Legislative Implementation of Flexibilities - Albania

Title:	Art.4 no.7-11, Art. 5(2) (a) and(5) and Art.6 (2) and (3) of the Industrial Property Law Nr. 9977 of 07/07/2008
Field of IP:	Patents
Type of flexibility:	Patentability of substances existing in nature
Summary table:

Provisions of Law

Article 4

7. "Biotechnological inventions" means inventions which concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used;

8. "Biological material" means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;

9. "Plant variety" means any plant grouping with a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be:

a) defined by the expression of the characteristics that result from a given genotype or combination of genotypes;

b) distinguished from any other plant grouping by the expression of at least one of the said characteristics; and

c) considered as a unit with regard to its suitability for being propagated unchanged;

10. "Essentially biological process for the production of plants or animals" means a process consisting entirely of natural phenomena such as crossing or selection;

11. "Microbiological process" means any process involving or performed upon or resulting in microbiological material;

Articles 5 (2) (a) and (5)

2. The following in particular shall not be regarded as inventions within the meaning of paragraph 1:

a) discoveries, scientific theories and mathematical methods;

5. Biotechnological inventions shall also be patentable if they concern:

a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;

b) plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety;

c) microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety;

d) an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

Article 6

Exceptions to patentability

Patents shall not be granted in respect of:

2. Plant or animal varieties or essentially biological processes for the production of plants or animals, without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process;

3. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene.