Opinion on DNA patents is cause for concern

A European Court ruling on GM soy protein imported from Argentina has implications for the patent rights of biotechs, say Nicholas Jones, partner, and Josie Zhou, trainee patent attorney, at the law firm Withers & Rogers LLP.

It may seem unlikely, but a relatively straightforward dispute between the global agrochemicals company Monsanto and a group of Dutch importers of Argentine soy meal, has escalated to the European Court of Justice and could potentially limit the rights of biotech inventors to protect the commercial value of their work.

The dispute arose when Monsanto discovered soy meal being imported into the EU from Argentina - one of the few territories where it does not have patent protection - contained traces of DNA covered by one of its 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 for the DNA sequence used to prompt the herbicide-resistance was granted in 1996.

Monsanto claims the importers are infringing its patent rights by bringing soy meal containing the proprietary genetic information into Europe. It bases this claim on the EU Biotechnology Directive, which was implemented across the EU in the early 2000s. This states that patent protection extends to all material in which the patented genetic information ‘is contained and performs its function’.

However, if Advocate General Paolo Mengozzi’s opinion, delivered last week, is upheld by the European Court of Justice – as is usual – Monsanto would not be able to block the import of the soy meal. While there may be few tears shed over this, the wider implication is that the rights of biotech patent holders in general 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 the function on which the patent protection was based. In the case of Roundup-ready soya, the DNA sequence in the herbicide-resistant plant performs its function when the plant is growing and is no longer doing so when it is later found inside a piece of soy meal.

For the biotech industry, such a ruling will 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. 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 been processed and the DNA is no longer 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 European Court of Justice 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 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.

It seems that what started out as 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.

About the authors

Dr Nicholas Jones is a partner and patent attorney at Withers & Rogers LLP, specialising in biotechnology and pharmaceutical research and development. He is a member of the Royal Pharmaceutical Society of Great Britain and the Royal Society of Chemistry.

Before joining Withers & Rogers LLP, Josie Zhou graduated with a degree in Biochemistry from Imperial College London in 2008.