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Articles & Updates – Details

2 June 2010

ECJ Considers Monsanto Technology LLC v Cefetra BV Case Following Advocate General Mengozzi Opinion of March 2010

Anthony Albutt

Scope of Patent Claims Directed to DNA Inventions - The Dawn of a Narrow Approach?

The patentability of gene sequences isolated from their natural environment is covered by the EU Directive on the Legal Protection of Biotechnological Inventions (Directive 98/44/EC). For a number of years now, it has been possible to obtain grant of patents at the EPO for isolated naturally occurring gene sequences provided, of course, those sequences fulfil all of the patentability requirements of novelty, inventive step, industrial applicability, etc.

The outcome of the case of Monsanto Technology LLC v Cefetra BV and others that is now before the European Court of Justice could have an impact on the scope of granted claims concerning DNA based inventions.

On 9 March 2010 Advocate General Mengozzi provided his opinion. If the legal rationale is followed by the European Court of Justice then a restrictive approach to construing the scope of DNA based claims may arise.

At the start of his opinion, Advocate General Mengozzi emphasises the importance of this case:

“The Court has so far had few opportunities to concern itself with the directive on the legal protection of biotechnological inventions. The present case, however, will give the Court a chance to clarify a number of important points relating to the protection which must be recognised, within the European Union, as accruing to patents awarded within the field of biotechnology, the significance of which cannot nowadays be underestimated.”

The Advocate General then turned his attention to the specific issues before the European Court of Justice. His conclusions are as follows (with emphasis added):

“Under the system established by Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, the protection for a patent relating to a DNA sequence is limited to situations in which the genetic information is currently performing the functions described in the patent. That holds true both as regards the protection of the genetic information as such and as regards the protection of the materials in which that genetic information is contained.

“In the areas with which it deals, Directive 98/44 constitutes an exhaustive body of rules governing the protection to be recognised in the territory of the European Union as accruing to a biotechnological invention. As a consequence, Directive 98/44 precludes national legislation from offering, in relation to biotechnological inventions, patent protection wider than that provided for under that directive.

“The fact that a patent was granted before the entry into force of Directive 98/44 has no bearing on the answers to be given to Questions 1 and 2.

“The provisions laid down in the TRIPS Agreement do not conflict with Directive 98/44, as interpreted in accordance with the proposed answers to Questions 1, 2 and 3.”

The gene world now awaits with interest on the expected decision from the European Court of Justice in the case of Monsanto Technology LLC v Cefetra BV and others.

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