Patents On Life: Crisis of Ethics in the EU

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Patents On Life Crisis of Ethics in the EU
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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

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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.

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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

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• Case studies Micro-organisms

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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.iprcommis
  sion.org)

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• Case studies Human genes

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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.

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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...

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Evidence about existing problems Human genes

• Myriads 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/u
  nescopress/2002/02-97e.shtml, DATE Nov 25,
  2002)

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• Case studies Plants

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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

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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.

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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

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New Quality Patent applications from Syngenta on
rice genome

• 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.

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New Quality Patent applications from Syngenta on
rice genome

• 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.

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New Quality Patent applications from Syngenta on
rice genome

• 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

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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)

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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

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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 gtinventionlt
  (see in comparision Monsantos 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 Syngentas rice
  claims)

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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)

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• Case studies Animals

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New Quality Patent applications from Monsanto on
pigs

• From 2005 on, the US company Monsanto filed about
  a dozen global patent applications on normal pigs
  and related breeding methods.

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New Quality Patent applications from Monsanto on
pigs

• 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.

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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

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STOP PATENTS ON SEEDS!