What is a Freedom To Operate (FTO) Search?

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What is a Freedom To Operate (FTO) Search? 

The definition of Freedom to operate (FTO) search is to check the existence of in-force patents, active pending publications, and lapsed patents in a jurisdiction of interest. The purpose of doing an FTO search is to predict and avoid infringement and litigation risk in advance. Generally, the FTO search is known by many other names like Freedom to Practice (FTP) search, Clearance search, non-infringement opinion, NI opinion (NIO), and Right to Use search. 

 

What is the Purpose of FTO Search? 

In general, the FTO search is conducted by an entity before launching a product or process in the market with the purpose of reducing the risk of future infringement of potential force Patents and publications. There is a well-known fact that patents are territorial rights, so the FTO search is also jurisdiction-specific, which is intended for the commercialization of the product or process. In case an entity intends to commercialize its product or process in multiple jurisdictions, then the FTO search should cover all the intended jurisdictions of interest.  

For instance, if a product/process is launched in a specific jurisdiction without the knowledge of freedom to operate search and analysis, there is a possibility of potential infringement of the patents for the product/process owned by another entity in that specific jurisdiction. 

This would create a huge loss in the future. Therefore, it is safe to ensure that there is no potential risk in the desired jurisdiction of interest by conducting an FTO search before launching the product in that market. This could pave the way to have the freedom to commercialize their product or process with minimal risk of infringement and litigation.

Grant for Freedom to Operate: 

The Freedom to operate a product/process in a specific jurisdiction is granted in view of the following reasons 

  • The expired patent which cannot be restored back to alive state 
  • The technology is not protected in the desired jurisdiction but protected in some other jurisdictions 
  • Difference in the scope of the claims in the desired jurisdiction. For example, the invention is broadly claimed in one country and narrowly claimed/not claimed in another country 
  • Based on the non-patentability criteria of the country 
  • Based on the dead patents/publications. In some cases, the legal status of the lapsed patents should be checked periodically, otherwise, upon paying maintenance fees it may become alive and act as a potential infringement. During the lapsed period the product can be commercialized in that specific jurisdiction. 

 

What are the Attributes of FTO Search? 

In general, the FTO search is to check the claims of the in-force patents and active pending publications. The FTO search covers the last 20-22 years in force citations. The importance of the FTO search is to identify all the individual features of the technology in the claims of the patents/publications without missing any patents. Then the independent claims along with the dependent claims of the retrieved patents are compared with all possible aspects/features of the product that is intended for commercialization

Several important attributes should be considered during the FTO search. They are the jurisdiction of interest, expiration date, and the legal status of the Patents/publications. Typically, importance is given to In-force patents and alive pending publications. Besides this, lapsed patents and international applications should also be considered during the FTO search. The reason is that the lapsed patents can be revived back to the alive state by paying the appropriate fees to the patent office within a specific period and the internationally filed applications can enter specific jurisdiction within a specific period. 

How to Perform FTO Search? 

The FTO search and opinion is performed by the below steps. 

The first step in performing an FTO search is to identify the features of the product/process planned for commercialization and then to classify the identified features into primary unique or novel features of the invention and secondary features of the invention. In some cases, the product/process to be launched may have multiple important aspects. In that case, it is desirable to split the single complex invention into multiple simple inventions and perform multiple FTO searches.  

The next step is to perform the search covering all possible keywords, classes, citations, semantic, inventors, and assignee-based searches in multiple databases with time and legal status restrictions and then reviewing the results. Then identifying and reporting the live patents/publications that are claiming the primary and/or secondary features of the invention and the patents/publications broadly claiming the primary features.  

One of the important aspects to be considered during the FTO search is the native language search. Some countries like China, Japan, South Korea, Germany, and other countries have patents written in their native language. Recently few of these countries have provided the feature of searching in the English language for their native language references by means of machine translation, but still, there is a slight probability of missing some potential references written in the native language. 

This is the importance of searching for patents in the English language using various combinations and it is equally important to perform a search in their native languages to ensure the full coverage of the references in those jurisdictions. Some of the patent databases like WIPO CLIR and commercial database sources have provided the feature of searching in the native language to ensure full coverage. 

Defining Patent Relevancy: 

While searching, the most important point to consider is the interpretation of the claim language. Typically, the claim uses two different types of transition phrases “comprising” and “consisting of” that determine the boundary of the technical features of the invention. Care must be taken while deciding the relevancy of the patents based on this claim language interpretation. After this step, a qualified professional would analyze the potential patents and evaluate the possibility of infringement of the invention. 

Importance of Patents in FTO: 

Patents are legal rights protecting an invention in their claims part. During the FTO search case, the researcher finds an in-force patent similar to that of the invention, which claims all the features as disclosed in the invention disclosed in the specific jurisdiction. Then the in-force patent is considered a relevant patent and may act as a potentially blocking patent for that invention in that specific jurisdiction. 

Importance of Patent Publications in FTO: 

Like in-force patents, the patent publications in the alive state are also equally important to consider during the FTO clearance search. These alive publications may get granted in the future and may act as potentially blocking patents to the product intended to launch in a specific jurisdiction. These alive patent publications are like preventive measures for the entity to predict the future risks in advance in terms of product launch. 

Importance of Expired Patents in FTO: 

It is always good practice to search and include expired patents in the FTO report, as the expired patents may sometime help in invalidating the infringing patent. For instance, if a person intends to invalidate an infringing patent in a specific jurisdiction for a product planned to be commercialized in that jurisdiction, then the expired patent may act as prior art for invalidation, in some cases.

Similarly, the lapsed patents can be revived back to the alive state upon paying the desired maintenance fees. Some of the expired patents can be extended beyond 20 years of their life term, so it is necessary to calculate the patent term using the patent term calculator at the time of FTO Search, to minimize the missing of in-force life term extended patents in a specific jurisdiction. 

Importance of Non-Patent Literature in FTO: 

Searching for Non-patent literature has less direct value in Freedom to operate searches. Typically, non-patent literature is journal/articles, thesis or dissertation, videos, websites, blogs or commercial products, and other materials. In some cases, this non-patent literature may be helpful to invalidate the infringing patent in a jurisdiction.

Further, the practice of checking the non-patent literature during FTO would pave the way to find if any product is infringing the patent of an entity that intends to launch a product in a specific jurisdiction. This is a different type of infringement search to check for potential infringers infringing an entity’s patent.

For instance, if an owner sells a product in a jurisdiction without the knowledge of the patent owner, then the patent owner has the right to sue the product owner or the product owner can get a license from the patent owner to continue with the commercialization of their product under certain circumstances.  

Though infringement is primarily focused on in-force patents followed by alive publications, it is good to look for non-patent literature and expired patents due to the above-mentioned points. To conclude, it helps in decision-making for operating the product/process freedom in that jurisdiction of interest. However, FTO search and opinion do not assure that an invention is safe to commercialize. It helps to reduce the risk of possible future infringement & litigation risks to a great extent. 

 

FTO Use Cases and TTC: 

In one scenario, one of our clients has requested freedom to operate a search for a specific jurisdiction. The FTO invention had three main features A+B+C. Our team has followed the unique process and has identified one relevant in-force patent having A+B features in the claims. The team also looked for expired patents (lapsed patents due to non-payment of fee, which can be revived later) having A+B+C and found one such kind. The literal meaning of expired would be patent whose life term is complete and have no significance in getting clearance for freedom to operate the product. 

Our team has provided the report with a claim comparison chart for both the potentially blocking in-force patent and the expired patent. Though the in-force patent did not cover all the required features of the invention, the expired patent was helpful for them to invalidate the blocking in-force patent in that specific jurisdiction. 

In another scenario, a client had an invention in the early budding stages in the healthcare domain and had approached us for a broader patent search. Our experts have recommended to the client a combined Freedom to operate and Patent Landscape Search, in view of covering the invention in the healthcare domain by a patent landscape search and to check for worldwide potentially blocking patents having the client’s invention (in the budding stage) in the claims by means of freedom to operate search. This type of approach has really helped the client to develop their invention in a better way. 

In yet another scenario, a client has approached us for Freedom to Operate to search for an invention in the field of pharmaceutical formulations having A+B+C+D+E features along with a few additional features for some jurisdictions. Our team has identified and reported the closest in force patent having all the described features in one of the jurisdictions along with its claim comparison chart. Based on our FTO search report, the client came back and has turned the type of search from FTO to patent landscape study to develop further their invention. 

In another scenario, a multinational company wanted to launch a nerve stimulating device that has A+B+C features. The company was also planning to add a few more optional features (D, E, F) to the product. For this, the company asked for a clearance search in a specific jurisdiction. Our team has provided a few closest in-force patents which disclose products with their main features. A Few of the citations also disclosed products’ optional features. Hence after reviewing our report, our client has decided to conduct different searches to identify documents disclosing nerve stimulating devices with individual features. The client wanted to understand the feasibility and compatibility of the different features with the device. Also, the possible variations or modifications for their product to avoid any violation.

How TT Consultant's FTO (Freedom to operate) Search flows?​

What is the FTO Search Cost? 

The common cost range for doing FTO search and opinion ranges between US$3,000 to US$20,000 which may go up to US$50000. The cost may vary from case to case depending upon the nature of the invention and the preferred jurisdictions of interest. Moreover, the native language search would additionally cost depending upon the jurisdictions.  

Generally, it is advisable to conduct a FTO search before launching the product/process in the market. This reduces the future risk of infringement, litigation cases, penalties, and the fees to be paid to the attorneys. The cost of conducting FTO search and opinion is very less when compared with the future infringement-based costs.  

Based on the search report the Freedom to operate search opinion or legal written opinion is provided by the attorney, which is used for exculpating purposes for patent infringement. This legal non-infringement written opinion will have an additional cost starting from $6000 approximately, based on the requirements. Both the FTO search report and the legal opinion would be helpful in the decision-making of product/process launch in the market or in the further development or modification of the product/process.  

Freedom to Operate Search Report: 

The FTO search report is like an investment that provides list of potential infringements in a specific jurisdiction, which helps for future research planning and minimizing the litigation and infringement losses. In general, the FTO search report comprises of several important sections. They are:

  • Objectives of the FTO search like the background of the technology, primary and secondary feature understanding based on the invention, search methodology, and data sources 
  • Executive summary of the identified in force patents, alive publications, international applications, and Lapsed Patents (optionally) 
  • Detailed analysis and mapping of the relevant portions from the prior art based on the relevancy criteria 
  • Claim mapping to identify potentially infringing patents 
  • FTO search details include queries used, CPC, IPC, or US classifications used, alternative keywords, top assignees, and top inventors used to perform the FTO search.  

 

When to do FTO Search? 

The freedom to operate search can be done at different stages before product commercialization. 

Based on the findings from the FTO analysis, if there is the freedom to operate the product in the desired jurisdiction then the entity can launch its product in the desired jurisdiction’s market. In case, if there is no freedom to operate the product in a specific jurisdiction of interest, then there are few possibilities for that entity as described below 

  • Modifying the product features 
  • Inventing the new features by developing the existing product 
  • Obtaining a patent license from the entity that is holding a patent for a similar product in the desired jurisdiction. In case there are multiple patents from the desired jurisdiction block the commercialization of the product then the license must be obtained from all the owners of the blocking patents to ensure the freedom to operability. 
  • Cross licensing the patents between the entity that intends to commercialize the product and another entity to further the development of the product or for the freedom to operate the product. 
  • Buying the patent from the entity or multiple entities that own an infringing patent for the product in the desired jurisdiction. It might be expensive. 
  • Opposing or invalidating the infringing patent for the product in the desired jurisdiction 
  • Terminating the idea to market the product which has IP protection in the desired jurisdiction. 

Why Conduct FTO Search and Analysis? 

Product development and commercialization of the product/process without the knowledge of intellectual property protection is always risky. The commercialized product may sometimes infringe on the IP protected product in the specific jurisdiction.  

For instance, the patented product owned by the entity in the specific jurisdiction may file an infringement suit or litigation case against the entity that launched the product in that jurisdiction without the knowledge of IP protection. The reason is that the patented product gives the legal right to the owners to prevent others from making, selling, and using their products. This reason clearly explains the right of the patent owner to file an infringement suit or litigation case against the owner of the commercialized product who launched the product without checking its freedom to operate in that jurisdiction.  

Mainly there are two types of patent infringement. If a person intentionally uses a patented product or patented method without the knowledge of the patent owner, then this type of infringement is called direct infringement. Another type is indirect infringement contrasting to direct infringement. In this case, the person who uses a patented invention is not directly involved in the infringement but encourages other people to infringe on the patented invention. 

These infringement suits and litigation cases are risky and expensive, where the owner of the commercialized product may ask to pay a huge amount of money as a penalty.  To avoid such risks, it is necessary to conduct a freedom to operate search before launching the product/process in the market. This FTO search would be cost-effective when compared with the future monetary risks that arise as a result of the infringement. Below are some of the examples for patent infringement cases in this scenario. 

This patent infringement between the giant Apple and Optis wireless Technology was started in the year 2019 where Optis filed an infringement suit against Apple for infringing their patents on 4GLTE Technology used in devices like phones and smart watches. At last, the technology giant Apple was ordered in 2021 to pay a sum of $300 million to Optis wireless Technology for infringing a few sets of patents. 

This patent infringement case was between Intel and VLSI Technology in the year 2019. This case was initiated by VLSI Technology by filing an infringement case against Intel for infringing few of their patents in chip making technology. In the year 2021, the decision was made by the jury in favor of VLSI Technology where Intel was ordered to pay an amount of $2.18 billion to VLSI Technologies. 

The patent infringement case was between Idenix Pharms and Gilead Sciences for the infringement of Idenix patent on methods for the treatment of patients with hepatitis C virus (HCV) infection. The jury has awarded Idenix with $2.54 billion in the year 2016 from Gilead. This reason is because of the Gilead products for Hepatitis C Drugs Sovaldi® and Harvoni® having sofosbuvir as an active pharmaceutical ingredient has infringed the Idenix Patent on Treatment of Hepatitis C virus infection. 

The Patent Infringement case was initiated by Novartis Ag against Sun pharmaceutical Industries. Novartis holds a patent for the “NILOTINIB” and its expiry date is on 4th July, 2023. But Sun Pharmaceuticals have planned to launch the drug in the market when the Novartis patent is still in force. At last, the decision came in favor of Novartis to stop Sun Pharmaceutical industries to launch their product in the market. 

 

Difference between Freedom to operate (FTO) and other types of searches: 

FTO vs Infringement search and analysis: 

The infringement analysis is done when the person or entity knows one or more closely in-force related patents/publications. In the infringement analysis, the claims of the known patents are compared and checked for potential similarities, whereas the FTO search covers the broad technology to identify all the in-force patents and alive publications in the technology that were not known by the entity earlier. Further, the FTO search is done before launching the product whereas the Infringement analysis is done when the client becomes aware of a particular patent. Finally, the purpose of both the FTO search and infringement analysis is to mitigate the risk of infringement and litigation cases. 

FTO vs Patentability: 

The patentability search is performed to check whether the invention satisfies the patentability criteria like novelty, non-obviousness, and usefulness over the prior art. The patentability search covers both alive and dead patents/ publications whereas in FTO mostly alive patents/publications are checked. The patentability search determines whether the invention is patentable, whereas the FTO search determines whether the product intended to commercialize is infringing any patent in that jurisdiction or not. The patentability search is performed to look for prior art all throughout the world whereas the FTO is jurisdiction-specific. 

FTO vs Patents: 

The FTO clearance search gives rights to the owner of the product to launch in the jurisdiction-specific market. Contrastingly, the patent gives the right to the owner of the invention to exclude others to make, using, and selling the invention for a limited period. 

About TTC

We’ve constantly identified the value of new technology carried out by our pretty skilled executive crew with backgrounds as our professionals. Like the IP professionals we empower, our starvation for development is never-ending. We IMPROVISE, ADAPT, and IMPLEMENT in a strategic manner.
TT Consultants offers a range of efficient, high-quality solutions for your intellectual property management ranging from Patentability Search, Invalidation Search, FTO (Freedom to Operate), Patent Portfolio Optimization, Patent Monitoring, Patent Infringement Search, Patent Drafting & Illustrations, and much more. We provide both law firms and corporations in many industries with turnkey solutions.
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