Freedom to Operate FTO

1. Freedom to Operate (FTO)
Plants, Patent & Profits
Professor Stan Kowalski, Ph.D., J.D.
February 24, 2009

2. Overview of FTO
 FTO Principles
 FTO Preparations
 FTO Procedure
 FTO Perspective
 FTO Obtaining
 FTO Strategy
 FTO Conclusions

3. FTO 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.

4. FTO 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.

5. FTO 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.

6. FTO 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.

7. FTO Principles
FTO Analysis, leading to Product
Clearance

8. FTO Principles
Property Rights of Others: Two Forms
Intellectual Property Rights
Tangible Property Rights

9. FTO Preparations
Assembling the FTO team

10. FTO Preparations
Interviewing the researchers

11. FTO Preparations
Locating notebooks, lab
records and computer files
and other documents

12. FTO Preparations
Finding Agreements and
Contracts

13. FTO Preparations
Formulating the series of FTO
questions

14. FTO Preparations
Selecting scientific databases

15. FTO Preparations
Selecting patent databases
“Value added” but when?

16. FTO Preparations
Identifying special resources
for pharmaceutical patent
information

17. FTO Preparations
Understanding United States
Patent and Trademark Office
(USPTO) information (file
wrappers and disclosures)

18. FTO Preparations
Remaining aware of the 18-
month “zone of silence”

19. FTO Preparations
Maintaining due diligence
throughout the FTO analysis

20. FTO 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.

21. FTO Procedure
Formulate Series of FTO analytical
questions

22. FTO Procedure
 Three tiers of FTO analysis:
Tier 1 review
Tier 2 review
Tier 3 review
The FTO Analytical Funnel

23. FTO Procedure
 Three tiers of FTO analysis:
Iterative …… iterative …… and then
Iterative again!
The FTO Analytical Funnel

24. FTO 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”.

25. FTO 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.

26. FTO 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.

27. FTO Procedure
Simultaneously embedded IP rights and TP
rights …..
What would be a real world example?
Technical example?

28. FTO Procedure
What is the single most powerful
tool in the FTO analysis leading
to product clearance?

29. FTO 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.

30. FTO 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.

37. FTO 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.

38. FTO 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

39. FTO Obtaining
Licensing options
Invalidate patents
Modify product
Abandon project
Invent around
Wait (and see)

40. FTO Strategy
FTO Analysis
FTO Opinion
FTO Status
FTO Strategy

41. FTO Strategy
FTO Analysis
An 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.

42. FTO 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.

43. FTO 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.

44. FTO 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.

45. FTO Strategy
FTO Analysis
FTO Opinion
FTO Status
FTO Strategy

46. FTO Conclusions
When should the FTO
analysis be done?
(At what stage of product cycle?)

47. FTO Conclusions
FTO in time and space
Evanescent