December 9, 2004
The country's
new biotech patent law is somewhat at odds with the relevant EU
directive
Germany's belated attempt to bring
its biotechnology patent law
into compliance with a
European Union Directive issued in 1998 appears to
contradict what the EU mandated, meaning the issue could end up
being debated in the European Court of Justice, according to a
patent and property rights expert.
Joseph Straus, managing director of the Max Planck Institute
for Intellectual Property, Competition, and Tax Law, told The
Scientist that a biotechnology amendment approved last
Friday (December 3) by Germany's Bundestag, or lower house of
Parliament, would limit patent protection on human gene
sequences to "disclosed functions" at the time of the patent
application.
That means that under German
law, a patent awarded to a scientist awarded on a human DNA
sequence used for a specific function would not cover a second
function discovered later by another researcher using the same
DNA sequence, Straus said.
This contradicts the intent of
the EU Directive to give full patent protection to the
discoverer of the human gene sequence, including for new
functions discovered later by other scientists using the same
gene sequence, he said. EU nations who have followed the intent
of the EU directive could at some point in the future file suit
against the German law in European court.
The German law does allow full
patent protection on non-human genome sequencing.
Straus said Germany's limited
protection on human DNA sequencing is in conflict with basic
international patent laws for other products and services. He
said that in most cases, limiting patents to disclosed functions
would not be a major issue because "it is relatively trivial to
find a gene sequence." In other cases, however, the process can
represent a major breakthrough, so limiting patent protection
for the discovering scientist to "disclosed functions" would not
be fair.
Straus criticized the Bundestag
for basically setting up new patent rules for biotechnology. "In
general, I don't like legislative interference with such
specific rules in rapidly moving technologies," he said. He
added that patent infringement disagreements are best resolved
in the courts.
Asked how Germany's scientific
community would view the new law, Straus said: "Well, that
depends. If you are the scientist that discovers the first
function of the DNA sequence, then you are not going to be
happy. But if you are the second scientist who discovers the
second function, then you will like the law."
German Justice Minister
Brigitte Zypries was quoted in the German press supporting the
law, saying that there is no patent on life. She also said that
Germany would attempt to convince other EU nations to support
Germany's stance.
Ricardo Gent, managing director
of German Association of Biotechnology Industries (DIB), also
told The Scientist that the DIB supports the new law. A
large portion of the research done in DIB member companies is on
non-human genomes, and a portion of the researchers conduct
research on already discovered human sequences to find new
functions, he said. "Yes, we are happy with this compromise," he
said. "This clarifies the legal situation."
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