In theory, biotechnological inventions must fulfill the same requirements as those of any other technological field in order to be patentable: novelty, inventive step and intellectual application. However, the special nature of this field of science, with its significant ethical implications, has led to the need to create a new series of specific rules, which are included in an EU Directive regarding biotechnological inventions. This Directive, which has been transposed into the national legislation of all EU countries, as well as the European Patent Convention, sets forth the considerations that must be applied to the patentability of a biotechnological invention.
For example, the Directive does not allow for the patenting of, among others, the human body or the different stages of its formation, methods for cloning human beings, methods for modifying the germline genetic identity of human beings, the use of human embryos for intellectual or commercial purposes, methods for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit, or animals resulting from such processes. However, inventions involving isolated biological material, even when it previously exists in a natural state, or plants or animals, are patentable if the technical feasibility of the invention is not confined to a particular plant variety or animal breed.
As such, genes and nucleic acid molecules, proteins and amino-acid sequences, enzymes, antibodies, viruses and the sequences thereof, cells, microorganisms, plants and animals constitute patentable inventions. Non-patentable inventions include genetic or protein sequences without a known function, genetically modified animals that suffer but do not contribute any significant medical benefit, plant varieties (which can no longer be protected under their own law) and animal breeds, human embryos and methods that necessarily include their use and destruction, human germ cells and human-animal hybrids.