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September 01, 2010 (Vol. 30, No. 15)

Purpose-Dependent Protection for DNA

Recent EU Decision Puts Molecule in a Class of Its Own with Regard to Biotechnology Patents

  • Harmonization Achieved?

    Monsanto brought equivalent actions in Spain and in the U.K. against soymeal importers. The decisions in these cases were the same: that importation of soymeal into the EU did not infringe Monsanto’s patent. The reasoning was, however, different.

    • In the U.K., the court found noninfringement based on its construction of words in the claim. The directive was not considered. Its implementation in the U.K. was restricted to patents that were applied for after July 28, 2000. Monsanto’s patent was applied for earlier than this date and so the directive did not apply. The law in the U.K. will have to be amended to rectify this.
    • The Spanish court applied Article 9 of the directive and decided that the imported soymeal did not therefore infringe.

    The Dutch court, of course, referred preliminary questions to the ECJ and did not make a final decision.

    Following the ECJ’s decision, each national court would have reached the same decision but, importantly, would have done so for the same reason: Article 9 of the directive applied and the DNA in the soymeal was not performing its function.

    One of the main thrusts of the ECJ decision is to give effect to the harmonization of the law in Europe as it relates to biotechnology inventions, and particularly to claims to DNA sequences. It is interesting, therefore, to note that—at least with regard to these decisions—the ECJ’s decision achieves its objective.

  • Practical Effect

    It is clear from the directive that the purpose of the DNA sequence must be disclosed in the patent. This requirement was generally understood to be for industrial application and not, as the ECJ has decided, to limit the protection. Some countries, notably Germany and France, provided purpose-bound protection to DNA claims when implementing the directive. Most, however, did not, so the decision will lead to a change in the law in many countries.

    The decision also confirms DNA’s special status. No other molecule’s protection is limited to its function (except for second medical uses of known compounds). There was a suggestion in the Advocate General’s opinion, which was not reproduced in the ECJ’s judgment, that mere discoveries were not patentable. This is not the case. 

    Naturally occurring chemicals that are found to have beneficial properties are patentable. Their inventiveness is judged on the ordinary principles of patent law. There is no barrier simply because they are a discovery, and protection extends to the molecule as such. The ECJ did not address why DNA should be treated differently.

    It is, of course, true that DNA is not the effector molecule. Its value comes from the information it carries, and in this respect it is unique. In the majority of cases, the DNA will be performing its function within viable cells and as such will be protected.

    The effects of the decision will be felt most keenly in the agricultural biotechnology sector. Claims to DNA sequences will not protect derivative or processed products, even if the DNA sequence is still present. The challenge for patentees in this area will be to find alternative ways to protect these products.

  • Conclusion

    This decision harmonizes the protection afforded to claims to DNA sequences in the EU. It also makes clear that protection for DNA sequences is limited to the purpose for which they were patented. This approach is, rightly or wrongly, different to all other molecules. When it comes to patent protection, DNA is undoubtedly now in a class of its own.

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