Intellectual Property in a changing world
-
Upload
idbs -
Category
Technology
-
view
161 -
download
1
Transcript of Intellectual Property in a changing world
©2015 IDBS, Confidential
Intellectual Property in a Changing World
Dr Stuart Ward, Head of Business Analysis, IDBS
©2015 IDBS, Confidential
2
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)
©2015 IDBS, Confidential
3
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
©2015 IDBS, Confidential
4
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)
©2015 IDBS, Confidential
5
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
©2015 IDBS, Confidential
6
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
©2015 IDBS, Confidential
7
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
©2015 IDBS, Confidential
8
How has collection of data / IP changed?
Data Amount and Complexity
Individuals and Paper
Collaboration Electronic
©2015 IDBS, Confidential
9
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
©2015 IDBS, Confidential
10
How do ELNs fit with IP?
Security Proving authorship Regulatory
compliance Long-term storage Searchability
©2015 IDBS, Confidential
11
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
©2015 IDBS, Confidential
12
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
©2015 IDBS, Confidential
13
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
©2015 IDBS, Confidential
14
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!
©2015 IDBS, Confidential
15
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
©2015 IDBS, Confidential
16
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
©2015 IDBS, Confidential
17
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
©2015 IDBS, Confidential
18
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
©2015 IDBS, Confidential
19
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
©2015 IDBS, Confidential
20
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
©2015 IDBS, Confidential
21
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
©2015 IDBS, Confidential
22
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
©2015 IDBS, Confidential
23
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
©2015 IDBS, Confidential
24
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
©2015 IDBS, Confidential
26
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
©2015 IDBS, Confidential
For further information view our website: www.idbs.com or email: [email protected]
Join the Community