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German biopatent law passed
December 9, 2004

The country's new biotech patent law is somewhat at odds with the relevant EU directive

Source: The Scientist.com
By Ned Stafford

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."

Links for this article

N. Stafford, "Germany debates gene patents," The Scientist, March 19, 2004.
http://www.biomedcentral.com/news/20040319/02/ 

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, July 30, 1998.
http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!pro d!CELEXnumdoc&lg=en&numdoc=31998L0044&model=guichett 

Joseph Straus
http://www.ip.mpg.de/Enhanced/Deutsch/Referate/Sachreferate/pat entrecht/staff/Prof_straus.cfm 
Source: The Scientist.com

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