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Freedom-to-operate (FTO) or clearance search is one of the most crucial exercise for any innovative business before planning commercial launch of a product/ technology. Businesses undertake such searches at multiple stages during the lifecycle of a product/ technology including at the time of inception, during research & development phase, and finally before the commercial launch. Carefully executed FTO analysis is critical for avoiding last minute roadblocks and associated commercial loss.

FTO search is more than just pulling out key terms and patent data analysis. An experienced patent searcher or attorney can make a huge difference to the output with maximum amount of sound information leading to an informed business decision. We (PatInnovate team) bring together some key aspects to be considered while conducting such clearance searches that may have clear impact on analysis output and associated FTO opinion.

1. Ensuring inclusion of recent PCT applications in search jurisdictions
As patent rights are territorial in nature, is of utmost importance to carefully select all-important territories of commercial interest. While selecting such territories, recent PCT applications should also be included in search parameters as such PCT applications may later enter national phase of these commercially important territories. For an example, in-case a business wants to commercialize a product in Europe and China, then search parameters should include EP, CN, and recent PCT applications to ensure accurate retrieval of the patent dataset. It is also important to have all key jurisdictions listed right at the start of the FTO search as addition of a new territory after the search may lead to unnecessary spending.

2. Multi-database searching platforms/ tools
There are several commercial industry standard databases currently available for executing patent searches (e.g. Questel Orbit, Derwent Innovation, PatSeer, STN). Using a dual database strategy (executing the searches on at least two databases) helps in eliminating errors in individual database indexing as well as search operator usage by the searcher. Another useful approach is to additionally supplement the searches with national patent office database based on territories of the interest (e.g. USPTO, Espacenet, JPO, WIPO-PatentScope). Patent search strategies based on a single patent database may lead to incomplete retrieval of patent data which may lead to an erroneous search output.

3. Including patent classification based searches
To ensure comprehensive coverage of the technology domain, it is important to conduct patent classification based searches restricted by broad key-terms. To implement this strategy, patent searcher should have a sound know-how of key patent classes for that specific technology domain and these classes should also be confirmed using some potentially relevant patents for the search. Most widely used patent classification systems include International patent classification (IPC) and Cooperative patent classification (CPC). For an example, if someone is conducting a FTO search around diagnostic markers, it may be useful to include classes – C12Q (related to measuring or testing processes involving enzymes, nucleic acids, Microorganisms) and G01N (Investigating or analyzing materials by determining their chemical or physical properties).

4. Carefully choosing timeframe for the patent research
As Freedom-to-operate (FTO) searches are restricted by a certain time range, wrong selection of the date criterion may lead to missing of potentially relevant results from the report. Special attention should be paid to human pharmaceuticals or biological medicines which require lengthy clinical trials and are eligible for patent terms extensions for around five (05) years in many jurisdictions including USA and Europe. Many experienced search experts recommend a 25 year timeframe search that provides dual advantage as it ensures that none of the potentially relevant patents are missed and also provides additional information on recently expired patents.

5. Due-diligence on Key Competitors/ Top Inventors
Apart from conducting key-words and patent classification searches, search protocol should also include additional research on key competitors and top inventors in the domain. List of the key competitors and top inventors should also be based on the findings from the patent searches. It is recommended to search these players and inventors with broad key-term restrictions to identify additional patent results that may have not been captured from the other searches. Many a times, the claims of potentially relevant patents are drafted in a way so that these can bypass search terms used by the searchers, hence such strategies may help in identification of such potentially relevant references.

6. Identification of old non-patent documents
Non-patent references are not directly linked to Freedom-to-Operate search. Many expert searchers and attorneys do understand the importance of relevant non-patent literature in preparation of FTO opinions as replicating any old teachings/ disclosure should not be of any concern from FTO aspect which are limited to active and enforceable patents/ published applications. Hence, identification of any such close old prior-art references especially non-patent documents may be really handy while preparation of FTO opinions.

These are some of the strategies that can be executed to ensure that all key potentially relevant patents/ published applications/PCT applications have been captured in the FTO search. These strategies may be implemented in searching protocols to bring comprehensiveness for the FTO/ clearance searches.