Abstract
In the biomedical field the developments of recent years in cloning, transgenic animals and plants, genome sequencing, stem cell research, pharmacogenomics and many other technologies have required important changes in the legislation and law interpretation of the Boards of Appeal of the European Patent Office. Although the extent of further developments is difficult to predict, the present law and jurisprudence provide a far more solid foundation to accommodate new developments than they have in the past.
It is foreseen that the new field of synthetic biology will not raise questions that cannot be answered by present legislation and interpretation of the law by the Boards of Appeal. The more “synthetic” biology becomes, the closer to classical chemical areas and the further away from the controversy raised by the patenting of products which exist in nature it becomes. The more “standardized” genetic and molecular engineering is, the more “predictable” and reliable it becomes for industrial and medical application.
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Notes
- 1.
The Royal Academy of Engineering, Synthetic Biology: scope, applications and implications, May 2009, ISBN 1-903496-44-6
- 2.
“Diamond vs Chakrabarty” decision regarding a US patent filed in 1972 in the US relates to a “a bacterium from the genus Pseudomons containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway” This human-made, genetically engineered bacterium is capable of breaking down multiple components of crude oil. Because of this property, which is possessed by no naturally occurring bacteria, Chakrabarty’s invention was believed to have significant value for the treatment of oil spills (http://supreme.justia.com/us/447/303/case.html#308)
- 3.
See also: Nature, Vol 440, 04-2006, 940–943.
- 4.
Nature, 27(12), December 2009, 1071–1073
- 5.
http://www.epo.org/about-us/epo/legal-foundations.html. The European Patent Organization is an intergovernmental organization that was set up on 7 October 1977 on the basis of the European Patent Convention (EPC) signed in Munich in 1973. The Organization currently has 38 member States, comprising all the member states of the European Union together with Albania, Croatia, Serbia, the former Yugoslav Republic of Macedonia, Iceland, Liechtenstein, Monaco, Norway, San Marino, Switzerland and Turkey. Its mission to grant European patents in accordance with the EPC is carried out by the European Patent Office. The Organization has its seat in Munich (Art 6 EPC).
The European Patent Convention Act revising the EPC of 29 November 2000 entered into force on 13 December 2007. Upon entry into force of the revised text of the Convention, the text valid until that time (the “EPC 1973”) ceased to apply (cf. Article 8(2) Revision Act).
After the grant of the European Patent and the publication in the European Patent Bulletin, the patent must be validated before the corresponding National Member State. The rights conferred by the European patent are, from that moment, the same as would be conferred by a national patent granted in that State. Infringements to the European Patent are dealt with by National law thereafter (Art 64 EPC)
- 6.
See T356/93, OJ 1995, 545 ; See also: G1/98, OJ 2000, 111
- 7.
See also: Syst Synth Biol, Vol 3, 55–63, 2009.
- 8.
See T356/93, OJ 1995, 545.
- 9.
See T409/91; T435/91.
- 10.
- 11.
Nature Biotechnology, 25: 822 (2007) http://www.nature.com/nbt/journal/v25/n8/full/nbt0807-822.html
- 12.
See: T19/90
- 13.
See: T409/91; T435/91
- 14.
Genetics in Medicine, Vol 12, Apr 2010, Suppl
- 15.
See: G1/98, OJ 2000, 111, reasons, 3.9
- 16.
See: T1213/05
- 17.
See: T866/01, reasons 5.7–5.9, 9.8; Guidelines for examination in the European Patent Office, Part G, Chapter II, 4.
- 18.
See: G1/98, OJ 2000, 111; Guidelines for examination in the European Patent Office, Part G, Chapter II, 4.1.2
- 19.
Guidelines for examination in the European Patent Office, Part G, Chapter II, 4.1.2
- 20.
See: T356/93, OJ 1995, 545, reasons point 5.
- 21.
See: T19/90, reasons point 5.
- 22.
See: T356/93, OJ 1995, 545.
- 23.
See: T356/93, OJ 1995, 545, reasons 18.4.
- 24.
See: T356/93, OJ 1995, 545.
- 25.
Nature Reviews Genetics, Vol 11, May 2010, 367
- 26.
Nature Reviews Genetics, Vol 11, May 2010, 367
- 27.
See: T19/90; T315/03.
- 28.
See: Nature, Vol 440, 04-2006, 940–943; see also Balmer and Martin (2008).
- 29.
See:T144/83; T19/86
- 30.
See: G2/08, OJ 28–10-2010, reasons, 5.3.
- 31.
See: G2/08, OJ 28–10-2010
- 32.
See: T51/93
- 33.
See: T19/86
- 34.
See: T 1172/03
- 35.
See: G1/04
- 36.
Nature Biotechnology, 30: 964–975, 2012
- 37.
% of the total of EP, Euro-PCT and PCT (EPO as ISA) patent applications filed before the EPO.
- 38.
European Commission, Patenting DNA sequences (polynucleotides) and scope of protection in the European Union: an evaluation. S J R Bostyn, 2004, EUR21122, Dir Gen for Research food quality and safety. Paragraph 10.14.
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Fernandez y Brañas, F.J. (2014). Patentability of Synthetic Biology Under the European Patent Convention (EPC). In: de Miguel Beriain, I., Romeo Casabona, C. (eds) Synbio and Human Health. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-9196-0_12
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