Opinion on DNA patents is cause for concern

Who would have thought that a relatively straightforward dispute between a global agrochemical company and a group of Dutch importers of Argentine soy meal could escalate to the European Court of Justice and potentially limit the rights of biotech inventors to protect the commercial value of their work?

The dispute arose when 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 claims that according to the EU Biotechnology Directive, which was implemented across the EU in the early 2000s, the importers are infringing its 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, if Advocate General Mengozzi’s opinion is upheld by the ECJ – as is usual – Monsanto would not be able to block the importation of the soy meal and the rights of biotech patent holders could be limited significantly. This is because patent protection would only extend to situations where the genetic information can be shown still to be actively performing its function on which the patent protection was based. Whereas the DNA sequence in the herbicide-resistant soya plant was performing its function when the plant was grown, arguably it was no longer doing so when it was later found inside a piece of soy meal.

For the biotech industry, such a ruling can be expected to be extremely concerning. In the past, many small and medium-sized companies have chosen to restrict the geographic reach of their patent protection to major territories in a bid to cut costs, and in doing so they have relied upon their ability to take action against third party importers. This may no longer be possible if the genetic material is contained in a product that has already been processed in such a way as to prevent the genetic material performing its function.

Even more worryingly for biotech patent holders, if a third party subsequently finds a different use for a particular piece of genetic material, this may be beyond the reach of existing patent protection. One wonders whether the Advocate General’s opinion could in future be applied to proteins as well as nucleic acids. This would depend in part on whether ‘genetic information’ – a term used, but not defined in the Directive – can include proteins within its scope. While it is relatively difficult to find an alternative use for a specific DNA sequence, for example, alternative uses for proteins are found relatively frequently. Biotech companies are likely to be concerned that the expected ECJ ruling could leave their inventions exposed to third party activity and restrict the commercial potential of their work.

There is no possibility of a let-off for patent holders due to jurisdictional variations either. Responding to a second question put to the ECJ, the Advocate General says that the Directive’s rules should be viewed as ‘exhaustive’ – in other words, individual Member States cannot provide wider patent protection than the framework set in the Biotechnology Directive.

What might once have been a straightforward dispute between a patent holder and a group of feedstock importers could leave a lasting impact on the biotech industry and force a re-think of patent protection strategies.

Nicholas Jones and Josie Zhou
Life Sciences & Chemistry Group