The Court of Justice of the European Communities just recently denied absolute product protection of patent claims directed to DNA sequences in the case Monsanto v Cefetra and others, C- 428/08.
In its judgment of 6 July 2010, the Court of Justice held that Art. 9 of the Biotechnology Directive would exclude national legislature from granting absolute product protection to patented DNA sequences. This would equally apply to DNA patents issued before the Directive’s adoption. It would not suffice that the DNA would perhaps be able to perform its function after having been extracted from the material in which it does not do so. Article 9 would rather imply that the function must be performed at the present time and in the actual material in which the DNA sequence is found.
The judgment is based on a referral of the Court of The Hague. The parties, however, settled patent litigation shortly before the Court of Justice rendered its decision. It is considered to be the first actual test of the Biotechnology Directive 98/44/EC of 1998.
Article 9 of the Directive requires that protection conferred by a patent on a product containing or consisting of genetic information extends to all material in which the product is incorporated and in which the genetic information is contained and performs its function.
Monsanto had found traces of the patented DNA in soy meal imported into The Netherlands. The soy meal was obtained from genetically modified soy plants in Argentina. These made use of the DNA by producing enzymes providing resistance to certain herbicides. Monsanto, which did not have any equivalent patent protection in Argentina, claimed infringement of the Dutch part of its European Patent in The Netherlands due to the presence of DNA in the soy meal.
Monsanto asserted the patented DNA to be subject to absolute product protection. It argued that Article 9 of the Biotechnology Directive was only aimed at extending the protection to material other than the DNA, if that material incorporated the DNA. It would not cover the use of the DNA as such. This was actually confirmed by the General Advocate Mengozzi in his Opinion of March 9, 2010 (marginal no. 27). He, however, generally considered the Directive to merely provide for purpose-related patent protection as opposed to absolute product protection for DNA sequences.
Article 9 expressly excludes the human body at various stages of its formation and development from the extension of patent protection to the material in which the DNA is contained by referring to Article 5 para. 1 of the Biotechnology Directive. In light of this reference, Article 9 indeed appears to be aimed at ensuring additional protection of the material in which the genetic information is contained, rather than limiting the scope of protection. This provision takes into account that further products could be generated by merely reproducing or multiplying the (live) material. Only the extension of patent protection to parts of the human body was excluded due to ethical considerations.
In Germany, as in other European countries, product claims generally provide absolute product protection. A patentee can prohibit each and every use of the product as patent infringement, irrespective of whether he actually knew of the specific use when applying for the patent. Even the express indication of a purpose, effect or function within the claim language is generally not considered to limit the scope of protection (Federal Supreme Court, IIC 1992, 111 – Fixing Device II).
The Court of Justice, in contrast, stipulates a purpose-related protection for DNA-sequences regardless of whether the function of the DNA is mentioned in the claims or merely somewhere in the patent description. For this the Court, inter alia, referred to Recital 23 of the Biotechnology Directive, according to which a mere DNA sequence without indication of function is not patentable. The Madrid Provincial Court of Appeal has incidentally decided similarly (IIC 2009, 971 et seq.).
From a German perspective, relying on questions of patentability is rather dubious in infringement proceedings due to the two track patent system in which different courts rule on validity (Federal Patent Court) and infringement (infringement courts). An infringement court can merely suspend proceedings on the merits in light of a pending validity action. Save in preliminary injunction proceedings however, it cannot dismiss an infringement action on the basis of the patent’s invalidity unless the invalidity has been finally confirmed by the competent court.
Furthermore, under German law, an interpretation beyond the meaning of the claim’s wording is not admissible. Limiting statements in the description of the patent which are not reflected in the claim language are to be disregarded when interpreting the protective scope of the claim (Federal Supreme Court, IIC 2007, 984 – Conveyance of Weft Threads; Federal Supreme Court, IIC 2005, 971 – Bottom Separating Mechanism).
Nevertheless the present case could have been resolved in Germany without having to generally limit the absolute product protection afforded to DNA-sequences: in an infringement case on the basis of a patent claim directed to an intermediate in the production of a (chemical) herbicide, the Regional Court Düsseldorf decided that the final product would not be covered by the patent’s scope of protection (GRUR 1987 – Grasherbizid). The final product only contained trace amounts of the patented intermediate. These were minor residues left over from its incomplete conversion into the final product. The intermediate found was therefore regarded as a mere impurity of the final product and no longer performing its function. For this reason, it was considered not to be infringing despite of the acknowledged absolute product protection in Germany.
The Advocate General rejected equivalent arguments in his Opinion (marginal nos. 39 et seq.) absent any de minimis provision in the Biotechnology Directive and as allegedly leading to greater legal uncertainty.
In any case, it cannot be excluded in future situations, which are not as clear-cut as the Monsanto case, that disputes will arise about the performed or intended function of patented DNA. In addition, patentees will have to make sure that all conceivable functions are disclosed in the patent in order to obtain the most extensive protection for the isolated DNA.