A combined patentability and Freedom to Operate (FTO) search is a type of patent search that examines these two important perspectives together at the same point in time, rather than separately. This type of search is conducted to help Legal/IP, R&D, business and other groups, (including outside IP counsel) to assess the potential risks and opportunities associated with developing, producing, or launching a new product.

In this article we define each search type, how they work together, timing considerations, advantages and disadvantages of combining them, and searcher expertise needed. We also discuss other considerations for whether one may consider combining patentability and FTO searches, and at what stages during a product lifecycle this may be advisable.

Distinguishing Patentability versus Freedom to Operate (FTO)

A patentability search (sometimes called a prior art or novelty search) and a Freedom to Operate (FTO) search are two different types of patent searches that are conducted for different purposes.

A patentability search is conducted to determine if an invention meets the “new and useful” requirements to be eligible for a patent. This search type identifies patent prior art, non-patent literature prior art, and product prior art relevant to the invention. The search analyzes the full disclosure (i.e., an analysis of the entire specification and drawings) of those references to determine if they contain any information that might preclude an assessment that the inventive concept is “new”. The goal of a patentability search is to give an IP practitioner the references that will allow fine-tuning of the claims of a patent application to describe just the “new” material (to avoid rejection), or to abandon the project entirely if the prior art uncovered during the patentability search does not support patentability, thereby saving significant drafting and filing fees if the invention is “not patentable”.

On the other hand, an FTO search* is conducted to determine if a product or process infringes on any existing patents, which might cause anyone practicing the invention to be subject to patent infringement lawsuits by the patent owners. An FTO search may also be used as a tool when a first company is in the process of acquiring a second company (with or without an IP portfolio), where the first company may want to see if any active patents may pose a patent litigation threat, should the first company implement the system(s) and/or practice the process(es) of the second company. This type of search identifies patents that cover the technology related to the product or process and analyzes the claims of those patents to identify specific independent and dependent claims that appear to “read on” the process or product; meaning that the invention “fits” the language of the claims, and that there is therefore a risk of infringement. Armed with the results of an FTO search, the IP counsel can seek to develop strategies to mitigate that risk, such as working with R&D teams of a company to develop claims that do not read on those of a blocking patent, performing validity searches to try to invalidate any such patents, or preparing cross-licensing agreements.

*A Freedom to Operate (FTO) search can be known by many names including IP Clearance, Infringement, Right to Practice (RTP) or Right to Use (RTU).

Getting the Timing Right

A patentability search is often conducted relatively early in the invention or product development process, whereas a fully-fledged FTO search is often conducted prior to the launch of the final product. In some cases, it may be appropriate to conduct a combined patentability search and an early stage FTO analysis, as the product development process is costly and companies may find value in assessing the patentability alongside FTO before too much is invested in R&D. Searching to identify prior art references that could impact the patentability of the invention, as well as patents that could pose a risk to the freedom to operate of the product or process, helps IP groups and R&D make more informed decisions early on.

Alternatively, if an invention is already well along the path and a patentability search has not yet been conducted, then a combined patentability and pre-commercialization FTO search could make sense.

Advantages of a Combined Patentability and FTO search

1. Cost savings: Conducting a patentability search and an FTO search separately can be more expensive than conducting a combined search. While the scope of a patentability search and an FTO search won’t overlap completely, as described in more detail below; many of the same references will be reviewed across both. Also, every search involves a first “gearing-up” process, whereby the searcher can develop the most effective search efforts for the upcoming search. By combining the searches, this “gearing-up” is performed only once, and you can save on search costs and reduce the overall time and effort required to complete both searches separately.
2. More thorough analysis: When combining the two types of searches, it allows for a more thorough analysis of the patent landscape. The results of each search can inform the analysis of the other, leading to a more complete understanding of the potential risks and opportunities related to the product.
3. Timeframe and jurisdictions: An FTO search alone will typically cover, within the patent prior art space, the last 20 years and focus on unexpired patents in particular jurisdictions where freedom to operate is actively being sought. However, pharmaceutical patents, for example, frequently have their patent life extended to protect the lifespan of the claimed product or process based on the granting jurisdiction. Thus, a patent granted prior to the last 20 year search cutoff date may still be in force and can be infringed. A patentability search, by contrast, will cover ALL time periods, and ALL jurisdictions, and across all prior art, i.e., patent prior art, non-patent literature prior art, and product prior art. Combining the FTO search with patentability, with no limit to timeframe or jurisdiction, can give a broader perspective for future commercialization opportunities. Also, while an expired patent does not present an infringement risk, and is therefore often omitted from an FTO search– expired patents are still sometimes useful in assessing FTO– because once a patent expires, the invention described in that patent then becomes “public domain”, and can be made, used, or sold without fear of infringement. The expired patents could also be useful for invalidating any potential blocking patents.
4. Strategic insights: As mentioned above, a combined search can provide valuable strategic insights that can help guide decisions on patentability and commercialization. For example, even though the search may identify strong patent references that could potentially preclude patentability, it may be strategic to focus on developing improvements to the invention, because such improvements might themselves be patentable. Similarly, if the search identifies strong patents that pose a risk to the freedom to operate, it may be strategic to try to invalidate the patents, seek a license or cross-license agreement, or develop innovations that do not read on the claims of a blocking patent.

Disadvantages of a Combined Patentability and FTO search

1. Separate objectives/scope of patentability and FTO: In many situations, the scope of the FTO search will be broader than what a potentially patentable idea describes. Depending on the way that the invention disclosure has been written, it may not provide all the information required from the FTO perspective. Analyzing the results of a patentability search ahead of time (even if separated by no more than a couple of weeks), can help the IP team to look for potential patent conflict concerns/features and guide the associated FTO search request accordingly. Also, the expanded scope of a combined search means potentially more references to consider for the information disclosure statement (IDS) vs being able to focus on patentability results alone.
2. Changes to the product: If later down the line, the product undergoes any significant changes that could impact its patentability or infringement risk, further searching may be required. As a product moves closer to commercialization, it may be necessary to run an update to the freedom-to-operate search to review any new patents or applications filed or changes in the legal landscape that may impact the road ahead. Nevertheless, addressing FTO early in the process helps to circumnavigate costly roadblocks later.
3. Established product clearance risk assessment process: While not a disadvantage in the strict sense, it should nevertheless be borne in mind that many organizations have their own established product clearance risk assessment processes to decide whether or not to evaluate clearance concerns for each product and, if so, at what stage. Thus, the merits of taking an early idea to the next level is often determined according to this set of pre-defined internal protocols. Funding and budgets play a large part in determining whether or not a particular product/process warrants further investment on a case-by-case basis, including investigation into FTO viability. Each company is different: For some, an invention disclosure will automatically trigger a patentability and/or FTO search without many restrictions; in other cases, the chosen level of diligence for patent searching may depend on the extent of the patent portfolios of key industry players and associated IP litigation history. In some situations, FTO searches may be approved even prior to invention disclosures being submitted. It is therefore important to understand such company protocols and to be aware of established procedures and budgets for ongoing inventions vs the resources available for the launch of a major new technology initiative, for example.

Fine-tuning a Combined Patentability and FTO Search

Conducting a combined patentability and FTO search can be complex, particularly if the search covers a large number of patents and patent applications and non-patent literature.

It is important to determine the most appropriate search criteria for both patentability and FTO issues, and therefore it can be helpful to engage in a discussion with your IP search provider before the search is initiated. The search criteria will need to be tailored to the specific technology area and the potential risks and opportunities associated with the invention or product. Also helpful is identifying material which can be “disregarded” during the search, being ancillary to the main thrust of the invention.

The desired format of the final report can also be discussed during the early stages of the search. Combining the results of both patentability and FTO searches in a meaningful way that easily indicates which documents are cited for which type of search, can be challenging. The analysis must consider the overlap between the two types of searches and integrate the results into a coherent and actionable report. Working with a seasoned search firm that is used to providing these types of results in a comprehensive report will alleviate such issues.

Search Results Reflect the Expertise of the Search Team

Search expertise is a critical factor in conducting a comprehensive and accurate combined patentability and FTO search. This type of search requires specialized expertise in both patentability and FTO analysis as well as other key areas, such as:

• Patent Searching and Resources: The search team should have many years of experience in conducting patent searches using a variety of databases due to the fact that each database has its own nuances and understanding these is critical. They should be proficient in various search techniques such as keyword searching, classification searching, specialized indexing, citation searching and any other search techniques specific to the technology e.g. Chemical and Markush structure searching, Biotechnology sequence searching, and specialized resources for high-tech/SEP technologies. In addition, they should be familiar with the various patent classifications and search tools available, and be able to design a search strategy that is tailored to the specific technology area and the potential risks and opportunities associated with the product.
• Patentability Analysis: In reviewing prior art for the purpose of patentability, the search team will need to be able to analyze the prior art they find to determine its relevance to the invention in question.
• FTO Analysis: The FTO search and analysis involves reviewing the claims of the identified patents and patent applications to determine whether they pose a risk to the freedom to operate. The language of the claims, often in “legalese”, can be complicated, broadly stated, and difficult to fully grasp. The search team should have experience in conducting FTO searching and analysis, including the ability to identify potential patents of interest, the relevant claims and clauses, and report them clearly in the report findings.
• Technical and Domain Expertise: The search team should have extensive subject-matter expertise in the relevant technology area, such as chemistry, life sciences, high-tech and engineering. This domain knowledge will enable them to understand the technical aspects of the invention or product and identify relevant prior art and patents. Further subject specialization within these broad categories is highly advisable for optimum results.
• Legal Aspects: The search team should be able to understand the legal aspects of patentability and FTO issues, including understanding claims language and construction and any subtle language issues, in-force dates and extensions, as well as the potential risks and opportunities associated with the invention or product.

Overall, conducting a combined patentability and FTO search requires a thorough understanding of both patentability and FTO issues, as well as the ability to integrate and interpret the results of both types of searches. It is recommended to work with a professional IP search firm that has experience in conducting combined searches and can provide the necessary expertise to ensure comprehensive and accurate search results.

Summary: A Strategic Approach with Better Insights

Overall, a combined patentability and FTO search provides a comprehensive analysis of the prior art landscape from both a patentability and FTO perspective. It provides IP groups and their outside counsel with the information they need to make informed decisions about their inventions, products, or processes, helping them to develop strategies to clear a path moving forward as well as protect and grow their IP portfolio.

It is possible to conduct patentability and FTO searches separately. However, if you get the timing right, combining these two searches can save costs, provide better insights and present the opportunity to make more informed decisions early on in the product lifecycle. This provides the opportunity to assess the potential risks and opportunities associated with developing, producing, or launching a new product.

There are advantages to combining searches as well as conducting them separately at different stages. IP groups and their outside counsel can weigh up these factors and decide the best approach, whether that is a combined patentability and FTO search in early stages and an updated FTO closer to commercialization, or to focus on only patentability in the R&D phase and hold-off on the FTO until a later stage.

Whether combined or separate, one should consider the expertise of the search team conducting these searches. There are complexities involved with each search and, as discussed in this article, the search team must possess many years of experience and a collection of skills to be able to perform a thorough search.

Should one choose a combined patentability and FTO search, this approach can save time, money, and potential legal disputes in the long run, paving the way for a successful product launch or commercialization.

If you have questions about combined patentability and FTO searches, or these searches performed separately, our TPR search team is available to discuss your IP search needs. Contact us.

 

TPR is the premier U.S. search firm for high quality patent and non-patent literature searching and analysis. As a recognized leader for over 25 years, TPR is widely known for its exclusive range of subject-matter IP Search Experts, high performance search results, an impressive global reach, and a passion to go the extra mile to locate critical information. TPR has a team of U.S. based IP Search Experts and can also conduct foreign language searching on-the-ground in Europe, China, Japan and other locations. Clients across engineering, high-tech, life sciences and chemistry turn to TPR for Validity/Invalidity, FTO/Clearance, Patentability, IPR, Due-Diligence and Landscape/White-Space search projects.

 

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