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IPRs in Research &
Material Transfer Agreements (MTAs) Linda Opati
ILRI IP&LEGAL COUNSEL BecA Lab Management & Equipment Operations Workshop
June 17-22, 2013
Cumulative innovation in R&D v Development of any product in biotech requires a multitude of technologies and reagents eg:-
Germplasm – Seeds which embody the results of previous generations of research Reagents – Vectors for transformation,
components of vectors eg. Promoters, markers; Elite plant varieties; Methods of breeding eg. Hybrid technologies;transformation of plant cells; methods of selecting and breeding.
v These components are usually proprietary and likely having IPRs of other parties.
Product Deconstruction Technological component, process, or tool
Likely Proprietary protection
Relevant documents
Cell culture IP Rights, TP Rights patents, MTAs
Genes IP Rights patents Research tools used and related techniques
IP Rights patents, technology-‐use licenses
Plant transformation techniques ( eg agrobacterium and/or bio-‐projectile methodologies)
IP Rights patents, technology-‐use licenses
Plant genetic transformation constructs (eg., vectors, promoters, transit peptide sequences)
IP Rights, TP Rights patents, MTAs
Plant cell culture techniques and cell lines
IP Rights, TP Rights patents, MTAs
Germplasm used for genetic transformation
IP Rights, TP Rights, possibly trade secrets (for example, if variety was developed using parental lines protected as trade secrets)
patents, plant variety certiFicates, possibly MTAs (for example, if germplasm is covered by the PGRFA), bag-‐tag licenses
Source: IP Handbook of best practices
Managing IP in R&D is critical v For all biotech scientists managing IP is a
practical necessity due to proprietary research tools or the product cannot be developed without negotiating the use of a patented technology – The need for freedom to operate.
v Patent law allows exceptions for pure research however beyond the research phase, it would be necessary to negotiate a license.
v IP strategy must be integrated with the R&D Strategy early in the research program.
What is a Material Transfer Agreement (MTA)???
• Biological materials were once freely and widely exchanged • Gained commercial value therefore protection necessary § CBD and ITPGRFA 5
An MTA is….
Ø A Legal Agreement between the Provider (owner) and the Recipient of biological research materials, for testing, evaluation, experimentation, or research.
Ø The biological materials may include reagents, cell lines, antibodies, genome sequence databases, vectors, live animals, transgenic animals, seeds, live plants), chemical compounds (drugs or pharmaceuticals) and accompanying information and data.
Ø Transfers possession NOT legal title.
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Ø The Goal of the MTA is to protect the rights of the Provider (owner of the material) and the Recipient while allowing research, analysis and evaluation to proceed unhindered e.g.
ü Protects the right of researchers to publish their results
and participate in ownership of any eventual IP. ü Protects the organizations from misunderstandings and
potential liability
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Typical Provisions in MTA q Identification of materials q Scope of use
q For noncommercial research only
q Provider may require confidentiality on research results or data provided
q Limitations on further transfer q Warranty and warranty disclaimer
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Other Typical Terms …
q Indemnification q Delay of publication
q Review period for manuscripts
q Control over IP q May require recipient to assign or license inventions back
to the provider
q Compliance with laws & Regulns eg. Export Controls q Export and Import permits
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Managing MTAs at ILRI
q Outgoing MTAs: Our Principal Investigator requests to PROVIDE materials (ILRI Template). Recipient will usually negotiate some changes to our MTA.
q Incoming MTAs: Our Principal Investigator requests to RECEIVE
materials. Provide will send us their MTA. q Bilateral MTAs: Our Principal Investigator wants to SEND
Materials from another organization and receive back modified Materials, information and/or data.
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submits
ILRI Principal Investigator
Completed ILRI MTA Template
IP Office q Reviews
q Shares with Recipient q Ideally to be signed
before transfer q Copies retained in IP
office
Managing MTAs Contd..
q Typically, MTAs with industry take the longest to negotiate. This is often because these agreement contain many of the “hotspots” we just reviewed and therefore they must be negotiated.
q Within the academic and non-profit community, there are several standard agreements to facilitate transfers, requiring little negotiation.
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www.ilri.org
Embrace the use of MTAs!
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