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Trade secrets in public-private research collaborations
Dr. R.NEETHU
CeBIL, Faculty of Law, University of Copenhagen
Seminar on Trade secrets 4th of September,2018,
University of Copenhagen
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CONTENTS OF THE PRESENTATION
1. Background: collaboration within PPP model
2. Foundational challenges for
3. Drivers of Disclosure in PPP
4. Legislative challenges
5. The 3 Approaches towards TS in collaboration
6. Case Study
7. way forward
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The Public Private colloboration Model
PPP-“long term contractual arrangements between thegovernment and a private partner whereby the latterdelivers and funds public services using capital assets and,sharing the associated risks involved’’- OECD
PPP offer an opportunity to translate research into productsand to close the gap between academic and industrialresearch".
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PPP models
can be classified based on
• scope or duration: eg. Project –based colloborations or alliance
between a company and an academic insitution e.g. Mistsubishi Genetic Therapy Center at Imperial college Lon.(GTC)
• paricipants involved: single one-on one partnerships or consortia eg. IMI
(innovative medicines intiative)
• Based on the aim :
1. Knowledge generation PPP (pre-competitive)eg.C-Path (critical path Institute)
2. Integrated Drug Discovery Partnerships CD3 (Center for drug design & discovery)
3. Product Development PPP Malaria Venture (MMV)
4. Product Access PPP GAVI (Global alliance for vaccines and Immunization)
Pre-discovery Drug
discoveryPreclinical drug development post-approval
Pre-competitive PPP
Drug discovery ppp
Product development ppp
Product access ppp
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Foundational challenges
Peceived Challange Realistic challenges Management of Complex
relationships, Modelling the ppp
Finding the right model ,
Seeking the purposes
Managing data and ICT oriented
research including cloud.
Devising Incentive structures
Responsiveness and flexibility
Finding Directionality of Purpose
"one-size-fits-none"
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Background : drivers of disclosure
• Pre-competitive space
• Predictability of outcomes
• Stakeholder feedback
• Regulatory requirements
• Self- Image Impact
• Aligning private investment
with public interests
• Improving public services
• Public accountability
• Public right of information
• Creating social Impact
• Assessing possible
risks involved
• Feedback and
assessing outcome of
research
• Public confidence and
trust
Increasing Private involvement
INCREASING PUBLIC RESPONSIBILITY
INCREASING FOCUS ON VALOURISED
OUTCOMES
NEED FOR DISCLOSURE
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Trade secrets
• Directive (EU) 2016/943
• (i) It is not generally known or readily accessible;
• (ii) It has commercial value because it is secret; and
• (iii) The owner has taken reasonable steps to keep it secret
information related to manufacturing processes, formulae, pattern
certain knowhow related to the process, technical information
Business related information eg. Suppliers or sales strategies
Different kinds of research data including compilation of data
Potentially Large Scope of information
Diffusion of Information: Independent discovery , observation, study, disassembly, testing of a product or object that has been made available to the public.
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Legislative challenges
Recital 8:The internal market is affected in so far as such differences lower theincentives for businesses to undertake innovation-related cross-border economic activity,including research cooperation or production cooperation with partners, outsourcing orinvestment in other Member States, which depends on the use of information that enjoysprotection as trade secrets.
Article 1 (2) Directive shall not affect:
the application of Union or national rules to disclose TS, in public interest, toadministrative or judicial authorities for the performance of the duties of thoseauthorities
the application of Union or national rules requiring or allowing Union institutions andbodies or national public authorities to disclose information submitted by businesseswhich those institutions, bodies or authorities hold pursuant to, and in compliance with,the obligations and prerogatives set out in Union or national law
However irrespective: such disclosure this should not release public authoritiesfrom the confidentiality obligations to which they are subject in respect ofinformation passed on by trade secret holder (Recital 18)
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TRADE SECRETS AND PPP
Private value
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CASE STUDY :Innovative Medicines Initiative (IMI)
Eu + European Federation ofPharmaceutical Industries and Associations
facilitating collaboration between the keyplayers involved in healthcare research
- universities,
- pharmaceutical and other industries,
- SMEs
- patient organisations, and
-medicines regulators
Regulation (EC) No 1049/2001 and Decision IMI-GB-036-24092008 of the IMI Governing Board implementing Regulation 1049/2001. And IMI2 JU Regulation No 557/2014 of 6 May 2014 (Art. 15)
2 major types of collaborations
- Basic Research projects
- Knowledge Management
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Case study Cont- Limits of CCI protection Access:
1. Where it involves IMI materials- any decision to deny access to a document or
part of a document shall state the reason for the refusal based on one of the
exceptions listed in Article 4 of Regulation 1049/2001. (Art. 5, IMI Governing
Board implementing Regulation 1049/2001)
2. Where it involves third party Materials- Article 4 of Regulation 1041/2001
applies. However in case where Joint Undertaking intends to give access to a
document against the explicit opinion of the author then offer an opportunity to
oppose such a disclosure.
Collaborations (Model Grant Agreement)
1. During collobaboration + 4years parties must keep confidential any
data, documents or other material (in any form) . This may be extended to an
additional period of 4yrs
2. Unless otherwise agreed between the parties, they may use confidential information
only to implement the Agreement
3. Disclosure to third party only if necessary for the purposes of the agreement and
they are bound by confidentiality
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No obligation to protect CCI in the Collaboation
The confidentiality obligations no longer apply if:
(a) the disclosing party agrees to release the other party;
(b) the information was already known by the recipient or is given to him without obligation of confidentiality by a third party that was not bound by any obligation of confidentiality;
(c) the recipient proves that the information was developed without the use of confidential information;
(d) the information becomes generally and publicly available, without breaching any confidentiality obligation, or
(e) the disclosure of the information is required by EU or national law
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SUCCESS
Seeking balance of interests to the needs of Public research through
greater participation,
maintaining dynamic relationship,
Time limited strategy along with
protectionist strategy,
identifying the contextual application
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• Or the Pre-competitive research partnerships being the early phases ofexploration offers to raises the level of knowledge of all actors involved in suchresearch :
• Careful management of intellectual inputs and outputs
Centre for Information and Innovation Law (CIIR)Copenhagen Biotech & Pharma Forum (CBPF)
June 14, 2013 15
strategies for balancing secrecy and disclosure
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Finding directions to the Larger question
Given the ways that TS prevents disclosure ofinformation in which public may have legitimateinterest the question is how to address the competingneed for democratic transparency ?
Eliminate TS in Public collaborations
Incentivising disclosure
finding scope for Patents in invention oriented
environments within PPP
Limiting the duration
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