Wednesday, 21 July 2010

DNA must be doing its (patented) job

Genetically modified crops are nothing if not controversial. There is at least a school of thought (represented here) that views modifications – at least some of them – as tools to boost demand for herbicides. If the crops are resistant, farmers can drench everything else with the stuff and save a lot of labour-intensive and therefore expensive work. Crop yields are improved – and so too are those of the herbicide makers. Case C-428/08, M onsanto Technology LLC v Cefetra BV and Others arises from ‘the mother of agricultural biotechnology’ ( ibid) attempting to use its Roundup Ready soybeans patent to stop soy meal from Argentina containing the DNA sequence protected by the patent being imported into the EU. The Dutch court where the infringement proceedings were brought referred several questions to the Court of Justice, the most important concerning Article 9 of Council Directive 98/44/EC:
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 containedand performs its function.
Advocate General Mengozzi proposed a narrow interpretation. DNA sequence patents should not be treated like any other patents, but rather the protection given by them should be ‘ purpose-bound’.
... a DNA sequence must be regarded as protected, even as a self-standing product, only where it performs the function for which it was patented. In other words, it seems to me that Directive 98/44 permits and, in fact, requires an interpretation to the effect that, in EU territory, the protection conferred on DNA sequences is a ‘purpose-bound’ protection. Even though the directive does not expressly indicate that the protection to be conferred on DNA sequences must be of that order, many elements connected with the overall system of patents for biotechnological products militate in favour of that interpretation. Opinion, paragraph 29
T he DNA sequence was not performing its patented function (protecting plants from Roundup) at the relevant time because it was found in soy meal, not in plants. Of course, it had once been in plants and had done the job then, and because the meal could be used to grow plants it could do the job again, but at the key moment it wasn’t, and couldn’t .
To go the other way would give patent owners disproportionate and excessively wide protection, and bring ‘an unspecified number of derivative products’ under the control of the patentee. Germany and France already have purpose-bound protection for human DNA sequences, and second use claims for pharmaceutical products where a substance has already been patented are pretty common.
The Court agreed with the Advocate General:
Article 9 ... is to be interpreted as not conferring patent right protection in circumstances ... in which the patented product is contained in the soy meal, where it does not perform the function for which it is patented, but did perform that function previously in the soy plant, of which the meal is a processed product, or would possibly again be able to perform that function after it had been extracted from the soy meal and inserted into the cell of a living organism.
The Dutch Court also asked:
  • whether patent protection under the Directive is exhaustive or whether national law could confer additional protection (the Court of Justice said it was exhaustive);
  • whether the Directive should be applied retrospectively to patents granted before the Directive came into force (the Court said it did); and
  • whether TRIPS should be taken into account for the purposes of the first three questions (the Court said it had no effect on the interpretation of Article 9).

No comments:


blogger templates | Make Money Online