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Italian provisions on biotech patenting: a short overview
1. Implementation of EU Directive 98/44/EC
The Directive 98/44/EC on the legal protection of biotechnological inventions was adopted in Italy in January 2006.
In 2010, the law was incorporated in a separate section of the Industrial Property Code (IPC) , i.e. Section IV bis.
Italian law on biotechnological inventions presents some differences from the Directive 98/44/EC.
Most relevant are:
- While Art. 6 of the EU Directive excludes from patentability uses of human embryos for industrial or commercial purpose, the IPC excludes every use of human embryos, included embryonic stem cells lines (Art. 81-quinquies.1.3 IPC) ). Thus, contrary to considerandum 42) of the Directive (and recentcase law from EPO and European Court of Justice), the Italian law seems to exclude from patentability also inventions for therapeutic or diagnostic purposes which are applied to the human embryos and are useful to the same.
- Art. 81 quarter d) IPC states that function and industrial applicability must be concretely indicated and described for an element isolated from the human body or otherwise produced by means of a technical process, while Art 5.3 of the EU Directive states that the industrial application must be disclosed in the patent application only for a sequence or a partial sequence of a gene.
- While Art. 5 of the EU Directive states that the industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application, the Italian law states that the specific function, which has to be industrially applicable, of a gene or fragments thereof must be indicated, described and specifically claimed (Art. 81 quinquies.1.c IPC).
2. Declaration to be provided for national Italian patent applications
Moreover IPC foresees that some procedures/declarations should be activated/required for Italian patent applications (Art. 170-bis IPC):
a) a declaration of origin of the animal or plant biological material (State of origin and biological organism from which it has been isolated) on which the invention is based (see also Considerandum 27 of the Directive and Art. 1 of the Convention on Biological diversity);
b) a free informed consent of the person donating human biological material that is object of the invention or used in the invention;
c) a declaration that guarantees on the fulfillment of obligations relating to modifications for of genetically modified microorganism or organism contained in the biological material that is object of the invention or used in the invention.
In the absence of such declarations, the Italian Patent Office asks for them and/or for filing observations (art. 173.7 IPC). The application is refused only if there is lacking of patentability requirements. The lacking of such declarations should be annotated in the Italian Register, not implying the refuse. On another hand such lacking of documents is not even ground for nullity of a granted patent.
3. Administrative sanctions (Art. 170 ter IPC)
Everyone who uses biological material of human origin, being aware of the fact that it was collected or used for patent purposes without the express consent is punished with a fine from € 100,000.00 to 1,000,000.00 (Art. 170-ter.1 IPC).
Everyone who falsely certifies the origin of the biological material of animal or vegetable origin or the compliance with the requirements of the law regarding genetically modified organism or microorganism is punished with a fine from € 10,000.00 to 100,000.00 (Art. 170-ter.2 and 3 IPC).
Elisa Turri and Olga Capasso
De Simone & Partners ©2012