1. Subject matter of patents -Louis Pasteur’s U.S. patent 135,245 for "Improvement in Brewing Beer and Ale Pasteurization" (1873)

2. Expansion of patent protection of biological materials US Supreme Court in re Chakrabarty (1980): patentability of ‘anything under the sun that is made by man“ US Supreme Court in re Chakrabarty (1980): patentability of ‘anything under the sun that is made by man“ Isolated natural gene + function patentable: discovery or invention? Isolated natural gene + function patentable: discovery or invention?

3. Microorganisms Microorganisms Cells Cells Subcellular parts (e.g. genes, partial sequences) Subcellular parts (e.g. genes, partial sequences)

4. European Directive on Biotechnological Inventions (98/44/EC ) Article 3 1. ‘…inventions… shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. 2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.

5. TRIPS Agreement 27.3(b)Members may also exclude from patentability:... (b)plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes...

6. Possible exclusions from patentability Plants (even if genetically modified) Plants (even if genetically modified) Plant varieties Plant varieties Parts and components of plants ? Parts and components of plants ? Natural’ microorganisms Natural’ microorganisms Essentially biological processes, including the use of marker-assisted selection (MAS) Essentially biological processes, including the use of marker-assisted selection (MAS)

7. Scope of patent rights: gene patents Absolute protection (all possible functions) Absolute protection (all possible functions) Use bound protection (only the disclosed function) Use bound protection (only the disclosed function)

8. ECJ General Advocate ‘Directive 98/44 permits and, in fact, requires an interpretation to the effect that, in EU territory, the protection conferred on DNA sequences is a 'purpose-bound' protection’. (C ‐ 428/08, Monsanto Technology LLC v Cefetra BV et alparagraph 29).

9. Article L613-2-1, French Industrial Property Code, as amended in 2004 The scope of a claim on a gene sequence is limited to that part of the sequence directly linked to the function specifically disclosed in the specifications. Such a claim cannot be enforced against a subsequent claim on the same sequence that discloses another specific application thereof.

10. Brazilian Industrial Property Code (No. 9.279, 14 May 1996) …excludes from patentability living beings or ‘‘biological materials found in nature’’, even if isolated, including the ‘‘genome or germplasm’’ of any living being (article 10.IX).

11. Myriad-Supreme Court Naturally occurring genes (DNA), even if isolated, are not a valid patentable subject matter. However, cDNA is patentable (synthesized DNA that contains the same information found in natural DNA although it omits portions – introns- that do not code for proteins ).

12. Gene patents: Gene patents: “a lawyer’s trick” “The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth,” US Department of Justice-Amicus curiae in Association for Molecular Pathology v Myriad Genetics (569 U.S. 12- 398, 2013)

13. Plant patents Plant patents

14. IP protection of plants Plant Patents USA 1930 Plant Patents USA 1930 PVP Netherlands 1942, Germany 1953 PVP Netherlands 1942, Germany 1953 Revision of the Paris Convention, Lisbon (1958) Revision of the Paris Convention, Lisbon (1958) UPOV 1961 UPOV 1961

15. Limits to patent protection of plants European Patent Convention (1973): exclusion of ‘plant varieties’ and of essentially biological processes European Patent Convention (1973): exclusion of ‘plant varieties’ and of essentially biological processes UPOV 1978: non-accumulation of patents and PVP UPOV 1978: non-accumulation of patents and PVP

16. DNA-related patents DNA sequence (complete or partial gene) DNA sequence (complete or partial gene) promoters promoters enhancers enhancers transit peptides transit peptides individual exons individual exons cloning vectors cloning vectors expression vectors expression vectors amino acid sequences (proteins) amino acid sequences (proteins) nucleic acid probes nucleic acid probes isolated host cells transformed with expression vectors isolated host cells transformed with expression vectors modified plants modified plants

17. Genetically modified plants The exclusion of plant varieties from patenting does not apply to plant types in general that are modified by patentable biotechnological processes. The exclusion of plant varieties from patenting does not apply to plant types in general that are modified by patentable biotechnological processes. EPO Enlarged Board of Appeal, Novartis (2000) EPO Enlarged Board of Appeal, Novartis (2000)

18. Implications of plant patents Patents may prevent… Patents may prevent… farmers from saving and re-using seeds farmers from saving and re-using seeds

19. Research exemption PVP: use of protected varieties for further breeding—new variety may be independently commercialized PVP: use of protected varieties for further breeding—new variety may be independently commercialized Patents: research or experimentation on the invention---improved plant/variety cannot be independently commercialized Patents: research or experimentation on the invention---improved plant/variety cannot be independently commercialized

20. Interface patent-PVP: compulsory license Breeder cannot commercialize a plant variety without infringing a patent Breeder cannot commercialize a plant variety without infringing a patent Patentee cannot commercialize an invention without infringing a PVP Patentee cannot commercialize an invention without infringing a PVP

21. Implications of plant patents Extension of protection to derivatives: the Monsanto case Extension of protection to derivatives: the Monsanto case

22. Are derivatives subject to a patent over a trait? Customs’ detainment of soya meal shipments from Argentina Customs’ detainment of soya meal shipments from Argentina Spain, UK: first instance; Netherlands: intervention of European Court of Justice Spain, UK: first instance; Netherlands: intervention of European Court of Justice European Commission: no infringement European Commission: no infringement

23. Implications of plant patents Protection of technologies in the state of the art Protection of technologies in the state of the art Misappropriation of genetic resources and TK Misappropriation of genetic resources and TK

24. Misappropriation + low inventive step US patent 5894079 April 13, 1999 on a ‘new field bean variety that produces distinctly colored yellow seed which remain relatively unchanged by season’ and a method for producing it. US patent 5894079 April 13, 1999 on a ‘new field bean variety that produces distinctly colored yellow seed which remain relatively unchanged by season’ and a method for producing it.

25. Process to obtain a hybrid A novel combination of traditional plant breeding techniques that results in plants and seeds A novel combination of traditional plant breeding techniques that results in plants and seeds Decision T320/87, Lubrizol (1990) Decision T320/87, Lubrizol (1990)

26. New developments: a turning point? Patent applications relating to ‘native’ traits and conventional breeding methods Patent applications relating to ‘native’ traits and conventional breeding methods (e.g. EP 1069819 on broccoli and EP 1211926 on tomatoes) (e.g. EP 1069819 on broccoli and EP 1211926 on tomatoes)

27. A method for the production of Brassica oleracea EP 1069819 A method for the production of Brassica oleracea (...) which comprises: A method for the production of Brassica oleracea (...) which comprises: (a) crossing wild Brassica oleracea species with Brassica oleracea breeding lines; and (a) crossing wild Brassica oleracea species with Brassica oleracea breeding lines; and (b) selecting hybrids with levels of 4- methylsulfinylbutyl glucosinolates, or 3- methylsulfinylpropyl glucosinolates, or both, elevated above that initially found in Brassica oleracea breeding lines. (b) selecting hybrids with levels of 4- methylsulfinylbutyl glucosinolates, or 3- methylsulfinylpropyl glucosinolates, or both, elevated above that initially found in Brassica oleracea breeding lines.

28. Method for breeding tomatoes having reduced water content and product of the method (EP 1211926 B1) A method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of: A method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of: crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to produce hybrid seed; crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to produce hybrid seed; collecting the first generation of hybrid seeds; collecting the first generation of hybrid seeds; growing plants from the first generation of hybrid seeds; growing plants from the first generation of hybrid seeds; pollinating the plants of the most recent hybrid generation; pollinating the plants of the most recent hybrid generation; collecting the seeds produced by the most recent hybrid generation; collecting the seeds produced by the most recent hybrid generation; growing plants from the seeds of the most hybrid generation; growing plants from the seeds of the most hybrid generation; allowing plants to remain on the vine past the point of normal ripening; and allowing plants to remain on the vine past the point of normal ripening; and screening for reduced fruit water as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin. screening for reduced fruit water as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin.

29. Patentability of animals Genetically modified or not Genetically modified or not Cloned Cloned Laboratory or farm animals Laboratory or farm animals

30. Animal patents in Europe Harvard ‘’oncomouse’’ Harvard ‘’oncomouse’’ Super-salmon Super-salmon Clones of pigs, horses, cows, antelopes, goats and sheeps (and resultant embryos) Clones of pigs, horses, cows, antelopes, goats and sheeps (and resultant embryos) Process for breeding cows which produce more milk or altered milk Process for breeding cows which produce more milk or altered milk

31. European Patent Convention Article 52 (a) Invention against public order or morality (abhorrent to the public; balance of interest Article 53 Exceptions to patentability (b) plant or animal varieties or essentially biological processes for the production of plants or animals... (b) plant or animal varieties or essentially biological processes for the production of plants or animals...

32. EPO jurisprudence -Relaxine case (isolation of RNAm from tissue of pregnant women) -Relaxine case (isolation of RNAm from tissue of pregnant women) Plant Genetic Systems (genetically modified plant) Plant Genetic Systems (genetically modified plant) Leland Stanford (use of human red blood cells extracted from aborted foetus or very young children) to modify an animal Leland Stanford (use of human red blood cells extracted from aborted foetus or very young children) to modify an animal

33. Animal patents in the USA Chicken Avian sex identification probes Cattle Genetic marker for superior milk products Allelic variants of bovine somatotropin gene Genetic marker for improved milk production Methods for assessing the beef characteristics Double muscling in mammals Assessing lipid metabolism Sheep Screening for … spider lamb syndrome in sheep Pig Diagnosis for porcine malignant hyperthermia Method…genetic marker for increased pig litter size Methods for determining the coat color …of a pig

34. Marine genetic resources Over 500 worldwide patents related to krill (pink gold)

35. Animal Hat Apparatus and Metbod Patent Number: 4,969,317 Date of Patent: Nov. 13, 1990 Inventor: April Ode, Lake Havasu City, AZ