Transcript media.ffii.org

Patents On Life:
Crisis of Ethics in the EU
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
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.
Granted patents in Europe: Overview 1980-2005
(from official figures EPO database)
Granted:
• Gene sequences from humans and animals
• Animals
• Plants
1752
233
558
Applications:
• Gene sequences from humans and animals
• Animals
• Plants
ca 10.000
ca 3000
ca 3000
Case studies: Micro-organisms
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)
Case studies: Human genes
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.
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...”
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)
Case studies: Plants
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
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.
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
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.
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.
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
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)
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
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)
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 publicsector 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)
Case studies: Animals
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.
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.
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
STOP PATENTS ON SEEDS!