Patentability of Biotech Inventions

With the EU Directive 98/44, the patentability of biotechnology inventions has been strongly debated by the member states of EU, such as Belgium, France, Germany, Italy and the Netherlands over the clarifications on the difference between patentable inventions and non-patentable discoveries with reference to the human body and protection of isolated elements of the human body. As in other countries, the Italian Parliament, before implementing the Directive 98/44, revised the Directive on January 10, 2006 with the law decree DL3/2006. According to the provision made in the revised Directive, biotech inventions are patentable and must comply with the fundamental patentability requirements, such as novelty, inventiveness and industrial applicability. They must respect the dignity and integrity of human beings as also an element isolated from the human body or otherwise produced by means of technical process, even if the structure of that element is identical to that of a natural element.

Plant and animal varieties and essentially biological processes for the production of plants or animals are not patentable. But on the other hand, inventions concerning plants or animals are patentable provided that the invention's application is not technically confined to a single plant or animal variety. In short, the following invetions are not patentable because of their commercial exploitation which are contrary to ordre public or morality:

processes for cloning human beings.
process for modifying the germ line generic identity of human beings.
uses of human embryos for industrial or commercial purposes.
processes for modifying the genetic identity of animals that are likely to cause suffering to man or animal.

The Directive DL3/2006 provides penalty provision for violating the prohibitions in case of the nullity of any judicial act and transaction based upon or nullity of the patent or any contract based on the patent. The new Directive also provides special procedures for filing new applications in the biotechnology field, such as: indication of genetic origins in the application - this provision derives from the CBD and has become a formal condition for patentability, Informed consent for biological material of human origin - genetically modified organism for biological material consisting in or deriving from a genetically modified organism or a microorganism, and Italian plant varieties- if the patent relates to the genome of plant varieties or their use and the denomination of origin or geographical denomination. If these required declarations are not presented, the Italian PTO may refuse the patent application.

As for as the marketing of breeding stock is concerned, DL3/2006 provides a broader farmer privilege to prohibit subsequent marketing with commercial aims unless the animals having the same properties have been obtained through exclusively biological means. The Directive introduces further restrictions to patentability and new formal requirements for filing patent applications.

In conclusion, the Italian position on patentability looks similar to the German and French ones, but does not fully comply with the initial aim of harmonization within EU of the patent laws, particularly on how the claims of European patent will be interpreted in the different countries. So it is likely that this will open a debate on the enforceability of biotechnology patents in the EU and may lead to further discussion, both at the European Court of Justice and at the European Parliament.

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Patentability of Biotech Inventions - Italy