Patents On Life: Crisis of Ethics in the EU

1. Patents On Life: Crisis of Ethics in the EU

2. Greenpeace opposes „patents on life“ • No patents on gene-sequences • No patents on living beings such as plants, seeds, animals • Keep genetic resources in the public domain • renegotiation of EU Dir 98/44 • clear exemptions under WTO/ Trips and WIPO

3. What is the problem? • ethical reasons: living nature is not a technical invention • science based 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 economical reasons: Patents can block access to genetic resources. This is a problem in agriculture, plant breeding and health care.

4. Granted patents in Europe: Overview 1980-2005(from official figures EPO database) Granted: • Gene sequences from humans and animals 1752 • Animals 233 • Plants 558 Applications: • Gene sequences from humans and animals ca 10.000 • Animals ca 3000 • Plants ca 3000

5. Case studies: Micro-organisms

6. Evidence about existing problems: Microorganism • “The Malaria Vaccine Initiative (MVI) has identified a particular protein antigen (MSP-1) which may be crucial to the development of an effective vaccine for malaria. The ownership of patents relating to this protein was investigated, uncovering some surprising findings: • The patenting of the DNA sequences for the antigen is very complex. There are up to 39 patent families that are potentially relevant in developing the vaccine from MSP • Faced with such a situation, a commercial research organisation might decide to shift to another area of research. “ (Integrating Intellectual Property Rights and Development Policy, CIPR Commission on Intellectual Property Rights, htttp//www.iprcommission.org)

7. Case studies: Human genes

8. Evidence about existing problems: Human genes • 25% of US laboratories questioned have stopped testing procedures due to claims by patent holders, • 53% did not develop their own, improved diagnostic methods because relevant patents had already been granted. • Conclusion: ”Laboratory directors in the US believe that patents and licenses have had a negative impact on access, cost, and quality of testing, and on information sharing between researchers.” • Mildred Cho, Stanford University Center for Biomedical Ethics, Effects of gene patents and licenses on clinical genetic testing, Presentation at OECD Workshop in Berlin, 25 Jan 2002 • Merz, J.F. et al, Nature, 7 February 2002, Diagnostic testing fails the test.

10. Patent of Myriad, BRCA1 • Claim 1: “An isolated nucleic acid which comprises a coding sequence for the BRCA1 polypeptide .....” • Claim 4: “An isolated nucleic acid which is ... comprising a DNA ... having the following mutations..” • Claim 15: “An isolated human BRCA1 polypeptide ....” • Claim 29: “A wild type BRCA1 polypeptide ..” • Claim 30: “Use of a polypeptide..for use in peptide therapy.” • Claim 31: “A method for screening potential breast and or ovarian cancer therapeutics...” • Claim 34: “A transgenic non human animal...”

11. Evidence about existing problems: Human genes • Myriad´s patent on breast cancer gene “The Europeans are challenging Myriad's patents that give it an unofficial monopoly. The Europeans also say that because the firm refuses to grant manufacturing licences, all DNA samples will have to be sent to the Myriad Genetics headquarters in Salt Lake City for processing, providing the company with a unique databank about people at high risk.” • (ETHICAL GUIDELINES URGENTLY NEEDED FOR COLLECTING, PROCESSING, USING AND STORING HUMAN GENETIC DATA, SOURCE: UNESCO, Press Release No.2002-93, http://www.unesco.org/bpi/eng/unescopress/2002/02-97e.shtml, DATE: Nov 25, 2002)

12. Case studies: Plants

14. Patent of Monsanto, herbicide resistant plants • Claim 28: A glyphosate tolerant plant .. Selected from the group consisting of corn, wheat, rice, soybean, cotton, sugerabeet, oilseed rape, canola, flax, sunflower, potato, tobacco, tomato, alfalfa, poplar, pine, apple and grape. • Claim 29: A method ..planting said crop seeds....and applying to said crop and weeds in said field a sufficient amount of ... herbicide

15. Patent of Monsanto, herbicide resistant plants !! On the basis of this patent Monsanto files court cases in Europe against Argentinean soy farmers which import their harvest by shipments, to force them to pay royalties.

17. Patent of Dupont, high oil maize corn • Claim 1: Corn grain having a total oil content of at least .... • Claim 8: Animal feed comprising the corn grain • Claim 11: Method of improving the carcass quality of animals by feeding ... • Claim 14: The use of the oil .. in food, animal feed, cooking.. • Claim 15: The use of the oil .. To make margarine, salad dressings, cooking oils .. • Claim 16: A method for producing the corn grain ... • planting ... • permitting said male corn plants to pollinate.. • Harvesting the resulting corn grain on all corn plants

18. MAB (marker assisted breeding) makes it possible to identify normal occurring genetic conditions which are for example related to pest or stress resistance, important food compounds (minerals, vitamins) or higher yielding. There is a change in the underlying paradigma: The genomic data are no longer only relevant for (highly controversial) genetic engineering in plants, but for optimizing conventional breeding. New Quality: Patent applications from Syngenta on rice genome

19. More than a dozen patents were filed worldwide, more or less claiming property on the whole genome of the rice plants Several thousands of gene sequences are claimed as invention of Syngenta. Related plant qualities are resistat to certain stress conditions, pest organism and compounds of special nutritional value. New Quality: Patent applications from Syngenta on rice genome

20. All uses of the listed gene sequences are claimed, no matter if the usage applies in biotechnological or conventional breeding. Claims are aiming to all gene sequences with similar structures and similar functions. All other plant species with similar genes are covered by the patent applications New Quality: Patent applications from Syngenta on rice genome

21. Some evidence about existing problems: Seeds • 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, http://www.iprcommission.org)

22. Legal framework - plants and seeds: pending problems patent vrs plant variety protection (PVP): • no clear distinction between PVP and patents ( see position of German Government) • patent protection stronger, broader and easier to obtain • in practise patentholder will dominate PVP holder – PVP will loose its key function for breeding • impact for structure of seeds market in Europe can be dramatical • farmers can not survive in legal cases with multinationals

23. Legal framework - plants and seeds: pending problems • Entry point for patents too low (see definition of biological procedures): natural components of plants, natural inherited (marker) genes can be used easily to describe a plant as an >invention< (see in comparision Monsanto´s application for pig breeding, WO 2005/015989) • patents cover seeds, planting, harvest up to food: European patents even used to gain roaylties from harvest in South America • Meanwhile patents are pending covering whole genome of plants (see for example Syngenta´s rice claims)

24. Some evidence about existing problems: Seeds “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.” (Crop improvement: A dying breed, Nature 421: 568-570, by Jonathan Knight, Feb 6, 2003)

25. Case studies: Animals

27. From 2005 on, the US company Monsanto filed about a dozen global patent applications on normal pigs and related breeding methods. New Quality: Patent applications from Monsanto on pigs

28. Examples: WO 2005/015989 covers the idea how to combine the normal elements of breeding and claims whole herds of animals. WO 2005/017204 refers to genetic diagnosis of pigs for a certain gene, which is related to faster growth. Not only the method is claimed but also the whole animals are subjected to the claims. New Quality: Patent applications from Monsanto on pigs

29. Conclusion • Human body is subjected to commercialisation on several levels (organs, cells, genes) • Legally unclear situation concerning patent on genes • Seeds under dramatically increasing monopoly control • Prohibitions in context of ethics not sufficient • Regulations and laws not coherent in EU • General legal uncertainity • Time for a new directive

30. STOP PATENTS ON SEEDS!