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Patents on Human Gene Sequences in Germany: On Bad Lawmaking and Ways to Deal With It
Published online by Cambridge University Press: 06 March 2019
Extract
Whether patents should be granted on human genes or gene sequences is highly controversial, both ethically and politically; not only in Germany but throughout Europe and in most parts of the world. Proof of this has been the attention created by US biotechnology company Myriad Genetics, which, in 2001, obtained European patents for human gene sequences indicating an increased risk of certain types of cancer. In Germany the Bundestag has recently addressed the issue: the core of a newly introduced provision of the German Patent Statute (PatG) is Paragraph 1a Sec. 4 PatG, which limits the scope of patent protection available for human gene sequences or parts thereof. If the subject of an invention is a human gene sequence, Paragraph 1a Sec. 4 PatG requires disclosure of not only the sequence but also at least one application. Without such disclosure a human gene sequence is not patentable under German Patent Law. This is remarkable, because under the Directive of the European Parliament and the Council on the Legal Protection of Biotechnological Inventions, the so-called Biotechnology Directive of 1998, a piece of European Union legislation, the situation is different.
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References
1 See Clark, Jeanne et al., Patent Pools: A Solution to the Problem of Access in Biotechnology Patents?, United States Patent and Tradmark Office, Dec. 5, 2000, http://www.uspto.gov/web/offices/pac/dapp/ opla/patentpool.pdf; David J. Faye, Bioprospecting, Genetic Patenting and Indigenous Populations – Challenges under a Restructured Information Commons, 7 J. World Int'l. Prop. 401 (2004); Atina Krajewska, Fundamental Rights Concerning Biomedicine in the Constitutional Treaty and Their Effect on the Diverse Legal Systems of Member States, 6 German L. J. 1693 (2005), http://www.germanlawjournal.com/article.php?id=666; Franklin Strier, Stemming the Gold Rush: Public Policy Alternatives to Gene Patenting, 110 Bus. & Soc. Rev. 47 (2005); Emma Toumi, In Defence of Gene Patents, 9 J. Comm. Biotech. 135 (2003); Human Genome Organisation (HUGO), Statement on Patenting of DNA Sequences, April 2000, http://www.gene.ucl.ac.uk/hugo/patent2000.html; German National Ethics Council, The Patenting of Biotechnological Inventions Involving the Use of Biological Material of Human Origin, Opinion of Oct. 6, 2004, http://www.nationalerethikrat.de/_english/publications/opinions.html.Google Scholar
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