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« House Slips Pay-For-Delay Provision into Appropriations Bill | Main | Biotech/Pharma Docket »

July 08, 2010


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.

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.

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.

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.

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.


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.

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.

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