Frequently Asked Questions
Is a freedom to operate search the same as a patentability search?
No. A patentability search asks whether an invention is new, and it reads everything published before the filing date, whatever its age or legal status. A freedom to operate search asks whether a product would infringe, and it reads only the claims of patents that are in force or pending in the countries of interest. A product can pass one search and fail the other.
Does owning a patent give freedom to operate?
No. A patent gives its owner the right to stop others from using the invention. It does not give the owner a right to use it. An improvement can be patented while the basic product is still covered by an earlier patent that belongs to another company. In that case the improver needs a licence, or has to wait until the earlier patent expires.
Is a clearance search required by law?
No. No patent office or court requires a clearance search before a product is sold. It is a way of managing risk, and investors, licensees and acquirers often ask for one during due diligence. In the US, an attorney’s opinion based on the search can also help to show good faith if the company is later accused of wilful infringement.
Do expired patents still matter?
Acts carried out after a patent has expired cannot infringe it, so an expired patent is not a risk for a new product. It is still useful, because a feature that does only what an expired patent describes is unlikely to be validly covered by a later patent. Later patents on improvements may still be in force, however, so an expired patent does not clear the whole product.
Should pending patent applications be included?
Yes. A pending application cannot be enforced until it is granted, although in the US and Europe the owner may then, under certain conditions, claim compensation for use after publication. It may be granted with claims that cover the product, and those claims can still be amended during examination. The report should list the relevant applications separately from the granted patents, and their status should be checked again shortly before launch.
Can a freedom to operate search be done with free databases?
Yes, a first check is possible in free databases such as Espacenet, Google Patents and the USPTO Patent Public Search, which show whether obvious blocking patents exist. They are weaker on legal status by country, on claim searching across many countries and on chemical structures. A search that a launch or an investment depends on is normally run in commercial databases by a trained searcher.
How often should an FTO search be updated?
An FTO search should be updated whenever the product changes in a way that adds or alters a feature. It should also be updated before any major commitment, such as a launch or entry into a new country. New applications are published every week, so a search that is 2 years old has a gap.
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