Freedom to Operate Biosciences Innovations & IP Management

OFFICIAL LAUNCH OF THE BIO-INNOVATE PROGRAMME

ILRI Kenya 16 March 2011Linda Opati

ILRI IP/LEGAL OFFICERl.opati@cgiar.org

Access to technologies for R&D

Access to agricultural biotechnology for public research institutions involved in developing improved seed varieties and technologies in developing countries is vital.

However most technologies required to develop agribiotech outputs are saddled with patents

and other IP rights of private companies.

E.g. Agribiotech R&D research tools:- Elite plant varieties & seeds (previous generations

of breeding); Reagents –e.g. Promoters, markers;

Methods of breeding e.g. Hybrid technologies, cloning methods.

What forms of agribiotech IP protection are likely to be encountered?

The major forms of IP protection available for agricultural biotechnology are:-

Patents

Plant Breeder’s Rights (Plant Variety Protection) PBRs/PVP

Other forms of legal protection are contractual obligations such as Material Transfer Agreements (MTAs) and Confidentiality Agreements (Trade secrets and know-how)

Forms of IP protection contd.

PATENTS: Protect the novel inventions of products

and processes and exclude others from using the

invention described in the patent document. Are

territorial and generally last for 20 years from the

date of filing.

Patents in agribiotech may cover eg. Screening

methods eg.marker assisted breeding; Breeding

methods eg. hybrid technologies; Methods for

certain types of selecting and crossing.

Territorial patent rights: No patent rights make,use, sell, import Patented technology patented technology can be exploited

Forms of IP Protection Contd.

PBRs these protect breeders of varieties that are

new and distinct from existing varieties, genetically uniform and stable through successive generations, usually for 20 years. It protects against use of the protected variety for further breeding including the propagating material (seeds, cuttings, tissue) or harvested material eg. fruit

MTAs Contractual Agreements for the transfer of biological material eg. seeds, plant varieties.

sMTAs Standard MTAs under the ITPGRFA multilateral system for plant genetic resources

New Plant Variety - 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 Ignorance about IPR laws may possibly

subject research institutions to financial liability or damage to their reputations.

Understanding and managing IP is a practical necessity for research scientists. Though patent law allows exceptions for pure research, commercialisation or application of the developed technology would require permission to use if IP exists.

IP strategy must be integrated with the R&D Strategy early in the research program. Effective IP policies, template contracts, internal monitoring mechanisms critical, FTO analysis.

Freedom To Operate Analysis

List all technologies used and any existing agreements eg. MTAs, Confidentiality agreements and any pertaining restrictions. Carry out patent searches and identify potentially relevant ones Find out all the countries where relevant patents are

filed - the extended patent family Obtain copies of relevant patents Ascertain legal status of each relevant patent Seek the assistance of a patent attorney to understand the claims Establish whether your activity would infringe the

claims of existing patents Check the legal status (expired, lapsed, cancelled)

and the term of the patent grant.

Options for dealing with existing patent/PBR rights

If that technology is very valuable to your invention - seek a license to use and pay royaltiesAlternatively cross-license your technology to the owner in exchange for theirs or negotiate a joint ventureIf the technology is not that vital - invent around it so that you do not require permission i.e. Find an alternative route to the same goalDevelop a strategic research and commercial alliance elsewhere with other research and commercial partners.Negotiate Humanitarian Use licenses (Eg. GoldenRice Project)

Other IPRs and FTOOther IPRs may need to be considered : Copyright – Software, data, graphic material; Trademark rights; Industrial designs

Compliance with government regulations and industry guidelines: Ethical standards; Industry guidelines; Biosafety issues; Cultural Issues; PIC if biological materials used relate to TK; Health and ethical research issues.

ILRI Spearheading a New Way Forward

Freedom to Operate It is the ability to proceed with the research, development, commercialization and production of a research product or process with minimal risk of infringing the unlicensed IP rights of third parties.

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PROPERLY MANAGED INTELLECTUAL PROPERTY MAY FACILITATE NOT HINDER ACCESS AND USE OF PROPRIETARY TECHNOLOGY!