1. L’INNOVAZIONE PER NUTRIRE IL PIANETA Challenges in IP Protection for Fruit Crops Dr. Edgar Krieger, CIOPORA 22 September, 2015 Milano, Italy 22 settembre 2015 – L’innovazione per nutrire il pianeta – Milano

2. Who is CIOPORA? 2

3. Research & Innovation need adequate IP Protection INNOVATION COSTLY TIME- CONSUMING BENEFITS THE SOCIETY PROPAGATION/ PRODUCTION NEW UNIQUE PRODUCT ROYALTY AS A REWARD: ROI FURTHER INNOVATION CONTINUITY OF INNOVATION FOR THE BENEFIT OF SOCIETY AND ECONOMY 3

4. PATENTS USA – Utility and Plant Patents, EU – if plants comprise a New Technical Feature, e.g. Genes, Non- Biological Processes PLANT BREEDERS’ RIGHTS Sui generis System, UPOV Conventions TRADEMARK Not Specific to Plants: Trademarks, Trade Secret Tools for IP Protection in Horticulture 4

5. UPOV 1991 UPOV 1961 UPOV 1972 UPOV 1978 UPOV was established in Paris in 1961. Since then… 3 Updates of the UPOV Convention; the latest in 1991 73 Member States (Montenegro to join next Thursday) 20 Members of UPOV 1978 Plant Breeders’ Rights: UPOV Regime 5

6. Minimum Requirements  UPOV Convention Establishes Minimum Requirements for Plant Variety Protection in its Member States. 24 Years Old  The Latest Act of UPOV is 24 Years Old and No Longer Reflects the Day-to-Day Needs of the Horticultural Business and Globalized Economy. UPOV Convention: A Critical View 6

7. Main Importers of Fruits into EU-27 – 2009 in Mio. T & % 7

8. RankArea Production (MT) 1China 197829.851.163 50,16% 2USA 19914.358.710 7,32% 3Poland EU2.830.870 4,76% 4Iran Not UPOV2.718.775 4,57% 5Turkey 19912.504.490 4,20% 6Italy EU2.208.227 3,71% 7India Not UPOV1.985.000 3,34% 8France EU1.940.200 3,26% 9Russia 19911.467.000 2,40% 10Chile 19781.370.000 2,30% 11Argentina 19781.300.000 2,18% 12Brazil 19781.124.155 1,89% 13Germany EU1.046.995 1,76% 14Japan 1991840.100 1,41% 15South Africa 1978770.741 1,30% 16Spain EU687.500 1,16% 17Ukraine 1991719.300 1,21% 18South Korea 1991635.000 1,06% 19Pakistan Not UPOV582.512 0,98% 20Hungary EU568.600 0,96% TOTAL 59.509.338100,00%66,72%15,60%17,60% Source: FAOSTAT Production of Apples 2008 8

9.  67% of all apples produced in the world originate from UPOV 1978 countries or Non-UPOV countries.  Already now China leads in apple exports (in quantity, 2008), although its export is less than 4% of its apple production. Chile is exporting 56%.  Six countries from outside the EU represent 60% of all fruit imports into the EU (in tons), and 4 of them are bound by the UPOV 1978 Act only. Fast Fruit Facts 9

10. Pictures: Morgufile.com - morgueFILE free photoMorgufile.com Sufficiently Broad Scope of the Right 10

11. Variety as Such  The Variety as Such is Not the Object of PBR Protection (vs. the Patented Invention, which is the Object of a Patent) UPOV Convention: A Critical View Article 14 UPOV 1991 Scope of the Breeder’s Right (1) [Acts in respect of the propagating material] (a) Subject to Articles 15 and 16, the following acts in respect of the propagating material of the protected variety shall require the authorization of the breeder: (i) production or reproduction (multiplication), (ii) conditioning for the purpose of propagation, (iii) offering for sale, (iv) selling or other marketing, (v) exporting, (vi) importing, (vii) stocking for any of the purposes mentioned in (i) to (vi), above. 11

12. “propagating material”  Direct protection only for “propagating material”, but no definition of the key term “propagating material” (intention vs. capability to propagate) “harvested material”  In the UPOV 1991 Act only conditioned protection of “harvested material” (obtained by unauthorized use of “propagating material” of the protected variety and breeder has had no reasonable opportunity to enforce on level of “propagating material”)  In the UPOV 1978 Act no protection of “harvested material” at all (Is UPOV 1978 an effective sui generis system?) UPOV Convention: A Critical View 12

13. “processed material”  Only voluntary protection of “processed material”  Members of UPOV 1978 are obliged to provide for protection for 24 species only; members of UPOV 1991 must offer protection for 15 species when joining, and all after 10 years. exhaustion  Broad exhaustion rule: covers not only the material marketed by the breeder or with his consent, but all material derived from it, except in case of further propagation and of export in territories which do not protect the species concerned.  Enforcement  Enforcement of PBR not as effective as of other IP regimes UPOV Convention: A Critical View 13

14. Minimum Distance How similar should varieties be? (Comparable to “Inventive Step / Non-Obviousness” in Patents) 14

15.  A variety, in order to obtain PBR protection, must be clearly distinguishable from any existing varieties  A variety, which is clearly distinguishable, falls out of the scope of the [earlier] protected variety (unless it´s an EDV, see later)  Currently, the term „clearly distinguishable“ is interpreted from a purely botanical standpoint, not from legal or commercial standpoint or a mix thereof  One difference in an unimportant characteristic can make a variety „clearly distinguishable“  If the minimum distance is small, it is easy to obtain a PBR, but the exclusive right of the breeder is weakened or de facto negated. Clearly Distinguishable / Minimum Distance 15

16. © Thomas Leidereiter 2012 Clearly Distinguishable? 16

17. © Thomas Leidereiter 2012 Clearly Distinguishable? 17

18. © Anthony Tesselaar Clearly Distinguishable? 18

19. © Anthony Tesselaar Clearly Distinguishable? 19

20. © Thomas Leidereiter 2012 Clearly Distinguishable? 20

21. Clearly distinguishable / Minimum Distance © Thomas Leidereiter 2012 Clearly Distinguishable? 21

22. Photo pommes © Dominique Thévenon Clearly distinguishable? 22

23. Illustration by Néstor Morales Flores 23

24. Essentially Derived Varieties (EDV) Are all Mutants and GMO EDV? 24

25.  The EDV concept has been introduced in the UPOV PBR system with the 1991 Act  The EDV concept is emulated from the concept of dependency in Patents, and means that the commercialization of an EDV requires the authorization of the title-holder of the Initial Variety.  Reason for it´s introduction was to allow PBR title holders the control over mutations of their varieties, to provide for a counter- balance vs. Patents in the Biotechnology world, and to prevent plagiarism. Essentially Derived Varieties 25

26. Article 14 Scope of the Breeder’s Right (5) [Essentially derived and certain other varieties] (a) The provisions of paragraphs (1) to (4) shall also apply in relation to (i) varieties which are essentially derived from the protected variety, where the protected variety is not itself an essentially derived variety, ….. (b) For the purposes of subparagraph (a) (i), a variety shall be deemed to be essentially derived from another variety (“the initial variety”) when (i) it is predominantly derived from the initial variety, or from a variety that is itself predominantly derived from the initial variety, while retaining the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety, (ii) it is clearly distinguishable from the initial variety and (iii) except for the differences which result from the act of derivation, it conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety. (c) Essentially derived varieties may be obtained for example by the selection of a natural or induced mutant, or of a somaclonal variant, the selection of a variant individual from plants of the initial variety, backcrossing, or transformation by genetic engineering. Essentially Derived Varieties 26

27. 22 years  It Takes 22 years for a Breeder to Develop a New, Innovative Apple Variety Pictures © IFO Essentially Derived Varieties 27

28.  What is the legal situation if somebody finds in his nursery a mutation of this apple variety, or if somebody introduces a resistance gene into a plant of this variety  Mutations and GMO of an innovative initial variety can take a big market share of the initial variety, at low cost  The breeder of the innovative initial variety will earn a reduced return on investment, if his market is shared by low-cost mutations and GMO  It is therefore fair that the original breeder of the innovative variety receives his share from the commercialization of the mutations and GMO Essentially Derived Varieties 28

29.  Differing Interpretations of the EDV Concept by Courts Complicates the Situation for Breeders: Danziger vs. Astée Flowers B.V. (Appeal Court of the Hague, 29 December 2009, case 105.003.932/01) Danziger vs. Hananya Azolay and Astée Flowers B.V. (District Court of Tel-Aviv-Jaffa, 5 March 2009, case 001228/03) Van Zanten Plants B.V. vs. Hofland B.V. (District Court of the Hague, 6 August 2008, case 310918/KG ZA 08- 594) Probstdorfer Saatzucht GmbH & Co. KG vs. Pflanzzucht Oberlimpurg (Court of First Instance of Mannheim, 10 December 2010, case 7 O 442/04) Essentially Derived Varieties 29

30. Patents for Plant Innovation Pluot ® 30

31.  Patent Protection for Plant Innovation in the EU and its Member States: No Patents for plant varieties No Patents for plant varieties (Article 53 b) of the European Patent Convention (EPC) and Article 4 1. (a) of the EU Biotech Directive 98/44/EC No Patents for essentially biological processes No Patents for essentially biological processes for the production of plants (Article 4 1. (b)). EBoA (Broccoli and Tomato I, of 9 December 2009, G2/07 and G1/08): Every process which consists of the steps of sexually crossing the whole genomes of plants and subsequently selecting plants is in priciple excluded from patentability Patents for Plant Innovation 31

32. 32 On 25 March, the EBoA had to answer the question whether plants or plant material, which have been produced by way of an essentially biological process, are patentable. The Decision: product inventions are not excluded from being patented. 1. The scope of application of the term “essentially biological processes for the production of plants” is interpreted to the effect that product inventions where the claimed subject matter is directed to plants or plant material such as fruit or plant parts other than a plant variety, as such, are not excluded from being patented. The exception to patentability is limited to claims directed to processes. 2. The exception to patentability is limited to claims directed to processes. Broccoli / Tomato Case II

33.  Patent Protection for Plant Innovation in the EU plants shall be patentable Inventions which concern plants shall be patentable if the technical feasibility of the invention is not confined to a particular plant variety. Plants obtained by an essentially biological process are patentable Plants obtained by an essentially biological process, such as crossing and selection, are patentable, too (EBoA G 2/2012 (Tomato II) and G 2/2013 (Broccoli II) There is a strong debate among stakeholders and politics about the future of Patents in the pant world. Patents for Plant Innovation 33

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35.  A look outside the EU on Patents for Plants and Plant Varieties: USA:USA: Plant Patent Utility Patent Plant Patent for asexually reproduced plant varieties Utility Patent for any kind of plants and plant varieties No breeders´ exemption Very limited research exemption Australia:Australia: Patent Patent for any kind of plants and plant varieties Patents for Plant Innovation 35

36.  As science progresses, the relevant IP tools should also be improved in order to cover the new scenarios  Patents or PBRs must offer adequate protection to those who invest huge resources in innovation  Breeders of ornamental and fruit varieties ask for an improvement of the UPOV 1991 Act  Tailor-made protection for these breeders may be found somewhere between UPOV 1991 and Patents Conclusions 36

37. Thank You for Your Time and Attention www.CIOPORA.org