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Trade secrets in public-private research collaborations

Dr. R.NEETHU

CeBIL, Faculty of Law, University of Copenhagen

rajam.neethu@jur.ku.dk

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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EMAIL: rajam.Neethu@jur.ku.dk

Twitter :

@JurRajam_Nhttps://twitter.com/JurRajam_N

@CeBIL_Center