Biotechnology

ITALIAN LAW

EU Directive 98/44 on the protection of biotechnological inventions has been ratified in Italy by legislative decree 2006/3, converted in Law 2006/78 (publication G.U. 58 on 10 March 2006).

In 13 articles, the legislative decree first identifies its purposes, list the definitions (Art. 2) and patentable inventions (Art. 3). Particularly, the Law establishes that to patent a DNA sequence or a protein, total or partial, it is necessary to disclose and claim its function and industrial applicability (Art. 3).

Further, the law establishes the exclusion from patentability for ethical reason such as safeguard of humans and environment, preservation of plants and biodiversity and prevention of environmental damages. Among the invention excluded from patentability (Art. 4):

- human body from the moment of its conception and during the various stage of its development,
- all the process for cloning human beings whichever the development stage of the cloned organism and the cloning purposes is
- any use of human embryos , including human embryonal stem cell lines;
- processes for modifying genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animals;
- genetic screening protocols having eugenic purpose and not diagnostic.

Other articles relate to procedural aspects (Art. 5), licenses and nullity (Art 6 and 7), extension and limits of patent protection (Art. 8 and 9). The Law further comprise deposit provision concerning access or new deposit of biological material (Art. 10).

Mainly, the articles mirror the Articles and considering of EU Directive 98/44/CE quite literally. However, we highlight that Italian Law has introduced more restrictive clauses as far as exclusion from patentability is concerned, that clearly recall the content of the recent Italian Law 2004/40 on assisted reproduction. In the light of the above the explicit prohibition of the use of embrional human stem cells and genetic screening protocols whose exploitation would have eugenic purposes.

EUROPEAN LAW

The EU Directive 98/44/CE on the Protection of biotechnological inventions was approved by the European Parliament on May 12 1998.

The Directive clarifies that legal protection of biotech inventions does not require the creation of a separate body of law. The Community's legal framework is limited to laying down certain principles.

Art. 3(2) tends to clarify the difference between inventions and discoveries and states that biological material which is isolated from its natural environment or produced by means of a technical process may be patentable (provided that it is new, inventive and industrially applicable) though it is previously occurred in nature. Therefore any material containing genetic information and capable of reproducing itself or being reproduced in a biological system is patentable.

Art. 5(2) states that this rule applies also to the human body, with the clear limitation that the human body, at any development stage, and the simple discovery of one of its element, including a gene or parts thereof, cannot be patentable (art. 5(1)).

Art. 6 deals with the prohibition to patent inventions which are contrary to the morality, comprised in all of major national patent laws. It is considered as contrary to the morality a process for cloning human beings, or for modifying the germ line genetic identity of human beings, or the use of human embryos for industrial or commercial purposes, or a process for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animals.

Further articles deal with the scope of protection (artt. 8-11), with compulsory cross-licenses (art. 12) and with the deposit of biological material according to the Budapest Treaty (artt. 13-14).