## Facts

- Monsanto held a European patent covering a DNA sequence inserted into soy plants that confers resistance to glyphosate-based herbicides (the “Roundup Ready” gene).
- Cefetra and other traders imported soy meal into the EU from Argentina in 2005–2006.
- The soy meal was produced from genetically modified soybeans containing Monsanto’s patented DNA sequence.
- In the soy meal, the patented DNA sequence remained detectable, but the soy meal was a processed, non-living product used as animal feed.
- In that processed material, the genetic information no longer carried out the biological function for which it was patented (herbicide resistance in a living plant).
- The Dutch District Court of The Hague referred questions to the Court of Justice of the European Union regarding the scope of protection under Article 9 of Directive 98/44/EC (Biotech Directive), including whether Member States could provide broader protection under national law and how the Directive applies to earlier-granted patents.

## Issues

1. Whether Article 9 of Directive 98/44/EC protects a patented DNA sequence present in soy meal when the genetic information does not perform its patented function in that material.
2. Whether Article 9 exhaustively harmonizes the scope of protection, precluding Member States from granting “absolute” product protection for DNA regardless of function.
3. Whether Article 9 applies to the future enforcement effects of patents granted before the Directive, preventing reliance on broader pre-Directive national rules.
4. Whether TRIPS Articles 27 and 30 require an interpretation that extends protection beyond the function-based limit in Article 9.

## Decision

- The CJEU held that Article 9 does not confer patent protection where the patented DNA is contained in soy meal but does not perform the function for which it was patented in that material.
- The CJEU held that Article 9 provides exhaustive harmonization of the protection it confers and precludes national rules granting absolute protection to DNA as such irrespective of function.
- The CJEU held that Article 9 precludes a patentee with a pre-Directive patent from relying on earlier national law granting broader absolute product protection for the future effects of that patent.
- The CJEU held that TRIPS Articles 27 and 30 do not affect this interpretation; TRIPS does not require broader protection than the function-based standard in Article 9.

## Legal Principles

- Under Article 9 of Directive 98/44/EC, patent protection for a product containing genetic information extends only to material in which the genetic information is contained and performs its function.
- Detectability of a patented DNA sequence in a processed product is insufficient for infringement if the genetic information does not perform its patented function in the accused material.
- The possibility that genetic information could perform its function again if extracted and inserted into a living cell does not satisfy Article 9’s function requirement for the material at issue.
- Article 9 exhaustively harmonizes this aspect of biotech patent scope, barring Member States from expanding protection through national “absolute” product-right rules.
- Absent an express derogation, EU rules apply to the future effects of situations arising under prior rules; therefore, Article 9 governs post-Directive enforcement of earlier-granted patents.
- TRIPS does not compel expansion of EU function-based protection for genetic inventions beyond the limit set by Article 9.

## Conclusion

The CJEU limited EU patent control over patented DNA in downstream products to situations where the genetic information performs its claimed function in the accused material, and it barred Member States and patentees from using national “absolute” product protection—whether under current or pre-Directive law—to extend rights to biologically inactive DNA in processed imports.


Monsanto Tech. LLC v. Cefetra BV, Case C-428/08 (C.J.E.U. 2010)