Title: | Articles 5, 6 and 7 (3) of the Patent Law of 10/07/2004 |
Field of IP: | Patents |
Type of flexibility: | Patentability of substances existing in nature |
Summary table: |
Patentable Inventions
Article 5
The subject matter of an invention protected by a patent may be a product (ex. a device, substance, composition, biological material) or a process.
The subject matter protected by a patent may also be related to:
1) a product consisting of or containing biological material;
2) a process by means of which biological material is produced, processed or used;
3) a biological material isolated from its natural environment or produced by means of a technical process, even if it previously occurred in nature.
Within the terms of this Law, "biological material" shall mean any material containing genetic information and capable of reproducing itself or being reproduced in a biological system (ex. microorganisms, plant and animal cell cultures, sequence of genes).
The following, in particular, shall not be regarded as inventions, within the meaning of this Law:
1) discoveries, scientific theories and mathematical methods;
Article 6
The human body, at any stage of its formation and development, and the simple discovery of one of its elements, including sequences or partial sequences of genes, shall not be regarded as invention.
An element isolated from the human body or produced by means of a technical process, including the sequences or partial sequences of genes, may be patentable, even where the structure of that element is identical to that of a natural element.
The industrial application of a sequence or partial sequence of a gene must be disclosed in the patent application on the day of its filing.
Exceptions to Patentability
Article 7
Patent protection shall not be granted in respect of:
3) a plant or animal variety or an essentially biological process for the production of a plant or animal, except:
- a biotechnological process concerning a plant or animal, if the technical feasibility of the invention is not confined to a particular plant or animal variety;
- a microbiological or other technical process, or a product obtained by means of such process.
Within the terms of this Law:
- "plant variety" is used in the meaning laid down in the law governing the protection of new plant varieties;
- an "essentially biological process" for the production of plants or animals is a process consisting entirely of natural phenomena such as crossing or selection;
- a "microbiological process" is a process involving or performed upon or resulting in microbiological material.