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Legal Affairs : Sep 1, 2008 ( )
Bio Directive Fails to Unify European Law
Implementation and Interpretation of Patent Protection Rules Vary Among Member States!--h2>
The Biotech Directive was conceived to clarify the patent position of biotechnological inventions in Europe. Directive 98/44/EC on the legal protection of Biotechnological Inventions (the Biotech Directive) had a rocky start. The Netherlands opposed its legality before the European Court of Justice (ECJ), and only a few member states had implemented it by July 30, 2000 (its implementation date).
Although the Biotech Directive has now been implemented throughout Europe, there is some suggestion that it is not exercised consistently.
Article 3(2) of the Biotech Directive confirms the patentability of such inventions: “Biological material, which is isolated from its natural environment or produced by means of a technical process, may be the subject of an invention even if it previously occurred in nature.”
The industrial application of the gene sequence must be disclosed in the patent application but not necessarily within the claim. Hence, the Biotech Directive arguably allows per se, or product-based, protection for a gene sequence that has been isolated from its natural environment.
Protection for Derivatives
Genes are not equivalent to NCEs in the pharmaceutical sector. They are not effector molecules as such, being vectors for information that allow biological systems to express therapeutically active molecules. There is a potential limitation to per se protection contained within the Biotech Directive in Article 9, which states:
“The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product is incorporated and in which the genetic information is contained and performs its function.”
The effect of Article 9 is well illustrated by Monsanto’s attempts to enforce its patent for genetically modified glyphosate-resistant soy plants against soymeal importers around Europe. These related cases, brought against Cargill in Spain and the U.K. as well as against Cefetra in the Netherlands, also demonstrate how the different implementation of the Biotech Directive has the potential to create different results around Europe.
In each action brought by Monsanto, soymeal was imported from Argentina into Europe. The soymeal was allegedly derived from genetically modified plants that were resistant to the herbicide glyphosate and that had been grown in Argentina. Monsanto had no patent protection in Argentina and thus sought to protect its rights by suing the importers of the soymeal in Europe.
Soymeal is highly processed and contains no viable cells. In these circumstances, the inserted gene, even if present, is not performing its function because to perform its function, it would need to be transcribed into mRNA and then translated into an amino acid sequence. Therefore, if the Biotech Directive was applied to such a situation, there would, arguably, be no infringement due to Article 9.
In Spain, the court held that the Biotech Directive applied, and importing soymeal did not infringe on Monsanto’s patent for this very reason.
In the U.K, the Biotech Directive did not apply because the application for the patent was made before July 28, 2000. The decision was, therefore, based purely on existing case law and claim construction. The intact gene sequence claimed in the patent and conferring resistance was held to be present in the soymeal.
Since the claim was restricted to isolated sequences, though, the soymeal did not infringe. “Isolated” was held to be a technical term that applied to DNA sequences that had been removed from a genome and were in a form ready for further processing. As the gene sequence in the soymeal was not isolated within this meaning, the importation of soymeal into the U.K. did not infringe on Monsanto’s patent.
The Dutch Court also adopted this construction of the word isolated and as a result, found noninfringement. For the claims not restricted by the word isolated, the Dutch court asked the ECJ to clarify the scope of Article 9 and to which patents the Biotech Directive applies.
While the three results were the same, the reasoning of the different courts was not consistent and thus could lead to divergent results on very similar fact patterns.
The differences in how each member state has chosen to implement the Biotech Directive and therefore the differences in how it might be interpreted were not highlighted by these cases, because only the Spanish Court made a substantive decision under the Biotech Directive. Other aspects of its implementation and interpretation, beyond which patents it applies to, however, are not necessarily consistent across Europe.
The wording of the Biotech Directive has been preserved in the U.K. and so could allow per se protection for genes in certain circumstances. Prior to the Biotech Directive, however, case law in the U.K. had not offered per se protection for DNA sequences. As no cases have yet been decided or are due to be decided under the Biotech Directive, the U.K.’s approach is yet to be seen.
In France, the sequence or partial sequence of a gene is not patentable per se. Instead, only the technical application of the gene sequence, which must be fully disclosed in the patent application, is protected.
Similarly, in Germany, the industrial application of a full or partial gene sequence must be fully described in the patent application. The German provisions go a step further and in the case of sequences or partial sequences of human genes, the function must be included in the claim. Again, the result of this requirement is purpose-bound protection for claimed DNA sequences.
This purpose-bound protection for gene sequences isolated from the human body may be at odds with the wording of the Biotech Directive. Inconsistent implementation and interpretation of the Biotech Directive by different member states might affect the outcome of future litigation relating to biotech patents.
The choice of jurisdiction could, therefore, be key to the success of an action brought in Europe under a biotechnology patent. Understanding the nuances of each member state’s laws will also be vital. The decision of the ECJ in the Dutch Monsanto vs. Cefetra case will be interesting, although the questions asked are quite narrow, and the decision is unlikely to resolve all the differences in implementation across member states.
Hence, it seems that the Biotech Directive has failed in its intention to clarify the law. The uncertainty about the scope of protection conferred by biotech patents around Europe is also likely to continue for the foreseeable future.
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