ECJ decision limits the scope of protection for DNA patents, says Withers & Rogers

A decision by the Court of Justice of the European Union has significantly limited the scope of patent protection for DNA and other genetic material and is cause for concern for UK biotechnology companies, according to Withers & Rogers LLP – a leading UK firm of patent and trade mark attorneys.

The case (Monsanto v Cefetra C-428/08) is rooted in a dispute that arose when global agrochemical company, Monsanto, discovered that soy meal being imported into the EU from Argentina – one of the few territories where it lacked patent protection – contained traces of DNA covered by one of their patents. The product from which the soy meal was derived was Roundup ready soya, a herbicide-resistant, genetically-modified form of the plant. A European patent was granted for the DNA sequence used to provide the herbicide-resistance in 1996.

Monsanto had claimed that according to the Biotechnology Directive, which was implemented across the EU in the early 2000s, the importers were infringing their patent rights by attempting to bring the soy meal containing the proprietary genetic information into Europe. After all, the Directive states that patent protection extends to all material in which the patented genetic information ‘is contained and performs its function’.

However, the ECJ’s decision means that Monsanto is unable to block the importation of the soy meal on the grounds that patent protection only extends to situations where the genetic information can be shown to still be performing the function specified in the original patent. In this instance, the judge determined that the plant-based DNA had been processed into soy meal and therefore, was no longer doing so.

Nicholas Jones, patent attorney and biotechnology sector specialist at Withers & Rogers LLP, 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.

“There is no possibility of a let-off for patent holders due to jurisdictional variations either. The ECJ’s decision confirms that patent protection should not be extended beyond the rules of the EU Biotechnology Directive.”