1. Huib Ghijsen ISF

2. 2  Mission  PBR / PVP  Patents  Other forms of protection  IP <> IT-PGRFA & CBD/Nagoya Protocol Source: Crispeels, 2008

3. 3 Strong and effective Intellectual Property (IP) protection encourages further plant breeding and research Plant Breeder’s Rights - ‘PBR’ / (Plant Variety Protection - ‘PVP’) and Patents are needed to stimulate the full scope of innovation Source: Crispeels, 2008

4. 4 An effective IP system balances protection as an incentive for innovation and access to enable further improvement. ISF considers that the preferred form of protection for varieties per se is through PBR The breeder’s exception is the cornerstone of the PBR system Source: Crispeels, 2008

5. 5  Novelty  DUS  Scope of protection  Exceptions Source: Crispeels, 2008

6. 6  Patentability  Scope  Exceptions Source: Crispeels, 2008

7. 7  Trademarks  Copyright  Trade Secrets  Contracts Source: Crispeels, 2008

8. 8  CBD / Nagoya Protocol  IT - PGRFA Source: Crispeels, 2008

9. 9 UPOV 1991 art. 6 A plant variety shall be deemed to be new if, at the date of filing of the application for a PBR, propagating or harvested material of that variety has not been sold or otherwise disposed of to others, by or with the consent of the breeder, for purposes of exploitation of that variety within specific time limits in ( 1 yr) or outside ( 4-6 yrs) the territory of filing.  ISF interprets “exploitation” as “commercial” exploitation, and hybrid parental lines should be subject to these same conditions  ISF is convinced from its interpretation of the UPOV Convention that the commercialization of a hybrid does not affect the novelty of the respective parental inbred lines But be aware: the court of Delhi took in January 2015 an opposite decision based on the same Convention!

10. 10  Full support for the UPOV Technical Guidelines for DUS testing in order to harmonize the test results for PBR.  DUS reports belong to the PBR holder  Reference samples belong to the PBR holder  Samples of parent lines only to be exchanged between Examination Offices by MTA’s Source: Crispeels, 2008

11. 11  Allowable in DUS testing when DNA-based markers are fully predictive of the expression of phenotypic DUS characteristics to simplify the testing of these characteristics  When used for the calibration of DNA-based markers with respect to the expression of phenotypic characteristics in the management of reference collections and in the proper planning of DUS trials Source: Crispeels, 2008

12. 12 Molecular markers can also be used for:  Identification of varieties if misappropriation or infringment is supected or as proof in infringement cases  To measure the conformity level in EDV cases Source: Crispeels, 2008

13. 13 Extended under UPOV 91 from production and sales of only commercial material to the production for all purposes, sales, storage, conditioning, import and export of propagating and harvested material BUT, complicated by the ‘Cascade provision’: The breeder can only excercise his Rights on the harvested material if that has been obtained by the unauthorized use of the propagating material and if he had no reasonable opportunity to excercise his Rights on the propagating material - Source: Crispeels, 2008

14. 14  The condition for the PBR-holder to exercise his Right at each reasonable opportunity should not require him to act against illegal reproduction of propagating material in order to exercise his right on the harvested material resulting there-from  The extension of protection of the parent line to its hybrid variety should mean that all acts performed with the hybrid material fall under the protection of the parent line, including the vegetative production of the hybrid Source: Crispeels, 2008

15. 15 For a variety to be considered as essentially derived it must fulfil three requirements in relation to the initial variety:  Predominant derivation from the initial variety  Clear distinctness in the sense of the UPOV Convention  Conformity to the initial variety in the expression of the essential characteristics that result from the genotype of the initial variety Source: Crispeels, 2008

16. 16  The concept of essential derivation is strongly supported  Determination of essential derivation is not part of granting PBR  EDV has drastically decreased plagiarism in plant breeding  An EDV will have a difference of only one or a few phenotypic characteristics compared to the initial variety  The ‘essential characteristics’ include all characteristics related to the description for DUS Source: Crispeels, 2008

17. 17 “predominant derivation” may result from:  The use of plant material of an initial variety for genetic engineering, selection or back-crossing, or  The use of molecular marker data, of an initial variety, for the purpose of selection of genotypes very close to the genotype of the initial variety  In the case of hybrids: for the purpose of selection of genotypes very close to the genotype of its parental line(s) - e.g. using the molecular data from the pericarp of maize hybrid seed - or of the initial hybrid itself. Source: Crispeels, 2008

18. 18 ISF has developed EDV testing protocols with an agreed molecular conformity threshold for the crops Maize91% - 95% SNP Lettuce96%AFLP Ryegrass60%SSR Oilseed Rape85%SSR Cotton87,5%more then 2 backcrosses Source: Crispeels, 2008

19. 19  Experimental purposes  Private, non commercial Use: allowing seeds to be produced and used by subsistence farmers (including exchange and small scale sales??)  Breeder’s exemption: the “cornerstone”, but parent lines which are not exploited as commercial varieties should not themselves be used by third parties for the purpose of further breeding without the consent of the owner. Source: Crispeels, 2008

20. 20  Farmer’s Privilege (optional!) The PBR law may restrict the breeder’s right to permit farmers to use for propagating purposes, on their own holdings the product of the harvest which they have obtained by planting, on their own holdings, of the protected variety, but within reasonable limits and subject to the safeguarding of the legitimate interests of the breeder  Farm-saved seed of protected varieties should not be permitted  However, if it is included in the PBR law, then farmers should have an obligation to pay a reasonable remuneration to the breeder  The Farmer’s Privilege should not be extended to agricultural or horticultural crops where such a privilege is not a common practice on the territory of the country concerned Source: Crispeels, 2008

21. 21 Source: Crispeels, 2008  Rigorous application of the criteria for patentability is necessary  Only true inventions are patentable and discoveries are not  The results of routine work such as conventional crossing and selection should not be patentable.

22. 22  Patent protection must not be exhausted after multiplication but should extend to a product obtained through propagation, provided it possesses the same patented characteristics or – when it comes to genetic information – to all material in which the genetic information is contained and performs its function  An alternative genetic composition that achieves the same phenotypic characteristic as a prior patented genetic composition should not be deemed to infringe the said prior patent  Compensation for loss of effective patent duration when excessive time is taken to obtain regulatory approvals should be available on a case-by-case basis e.g. by prolonging patent protection to a reasonable effective period Source: Crispeels, 2008

23. 23 For the seed industry a general research exception, which allows for research on (but not with) patented inventions and a specific breeders’ exception in patent laws should be considered Source: Crispeels, 2008

24. 24  Breeding with a commercialized plant variety comprising a patented gene or trait in a non-patented genetic background should not be an infringement of the respective patent  If a new plant variety, resulting from that breeding, is outside the scope of the patent claims, it should be freely exploitable by its developer with regard to said patent  If the newly developed variety still falls under the scope of the patent claims, no commercial acts - as defined in the UPOV 1991 Act - should be undertaken with the new variety without prior consent of the patent holder Source: Crispeels, 2008

25. 25  Trademarks are frequently used in the plant breeding and seed trade business and are an important means to help prevent sale of counterfeit products. Variety denominations are by definition the generic name of the variety and can therefore not be used as trademark for that variety, but a trademark can be added to the variety name  Copyright protection should be considered for catalogs, product brochures, labels or packaging  Trade secrets: e.g. for parental lines, breeding records, specific methods used, gene-agronomic trait associations, molecular markers used in marker assisted selection Source: Crispeels, 2008

26. 26  A contract can be linked to notices or tags on seed bags, or on sales documents indicating that grower or purchaser agrees contractually to certain terms.  These forms of contracts provide the opportunity for breeders and trait providers to inform end users and competitors about its rights and their obligations (e.g. protection of intellectual property, and stewardship obligations). Source: Crispeels, 2008

27. 27 Clauses that could be stipulated in the contract may include, for example:  The non-exhaustive and exclusive right of the breeder for reproduction;  The export and import restrictions on seed;  The extension of protection to harvested material;  An obligation of the farmer to pay a royalty on farm saved seed used for replanting;  The prohibition for the farmer to sell farm saved seed for the purpose of replanting;  That any parental lines that might inadvertently be in a bag of hybrid seed remain the property of the breeder;  Stewardship obligations regarding transgenic crops and harvested seed;  The right of the breeder to be provided with the information required for the purposes of auditing and verifying the proper use of protected varieties Source: Crispeels, 2008

28. 28  ABS arrangements should be facilitated by the use of standard material transfer agreements that are consistent with prior informed consent and mutually agreed terms, such as the mechanism of the sMTA.  Access for further breeding and exploitation of the resulting varieties as provided for under the breeder’s exemption of PBR protected varieties is a fair and reasonable benefit sharing  This also applies to varieties bred from material obtained under the Nagoya protocol!  Any benefit sharing for genetic resources that is claimed on top  of this ‘free access’ goes against this principle Source: Crispeels, 2008

29. 29  There should be no direct linkage of access and benefit sharing procedures with the specific criteria required to obtain PBR or patent protection  The list of crops in Annex I of the ITPGRFA should include all crops where breeding occurs and other genetic resources utilized in breeding these crops Source: Crispeels, 2008

30.  Intellectual Property protection (both PBR & Patents) is crucial for:  A sustainable contribution of plant breeding and seed supply.  To Meet challenges ahead  To provide return on investment IP is the motor of innovation!

31. 31 More information: www.worldseed.org