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Legal Affairs : Sep 1, 2010 (Vol. 30, No. 15)

Purpose-Dependent Protection for DNA

Recent EU Decision Puts Molecule in a Class of Its Own with Regard to Biotechnology Patents
  • Matthew Royle, Ph.D.

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.

Harmonization Achieved?

Monsanto brought equivalent actions in Spain and in the U.K. against soymeal importers. The decisions in these cases were the same: that importation of soymeal into the EU did not infringe Monsanto’s patent. The reasoning was, however, different.

  • In the U.K., the court found noninfringement based on its construction of words in the claim. The directive was not considered. Its implementation in the U.K. was restricted to patents that were applied for after July 28, 2000. Monsanto’s patent was applied for earlier than this date and so the directive did not apply. The law in the U.K. will have to be amended to rectify this.
  • The Spanish court applied Article 9 of the directive and decided that the imported soymeal did not therefore infringe.

The Dutch court, of course, referred preliminary questions to the ECJ and did not make a final decision.

Following the ECJ’s decision, each national court would have reached the same decision but, importantly, would have done so for the same reason: Article 9 of the directive applied and the DNA in the soymeal was not performing its function.

One of the main thrusts of the ECJ decision is to give effect to the harmonization of the law in Europe as it relates to biotechnology inventions, and particularly to claims to DNA sequences. It is interesting, therefore, to note that—at least with regard to these decisions—the ECJ’s decision achieves its objective.

Practical Effect

It is clear from the directive that the purpose of the DNA sequence must be disclosed in the patent. This requirement was generally understood to be for industrial application and not, as the ECJ has decided, to limit the protection. Some countries, notably Germany and France, provided purpose-bound protection to DNA claims when implementing the directive. Most, however, did not, so the decision will lead to a change in the law in many countries.

The decision also confirms DNA’s special status. No other molecule’s protection is limited to its function (except for second medical uses of known compounds). There was a suggestion in the Advocate General’s opinion, which was not reproduced in the ECJ’s judgment, that mere discoveries were not patentable. This is not the case. 

Naturally occurring chemicals that are found to have beneficial properties are patentable. Their inventiveness is judged on the ordinary principles of patent law. There is no barrier simply because they are a discovery, and protection extends to the molecule as such. The ECJ did not address why DNA should be treated differently.

It is, of course, true that DNA is not the effector molecule. Its value comes from the information it carries, and in this respect it is unique. In the majority of cases, the DNA will be performing its function within viable cells and as such will be protected.

The effects of the decision will be felt most keenly in the agricultural biotechnology sector. Claims to DNA sequences will not protect derivative or processed products, even if the DNA sequence is still present. The challenge for patentees in this area will be to find alternative ways to protect these products.

Conclusion

This decision harmonizes the protection afforded to claims to DNA sequences in the EU. It also makes clear that protection for DNA sequences is limited to the purpose for which they were patented. This approach is, rightly or wrongly, different to all other molecules. When it comes to patent protection, DNA is undoubtedly now in a class of its own.