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.