[BIO-IPR] Update on the EU patenting directive
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- Subject: [BIO-IPR] Update on the EU patenting directive
- From: GRAIN Los Banos <firstname.lastname@example.org>
- Date: Mon, 25 Sep 2000 20:27:34 +0800
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TITLE: The Directive That Just Won't Lie Still
AUTHOR: Tommy Schweiger and GRAIN
PUBLICATION: Jointly elaborated for BIO-IPR
DATE: September 2000
NOTE: Fuller reference and contact details below.
THE DIRECTIVE THAT JUST WON'T LIE STILL
Tommy Schweiger and GRAIN (*)
If proponents of the European Union's (EU) directive 98/44/EC on
Protection of Biotechnological Inventions" had thought that its
1998 was the final step in a tumultuous 10-year saga, they are in for a
awakening. The directive is back on Europe's political agenda. The
for the transposition of the directive into national law was 30 July
But only three countries of the 15 made it. Many European governments
become very reluctant to implement the text which most of them adopted
enthusiastically at the EU level only two years ago. The stumbling block
the question of patenting human genes -- which the directive
Cracking the genome cracks the directive
Whatever hopes the EU had for smooth transposition of the directive
the deadline were derailed by the announcement on 26 June that the
genome had been decoded. In Europe, this opened up a strong public debate
the question of patentability of human genes. That debate was already on
rise. Just weeks prior to the news that our genetic code had been
US President Bill Clinton and UK Prime Minister Tony Blair called for
human genes to remain in the public domain. And earlier in the year,
publicity over a patent on human embryos, which had been granted by
European Patent Office (EPO) in 1999, caused an unprecedented public
As a result, the German government filed a legal opposition to the
Throughout these past months, the anxieties raised by patents on human
have dug deep into public policy-makers, east and west of the
There are several angles to their confusion and doubt:
(1) Are human genes inventions or discoveries?
Everyone seems to say that "raw" DNA sequences are definitely a
discovery. But why would finding out that, say, a protein serves a
function in the body, and trying to patent its use, amount to an
(2) What is the measuring stick of "novelty" and
"utility", requirements for
patent protection, in the field of gene patenting?
The US Patent and Trademark Office is in the process of redefining its
guidelines on this issue. And it is here that the EU directive is
(3) Is it ethical to grant patents over parts of the human genome?
Many professional societies, not to mention ordinary citizens, say no.
the 1997 Universal Declaration on the Human Genome and Human Rights tries
uphold the human genome as "the heritage of humanity".
(4) How will medical research proceed if access to information
human DNA requires costly licenses and complex negotiations? And what
the implications for the commercial development of new drugs and
To use a famous example, Myriad Genetics in the US holds numerous patents
the BRCA1 and BRCA2 breast and ovarian cancer genes. Myriad has given
Lilly and Co., also of the US, exclusive rights to market treatments
on the BRCA I sequence. On its own, Myriad charges $2,400 to $3,500
sequence a woman's DNA in search of BRCA mutations, which number in
hundreds. The cost is prohibitive, and the company has denied
rights to use the test.
In the face of these problems, one body after the other has been coming
hard against the patenting of human genes --and the EU directive. The
National Bioethics Committee, under mandate from the Secretary of State
Industry, filed an opinion on 6 June against the directive, calling for
renewal of discussions instead. "Knowledge of a gene sequence,"
human or non-human origin, the committee stipulated, "cannot in any
considered an invented product, and is therefore not patentable."
later, the Ministers of Research of the eight most industrialised
the so-called G8, communicated their consensus against the patenting
human genes. Then, on 30 June, the Parliamentary Assembly of the Council
Europe unanimously passed a resolution urging for a moratorium on
patenting of human genes. And if that weren't enough, the Assembly called
EU Member States to renegotiate the directive, not transpose it.
The Munich-Brussels fault line
If the aim of the EU directive was to harmonise patent law in Europe, it
failed miserably. The situation has become legally more confusing
incoherent than ever before.
The European Patent Office (EPO) in Munich has been rolling ahead despite
political wrangling. To date, the EPO has issued hundreds of human
patents. And it has managed to do so in a very devious way. In June
the Administrative Council of the EPO decided to adopt the EU directive
guideline for patent examination. That means that the EPO is
the rules of directive, even though the EU member states have not
it in their national laws! This is all the more twisted since the EPO is
an institution of the European Union. It implements the European
Convention (EPC), a treaty drawn by both EU and non-EU countries.
To complicate matters further, the parties to the EPC are going to
renegotiate their Convention this November. And as far as
patents are concerned, they do not plan on changing their rules. They
on sticking with the directive, as adopted by the EU membership in
a basis for deciding what is permissible in this field. Even if
governments are not willing to fix the directive in national law?
Three strikes, you're out
There seems only one way out of the mess: renegotiate the whole directive
European level, for a third time. There are increasingly loud voices
for this. Several powerful lobby groups, which kept silent during the
in 1998, have since come out against the directive. Most notably,
very large and influential Farmer's Association recently called for
moratorium on patents on plants and a renegotiation of the directive.
government of Germany is reported to have contacted France and the UK
discuss this possibility as well.
To take the challenge seriously, the EU Ministers would need to call on
European Commission to prepare a new proposal. This would appear
since the Commission has always been a strong supporter of the
But things might change at the Commission as well. In a recent speech,
Commissioner responsible for Research, Mr. Busquin, implied a need to
"The rule that the product of a discovery should remain within the
domain but that the fruit of invention work can be protected is clear
terms of principle. However, the conditions under which it is applied in
case of 'genomics' need to be clarified in order to avoid any ambiguity
abuse." Since the biotech directive is Community law in this
is clearly in order.
STATUS OF IMPLEMENTATION OF THE EU PATENTING DIRECTIVE (98/44/EC)
Waiting for the outcome of the European Court of Justice's (ECJ) ruling
the Dutch/Italian challenge to the directive before implementation.
a new debate might be coming up in Parliament over the next months.
After strong internal and public controversy, the Government has put
proposal forward and has asked the public for comments.
After a brief but fierce debate in the Parliament, the directive
narrowly passed, despite its Ethics Committee arguing against it.
The directive has been passed by Parliament.
Government officials have spoken out publicly against the directive,
they do not want to implement it as it stands. In July, the Prime
requested the European Commission to issue an interpretation of the
directive, without which the French government will not implement.
The German government is unhappy with the directive as it stands and,
France, is willing to implement only with major amendments. Is
The draft law which transposes the directive is at ministry level only,
beginning of a very long process. The government is aware of
attitudes in other EU countries, but so far has no position on it.
The Government is supporting the Dutch challenge against the directive
the ECJ. Before a ruling can be expected, the ECJ will call a public
on the case. No date has been set.
A national law identical to the directive is due in Parliament
Initiated the challenge at the ECJ, which is based on several legal
principles. No concrete plans for national implementation.
Norway is not a member of the EU, but as member of the European
Area it usually has to implement EU law. The previous government was
critical of the directive, and did not intend to implement it. The
government can also be expected to be critical.
Currently drafting its national law, which is most likely based on
A first draft law was presented by the government to the European
Commission. Brussels determined it was "not appropriate" and
sent it back.
A Parliamentary debate is expected not before next year.
Legislation passed, with hardly any debate, in July.
(*) Jointly elaborated version of an article prepared by Tommy Schweiger
the September 2000 issue of GRAIN's quarterly newsletter
"Seedling". It will
soon be online at
Tommy Schweiger can be contacted at
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