Freedom to Operate (FTO)Freedom to Operate (FTO)

Plants, Patent & Profits

Professor Stan Kowalski, Ph.D., J.D.

February 24, 2009

Plants, Patent & Profits

Professor Stan Kowalski, Ph.D., J.D.

February 24, 2009

Overview of FTOOverview of FTO

FTO Principles FTO Preparations FTO Procedure FTO Perspective FTO Obtaining FTO Strategy

FTO Conclusions

FTO Principles FTO Preparations FTO Procedure FTO Perspective FTO Obtaining FTO Strategy

FTO Conclusions

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 crop science 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 crop science 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 biotechnological 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 biotechnological 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

Assembling the FTO teamAssembling the FTO team

FTO PreparationsFTO Preparations

Interviewing the researchersInterviewing the researchers

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

Finding Agreements and Contracts

Finding Agreements and Contracts

FTO PreparationsFTO Preparations

Formulating the series of FTO questions

Formulating the series of FTO questions

FTO PreparationsFTO Preparations

Selecting scientific databasesSelecting scientific databases

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

FTO Search:

Purpose, identify patents (IP rights) or applications that may cover a proposed product of process …. “Blocking patents”

Coverage, patents (and other IP rights) still in force. Includes narrow and broad concepts.

FTO Search:

Purpose, identify patents (IP rights) or applications that may cover a proposed product of process …. “Blocking patents”

Coverage, patents (and other IP rights) still in force. Includes narrow and broad concepts.

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.

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.

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.

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.

Coverage, patents only

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?)

FTO ConclusionsFTO Conclusions

FTO in time and space

Evanescent

FTO in time and space

Evanescent