Biotech patents - Cutting the scope of protection

Summary and implications

The Advocate General of the Court of Justice (the renamed European Court of Justice) has published the first-ever opinion on the extent of protection that European patents should give to biotech patents1.

This controversial opinion proposes that the full Court should give a narrow interpretation to the Biotechnology Directive2 which was implemented to harmonise EU laws on the patentability of biotech inventions. Although now implemented in all Member States, there are major differences in how the Directive has been implemented.

This is the first time the Court of Justice has been able to consider the scope of the protection of biotech inventions, particularly DNA sequence patents, in the ten years the Directive has been in force. This opinion is therefore significant for a number of reasons:

The Advocate General recommended that traditional patent protection should not be applied to DNA sequence patents. The protection given by such DNA patents should instead be 'purpose-bound'. Although formally non-binding, Advocate General opinions are given great weight by the full Court and are usually upheld. This opinion is therefore likely to determine how Member States should apply the Biotechnology Directive, what balance to strike between patentee's rights and those of their competitors, and result in a more harmonised approach across the EU. Factual background

The case arises from Monsanto's attempt to prevent Argentinean soy meal (containing the DNA sequence protected by the Monsanto's Roundup Ready soybeans patent) being imported into the EU. This DNA sequence makes soybean plants resistant to the Roundup Ready herbicide, allowing farmers to use high levels of herbicide to produce greater yields.

The patent covers DNA sequences encoding a class of enzyme variants resistant to this herbicide. These can be introduced into soybean plants to replace the non-resistant native form of the enzyme (which would otherwise be affected by the herbicide, killing the plant).

Cefetra imported soy meal from Argentina made from plants expressing the patented DNA. Monsanto had no Argentine patent and so could not argue that cultivation of these Argentine plants was an infringement. Monsanto therefore sued Cefetra and the other importers of this Argentine soy meal in the Netherlands based on Article 9 of the Directive (see box).

Article 9 of the Directive

The protection conferred by a patent on a product containing or consisting of...

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