News from Abroad: European Gene Patent Scope Limited by Landmark EU Court Ruling

    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.

Comments

[Dan Feigelson]

I wonder how this decision will impact claims on crystalline forms of active pharmaceutical ingredients. There have been cases where after a second crystalline form was discovered, it was impossible to get batches of the first form without some small amounts of the second form being present. This ruling would seem to suggest that in the EU, claims on the second form would be ineffective against such batches containing only trace amounts of the second form.

[EG]

This ruling is consistent with the general hostility of the EU against US agrobiotech. My understanding is that the EU has repeatedly opposed importation of US agroproducts (including that developed by Monsanto) on the ground that genetically engineered food poses potential health/other issues. But apparently if developed in the EU, those issues go away. Blatant hypocrisy and protectionism if I ever saw it.

[tto_newbie]

EG, I am new to this so I am sorry if I missed your point. Why do you think the claims should cover products where the claimed composition is either a contaminant or not functional? My read on this is that its a fair decision, unless I am missing some ramifications such as what Dan posited/posted.

[crelboyne]

Funny that gene patent opponents in the US claim that all civilized jurisdictions disallow gene patents. EU has a directive specifically allowing them and JP allows them. Bold-faced lies or ignorance... you decide.

[Dev Crease]

This decision is expressly limited to genetic material by virtue of Article 9 of the Biotech directive. In relation to the earlier comment on pharmaceutical preparations, my view is that the status quo prevails in that claims covering the second form would catch a product comprising mostly first form but which contains trace but detectable amounts of that second form. In the UK at least there is no de minimis exemption from infringement, although it may affect quantum of damages awarded.

[EG]

TTO-Newbie,

I'm just ranting about the EU's general hostility to imported American agrobiotech products. From reading Article 9, this decision may be perfectly reasonable. I'm just suspicious because the EU countries (especially France) are very protective of their domestic agriculture, relative to imported American agricultural products.

[patent litigation]

This ruling makes some sense. A different decision would have facilitated a ridiculous amount of unnecessary patent litigation. Also, it seems fair, since one has to draw the patent-eligibility line somewhere. Though I suppose the anomalous treatment of genetic products could be grounds for accusations of arbitrariness.
http://www.industryweek.com/articles/patent_enforcement_21538.aspx?SectionID=2