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Biotechnology and patents: focus on monoclonal antibodies

corresponding

Giulia Tagliafico
European and Italian Patent and Trademark Attorney

Simona Venturini
Italian Trademark Attorney and IP documentation specialist

The European Union Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (OJ EPO 1999, 101) has established that biotechnological inventions are in principle not excluded from patentability.

For European patent applications and patents concerning biotechnological inventions, the relevant provisions of the EPC (European Patent Convention) are now to be applied (see for example Rules 26 to 29 EPC, amended after the entry into force of the Directive) and the recitals of the EU Directive may be used as a means of interpretation.

More specifically, according to the EPC provisions, biotechnological inventions are patentable, if they concern an item on the following non-exhaustive list: (i) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature, (ii) plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety and if said plants or animals are not exclusively obtained by means of an essentially biological process, (iii) a microbiological or other technical process, or a product obta ...