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Patent protection for DNA sequences – Part 2 – Monsanto (Europe)

September 2010 - Intellectual Property. Legal Developments by Hertin Anwaltssozietät .

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Further to the Myriad decision from the United States (see part 1 of this blog), a European Court of Justice (ECJ) decision from July 2010 demonstrates another potentially significant setback to the validity and enforceability of patents directed to DNA sequences.

The ruling in Monsanto Technology LLC v. Cefetra BV et al. essentially concluded that patent claims covering isolated DNA or transgenic products that contain the patented DNA cannot be infringed if the DNA is not functional at the time of alleged infringement. The decision rests on the ECJ's interpretation of Directive 98/44/EC of the European Parliament on the legal protection of biotechnological inventions. If applied broadly, this ruling may in fact do serious economic harm to the European biotechnology industry, according to Peet et al.

On the grounds of this decision, the infringement of countless biotechnology patents may be avoided by infringers who claim the protected DNA was inactive at the time of infringement.

The obvious problem is that, according to this rationale, biological matter may be grown and the functional properties of a patented DNA sequence exploited, but bringing such material onto the market would not represent an infringement if the biological matter is sufficiently processed so that the gene is inactive, for example at the time of sale. However, if taken even further, diagnostic tests or analytical methods (such as microarrays) that use nucleic acid sequence markers or probes may be unenforceable, if one could successfully argue the function of the sequence is not being fulfilled at time of alleged infringement.

Monsanto legal action

In the case at hand Monsanto, who have no rights over their EPSPS glyphosate tolerance technology in Argentina, sued various importers of soybean meal coming from Argentina into Europe for infringement of EP 0 546 090.

Monsanto's patent provided protection for isolated DNA encoding EPSPS and a method of producing a genetically transformed plant which tolerates the herbicide glyphosate via the EPSPS gene, in addition to other glyphosate-tolerant plant cells and plants, and methods for controlling weeds. However, EP 0 546 090 did not contain claims to a method of making soybean meal from glyphosate-tolerant plants.

The parties to the Dutch litigation disagreed about the scope and interpretation of Directive 98/44/EC and whether it was applicable, thus referring the case to the ECJ. The ECJ held that "under the system established by Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, the protection for a patent relating to a DNA sequence is limited to situations in which the genetic information is currently performing the functions described in the patent. That holds true both as regards the protection of the genetic information as such and as regards the protection of the materials in which that genetic information is contained."

The decision has been met with criticism. Peet et al argue that the ECJ's interpretation of Article 9, in the context of the Monsanto litigation, is incorrect and potentially damaging to biotechnology business in Europe. Although the present ECJ ruling does not undermine the patentability of genes in any way, it could undermine patent enforcement for many biotechnology inventions.

Does DNA information content play a role?

The infringing act here was the importation of soy meal, at a time when the patented gene was "inactive". In this particular case, we assume the "activity" of the DNA sequence relates to gene expression and protein production. However, this raises various fundamental questions:

-          How does the DNA sequence materially differ when "active" or "inactive"?

-          Would expression of a patented gene (mRNA production? protein production?) need to be demonstrated by the patent holder when suing for infringement?

-          When does a DNA sequence become "inactive" and thus incapable of performing its function? "Inactive" DNA may of course be extracted, cloned and "re-activated".

-          Is the presence of a protected sequence not a sufficient requirement for infringement?

In contrast to the opinion of the District Court Judge in the US Myriad case, the present ruling seems to provide a different view towards whether the information content of DNA plays a role in ascertaining legal rights. To the ECJ, the information coding nature of DNA is almost irrelevant. The fact that the DNA contained in the imported soy meal still exhibits the same information content was not sufficient for the court to rule an infringement. Essentially the coding nature of DNA has been pushed to the sidelines.

The ECJ ruling implies that what is important about the patented DNA is not the encoded information, but its "activity", similar to a chemical or active substance when applied to a crop. Despite the different jurisdictions and the differences between validity and enforceability, this line of reasoning seems to conflict with the reasoning of the Myriad case, where the coding nature of DNA played a central role in assessment of patentability.

The present ECJ ruling will however force biotechnology companies to reassess what protection their patents on DNA sequences offer, and whether embodiments are claimed that encompass "active" DNA sequences (whatever that in fact means) capable of being infringed.

 


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