EU Court restricts protection for gene patents

In a recent decision (Monsanto Technology LLC v Cefetra BV and Others), the Court of Justice of the European Union declared that patent protection for gene patents will only extend to gene sequences which are performing the specific function for which they were patented.  The decision of the Court is the first-ever judicial assessment of the extent to which European patent law will protect gene patents.

Background

In 2005 Monsanto learnt that various companies had begun to import soybean meal into Europe from Argentina.  The soybean meal was derived from genetically modified soybean plants and subsequent testing established that the soybean plants were Monsanto’s Roundup Ready soybean plants.  The Roundup Ready soybean plants contained Monsanto’s patented gene sequences which confer herbicide resistance on a plant when the sequence is inserted into the plant’s genome.  Monsanto had patented the gene sequences in Europe, but not in Argentina.

Monsanto commenced proceedings in a Dutch Court alleging that the mere presence of the gene sequences in the processed soybean meal was sufficient to infringe its European patent.  The Dutch Court referred various questions to the Court of Justice for a preliminary ruling.  The proceedings were subsequently settled, however the Court of Justice decided to issue a decision to clarify the issue of patent protection for gene patents in Europe.

The Court finds no protection where the DNA sequence is not performing its patented function

The Court of Justice was asked to rule on the meaning of Article 9 of European Directive 98/44/EC, otherwise known as the Biotech Directive, regarding the scope of protection that should be given to gene patents.  Article 9 of the Directive makes the protection conferred by a European patent on a product containing genetic information subject to the condition that the genetic information is contained in the patented product and performs its function in the product in which it is contained.

The Court held that the protection given by Article 9 is not available where the gene sequence has ceased to perform the specific function for which the patent was granted.  This interpretation therefore excludes any downstream derivative products which no longer perform this function.

The Court held that the function of Monsanto’s patent was to protect the soybean plant from the herbicide glyphosate.  Since this function could no longer be performed in the downstream product, the protection conferred by the patent was not available.  Monsanto’s argument that the gene sequence had performed its function (ie it had at some point conferred herbicide resistance) or could at some point in the future perform its function (ie if the gene sequence was extracted from the soybean meal and inserted into a new cell) was rejected by the Court as it would deprive Article 9 of its effectiveness since one of these alternatives could, in principle, always exist.

Developments in the US & Australia

The decision in Europe follows an earlier ruling in the US that patents claiming the BRCA1 and BRCA2 genes associated with breast cancer were invalid as they were directed towards a law of nature (click here to read our earlier post).

Similar proceedings have been commenced in Australia to invalidate patents to the breast cancer genes licensed to Genetic Technologies and owned by Myriad Genetics (click here to read our earlier post).

We also note that the reporting date for the Senate Community Affairs Committee’s Inquiry into Gene Patents has been extended until 2 September 2010.  For more information on the Inquiry please click here.

About the Author

James Ellsmore
James is a senior associate with King & Wood Mallesons' Intellectual Property team in Sydney. James assists clients to resolve intellectual property disputes, with a particular focus on patents, pharmaceuticals and the life sciences. He has acted for a variety of clients in matters concerning patent infringement and revocation proceedings in the Federal Court of Australia, patent opposition proceedings before the Commissioner of Patents, and matters arising from patent licence and technology agreements. James also has experience in the preparation of commercial, R&D and IP agreements for leading universities, research organisations and pharmaceutical companies. He also advises clients on regulatory issues affecting clients in the industrials, consumer and health sectors.
View all posts by James Ellsmore

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