Do I have freedom to operate?
Best practices in IP protection
A step-by-step guide
or view the flowchart
Patent law is a very complicated field and the legal requirements for patentability and for assessing freedom-to-operate vary from country to country. Accordingly, the contents of this site should not be taken as legal advice. A patent lawyer or qualified patent agent should be consulted to review your particular matter and provide advice based on the facts at hand.
This tool was designed in collaboration with Wendy Lamson, Patent Agent: wlamson@perlaw.ca.
You ultimately want to commercialize your invention...
But does it infringe any other patents?
Before you make, use or sell your invention, you should conduct a freedom-to-operate (FTO) patent search and analysis.
The purpose of the FTO search and analysis is to determine if there are any patent rights owned by others that would be infringed by present or future R&D or commercialization activities arising from your project.
Patent infringement represents a risk to market entry.
These are the main steps in conducting an FTO patent search.
Click on any step for details or
This tool was designed in collaboration with Wendy Lamson, Patent Agent: wlamson@perlaw.ca.
STEP 2: Define the topic of the FTO patent search
TOPIC
List all your invention's "enabling features:" the features that make your invention work.
Does your invention have just one such feature, or multiple?
Many inventions in medical research are complex and multi-faceted. For example, a lipid nanoparticle (LNP) invention may be composed of various lipids with different properties that vary depending on the external environment. In addition, an encapsulated drug may be covered by one or more patents. Try to identify all such distinct aspects of your invention as separate enabling features.
Multiple enabling features (STEP 2 continued)
Do you have the time & budget to explore FTO for every enabling feature of your invention?
TOPIC
STEP 1: Define the scope of the FTO patent search
SCOPE
Have you begun your research project/R&D yet?
STEP 1: Define the scope of the FTO patent search
SCOPE
Have you begun your research project/R&D yet?
If your project is already underway, and you have identified a commercial candidate or have a product or process that is nearly ready for market entry, you should conduct a more detailed or in-depth "clearance" search and analysis, to ensure there are no "blocking patents" that might function as barriers to commercialization.
STEP 1: Define the scope of the FTO patent search
SCOPE
Have you begun your research project/R&D yet?
If you have not begun R&D, you might simply want to get to know the “lay of the land”—an overview of the patent landscape in the field. Identifying any blocking patents early will allow you to design around them early on, before spending time/money on a project, and thus allow you to avoid commercialization headaches down the road.
For this, you should conduct an initial or preliminary inquiry, to determine if entry into a technology field is precluded by the existence of patent rights. The scope of the analysis can be more narrow than it would be if your project was already under development.
STEP 3: Analyze the results (continued)
ANALYSIS
Is there a blocking patent(s)?
A blocking patent contains claims encompassing your product or process. ("Claims" are the numbered clauses at the end of a patent document defining the scope of the patent-holder's legal rights). It is only necessary that a single claim be infringed for the owner of the patent to be entitled to initiate an infringement suit.
Note: Most FTO searches retrieve patent applications (i.e., applications that are still pending), which typically contain broader claims than a granted patent; claims are often narrowed as examination of the patent application proceeds. Also, pending applications may lapse, following the applicant's failure to pay a fee or complete an action required; in this case, none of the claims contained in the application become legally enforceable. Any potentially blocking patent applications will need to be followed to determine whether their relevancy or legal status changes.
Did your FTO search identify one or more blocking patents?
Novelty:
Is your invention new?
Legal criteria
Novelty
3. Have you previously disclosed your invention yourself?
For example, did you disclose it in a publication or conference presentation, or in any other context where the audience was not bound by confidentiality?
Did you previously disclose your invention?
Did you disclose your invention more than one year ago?
STEP 2: Conduct an FTO search
SEARCH
Conduct a separate FTO search for each anticipated enabling feature of your invention's technology, to determine if potentially blocking patents exist for any of them.
If time and/or resource limitations preclude an exhaustive search of all your invention's enabling features, focus your search on the most unique and important aspects of the technology. Note, however, that excluding features from your search entails the risk of overlooking a patent that could result in future infringement.
Read Patsnap's article on Top Tips for an Effective FTO Search. See also IPWatchdog's article on the difference between an FTO and a patentability search.
NOTE: If you are just setting out on an R&D project, a preliminary FTO search will give you an idea of the general patent landscape so that you can design around and avoid blocking patents early on. This eliminates any surprises down the road, such as expensive late-stage re-designs of products/processes to avoid third-party IP rights. However, this search will only identify those patents/applications that are published at the date of the search. Follow-up searches should be conducted periodically to ensure continuing freedom to operate. If your R&D leads to an invention nearly ready for market entry, at that point you should conduct another, more in-depth FTO product/process clearance search.
STEP 3: Conduct a preliminary FTO search
SEARCH
If you are just setting out on an R&D project, a preliminary FTO search will give you an idea of the general patent landscape so that you can design around and avoid blocking patents early on. This eliminates any surprises down the road, such as expensive late-stage re-designs of products/processes to avoid third-party IP rights.
Note that this search will only identify those patents/applications that are published at the date of the search. Follow-up searches should be conducted periodically to ensure continuing freedom to operate.
If and when your R&D leads to an invention that is close to being ready for market entry, you should then also conduct an in-depth product/process clearance search.
STEP 3: Analyze the results of the FTO search
The FTO search will yield a list of potentially blocking patents and patent applications that should be analysed to determine if any present a barrier to your R&D or commercialization activities, or whether they can be circumvented. The legal status of each potentially blocking patent should also be determined and its expiry dates calculated.
This analysis can be complex and should involve a patent professional, although he or she may rely on your technical input. See this basic information about FTO analyses.
The following are general guidelines on making business decisions based on the findings of an FTO search.
ANALYSIS
STEP 3: Analyze the results (continued)
Can you design around the blocking patent(s)?
Determine if it is possible to “design around” the claims that your invention would otherwise infringe. Can you substitute a feature encompassed by a claim with another that provides a different result?
Note: At this stage, you will need to engage a patent lawyer since it is possible to still infringe a patent even if minor modifications are made in an effort to ensure that the product/process falls outside the claim scope. A whole body of case law exists on this topic. Typically, a patent lawyer would draw up a legal opinion, involving a detailed legal and technical analysis of the claims to determine their scope more precisely, and make a determination as to whether your product/process falls outside the claim scope.
Can you design around the blocking patent(s)?
ANALYSIS
STEP 3: Analyze the results (continued)
Is designing around too costly?
Undertake a cost-benefit analysis of any proposed "design around." If it is not too costly, designing around may be a feasible means to circumvent a blocking patent.
Assess if modifying your product/process to avoid potential infringement would be prohibitively expensive.
Assess if modifying your product/process would make the technology overly complex and scale-up more difficult and costly.
Is designing around the blocking patent(s) too costly?
ANALYSIS
STEP 3: Analyze the results (continued)
Is the blocking patent valid (enforcable)?
Seek an invalidity opinion from outside counsel. An invalidity opinion is one that finds the blocking patent (or key claims) to be unenforceable because it (or they) fails to meet legal requirements such as novelty, non-obviousness or proper demonstration, among others.
Note: A patent lawyer will need to prepare the opinion for you. Patent counsel often cannot give 100% assurance that a patent or claim is invalid, but it may be possible to proceed with product development/commercialization despite the existence of a legally enforceable “blocking patent,” assuming the risk is manageable. Factors you might consider regarding whether or not to proceed include how litigious the owner of the blocking patent is (i.e., whether the owner aggressively enforces its patents) and how certain you are that a relevant claim of the patent is invalid.
Is the blocking patent enforcable?
ANALYSIS
STEP 3: Analyze the results (continued)
Can you license the blocking patent?
Explore licensing the blocking patent from the patent holder. Often universities are amenable to licensing their technology, while companies are often less so. If you have a patent application or patent in your portfolio that is key to the other company, then you might consider cross-licensing with the company (i.e., agreeing to a reciprocal, mutually beneficial licensing of each other’s technology) to gain access to the blocking patent. A patent lawyer should be engaged to negotiate any cross-licensing agreements.
Can you license or cross-license the blocking patent?
ANALYSIS
You do not have freedom to operate.
You need to reassess your R&D project and possibly stop all research activities in this area.
Consult a patent agent to arrive at an informed decision.
If a blocking patent is identified and you cannot design around the patent, and if the patent is enforceable (i.e., would be found valid by a court), and if you cannot access the patented technology by licensing or cross-licensing, then the blocking patent poses an insurmountable barrier to your product/process development or commercialization efforts.
This tool was designed in collaboration with Wendy Lamson, Patent Agent: wlamson@perlaw.ca.
You have freedom to operate.
Note that preliminary FTO searches, conducted early on in the R&D process, can only assure your freedom to operate at the date of the search. Follow-up searches should be conducted periodically to ensure continuing freedom to operate.
This tool was designed in collaboration with Wendy Lamson, Patent Agent: wlamson@perlaw.ca.
Freedom to operate
FLOWCHART
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This tool was designed in collaboration with Wendy Lamson, Patent Agent: wlamson@perlaw.ca.
Multiple enabling features (STEP 2 continued)
Do you have the time & budget to explore FTO for every enabling feature of your invention?
TOPIC
Conduct a separate in-depth FTO search for each enabling feature of your invention's technology, to determine if patents exist for any of them.
Multiple enabling features (STEP 2 continued)
Do you have the time & budget to explore FTO for every enabling feature of your invention?
TOPIC
You will need to prioritize features for in-depth FTO analysis.
Is there a key feature—or a few—that is/are particularly important for the functioning of the invention? One (or more) that cannot be easily substituted without impacting the way the invention works?
Multiple enabling features (STEP 2 continued)
Do you have the time & budget to explore FTO for every enabling feature of your invention?
TOPIC
You will need to prioritize features for in-depth FTO analysis.
Prioritize that feature/these features for the in-depth FTO analysis.
Is there a key feature—or a few—that is/are particularly important for the functioning of the invention? One (or more) that cannot be easily substituted without impacting the way the invention works?
Proceed with caution.
If your invention has multiple enabling features of equal value, among which you cannot prioritize, and you do not have the time or budget to conduct an in-depth FTO search on all of them, conduct an FTO search on as many as you can.
If you choose to proceed with filing a patent though you have not conducted an in-depth FTO search on all your invention's potentially patented features, you may later face legal action for patent infringement.
STEP 1: Define the topic of the FTO patent search
TOPIC
List all your invention's "enabling features:" the features that make your invention work.
Many inventions in medical research are complex and multi-faceted. For example, a lipid nanoparticle (LNP) invention may be composed of various lipids with different properties that vary depending on the external environment. To further illustrate, an LNP may incorporate surface stabilizing polymers, targeting moieties or unique cargo.
Identify all such important enabling aspects of your technology, to define the foci of your FTO search. You may wish to list separately the most important enabling features of your invention to help focus the search.
Freedom to operate
FLOWCHART
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SEARCH
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INQUIRY
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This tool was designed in collaboration with Wendy Lamson, Patent Agent: wlamson@perlaw.ca.
Freedom to operate
FLOWCHART
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ID features
Prioritize
This tool was designed in collaboration with Wendy Lamson, Patent Agent: wlamson@perlaw.ca.
Freedom to operate
FLOWCHART
SCOPE
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TOPIC
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SEARCH
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ANALYSIS
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ID features
Prioritize
This tool was designed in collaboration with Wendy Lamson, Patent Agent: wlamson@perlaw.ca.
