ECJ decision limits DNA patent protection

A decision by the Court of Justice of the European Union, that patent protection for DNA and other genetic material only extends to situations where the information can be shown still to be performing the function specified in the original patent, has significantly limited the scope of patent protection for DNA and other genetic material, according to Withers & Rogers LLP, a UK firm of patent and trade mark attorneys. 

This decision reflects that the EU Biotechnology Directive, which states that patent protection extends to all material in which the patented genetic information 'is contained and performs its function', is exhaustive.

The decision was rendered in the case of Monsanto v Cefetra C-428/08, following the dispute that arose when global agrochemical company Monsanto discovered that soy meal being imported into the EU from Argentina, where it lacked patent protection, contained traces of DNA covered by a Monsanto patent. According to Jim Tobin, vice president of industry affairs at Monsanto, approximately 95 per cent of the 43m acres of soybeans grown in Argentina contain the company's patented DNA. 

Monsanto had claimed that the importers were infringing their patent rights by attempting to bring the soy meal containing the proprietary genetic information into Europe. However, five EU Member States intervened in the case, stating that Monsanto was over-extending its patent rights.

Advocate General Mengozzi, who was responsible for the decision in the case, ruled against Monsanto. He determined that the plant-based DNA was in a 'residual' state, having been processed into soy meal, and was therefore no longer performing the function specified in the original patent. The decision is binding across all 27 EU Member States and cannot be appealed. 

Nicholas Jones, patent attorney and biotechnology sector specialist at Withers & Rogers, said: "This ruling is extremely concerning for the UK's biotech industry and in future, companies can no longer afford to take the risk of restricting the geographic reach of their patent protection, without leaving the door open to third party importers seeking to infiltrate European markets.

"Even more worryingly for biotech patent holders, if a rival company finds a different use for a particular piece of genetic material, their activity may now be beyond the reach of existing patent protection."

The final judgment is due by September this year.