1. Ownership and use of DUS samples and DNA of DUS samples during and after the DUS test Kees Jan Groenewoud Secretary to the Dutch Board for Plant Varieties

2. Use of DUS material and DNA thereof Use of DNA of DUS samples2 Breeder X of existing Tomato Variety X Breeder Y of new Tomato Variety Y Existing Tomato Variety X New Tomato Variety Y Variety Y EDV of X? Infringement? Suspicion of Breeder X: = New Variety Y EDV of X? Court: Permission to Take a sample of Variety Y from reference collection Naktuinbouw

3. Result: we started to ask ourselves some questions of principle: o What is the procedure regarding this kinds of requests? o Who is the owner of the DUS sample? o Why did owner first go to Naktuinbouw? o More then 60.000 DUS samples, more requests? o Is this good for PBR in general? o And….what is our role? Use of DNA of DUS samples3 Use of DUS material and DNA thereof

4. It is material of the variety which you are sure of that ik realy is the material of the variety because it is tested In a legal sence: its the most pure material, and the DUS material may well serve as evidence in a legal procedure Use of DNA of DUS samples4 Use of DUS material and DNA thereof

5. Use of DNA of DUS samples5 Use of DUS material and DNA thereof legal basis DUS sample UPOV 91; art 12: Examination of the application. “For the purposes of examination, the authority may require the breeder to furnish all the necessary information, documents or material.” TGP 5: Experience and cooperation in DUS testing. Section 11 Examples of policies and contracts for material submitted by the breeder. Annex 1 Example from Australia Annex 2 CPVO Policy on the status of plant material used for DUS testing purposes.

6. Use of DNA of DUS samples6 Use of DUS material and DNA thereof current policy DUS sample Community Plant Variety Office of the European Union (CPVO) Policy on the status of plant material used for DUS testing purposes (http://www.cpvo.europa.eu/documents/announcement/2012) Netherlands; Desire to create clarity for the breeders and testing authority on the do’s and dont’s around the use of DUS samples and its derivatives such as variety description, photographs, DNA and DNA data.

7. Use of DNA of DUS samples7 Use of DUS material and DNA thereof General statement NL DUS policy Principles in the Netherlands on DUS samples: Applicant/breeder is owner of the sample (also during the DUS procedure) Board for Plant Variety Rights may use the sample for DUS Purposes Naktuinbouw as Examination Office is holder of the sample.

8. 1. What should an Examination Office entrusted by CPVO do with plant material if the application is withdrawn or if it is rejected? 1.1 Destroy or send back, or 1.2 In its reference collection 2. May a CPVO entrusted Office send material to another CPVO entrusted Office? yes to another entrusted office in the same species. If parent lines: inform the person entitled. Only to be used for DUS purposes. Use of DNA of DUS samples8 Use of DUS material and DNA thereof cpvo policy on DUS material

9. 3. May a CPVO entrusted Office send material to an other (non entrusted) Examination Office? Only with consent from the person entitled. 4. What may the Examination Office do after the variety has been granted EU pvr? 4.1 Destroy or sent back to the applicant, or 4.2 Keep in a living reference collection. 4.3 If material is kept, material may be transferred as in Section 2 above. 5. After the Community Plant Variety Expires 5.1 Material kept in a reference collection should be kept also after expiry of EU pvr. Use of DNA of DUS samples9 Use of DUS material and DNA thereof cpvo policy on DUS material

10. Use of DNA of DUS samples10 Additional in the Netherlands: In the process of DUS testing DNA is taken from all DUS samples to use for: o character based DNA tests (resistances) o management of the reference collection o inclusion in a database o (suspected) infringement cases (under conditions) DNA is stored by Naktuinbouw Use of DUS material and DNA thereof dna from DUS samples in NL

11. Use of DNA of DUS samples11 Use of DUS material and DNA thereof use of data derived from DUS samples o Use DNA outside scope of DUS testing o Delicate matter – well tuned with Plant Breeding Companies o General rule – consent from the Breeder required

12. Use of DNA of DUS samples12 Use of DUS material and DNA thereof use of data derived form DNA samples Consent needed for: o Use of DUS sample as an identified standard which represents the variety. No consent needed for: o Use as an anonymously background sample in a DNA comparison test between two samples in the case under 1. o Use as anonymous sample to establish possible genetic (EDV) tresholds in EDV cases within plant species Confidentiallity same level as breeding history

13. General principle: how to treat DUS sample and DNA thereof? o DUS sample and DNA thereof treated the same - same policy o Means: The applicant/breeder is considered the owner, the Board for Plant Varieties gets posession of the sample for DUS purposes and Naktuinbouw keeps the sample. o New: sligtly broader use Use of DNA of DUS samples13 Use of DUS material and DNA thereof policy: DNA from DUS samples in NL

14. Use of DNA of DUS samples14 Need for clear policy rules that are communicated with the industry. Consederations to amend the existing CPVO policy by: o Including the obligation to always inform the applicant when material is exchanged o Modifying the CPVO policy on the status of plant material by including the use of DNA o Clearly stating that DNA information is considered as confidential Purpose – to strengten PBR system Use of DUS material and DNA thereof closing remarks