Do I have freedom to operate?


Best practices in IP protection

A step-by-step guide

or view the flowchart

You want to patent your invention...

But does it infringe any other patents?

Before embarking on a research project, and again shortly before attempting to commercialize an 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

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 4: 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 3: Conduct an in-depth product/process clearance search

SEARCH

Having progressed in your R&D and having identified a commercial candidate, you should conduct a detailed FTO clearance search that focuses on the specific technical features of the commercial candidate (the invention).

Preferably, each technological aspect (or enabling feature) of the commercial candidate will be analyzed in detail.

The search should identify potentially blocking patents, and these should be analyzed by a lawyer or agent to determine if your commercial candidate is encompassed by any of their claims.

NOTE: If you are not far advanced in your R&D and have not yet identified a commercial candidate, you should instead conduct a more narrow preliminary FTO search.

The legal status of each potentially blocking patent should also be determined and its expiry dates calculated.

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 4: Analyze the results of the FTO/patent search

The patent search will yield a list of 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. This analysis can be complex and should involve a patent professional, although he or she may rely on your technical input.

The following are general guidelines on making business decisions based on the findings of an FTO search.

ANALYSIS

STEP 4: 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 new benefit?

Note: At this stage, you will need to engage a professional 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 professional would draw up a legal opinion, involving a detailed legal and technical analysis of the claims to determine their scope more precisely, and a determination as to whether your product/process falls outside the claim scope.

Can you design around the blocking patent(s)?

ANALYSIS

STEP 4: 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 4: 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 or agent 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 4: 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.

You have freedom to operate.

Note that preliminary FTO searches, which are conducted before you are actually ready to file a patent, 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.

Freedom to operate
FLOWCHART

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ID features

Prioritize

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 2: Define the topic of the FTO patent search

TOPIC

List all your prospective 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. In addition, an encapsulated drug may be covered by one or more patents. Try to identify all such distinct aspects of your prospective invention as separate enabling features.

Conduct a separate preliminary FTO search for each anticipated enabling feature of your prospective invention's technology, to determine if patents exist for any of them.

Freedom to operate
FLOWCHART

SCOPE

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ID features

Prioritize

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