Freedom to operate: Biosciences innovations and intellectual property management


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Presented by Linda Opati at the Launch of the BioInnovate Programme, ILRI, Nairobi, 16 March 2011

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Freedom to operate: Biosciences innovations and intellectual property management

  1. 1. Freedom to Operate Biosciences Innovations & IP Management OFFICIAL LAUNCH OF THE BIO-INNOVATE PROGRAMME ILRI Kenya 16 March 2011 Linda Opati ILRI IP/LEGAL OFFICER [email_address]
  2. 2. <ul><li>Access to technologies for R&D </li></ul><ul><li>Access to agricultural biotechnology for public research institutions involved in developing improved seed varieties and technologies in developing countries is vital. </li></ul><ul><li>However most technologies required to develop agribiotech outputs are saddled with patents and other IP rights of private companies. </li></ul><ul><li>E.g. Agribiotech R&D research tools:- </li></ul><ul><li>Elite plant varieties & seeds ( previous generations of breeding); </li></ul><ul><li>Reagents –e.g. Promoters, markers; </li></ul><ul><ul><li>Methods of breeding e.g. Hybrid technologies, cloning methods. </li></ul></ul>
  3. 3. What forms of agribiotech IP protection are likely to be encountered? <ul><li>The major forms of IP protection available for agricultural biotechnology are:- </li></ul><ul><ul><ul><li>Patents </li></ul></ul></ul><ul><ul><ul><li>Plant Breeder’s Rights (Plant Variety Protection) PBRs/PVP </li></ul></ul></ul><ul><li>Other forms of legal protection are contractual obligations such as Material Transfer Agreements (MTAs) and Confidentiality Agreements (Trade secrets and know-how) </li></ul>
  4. 4. Forms of IP protection contd. <ul><ul><li>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. </li></ul></ul><ul><ul><li>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. </li></ul></ul><ul><li>Territorial patent rights: No patent rights make,use, sell, import Patented technology patented technology can be exploited </li></ul>
  5. 5. Forms of IP Protection Contd. <ul><li>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 </li></ul><ul><li>MTAs Contractual Agreements for the transfer of biological material eg. seeds, plant varieties. </li></ul><ul><li>sMTAs Standard MTAs under the ITPGRFA multilateral system for plant genetic resources </li></ul>
  6. 6. New Plant Variety - Deconstruction Source: IP Handbook of best practices 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
  7. 7. Managing IP in R&D is critical <ul><li>Ignorance about IPR laws may possibly subject research institutions to financial liability or damage to their reputations. </li></ul><ul><li>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. </li></ul><ul><li>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. </li></ul>
  8. 8. Freedom To Operate Analysis <ul><ul><li>List all technologies used and any existing agreements eg. MTAs, Confidentiality agreements and any pertaining restrictions. </li></ul></ul><ul><ul><li>Carry out patent searches and identify potentially relevant ones </li></ul></ul><ul><ul><li>Find out all the countries where relevant patents are filed - the extended patent family </li></ul></ul><ul><ul><li>Obtain copies of relevant patents </li></ul></ul><ul><ul><li>Ascertain legal status of each relevant patent </li></ul></ul><ul><ul><li>Seek the assistance of a patent attorney to understand the claims </li></ul></ul><ul><ul><li>Establish whether your activity would infringe the claims of existing patents </li></ul></ul><ul><ul><li>Check the legal status (expired, lapsed, cancelled) and the term of the patent grant. </li></ul></ul>
  9. 9. Options for dealing with existing patent/PBR rights <ul><ul><ul><li>If that technology is very valuable to your invention - seek a license to use and pay royalties </li></ul></ul></ul><ul><ul><ul><li>Alternatively cross-license your technology to the owner in exchange for theirs or negotiate a joint venture </li></ul></ul></ul><ul><ul><ul><li>If 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 goal </li></ul></ul></ul><ul><ul><ul><li>Develop a strategic research and commercial alliance elsewhere with other research and commercial partners. </li></ul></ul></ul><ul><ul><ul><li>Negotiate Humanitarian Use licenses (Eg. GoldenRice Project) </li></ul></ul></ul>
  10. 10. Other IPRs and FTO <ul><ul><ul><li>Other IPRs may need to be considered : </li></ul></ul></ul><ul><ul><ul><li>Copyright – Software, data, graphic material; Trademark rights; Industrial designs </li></ul></ul></ul><ul><ul><ul><li>Compliance with government regulations and industry guidelines: </li></ul></ul></ul><ul><ul><ul><li>Ethical standards; Industry guidelines; Biosafety issues; Cultural Issues; PIC if biological materials used relate to TK; Health and ethical research issues. </li></ul></ul></ul>
  11. 11. 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 .