Monsanto Technology v Cefetra (CJEU, C-428/08, 2010)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the Hague District Court (Rechtbank ‘s-Gravenhage), the Grand Chamber held that Article 9 of Directive 98/44 confers no protection on the holder of a patent for a DNA sequence where that sequence is contained in soy meal in which it no longer performs the function for which it was patented, even though it performed that function in the plant or might perform it again after extraction and insertion into a living cell. Article 9 effects an exhaustive harmonisation, which precludes national law from granting absolute protection to the sequence as such, including for patents granted before the directive.

Facts and procedure

Monsanto held European patent EP 0 546 090, granted on 19 June 1996 and valid in the Netherlands, relating to glyphosate-tolerant EPSPS enzymes; the corresponding genes had been introduced into « Roundup Ready » soybeans, grown on a large scale in Argentina, where the invention is not patented (paras 15 to 18). Three cargoes of soy meal from Argentina arriving in Amsterdam in 2005 and 2006 were detained by customs and released after samples were taken; tests revealed the presence of the CP4-EPSPS enzyme and of the DNA sequence encoding it (paras 19 to 21). Monsanto sought injunctions against Cefetra, Vopak and Toepfer and an order prohibiting infringement of its patent in all countries in which it is valid (para 21), the Argentine State intervening in support of defendants. The court considered it established that the protected sequence was present in one of the cargoes but doubted whether that presence alone amounted to infringement (para 22), and referred four questions (para 32).

The applicable law

Under Article 9 of Directive 98/44, the protection conferred by a patent on a product containing or consisting of genetic information extends to all material in which the product is incorporated and in which the genetic information is contained and performs its function. The Court read that provision together with Article 5(3) and recitals 22 to 24, under which a DNA sequence without indication of a function is not a patentable invention (paras 43 to 45).

Question

May the holder of a patent for a DNA sequence oppose the marketing of dead material containing that sequence where it no longer performs its function, and may national law grant the sequence absolute protection regardless of its function?

Decision

The wording of Article 9 implies that the function is being performed at the present time and in the actual material in which the sequence is found (para 35). For the invention at issue, that function is to protect the biological material against the herbicide, whose use on the meal is not foreseeable; the genetic information is found only in a residual state in the meal, which is dead material (paras 36 and 37). Protection is therefore not available once the information has ceased to perform the function it performed in the initial material (para 38), and it cannot be relied on solely because the sequence could be extracted and perform its function in a different biological material (para 39). The Court rejected the argument based on protection of the sequence as such: the directive accords no protection to a patented DNA sequence that is not able to perform its specific function (paras 45 and 49).

The harmonisation effected by Article 9 is exhaustive: a minimalist approach favouring patentees would upset the balance between their interests and those of other operators and foster barriers to trade (paras 55 to 60), and the reference to national patent law in Article 1(1) does not militate against that conclusion (para 61). The rule applies to the future effects of patents granted before the directive, since there is no derogation and protection would otherwise differ between Member States (paras 66 to 68). Lastly, Articles 27 and 30 of the TRIPS Agreement do not affect that interpretation, Article 9 being concerned with the scope of protection (paras 75 to 77).

Key points for practice

• Protection of a patented genetic sequence requires that it currently performs its function in the product at issue; past or potential function is not enough (paras 35, 38 and 39).
• National law may not grant absolute protection to the sequence as such, Article 9 effecting exhaustive harmonisation (paras 60 to 63).
• The rule extends to patents granted before the directive came into force (paras 66 to 69).
• Practical point: for derived products imported from countries without protection, proving infringement of a patent on a genetic sequence requires showing that the sequence actually performs its function in them; detection of the DNA alone is not enough.

Provisions applied

Directive 98/44/EC

Arts 1, 5(3) and 9; recitals 3, 5 to 8, 13 and 22 to 24

National law

Rijksoctrooiwet 1995 (Netherlands), Arts 53 and 53a

Other provisions

Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Arts 27 and 30

Case law cited

Commission v Freistaat Sachsen (C-334/07 P); Dior and Others (C-300/98 and C-392/98); Merck Genéricos Produtos Farmacêuticos (C-431/05)

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, English version), consulted on 11 October 2026. Only the official text is authoritative.