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Purpose-Bound Patent Protection for Genes

Published online by Cambridge University Press:  20 January 2017

Matthias Lamping
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Abstract

Case C-428/08, Monsanto Technology [2010]

The Biotech Directive does not provide for absolute patent protection of DNA sequences. Protection is subject and restricted to the disclosed function (or purpose) of a gene; if the function is not fulfilled at the time of the alleged infringement the protection is therefore suspended. National law may not depart from the protection conferred by the Directive due to its exhaustive character (author's headnote).

Type
Case Notes
Information
European Journal of Risk Regulation , Volume 1 , Issue 4 , December 2010 , pp. 445 - 450
Copyright
Copyright © Cambridge University Press 2010

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References

1 Available on the Internet at <https://register.epoline.org/espacenet/application?number=EP91917090>, last accessed on 22 October 2010.

2 Monsanto sells “Roundup Ready” seeds to the farmers together with the “Roundup” herbicide in order to apply it post-emergence against broadleaf and cereal weeds.

3 Monsanto Technology L.L.C. v. Cargill International S.A. & Anor, 10 October 2007, [2007] EWHC 2257 (Pat); see IIC 2009, 237.

3 Sentencia nº 488/2007 de 27 Julio 2007 de Juzgados de lo Mercantil nº 6 de Madrid; see IIC 2009, 233.

5 Rechtbank ‘s-Gravenhage, sector civiel recht, vonnis van 24.9.2008 – 249983; HA ZA 05-2885; 270268; HA ZA 06-2576; see IIC 2009, 228.

6 Article 9 of the Biotech Directive: “The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product is incorporated and in which the genetic information is contained and performs its function.”

7 C-334/07 P, Commission/Freistaat Sachsen, ECR 2008, I-9465, para. 43.

8 See Machlup, /Penrose, , “The Patent Controversy in the Nineteenth Century”, 10 J. Econ. Hist. (1950), pp. 10 et sqq.CrossRefGoogle Scholar

9 Kraßer, Patentrecht, 6th ed. 2009, pp. 131, 230 et sqq.

10 See BPatG, 28.7.1977, 16 W (pat) 64/75 – Naturstoffe, GRUR 1978, p. 239.

11 In turn, an absolute protection of DNA sequences would cover every imaginable function, irrespective of its obviousness.

12 Article 3.2 of the Biotech Directive: “Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.” Article 5.2 of the Biotech Directive: “An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.” As long as no function of the DNA sequence is identified by the patent applicant it merely lacks a statutory requirement of patentability: Article 5.3 of the Biotech Directive: “The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.” According to the preamble, “the simple discovery of one [the human body's] elements or one of its products, including the sequence or partial sequence of a human gene, cannot be patented” (para. 16); “a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention” (para. 23); “in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs” (para. 24). See also C-377/98, Netherlands/Parliament and Council, ECR 2001, I-7079, paras. 73 et sqq.: “The result of [work on the sequence or partial sequence of a human gene] can give rise to the grant of a patent only if the application is accompanied by both a description of the original method of sequencing which led to the invention and an explanation of the industrial application to which the work is to lead, as required by Article 5(3) of the Directive. In the absence of an application in that form, there would be no invention, but rather the discovery of a DNA sequence, which would not be patentable as such.”

13 Ullrich, , “National, European and Community Patent Protection”, in Ohly, /Klippel, (eds), Geistiges Eigentum und Gemeinfreiheit (2007), p. 98.Google Scholar

14 Canada – Patent Protection of Pharmaceutical Products, 17 March 2000, WT/DS114/R, para. 7.92.