Since their inception, DNA sequence patents have proved a hot topic in patent law. Advocate General Mengozzi's opinion in the Monsanto case has been keenly awaited as it provided the first opportunity for the European Court of Justice (ECJ) to interpret the scope of EU legislation on the protection of biotechnological inventions, in particular in relation to DNA sequence patents. The Advocate General's opinion on the scope of protection to be afforded to DNA sequence patents is likely to cause controversy, partly due to the subject matter and partly due to the relatively narrow scope of patent protection he seeks to create.

Although the Advocate General's opinion has yet to be considered by the ECJ, in the majority of cases the ECJ does accept its Advocate General's opinion.

Background

Monsanto's patent identified DNA sequences encoding a class of enzyme variants which are resistant to a specific herbicide (Round Up) and can be incorporated into plant DNA to compensate for the non-resistant form of the enzyme which is native to the plant.

The basis of Monsanto's claim is that Cefetra imported soy meal made from plants expressing Monsanto's patented DNA sequence into the EU and that the soy meal contained traces of the sequence. Monsanto was unable to claim that the growing of the genetically modified soya plants incorporating the patented DNA infringed its patent because the plants were grown in Argentina, where Monsanto had been unable to obtain a patent.

The Dutch court hearing the Monsanto case referred various questions to the ECJ to obtain its interpretation of certain aspects of the Biotechnology Directive, Council Directive 98/44/EC (Directive); a directive implemented to harmonise national laws governing the patentability of biotechnological inventions.

Advising the ECJ, Advocate General Mengozzi's opinion is as follows.

A DNA sequence must currently perform its patented function

The first question the Dutch court referred to the ECJ was whether, in circumstances where the DNA sequence in question is part of another material (e.g. soy meal), Article 9 of the Directive would provide patent protection for the DNA sequence even though the DNA sequence was not performing its patented function at the time of alleged infringement, but had previously performed its function and was capable of performing that function again.

Article 9 states that patent protection for "product[s] containing or consisting of genetic information shall extend to all material... in which the product [is] incorporated and in which the genetic information is contained and performs its function." [1]

Discussing Article 9, the Advocate General recognises a traditional principle in patent law; that incorporating a patented substance into another product will not generally prevent protection of that patented substance. Despite this, the Advocate General states that in relation to DNA sequences incorporated into other material, Article 9 was clear that patent protection should only be afforded when the DNA sequence is currently expressing its function.

Monsato argued that its claim was not however limited to Article 9 rather the importation of the DNA sequence in itself (which happened here to be incorporated within soy meal) was an infringement under classic patent law principles preserved by and irrespective of the Directive. The Advocate General's view is that the Directive has exhaustively harmonised patent law protection in respect of inventions which fall within its scope.

Article 9 is intended to be an "extension" to the protection provided by ordinary patent law principles. Therefore, although the Directive does not expressly say so, the protection of the DNA sequence "as such" is similarly "purpose bound" by the Directive. If this was not the position then Article 9 would be redundant as the Monsato style argument would always be used whenever a DNA sequence was incorporated into other material. In the Advocate General's own words "a DNA sequence must be regarded as protected, even as a self-standing product, only where it performs the function for which it was patented. In other words, it seems to me that Directive 98/44 permits - and, in fact, requires - an interpretation to [that] effect... Even though the directive does not expressly indicate that the protection to be conferred on DNA sequences must be of that order."

The Advocate General justifies his purposive interpretation of the Directive, stating that it is necessary to avoid patentees obtaining disproportionate protection and to prevent patent protection encompassing "an unspecified number of derivatives products" and being unworkable, particularly where the DNA present in the derivative product is only a residual amount. Indeed, a wider view of the Directive may lead Monsanto to find a claim for the presence of its DNA sequence in the stomach of a cow that consumed the soy meal!

The Advocate General clarifies that, for the purpose of the Directive, a dormant gene (which by definition is not currently being expressed) is to be regarded as currently performing its function provided it is of a type which may be activated by a particular event and is in such a situation that it could be activated to perform its function on that event occurring.

Applying the Advocate General's interpretation to the Monsanto case, there is no infringement of Monsanto's patent because, at the time of the alleged infringement, the patented DNA sequence in the soy meal did not express its function (it did not protect plants from Round Up), even though the sequence had already performed its function when the soya plants were grown and could perform its function again if it were isolated and reinserted into a plant.

Patent protection only covers the function specified in the patent

In answer to the first question, the Advocate General also considers whether patent protection should extend to encompass all functions of a DNA sequence, regardless of whether they are specified in the patent.

In order to prevent the isolation of an identified DNA sequence (which is a "mere discovery" rather than an invention) being patentable, the Directive specifically requires the function of the DNA to be specified before a patent can be granted. The Advocate General uses this requirement to justify his view that the scope of DNA patent protection should be narrow, stating that, unlike 'traditional' patent protection, DNA sequence patents should only cover the function specified in the patent. The Advocate General notes that if finding and disclosing one function of a sequence permits protection against all as yet unknown uses of that sequence, the DNA has effectively been patented in itself as if it were a traditional inventive "product".

The Advocate General further states that limiting patent protection to the purpose specified in the patent is not a new concept - the European Parliament advocates this approach in relation to human DNA and a similar concept is common in relation to pharmaceuticals, where a second medical use is separately patentable but only provides protection in relation to use for that specified second medical use.

National law cannot provide greater protection

The second question referred to the ECJ was whether the patent protection in the Directive is exhaustive or whether national law could provide additional protection. The Advocate General advises that although the Directive does not encompass all aspects of biotechnological patents, in the areas in which it legislates, it is exhaustive and national law cannot provide a greater level of protection. His rationale is that there is nothing in the Directive to the contrary and the intention of the Directive is to harmonise the law and further the single market. This intention would not be achieved if national law could provide additional protection.

The date the patent was granted is irrelevant

The Dutch court also asked the ECJ to clarify whether the Directive would apply to patents granted prior to the Directive coming into force. The Advocate General maintains that the date the patent was granted is irrelevant because there are no transitional provisions in the Directive. Applying differing treatment to earlier patents would go against the intention of the Directive which is to harmonise the law.

There is no conflict with TRIPS

The final reference to the ECJ requested confirmation as to whether the international agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) could be taken into account when considering the previous questions. The Advocate General explains that where a Member State acts in accordance with TRIPS, it could not be accused of infringing the Directive but, in any event, his interpretation of the Directive did not conflict with TRIPS.

Article 27 of TRIPS states that "patents shall be available and patent rights enjoyable without discrimination as to... the field of technology". The Advocate General carefully notes that this Article concerns patentability rather than the scope of patent protection and does not therefore stand in the way of his interpretation of the Directive.

Article 30 of TRIPS concerns permissible exceptions to the rights conferred on a patent holder. The Advocate General is of the view that there is no conflict between his opinion and Article 30 as the requirement for a DNA sequence to perform its function is not an exception to patent protection, but a restriction on the scope of the protection itself.

Comment

The Advocate General's opinion is likely to be controversial. It is widely recognised that DNA sequence patent protection needs to be approached with caution due to DNA being a fundamental biological substance and the moral concerns this may raise. However, the Advocate General has interpreted the Directive in an unexpectedly narrow manner.

The Advocate General has effectively read the word "currently" into the Article 9 requirement for a DNA sequence to perform its function and has extended this requirement to apply to a DNA sequence in its own right as well as applying it to DNA sequences contained in other material. This approach will be viewed by some as too restrictive. For instance, applying this interpretation, if Cefetra were to import soya beans (rather than soy meal)containing Monsanto's patented DNA sequence this may not infringe Monsanto's patent (as the DNA sequence would not at that time be performing its function of protecting plants from Round Up).

The Advocate General suggests that DNA sequence patent protection should only extend to the function of the DNA specified in the patent. Although this bears similarity to the treatment of pharmaceuticals and their second medical use, it creates a narrow protection for DNA sequence patents. It would have been useful for the Advocate General to have given further guidance on this point. For instance, is the DNA's "function" the production of a specified protein (and protection will therefore cover all potential uses of this protein), or is the "function" the specified use of the protein encoded by the DNA (and protection will only therefore only cover the specified use of that protein)?