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.

6

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

7

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

8

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

9

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.

10

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.

11

www.ilri.org

Embrace the use of MTAs!

12