The application of the FTO Assessment. Digest # 01, 2021

Vitaliy Orihon
Patent Counsel for IPR GROUP

As is known, the main advantage of the patent holder is exclusivity to produce and sell goods and services according to the patented method and/or device or substance. The registered patent gives the holder a market advantage. However, in order to estimate and understand the potential of the object, similar patents “the patent environment”, should be analyzed with a conclusion on the limits of freedoms & advantages the patent holder has on the market with this object.  Understanding these limits, is the concept of Freedom to Operate (FTO) for the patent holder or potential Licensee of the patent.

An FTO Assessment is necessary for risk analysis and competitiveness for further action. It is also an opportunity to assess the potential actions you can take with a registered patent without infringing on the valid intellectual property (IP) rights of third parties. FTO Assessment is also necessary before entering into a new market in countries where the product/service will be commercialized. All these types of analysis fall under the definition of FTO Assessment.

The FTO is also valuable in the early stages of business development. If there is a possibility of a third-party patent infringement, amendments to the application specification can be made to avoid possible conflict. During the analysis of the state of art regarding your potential invention, features that haven’t been fully explored on the market can be found and also used in drafting of the new application.

With this strategy, the FTO search may create added value by discovering new, untapped features, while reducing any chances of being in further conflict and possibly facing infringement.

We can therefore conclude that the FTO is an analysis of the environment of the patent of interest, which essentially estimates the possibility of commercializing the invention on the market without violating IP rights and acting within the maximum coverage of the current patent.

A standard FTO should contain the following sections:

  • Determining the scope of the object of assessment

Analysis of the patent of interest and the state of the art materials of the specific object/method of the invention, the purpose that it follows, and the parts that it consists of. It is important to note that the complete features of the claims, dependent and independent claims, should be analyzed. However, it should also be taken into account that there might be situations where some parts of the object are not protected by the claims, because some possibility of  use or result of the object can be described as an alternative in the application materials but not as disclosures in the claims. The invention should be broken down into all its constituent elements (specific units, materials, and processes involved in the object’s production or sale).

  • Conducting a patent search

The search for patentability criteria and the search for FTO assessment are similar, and are conducted in relation to the claimed object. However, the subsequent approach to the analysis of search materials is different. The search for patentability focuses on the patent from the state of art in order to find out what new inventive is proposed. The FTO search focuses on the cross-platform comparison of the feature of the objects to analyzing similar and distinct parts of invention.

  • Determining the scope of the object of assessment

In this analysis, it is necessary to summarize the results and indicate the invention’s possible scope without violation of third-party patents. A “literal violation” is established when all the features specified in the claims are present in an already existing patent. Based on the conclusion, the Patent Holder or potential User of the patent can build a commercial prediction concerning the patent object’s use and detail their potential in the market.

The FTO can be conducted for one country or a number of countries for the subsequent implementation of the invention or countries’ list. It is the same approach for any jurisdiction due to the similar grounds of patent law in several countries, whether in Europe, Asia or America.

To summarize the information above:

  • The FTO is necessary for:
  1. the initial stage of drafting the application when the analysis of the potential conflict on the business market is needed;
  2. to assess the market prospects of the investment before transferring the patent rights or purchasing a patent license;
  3. analyzing the area of intersection of rights after identifying the nearest analog disclosure of other patents.
  4. estimating the number of companies on the market that use the closest analogues of the invention to assess competitiveness.
  • The FTO assessment can be conducted in relation to:
  1. comparison of the essence of the potential invention to the state of the art in the field of technology;
  2. comparison of the idea of the object of a potential invention and the patent/patents present on the market of the jurisdiction/jurisdictions of interest;
  3. comparing the registered patent and the nearest specific analog that is already available on the market for a clear understanding of the overlap to be able to identify risks of potential conflict and the possibility to invalidate\to face revocation on the registered patent.

When determining the approach to FTO, it is necessary first of all to start from the understanding of the object to which the invention relates. The objects of the invention may be a device, method, substance, strain of a microorganism, cell cultures of plants and animals, as well as the use of a previously known device, method, substance, strain for a new purpose.

For a device, the following should be analyzed and covered:

  • the field of art for which the device is proposed;
  • identification of the device as a whole;
  • identification of the parts of the device (parts if the object is not integral);
  • variants of the parts in various combinations;
  • functions of the device as a whole and components parts separately;
  • method of obtaining the device;
  • method of using the device;
  • description of conditions on how successfully the invention copes with the main task.

For a method, the following should be analyzed:

  • the field of art for which the method is proposed;
  • clarification of the process for which the method is proposed;
  • clarification of each step of the method;
  • analysis of the various steps and combinations that use the method;
  • description of conditions on how successfully the method copes with the main task.

For a substance, the following should be analyzed:

  • the field of art for which the substance is proposed;
  • the identification of the main chemical compound (first active substance);
  • the identification of the additional chemical compounds (second active substance) or combination of the additional substance;
  • the classification for what the substance is used for;
  • the method of administration;
  • description of conditions on how successfully the invention copes with the main task.

For a strain of a microorganism, the following should be analyzed:

  • the characteristic conclusion of the strain of a microorganism;
  • determination of the type of microorganisms;
  • where the strain of microorganisms is used;
  • description of the conditions on how successfully the invention copes with the main task.

For cell cultures of plants and animals, the following should be analyzed:

  • the characteristic (size or shape) conclusion of the cell;
  • additional inclusions in the cell;
  • determining cell function;
  • where the cell can be used;
  • description of the conditions of the novelty of the subject cell in the field of art

It is necessary to summarize that the FTO assessment should be drafted by an expert in the field of technology, and result should be supervised by a patent attorney who is familiar with the nuances and processes from drafting of the application to possible litigation in the jurisdictions of the FTO.