patent mining for freedom to operate (fto) analysis professor stan kowalski, ph.d., j.d. february...
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Patent Mining for Freedom to Operate (FTO) Analysis
Patent Mining for Freedom to Operate (FTO) Analysis
Professor Stan Kowalski, Ph.D., J.D.
February 24, 2009
Professor Stan Kowalski, Ph.D., J.D.
February 24, 2009
FTO PrinciplesFTO Principles
Freedom to operate (FTO) is the ability to proceed with research, development and commercialization of a product, while fully accounting for any potential risks of infringing activity, i.e., whether a product can be made, used, sold, offered for sale, or exported, with a minimal risk of infringing the unlicensed intellectual property rights (IPR) or tangible property rights (TPR) of others.
Freedom to operate (FTO) is the ability to proceed with research, development and commercialization of a product, while fully accounting for any potential risks of infringing activity, i.e., whether a product can be made, used, sold, offered for sale, or exported, with a minimal risk of infringing the unlicensed intellectual property rights (IPR) or tangible property rights (TPR) of others.
FTO PrinciplesFTO Principles
The term “freedom” in FTO does not imply an absolute freedom or guarantee, but instead indicates a carefully executed analysis leading to a reasoned opinion that one can legally proceed with research, development or sale, in a given jurisdiction at a given point in time.
The term “freedom” in FTO does not imply an absolute freedom or guarantee, but instead indicates a carefully executed analysis leading to a reasoned opinion that one can legally proceed with research, development or sale, in a given jurisdiction at a given point in time.
FTO PrinciplesFTO Principles
FTO analysis (the assessment of potential IPR and TPR appurtenant to a product) is about risk management: providing the maximum amount of sound information and proficient analysis, such that informed decisions are made, and a reasonable course of action taken.
FTO analysis (the assessment of potential IPR and TPR appurtenant to a product) is about risk management: providing the maximum amount of sound information and proficient analysis, such that informed decisions are made, and a reasonable course of action taken.
FTO PrinciplesFTO Principles
FTO Opinion Based on the results of the FTO analysis, patent counsel will draft an FTO opinion that indicates the likelihood that the product or process infringes the IPR or TPR of others. Such infringement likelihood might be either low or high, depending on the results of the FTO analysis.
FTO Opinion Based on the results of the FTO analysis, patent counsel will draft an FTO opinion that indicates the likelihood that the product or process infringes the IPR or TPR of others. Such infringement likelihood might be either low or high, depending on the results of the FTO analysis.
FTO PrinciplesFTO Principles
FTO Analysis, leading to Product Clearance
FTO Analysis, leading to Product Clearance
FTO PrinciplesFTO Principles
Property Rights of Others: Two Forms
Intellectual Property Rights
Tangible Property Rights
Property Rights of Others: Two Forms
Intellectual Property Rights
Tangible Property Rights
FTO PreparationsFTO Preparations
Locating notebooks, lab records and computer files and other documents
Locating notebooks, lab records and computer files and other documents
FTO PreparationsFTO Preparations
Formulating the series of FTO questions
Formulating the series of FTO questions
FTO PreparationsFTO Preparations
Selecting patent databases
“Value added” but when?
Selecting patent databases
“Value added” but when?
FTO PreparationsFTO Preparations
Identifying special resources for pharmaceutical patent information
Identifying special resources for pharmaceutical patent information
FTO PreparationsFTO Preparations
Understanding United States Patent and Trademark Office
(USPTO) information (file wrappers and disclosures)
Understanding United States Patent and Trademark Office
(USPTO) information (file wrappers and disclosures)
FTO PreparationsFTO Preparations
Remaining aware of the 18-month “zone of silence”
Remaining aware of the 18-month “zone of silence”
FTO PreparationsFTO Preparations
Maintaining due diligence throughout the FTO analysis
Maintaining due diligence throughout the FTO analysis
FTO ProcedureFTO Procedure
Product Deconstruction: what are the steps needed to dissect and identify the essential components and processes used to generate a product. Analyzing, understanding and dissecting the technology.
Product Deconstruction: what are the steps needed to dissect and identify the essential components and processes used to generate a product. Analyzing, understanding and dissecting the technology.
FTO ProcedureFTO Procedure
Formulate Series of FTO analytical questions
Formulate Series of FTO analytical questions
FTO ProcedureFTO Procedure
Three tiers of FTO analysis:
Tier 1 review
Tier 2 review
Tier 3 review
The FTO Analytical Funnel
Three tiers of FTO analysis:
Tier 1 review
Tier 2 review
Tier 3 review
The FTO Analytical Funnel
FTO ProcedureFTO Procedure
Three tiers of FTO analysis:
Iterative …… iterative …… and then
Iterative again!
The FTO Analytical Funnel
Three tiers of FTO analysis:
Iterative …… iterative …… and then
Iterative again!
The FTO Analytical Funnel
FTO ProcedureFTO Procedure
Tier 1 review: widest part of the FTO Analytical Funnel.
Sweeping search for any potentially relevant IPR, TPR.
Goal is to corral any information that appears to be potentially relevant.
Big net, pulling in all the fish: cod, hake and various “trash fish”.
Tier 1 review: widest part of the FTO Analytical Funnel.
Sweeping search for any potentially relevant IPR, TPR.
Goal is to corral any information that appears to be potentially relevant.
Big net, pulling in all the fish: cod, hake and various “trash fish”.
FTO ProcedureFTO Procedure
Tier 2 Review For IPR, the FTO team should cross-
reference patents with the scientific literature. This type of survey will further map the relevant IPR landscape.
Examine the specifications of relevant patents, in order to interpret and construe more precisely what each patent claims.
Tier 2 Review For IPR, the FTO team should cross-
reference patents with the scientific literature. This type of survey will further map the relevant IPR landscape.
Examine the specifications of relevant patents, in order to interpret and construe more precisely what each patent claims.
FTO ProcedureFTO Procedure
Tier 3 Review The narrowest part of the FTO funnel Patent counsel will carefully scrutinize
the remaining relevant patents: examining and reviewing the claims and cataloging pertinent patent families.
Issues such as direct, contributory or DOI infringement liability.
Tier 3 Review The narrowest part of the FTO funnel Patent counsel will carefully scrutinize
the remaining relevant patents: examining and reviewing the claims and cataloging pertinent patent families.
Issues such as direct, contributory or DOI infringement liability.
FTO ProcedureFTO Procedure
Simultaneously embedded IP rights and TP rights …..
What would be a real world example?
Technical example?
Simultaneously embedded IP rights and TP rights …..
What would be a real world example?
Technical example?
FTO ProcedureFTO Procedure
What is the single most powerful tool in the FTO analysis leading to product clearance?
What is the single most powerful tool in the FTO analysis leading to product clearance?
FTO PerspectiveFTO Perspective
Prior Art Search:
Purpose, identify art which may affect the patentability of an invention
Coverage, patents and non-patent literature, many sources of information depending on jurisdiction.
Prior Art Search:
Purpose, identify art which may affect the patentability of an invention
Coverage, patents and non-patent literature, many sources of information depending on jurisdiction.
FTO PerspectiveFTO Perspective
Patent invalidity, Opposition search:
Purpose, identify art that may impact the claims of a specific patent. Target weak claims. Coverage, patents and non-patent literature: undiscovered prior art; investigative and legal techniques to define obviousness, anticipation and other risks to patent validity.
Patent invalidity, Opposition search:
Purpose, identify art that may impact the claims of a specific patent. Target weak claims. Coverage, patents and non-patent literature: undiscovered prior art; investigative and legal techniques to define obviousness, anticipation and other risks to patent validity.
FTO PerspectiveFTO Perspective
Patent landscape search:
Purpose, show patent landscape to uncover trends, gaps, overlaps and links in the broad patent landscape for a given technology. For directing research and developing strategy.
Coverage, patents only
Patent landscape search:
Purpose, show patent landscape to uncover trends, gaps, overlaps and links in the broad patent landscape for a given technology. For directing research and developing strategy.
Coverage, patents only
FTO PerspectiveFTO Perspective
Freedom to operate vs. patentability
FTO looks forward
Patentability looks backward
Statutory Invention Registration, USPTO (35 U.S.C. 157)
Freedom to operate vs. patentability
FTO looks forward
Patentability looks backward
Statutory Invention Registration, USPTO (35 U.S.C. 157)
FTO PerspectiveFTO Perspective
Freedom to operate vs. patent landscape
FTO focuses on product or proposed product
Landscape surveys field of technology
Freedom to operate vs. patent landscape
FTO focuses on product or proposed product
Landscape surveys field of technology
FTO ObtainingFTO Obtaining
Licensing options
Invalidate patents
Modify product
Abandon project
Invent around
Wait (and see)
Licensing options
Invalidate patents
Modify product
Abandon project
Invent around
Wait (and see)
FTO Strategy FTO Strategy
FTO Analysis
FTO Opinion
FTO Status
FTO Strategy
FTO Analysis
FTO Opinion
FTO Status
FTO Strategy
FTO StrategyFTO Strategy
FTO AnalysisAn FTO analysis is a focused and intense
investigation, performed by meticulously dissecting a biotechnological product or process into its fundamental components and then scrutinizing each for any attached, unlicensed intellectual property (such as patents, plant variety protection, or trade secrets) and tangible property of third parties.
FTO AnalysisAn FTO analysis is a focused and intense
investigation, performed by meticulously dissecting a biotechnological product or process into its fundamental components and then scrutinizing each for any attached, unlicensed intellectual property (such as patents, plant variety protection, or trade secrets) and tangible property of third parties.
FTO StrategyFTO Strategy
FTO Opinion
Based on the results of the FTO analysis, patent counsel will draft an FTO opinion that indicates the likelihood that the biotechnological product or process infringes the IP rights or tangible property rights of others. Such infringement likelihood might be either low or high, depending on the results of the FTO analysis.
FTO Opinion
Based on the results of the FTO analysis, patent counsel will draft an FTO opinion that indicates the likelihood that the biotechnological product or process infringes the IP rights or tangible property rights of others. Such infringement likelihood might be either low or high, depending on the results of the FTO analysis.
FTO StrategyFTO Strategy
FTO Status
The FTO opinion will inform, with respect to the overall status of FTO for a given product—depending on the time and place—the level of potential risk associated with contemplated R&D and/or commercialization activities. Such risks vary; hence, FTO status is relative.
FTO Status
The FTO opinion will inform, with respect to the overall status of FTO for a given product—depending on the time and place—the level of potential risk associated with contemplated R&D and/or commercialization activities. Such risks vary; hence, FTO status is relative.
FTO StrategyFTO Strategy
FTO Strategy The FTO status establishes a baseline for
formulating a strategy for product development. This involves business and legal considerations, balancing potential risks with anticipated benefits. The FTO strategy involves considering all options and then deciding on the approach that best fits the mission of the organization and its tolerance for risk.
FTO Strategy The FTO status establishes a baseline for
formulating a strategy for product development. This involves business and legal considerations, balancing potential risks with anticipated benefits. The FTO strategy involves considering all options and then deciding on the approach that best fits the mission of the organization and its tolerance for risk.
FTO StrategyFTO Strategy
FTO Analysis
FTO Opinion
FTO Status
FTO Strategy
FTO Analysis
FTO Opinion
FTO Status
FTO Strategy
FTO ConclusionsFTO Conclusions
When should the FTO
analysis be done?
(At what stage of product cycle?)
When should the FTO
analysis be done?
(At what stage of product cycle?)