Press releases

21/05/2010

European Court Deals Blow to Scottish Biotech

Scotland's burgeoning life sciences and bio-tech industry - now employing more than 32,500 people - has been dealt a blow by a European court ruling.

A European Court of Justice opinion issued recently could affect the value of existing patent portfolios - potentially limiting the ability of companies operating in the cash-hungry research sector in raising money from licensing their patents.

The sector now has more than 630 companies operating in Scotland, and generates more than £3 billion for the economy.

Liz Cohen, a Partner at leading law firm Bristows, said: "If this Opinion is followed by the ECJ, it may have serious implications for biotech companies, who are reliant on European Patents to protect import of products containing patented DNA sequences from outside Europe.  In an industry where funding is already in short supply, any limitation in the extent to which claims to DNA sequences can be infringed may in turn affect the value of biotechnology patent portfolios.  This will affect the future of biotechnology companies in Europe, whose ability to generate income from licensing their patents is often the difference between survival and failure."

Fiona Nicolson, Partner, and one of the leading Scottish Intellectual Property lawyers, added: "Organisations and companies need to be aware of the scope of protection afforded by their patent portfolio in the light of this opinion, and to look at how that scope can be broadened effectively."

Scott Johnstone, director of the Bio Industry Association, said: " Scottish Companies have intellectual property as their core value driver. Any ruling that potentially limits the income that can be derived from IP reduces the potential for growth in the sector. Scottish companies are alert to this and through the BIA (Scotland) we will campaign against any legislation that restricts this"

Donald McPhail, a director of Antoxis "We are aware of the recent ruling and, whilst it does not affect us directly, it is something that will impact other companies in our sector. Having a good legal advice is essential to allow us to navigate our way around rulings such as this and enables us, not only to maintain, but strengthen our existing IP estate"

Earlier this month the European Court of Justice (ECJ) issued its long-awaited opinion on the scope of the Biotechnology Directive, and in particular the extent to which DNA sequences can be patented in Europe.

The Advocate General found that the protection conferred by claims to DNA sequences is limited to instances where the DNA is performing the functions described in the patent at the time of the infringement.  This applies both to the protection of the DNA sequence as such as well as the protection of materials in which the DNA is contained.

The Advocate General also concluded that the Biotechnology Directive applies retrospectively and supersedes national patent legislation.  Thus, the scope of protection afforded by national laws - including the UK - is restricted.

The case, which follows a referral from the Dutch District Court of The Hague, concerns the importation from Argentina of soya meal derived from genetically modified soybean developed by Monsanto.  Monsanto alleged that the imported soya meal contains DNA which falls within the scope of its patent for an enzyme that promotes herbicide resistance.

Although not binding, this opinion is an indication of how the ECJ is likely to interpret the Biotechnology Directive.  The final decision of the ECJ is expected sometime later this year.



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