8-Humans: European Parliament and medical geneticists object to patents on breast cancer genes

[GENET <genetnl@xs4all.be>]

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TITLE:  European Parliament and medical geneticists object to patents on
        breast cancer genes
SOURCE: Human Genetics Alert, UK
DATE:   October 2001

------------------ archive: http://www.gene.ch/genet.html ------------------


European Parliament and medical geneticists object to patents on breast 
cancer genes

Earlier this month, the European Parliament passed a resolution condemning 
the decision of the European Patent Office to grant a patent to the US 
company Myriad Genetics covering all DNA testing for mutations in the BRCA1 
gene (scroll down list of EP texts for 4 October <http://
www3.europarl.eu.int/omk/omnsapir.so/pv2?PRG=CALEND&APP=PV2&LANGUE=EN&TPV=
PROV&FILE=011004> to find "Patenting of human genes"). The resolution 
instructs EP officials to prepare an official objection to the patent. The 
medical genetics societies of the UK, the Netherlands, Belgium, Germany and 
Denmark have released a statement supporting the stance of the European 
Parliament. Their objections to the patent include a claim that the test 
offered by Myriad is not the best test available (it fails, for example, to 
detect large deletions in the gene, a type of lesion that is "a common 
feature of mutant BRCA1 genes in Europe"), and that the removal of BRCA1 
testing from European medical genetics laboratories would prevent the 
development of improved testing technology. The UK Clinical Molecular 
Genetics Society, issuing the statement in the UK, adds that the patent 
grants Myriad a monopoly on BRCA1 testing that is against the public 
interest (further detailed arguments <http://www.cmgs.org/patents.htm> are 
presented on the CMGS website). These moves come shortly after the French 
government announced that it would support the Institut Marie Curie in 
opposing the granting of the BRCA1 patent (see item in September newsletter 
<http://www.medinfo.cam.ac.uk/phgu/newsletter/past_issues/sep01.asp> ), and 
appear to be part of a growing opposition in Europe to the granting of 
patents on gene sequences.

*****

European Parliament
Texts Adopted by Parliament
Provisional Edition : 04/10/2001
Contents
Patenting of human genes
Top of Form
B5-0633, 0641, 0651 and 0663/2001

European Parliament resolution on the patenting of BRCA1 and BRCA2 ('breast 
cancer') genes

The European Parliament,

- recalling its resolution of 30 March 2000 on the decision by the European 
Patent Office with regard to patent No EP 695 351 granted on 8 December 
1999(1) <http://www3.europarl.eu.int/omk/omnsapir.so/> , calling on the EPO 
"to ensure that all ... patent applications in Europe do not violate the 
principle of non-patentability of humans, their genes or cells in their 
natural environment...",

- having regard to the "Advice on the patentability of the human genome", 
adopted by consensus by the International Bioethics Committee of Unesco 
(IBC) at the conclusion of its Eighth Session on 14 September 2001 which 
states "that there are strong ethical grounds for excluding the human 
genome from patentability" and further recommends "that the World Trade 
Organisation (WTO), in its review of the TRIPS Agreement, clarify that, in 
accordance with the provision of Article 27(2)1, the human genome is not 
patentable on the basis of the public interest considerations set out 
therein, in particular, public order, morality and the protection of human 
life and health",

A. whereas a US company, Myriad Genetics, has been granted US patents on 
the so-called "breast cancer genes" BRCA1 and BRCA2 and has applied to the 
European Patent Office for patents on these genes as well,

B. whereas, in the US, genetic laboratories are licensed by Myriad Genetics 
to test for a very limited number of mutations of BRCA1 and 2 only (with a 
fee payable) and are obliged to refer for any further testing to Myriad 
Genetics, thus incurring further and considerable expense,

C. whereas cheaper and more effective methods of testing for breast cancer 
genes BRCA1 and BRCA2 exist in the European Union and whereas the existing 
US patents are already impeding their use,

D. whereas the European Patent Convention, in particular its Article 
52.2(a), stipulates that no patents shall be granted for discoveries, and 
Article 53(a) excludes inventions the publication or exploitation of which 
would be contrary to "public order" or morality from patentability,

E. whereas the granting of similar patents by the EPO could create a 
monopoly for the firm in question within the European Union as well, which 
could seriously impede or even completely prevent the further use of 
existing cheaper and more effective tests for the breast cancer genes BRCA1 
and BRCA2; whereas this development could have an unacceptable detrimental 
effect on the women concerned and constitute a serious drain on the funds 
of public health services; whereas moreover it could seriously impede the 
development of and research into new methods of diagnosis,

F. whereas the EPO granted patents on BRCA1 to Myriad Genetics in the form 
of Patent No 699 754 of 10 January 2001 and Patent No 705 903 of 23 May 
2001 and is considering granting further patents on the breast cancer genes 
BRCA1 and BRCA2,

G. whereas the time limit for lodging objections to Patent No EP 699 754 of 
10 January expires on 10 October 2001, and whereas the Institut Curie and 
the French Ministry of Health intend to lodge an objection to this patent,

1. Expresses its dismay at the possible consequences of the granting by the 
European Patent Office of a patent on a human gene;

2. Reiterates its call on the European Patent Office "to ensure that all 
... patent applications in Europe do not violate the principle of non-
patentability of humans, their genes or cells in their natural 
environment...";

3. Calls on the EPO to reconsider patenting these genes and associates 
itself with those tabling objections to the granting of these patents, such 
as the Institut Curie, and reiterates its demand for a review of the 
operations of the EPO to ensure that it becomes publicly accountable in the 
exercise of its duties, and for amendment of the European Patent Convention 
to ensure that the EPO may revoke patents on its own initiative;

4. Reiterates its call on the Council, the Commission and the Member States 
to adopt the measures required to ensure that the human genetic code is 
freely available for research throughout the world and that medical 
applications of certain human genes are not impeded by means of monopolies 
based on patents;

5. Asks its competent services to prepare without delay an objection to be 
filed to European patents No. 699 754 and No. 705 903 and calls on the 
other institutions of the EU and Member State governments to do likewise;

6. Instructs its President to forward this resolution to the Council, the 
Commission, the European Patent Office and the governments of the Member 
States.



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