By Devanand Crease —
The much anticipated ruling in Monsanto Technology v Cefetra (Case C-428/08) has now issued and confirms the earlier indications that within the European Union (EU) patent protection for gene sequences only extends to material in which the patented gene is actually performing its function. In Monsanto's case (European Patent No. 0 546 090), claims to an isolated herbicide resistance gene sequence were not held to extend to cover soya meal derived from transgenic plants and containing trace amounts of the patented gene, because the residual genetic material was not actually performing its intended function in the soya meal.
The Court of Justice of the EU handed down its ruling following a referral from a Dutch Court. Determination of whether soya meal from Argentina, where Monsanto did not have patent protection, infringed Monsanto's European gene patents when imported into Europe revolved around interpretation of Article 9 of Directive 98/44/EC (the "Biotech Directive").
Article 9 of the Biotech Directive states:
The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material . . . in which the product is incorporated and in which the genetic information is contained and performs its function.
The European Court took the view that because it is a requirement to disclose the function of a DNA sequence for it to be patentable, it follows that the patented DNA must be able to perform its function in the material in which it is incorporated in order to benefit from that patent protection.
The judgment applies to all patented gene claims within the European Union and, thus, applies to patents granted in the UK, Germany, and France amongst others. The judgment also has retroactive effect even to patents filed before implementation of the Biotech Directive into national laws.
Dr. Crease is a Partner at Keltie in London, UK.
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