Scope of the Patent and Uses of the Product in the European Biotechnology Directive
Italian Intellectual Property, No. 1, 2007
27 Pages Posted: 26 Oct 2006
Patent scope is probably one of the most debated issues in patent law generally and it has recently gained new contours thanks to the substantial scientific improvements in genetics and modern biology, which have resulted in the creation of what we now address as the biotech industry. Indeed, the particular features of research carried on genes, proteins, virus, etc. has led many to question the appropriate degree of exclusivity to be granted to the inventor who studies process and elements belonging to nature. This multi-faceted issue has been carefully addressed by the European Directive 98/44/EC on the legal protection of biotechnological inventions which offers, especially at art. 5, significant insights to appropriately distinguish what is patentable from what is not, and to delimit the proper scope of protection.
With regard to the latter point, art. 5.3 specifies that the industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. This is surely one of the most remarkable provision contained in the Directive. Interestingly, at a first glance some national laws implementing the European text seem all to closely follow the blueprint provided for by the Directive. However, there is a significant difference. The Directive establishes that the industrial application of a gene sequence be concretely disclosed in the patent application but, differently from national laws, the Directive does not expressly mention the need to claim the industrial application of the gene sequence.
The need to specify the concrete function performed by the genetic sequence, as codified by the French, the German and the Italian legislator, might reasonably lead one to conclude that the scope to be afforded to the patent should be limited to the industrial application disclosed. This interpretation could lead to a substantive departure from what happens in the chemical industry where patent protection (wrongly, in our modest opinion) is generally intended to be absolute.
A change towards a so called purpose-bound protection would be, in our opinion, particularly welcome, although extremely criticized in part of the patent law literature.
In what follows we will try to provide an exhaustive explanation of why we think that a narrower protection for biotechnological innovation would be more appropriate, especially in light of the peculiarities of the biotech sector.
Keywords: Patent, invention, biotechnology, gene, dna, rna, splicing, second use patent, industriality, claims, purpose-bound protection
JEL Classification: K11, K2, K20
Suggested Citation: Suggested Citation