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[BIO-IPR] Update on the EU patenting directive

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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.


Tommy Schweiger and GRAIN (*)
September 2000

If proponents of the European Union's (EU) directive 98/44/EC on "The Legal
Protection of Biotechnological Inventions" had thought that its adoption in
1998 was the final step in a tumultuous 10-year saga, they are in for a rude
awakening. The directive is back on Europe's political agenda. The deadline
for the transposition of the directive into national law was 30 July 2000.
But only three countries of the 15 made it. Many European governments have
become very reluctant to implement the text which most of them adopted so
enthusiastically at the EU level only two years ago. The stumbling block is
the question of patenting human genes -- which the directive allows.

Cracking the genome cracks the directive

Whatever hopes the EU had for smooth transposition of the directive within
the deadline were derailed by the announcement on 26 June that the human
genome had been decoded. In Europe, this opened up a strong public debate on
the question of patentability of human genes. That debate was already on the
rise. Just weeks prior to the news that our genetic code had been cracked,
US President Bill Clinton and UK Prime Minister Tony Blair called for all
human genes to remain in the public domain. And earlier in the year, the
publicity over a patent on human embryos, which had been granted by the
European Patent Office (EPO) in 1999, caused an unprecedented public outcry.
As a result, the German government filed a legal opposition to the patent.

Throughout these past months, the anxieties raised by patents on human genes
have dug deep into public policy-makers, east and west of the Atlantic.
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 matter of
discovery. But why would finding out that, say, a protein serves a specific
function in the body, and trying to patent its use, amount to an invention?

(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 very
guidelines on this issue. And it is here that the EU directive is
notoriously ambiguous.

(3) Is it ethical to grant patents over parts of the human genome?
Many professional societies, not to mention ordinary citizens, say no. Even
the 1997 Universal Declaration on the Human Genome and Human Rights tries to
uphold the human genome as "the heritage of humanity".

(4) How will medical research proceed if access to information regarding
human DNA requires costly licenses and complex negotiations? And what are
the implications for the commercial development of new drugs and treatments?
To use a famous example, Myriad Genetics in the US holds numerous patents on
the BRCA1 and BRCA2 breast and ovarian cancer genes. Myriad has given Eli
Lilly and Co., also of the US, exclusive rights to market treatments based
on the BRCA I sequence. On its own, Myriad charges $2,400 to $3,500 to
sequence a woman's DNA in search of BRCA mutations, which number in the
hundreds. The cost is prohibitive, and the company has denied researchers
rights to use the test.

In the face of these problems, one body after the other has been coming down
hard against the patenting of human genes --and the EU directive. The French
National Bioethics Committee, under mandate from the Secretary of State for
Industry, filed an opinion on 6 June against the directive, calling for a
renewal of discussions instead. "Knowledge of a gene sequence," whether of
human or non-human origin, the committee stipulated, "cannot in any way be
considered an invented product, and is therefore not patentable." Two weeks
later, the Ministers of Research of the eight most industrialised countries,
the so-called G8, communicated their consensus against the patenting of
human genes. Then, on 30 June, the Parliamentary Assembly of the Council of
Europe unanimously passed a resolution urging for a moratorium on the
patenting of human genes. And if that weren't enough, the Assembly called on
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 has
failed miserably. The situation has become legally more confusing and
incoherent than ever before.

The European Patent Office (EPO) in Munich has been rolling ahead despite the
political wrangling. To date, the EPO has issued hundreds of human gene
patents. And it has managed to do so in a very devious way. In June 1999,
the Administrative Council of the EPO decided to adopt the EU directive as a
guideline for patent examination. That means that the EPO is implementing
the rules of directive, even though the EU member states have not accepted
it in their national laws! This is all the more twisted since the EPO is not
an institution of the European Union. It implements the European Patent
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 biotechnology
patents are concerned, they do not plan on changing their rules. They plan
on sticking with the directive, as adopted by the EU membership in
Brussels, as
a basis for deciding what is permissible in this field. Even if European
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 at
European level, for a third time. There are increasingly loud voices calling
for this. Several powerful lobby groups, which kept silent during the vote
in 1998, have since come out against the directive. Most notably, Germany's
very large and influential Farmer's Association recently called for a
moratorium on patents on plants and a renegotiation of the directive. The
government of Germany is reported to have contacted France and the UK to
discuss this possibility as well.

To take the challenge seriously, the EU Ministers would need to call on the
European Commission to prepare a new proposal. This would appear difficult,
since the Commission has always been a strong supporter of the directive.
But things might change at the Commission as well. In a recent speech, the
Commissioner responsible for Research, Mr. Busquin, implied a need to act:
"The rule that the product of a discovery should remain within the public
domain but that the fruit of invention work can be protected is clear in
terms of principle. However, the conditions under which it is applied in the
case of 'genomics' need to be clarified in order to avoid any ambiguity or
abuse." Since the biotech directive is Community law in this respect, action
is clearly in order.



Waiting for the outcome of the European Court of Justice's (ECJ) ruling on
the Dutch/Italian challenge to the directive before implementation. However,
a new debate might be coming up in Parliament over the next months.

After strong internal and public controversy, the Government has put a
proposal forward and has asked the public for comments.

After a brief but fierce debate in the Parliament, the directive was
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, saying
they do not want to implement it as it stands. In July, the Prime Minister
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, like
France, is willing to implement only with major amendments. Is considering

The draft law which transposes the directive is at ministry level only, the
beginning of a very long process. The government is aware of changing
attitudes in other EU countries, but so far has no position on it.

The Government is supporting the Dutch challenge against the directive at
the ECJ. Before a ruling can be expected, the ECJ will call a public hearing
on the case. No date has been set.

A national law identical to the directive is due in Parliament mid-October.

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 Economic
Area it usually has to implement EU law. The previous government was highly
critical of the directive, and did not intend to implement it. The new
government can also be expected to be critical.

Currently drafting its national law, which is most likely based on the

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 for
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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