Patents on Seeds and Animals, Eggs & Bacon, Tomatoes and Melons

Transcription

1 Patents on Seeds and Animals, Eggs & Bacon, Tomatoes and Melons November 2011 Dr. Christoph Then

2

3 History of patent law English patent law of 17th century was about granting privileges by the crown the markets of salt, steel, glass, beer and others were controlled by 'patent' monopolies

4 History of patent law Modern patent law: granting patents for technical inventions Not meant to cover discoveries or natural phenomena but to foster new inventive technical processes and products Nowadays: Patents are granted on gene sequences, plants and animals... Shift of paradigm: from protection of inventions to control on resoures

5 History of patent law: Examples 1980: bacteria (USA) 1988: 'oncomouse' (genetically engineered mammal) (USA) 1992: 'oncomouse' (Europe) 1996: genetically engineered soy (Europe) 1998: European Patent Directive 98/44 EC 2001: human gene for hereditary breast cancer (BRCA) (Europe) 2002: patent on conventional broccoli (vegetable) (Europe) 2008: patent on conventional breeding in pigs (Europe) 2010: EPO decides about conventional breeding (G2/07; G1/08) 2011: EPO forwards tomato patent to Enlarged Board of Appeal

6 general problems with >patents on life< ethical reasons: living nature is not a technical invention scientific arguments: a gene sequence is not a normal chemical substance but a code of information with a lot of different functions. A holder of a patent which describes one commercial use should not get a monopoly on all possible functions. social and economic reasons: Patents can block access to genetic resources. This is a problem in agriculture, plant breeding and health care.

7 granted patents in Europe until end of 2010 Granted: Gene sequences humans / animals Animals Plants

8 The 'oncomouse'

9 The 'oncomouse' Patent covers: the technical process the animals their offsprings

10 European patents on animals

11 European patents on plants

12 the Roundup Ready case, EP

13 Das Imperium von Monsanto Quelle: Economic research service/ USDA Howard, P.H Visualizing Consolidation in the Global Seed Industry: , Sustainability 2009, 1, ; doi: /su Institut für unabhängige Begleitforschung in der Biotechnologie

14 EPO/ WIPO: patent applications covering conventional breeding Patent applications covering methods without genetic engineering

15 EPO: Patents granted on conventional breeding EP patents granted on conventional breeding

16 Patent applications on conventional breeding : Dupont, Monsanto, Syngenta Dupont/ Pioneer 2005 Monsanto % of their plant patent applications 2006 Syngenta

17 Patent applications on vegetables at the EPO melon, cucumber, squash lettuce tomato onion brassica carrot pepper

18 Broccoli: the precedent case (G2/07)

19 Broccoli: the precedent case (G2/07) 1. A method for the production of Brassica oleracea with elevated levels of (...) glucosinolates (...) which comprises: (a) crossing wild Brassica oleracea species with Brassica oleracea breeding lines; and, (b) selecting hybrids with levels (...) glucosinolates (...), elevated above that initially found in Brassica oleracea breeding lines.

20 Broccoli: the precedent case (G2/07) 9. An edible Brassica plant produced according to the method (...) 10. An edible portion of a broccoli plant produced according to the method (...) 11. Seed of a broccoli plant produced according to the method (...)

21 Tomato: the second precedent case (G1/08) Reduced water content

22 Sunflower seed, plant and oil derived from mutation breeding

23 EP Monsanto Resistance against viral disease

24 Soy patent covering the food chain

25 Trees selected by genetic fingerprints

26 EP MARKER ASSISTED SELECTION OF BOVINE FOR IMPROVED MILK PRODUCTION

27 'Monsanto' pig patent EP Claim 4: A method of enhancing meat production from a swine herd comprising: a) screening a plurality of pigs [...] b) selecting those pigs having a desired allele; and c) using the selected pigs as sires/dams in a breeding plan to produce offspring; [...] d) repeating steps a) through c) until an increased allelic frequency for the desired allele is achieved.

28

29 Upcoming: from feed to meat % Yield % Chemicals % Seeds Wheat Rice Maize Soy??? Cotton

30 Monsanto's patent applications on meat and fish WO Claim 1: a pork product for human consumption... Claim 18: (...) consisting of bacon, ham, pork loin, pork ribs, pork steaks (...) Claim 34: A method of producing pigs comprising: a) providing a nutritious composition (...), b) feeding said nutritious composition to at least one pig; and c) producing progeny from said at least one pig... WO : similar claims in aquaculture

31 How to turn plants into inventions measuring content of compounds in plants (such as oil or protein) describing phenotypical features (such as number of leaves or size of plants, yield, growth, biomass) detecting resistance against biotic or abiotic stress genomic screening for naturally occurring genetic conditions mutagenesis

32 plant variety protection vrs. patents PVP rights are restricted to a distinct single variety, while patents cover whole range of species and classes. PVP system allows free access to any commercial traded seed for the purpose of further breeding ( breeders exemption ). Thus it works as a open source system for other breeders. Patents can block access to genetic resources to large extent.

33 plant variety protection vrs. patents Patents do not end as long as the patented genetic conditions can be found in any progeny. After crossing of plants there can be an increasing accumulation of patents. Patents allow claiming the whole chain of food production: Seeds, plants, cultivation, harvest and its processing are subjected to monopoly control.

34 abuse of patent law to control chain of food production

35 Impact on breeders, farmers and world food supply The European Group on Ethics in Science and New Technologies to the European Commission, Opinion Nr. 24, Oktober 2008: The Group supports promotion of innovation in agriculture but is concerned about the impact of patents on agricultural crops.

36 Impact on breeders and innovation Recently more and more patents are applied on naturally occurring genetic resources on the basis of new technologies that allow precise description of natural genetic conditions up the sequencing of whole genomes. This practise in patenting opens up new conflicts and inherits the risk to erode the principles of plant variety protection, especially concerning the access plants and therefore to genetic variability. The development is a threat of slowing down innovation in plant breeding, to narrow genetic diversity and increase dependency from license holders. (German Plant Breeders Association)

37 Impact on breeders and innovation Some IP systems, such as trademark law and plant breeder s rights, can simply be used by small companies but patent rights are different. ( ) Patent applications, however, require specialised patent attorneys to describe the invention and to formulate the claims. It may take years before rights are granted and the value of a patent may not become clear until it has been opposed, which may lead to long legal procedures. The legal costs of such a procedure may cause a financially weaker party to surrender already after a threat with a court case. (Louwaars, 2009)

38 Impact on breeders and innovation Earlier discussions, however, indicate that large American companies spend more on legal council than on R&D. This justifies the question whether the current patent system yields the best added value for society in the plant breeding sector, assuming that innovative R&D and not lawyers are coming up with solutions for policy challenges such as food security, protection of the environment, adaptation to climate change etc. (Louwaars, 2009)

39 Impact on farmers For most crops only a few companies are controlling a large part of the world market. This makes a growing part of the global food supply dependent on a few companies. (...) Farmers and growers fear that their freedom of choice is threatened and that no varieties will be developed for certain crops that specifically meet their requirements (...). (Louwaars, 2009)

40 Impact on world food supply If this trend isn't halted, some experts claim, tomorrow's supercrops may end up like many of today's medicines: priced out of the reach of much of the developing world's growing population. `We are headed down the same path that public-sector vaccine and drug research went down a couple of decades ago, says Gary Toenniessen, director of food security at the Rockefeller Foundation in New York. source: Crop improvement: A dying breed, Nature 421: , by Jonathan Knight, Feb 6, 2003

41 Impact on world food supply IAASTD (International Assessment of Agricultural Science and Technology for Development), 2008: In developing countries especially, instruments such as patents may drive up costs, restrict experimentation by the individual farmer or public researcher while also potentially undermining local practices that enhance food security and economic sustainability.

42 Impact on world food supply Because of the generally negative effects of patents in plant breeding, the UK Commission on Intellectual Property Rights explicitly advises developing countries to completely ban patents on plants and seeds. (UK Commission on Intellectual Property Rights, 2002, Integrating Intellectual Property Rights and Development Policy,

43 Impact on world food supply The essential purpose of food, which is to nourish people, has been subordinated to the economic aims of a handful of multinational corporations that monopolize all aspects of food production, from seeds to major distribution chains (...). Miguel d Escoto Brockmann, UN-General Assembly, 2008

44 EU Legal framework patent on plants (Dir. 98/44) Article 4 1. The following shall not be patentable: (a) plant and animal varieties; (b) essentially biological processes for the production of plants or animals.

45 EU Legal framework patent on plants (Dir. 98/44) Article 4 2. Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety

46 EU Legal framework patent on plants (Dir. 98/44) Article 2: A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.

47 EU Legal framework patent on plants (Dir. 98/44) Article 8 1. The protection conferred by a patent on a biological material (...) shall extend to any biological material derived from that.. 2. The protection conferred by a patent on a process (...) shall extend to biological material directly obtained through that process and to any other biological material...

48 What was decided at the EPO (G1/08) 1. A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being "essentially biological" within the meaning of Article 53(b) EPC. 2. Such a process does not escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants.

49 What was decided at the EPO (G1/08) 3. If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under Article 53(b) EPC. 4. In the context of examining whether such a process is excluded from patentability as being "essentially biological" within the meaning of Article 53(b) EPC, it is not relevant whether a step of a technical nature is a new or known measure, whether it is trivial or a fundamental alteration of a known process, whether it does or could occur in nature or whether the essence of the invention lies in it.

50 The coalition of 'no patents on seeds' is demanding no patents on: Plants and animals Process for breeding plants and animals Gene sequences from plants and animals Food derived from plants and animals

51 Recent statements

52

53

54

55 contact: