Learn how to make it easier to capture your IP and manage your evolving IP needs.

1. ©2015 IDBS, Confidential
Intellectual Property in a
Changing World
Dr Stuart Ward,
Head of Business
Analysis, IDBS

2. ©2015 IDBS, Confidential
What is intellectual property?
“Intellectual property (IP) refers to creations of the mind,
such as inventions; literary and artistic works; designs;
and symbols, names and images used in commerce.”
(World Intellectual Property Organization)
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Importance of IP
 IP is an important company
asset
• Used to drive revenue
• Used to create ideas
• Used to make decisions
 IP needs to be protected and
used
• Appropriate management and
documentation of data
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Patents
 Filing and defence of patents
• Leahy-Smith America Invents Act (2011)
• First to file
• Well-maintained documentation and record keeping
is important
• Easily and quickly find all relevant data
 Patent expiry
• Leverage IP in an efficient manner to drive new
inventions (and patents)
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Understanding the organization’s IP needs
 Understand the needs of stakeholders
• Scientists
• Want to be able to capture and analyze data easily
• Decision-makers
• Want to be able to access and leverage IP easily
• Legal and compliance teams
• Want to make sure that IP is created, used and stored in a secure and
compliant manner
• May be a legal need to be able to defend in court
 Determine the main IP risks
• Data loss
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How to maximize benefits of IP?
 Secure
• Protect information
 Accessible and usable
• Use IP to make decisions
• Gain extra value from the data
 Narrative / traceability
• IP defines what has been done
• Regulatory compliance
 Efficiency
• Faster decisions and further use
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IP in a changing world
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Pre-computer systems
Format - Paper lab notebook
Secure - Can be locked away…
…but this impacts accessibility
Accessible /
Usable
- Hand written text can be illegible:
Lose meaning of the data
- Finding the data can be difficult:
Hand written index is user specific
and not always clear
Narrative /
Traceability
- Provides narrative / traceability for a
specific user
- Limited for collaborations books tends to
be for individuals
- Need good indexes / references to find
data in other books
Efficiency - Can be slow to find data

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How has collection of data / IP changed?
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Data Amount
and
Complexity
Individuals and Paper
Collaboration Electronic

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Collaboration / Externalization
 Multiple people (organizations)
contributing data
 Efficient creation and use of IP
 Need to be able to share IP
appropriately and easily
 Considerations
• Security: controlling access
to the data
• IP ownership
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How do ELNs fit with IP?
 Security
 Proving authorship
 Regulatory compliance
 Long-term storage
 Searchability
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Security
 Access control
• It is important that you know who is
accessing / changing your data!
• Who - User authentication
• What - User authorization
• When - Timestamps
• Is there suspicious / non-authorized
behavior?
• Minimize data loss
• Combination of user authentication,
authorization and audit trail will
help to secure the data
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Proving authorship – authentication
 Goal
• Proving who is creating / editing data
 User authentication
• Simplest form of identifying an
individual
• Needs appropriate controls in place
• Policies around usernames / passwords
• Various authentication mechanisms
• Username and password
• Two factor
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Proving authorship – signing
 Signing
• ‘Completion’ action that can tie a
users identity to the data
• On raw data or PDF
• Signature methods
• E-signature
– Various formats
– Not necessarily bound to the data
• Digital signatures
– Standard format using a PKI
– Directly bound to the data
– Can be trusted by a third party
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How is signing changing?
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 Less signing and more reliance on audit trail to prove
authorship
• Data is stored centrally
• Audit trail happens automatically
• Less user operations
Less process
and more
compliance!

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Proving authorship – audit trails
 Audit trails
• History that covers all actions performed on the data by a
particular user
• Entries are associated with time from a single time source
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Regulatory Compliance
 Regulatory requirements.
• For example
• FDA 21 CFR Part 11
• EU Annex 11
• General aim of requirements
is to prove authorship
• User authentication
• Audit trails
• Signing
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Long-term storage
 PDF
• Accepted for long-term storage
• Creates an ‘as printed’ document
• Standards such as PDF/A for archiving
• PDF/A may not be compatible with the
wide variety of data formats that users
want to capture
 Storage types
• PDF placed in separate storage solution
• Data (and PDF) kept in ELN
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Searchability
 Ability to search IP easily
allows:
• Decisions to be made quickly
• Extra information to be gained
from the data
• Reduction in the need to
repeat work
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IP in a changing world
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Pre-computer systems
Format - Paper lab notebook
Secure - Can be locked away…
…but this impacts accessibility
Accessible /
Usable
- Hand written text can be illegible:
Lose meaning of the data
- Finding the data can be difficult:
Hand written index is user specific
and not always clear
Narrative /
Traceability
- Provides narrative / traceability for a
specific user
- Limited for collaborations books tends to
be for individuals
- Need good indexes / references to find
data in other books
Efficiency - Can be slow to find data
In the digital world
- Electronic Lab Notebook (ELN)
- Data is stored centrally in an organization
- Authorized users can access the data
- Audit trail records what has happened
- All data in one place
- Data input can be harmonized
- Data can be searched
- Data can be shared
- Records in the system can be linked
- Versioning:
Can see how the data has developed
- Data can be found quickly

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Trends
Paper Lab
Notebook
Sign PDF
Sign Data
Items
Do Not
Sign
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 PDF
• Generated by most organizations for long term storage
• Archive storage solutions are used if already available
else PDF remains in ELN
 Signing
• Many organizations are moving away from signing
and/or rolling out their own PKI
 Harmonizing IP capture and searching
• All organizations are using ELNs to efficiently obtain
increased value from their IP

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How can E-WorkBook support your IP needs?
 A secure place to store your IP
• All data stored in a central database
 An environment that can prove authorship
• User authentication and a granular security model
 Ability to digitally sign records and / or PDFs
• Out of the box functionality as well as the ability to use
other PKIs
• E-WorkBook has been shown to meet the requirements of SAFE-
BioPharma
• Workflows can be used to ensure signing processes are
followed
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How can E-WorkBook support your IP needs?
 Audit trails that show how data has been changed and
who has changed it
• All timestamps come from a central point
• A trusted timestamp server can be used
 E-WorkBook meets regulatory requirements such as
21 CFR Part 11 and Annex 11
 Ability to create PDFs of the data for long-term
storage
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How can E-WorkBook support your IP needs?
 Making the best use of IP
• Harmonizes data capture
• Comprehensive search interface allows for structured and
unstructured searching to be performed
• Combine data from multiple sources
• Fast decision-making
• Gain maximum value from the data
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How can E-WorkBook secure your IP?
 Needs of IP capture and use change!
 E-WorkBook provides a configurable environment
which can adapt to these changes
 Designed to meet the needs of your whole
organization
• Scientists
• Decision-makers
• Legal and compliance teams
 Minimizes your IP risks
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E-WorkBook – an accessible, flexible,
but secure, home for your IP
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Summary
 Understand your organization’s IP needs and risks
• Security
• Legal/regulatory
• Accessing IP
 Use an ELN that fits both the organization’s and user’s
needs
• Strike the right balance between compliance and usability
• Ensure that IP can be leveraged to get maximum benefit
and value
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27. ©2015 IDBS, Confidential
Intellectual Property in a
Changing World

28. ©2015 IDBS, Confidential
For further information view our website: www.idbs.com or email: info@idbs.com
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