Intellectual Property in a changing world

©2015 IDBS, Confidential

Intellectual Property in a Changing World

Dr Stuart Ward, Head of Business Analysis, IDBS


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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 worldPre-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?

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?

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 worldPre-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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TrendsPaper Lab Notebook

Sign PDF

Sign Data Items

Do Not Sign

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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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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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


Intellectual Property in a Changing World


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Intellectual Property in a changing world

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