On July 6, the Court of Justice of the European Union (ECJ) handed down judgment on a reference from The Netherlands relating to Directive 98/44/EC on the legal protection of biotechnological inventions. The decision limits the protection of DNA sequences claimed in a patent to those situations in which the DNA is performing its function—so-called purpose-bound protection. This article considers the background to the reference, the decision, and its effect on biotechnology inventions.
Glyphosate (Roundup®) is an herbicide that blocks the biosynthesis of aromatic amino acids in plants by inhibiting an enzyme in the pathway. Monsanto identified a glyphosate-resistant enzyme and used it to create a soybean plant that was able to grow in the presence of glyphosate.
Monsanto sold glyphosate-resistant soybean plants in Argentina. The plants were successful and now most soybean plants grown in Argentina are glyphosate resistant. However, Monsanto had no patent protection in Argentina and no income stream. It therefore sought to assert its patent rights against importers of soymeal into the EU from Argentina. One of the actions started was in The Netherlands.
Reference by The Netherlands
The court decided as a fact that Monsanto had shown the presence of the DNA encoding the claimed enzyme in the imported soymeal. The question before the court was therefore whether or not the presence of that DNA in the soymeal was enough to infringe.
Article 9 of the directive states that:
“The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material…in which the genetic information is contained and performs its function.”
This provision suggests that the soymeal cannot infringe a claim to DNA because the soymeal is not viable and the DNA does not perform its function. The Dutch court wanted to clarify this point and therefore referred questions to the ECJ about the correct interpretation of the directive.
The ECJ's Judgment
The first question was about the interpretation of Article 9. Did it confer patent protection where the DNA was present and had performed its function or could do so again if isolated and introduced into another organism? Article 9 uses the present tense; the DNA “performs its function”. It also extends only to “material…in which the [DNA] is contained”. This excludes past and future performance of the DNA.
The ECJ also addressed Monsanto’s argument that the protection available was for the DNA molecule as such. It held that this was not the case and that protection of the DNA molecule is purpose-bound. In doing so, it relied upon the recitals and provisions of the directive that require the function of the DNA to be disclosed in the patent.
To decide otherwise in respect of either of these points would be to deprive Article 9 of any effect. It is true in all situations that the DNA has either performed its function or could perform its function again. Further, protection for the DNA molecule as such would mean that extending protection to the material containing it would be unnecessary.
The second and third questions were: did Article 9 preclude a Member State from offering absolute protection to DNA molecules; and did the directive apply to all patents or only to patents applied for after the directive was adopted? In answer to both of these questions, the ECJ considered the stated purpose of the directive: to harmonize protection throughout the EU and to encourage investment in biotechnology. In order to give effect to this purpose, Article 9 of the directive must be exhaustive and must apply to all patents.