UK: Biotech patents – Cutting the scope of protection

Summary and implications

The Advocate General of the Court of Justice (the renamed European Court of Justice) has published the first-ever opinion on the extent of protection that European patents should give to biotech patents1.

This controversial opinion proposes that the full Court should give a narrow interpretation to the Biotechnology Directive2 which was implemented to harmonise EU laws on the patentability of biotech inventions. Although now implemented in all Member States, there are major differences in how the Directive has been implemented.

This is the first time the Court of Justice has been able to consider the scope of the protection of biotech inventions, particularly DNA sequence patents, in the ten years the Directive has been in force. This opinion is therefore significant for a number of reasons:

  • The Advocate General recommended that traditional patent protection should not be applied to DNA sequence patents. The protection given by such DNA patents should instead be 'purpose-bound'.
  • Although formally non-binding, Advocate General opinions are given great weight by the full Court and are usually upheld.
  • This opinion is therefore likely to determine how Member States should apply the Biotechnology Directive, what balance to strike between patentee's rights and those of their competitors, and result in a more harmonised approach across the EU.

Factual background

The case arises from Monsanto's attempt to prevent Argentinean soy meal (containing the DNA sequence protected by the Monsanto's Roundup Ready soybeans patent) being imported into the EU. This DNA sequence makes soybean plants resistant to the Roundup Ready herbicide, allowing farmers to use high levels of herbicide to produce greater yields.

The patent covers DNA sequences encoding a class of enzyme variants resistant to this herbicide. These can be introduced into soybean plants to replace the non-resistant native form of the enzyme (which would otherwise be affected by the herbicide, killing the plant).

Cefetra imported soy meal from Argentina made from plants expressing the patented DNA. Monsanto had no Argentine patent and so could not argue that cultivation of these Argentine plants was an infringement. Monsanto therefore sued Cefetra and the other importers of this Argentine soy meal in the Netherlands based on Article 9 of the Directive (see box).

Article 9 of the Directive

The protection conferred by a patent on a product 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.

Must a DNA sequence "currently" perform its patented function?

The Dutch court asked whether Article 9 would protect the Roundup Ready DNA sequence even though the DNA sequence was not performing its patented function (protecting plants from Roundup) at the time of the alleged infringement (the act of importation as soy meal), but had previously done so (as a plant), and was capable of performing that function again (the meal can potentially be used to create such plants again).

The Advocate General acknowledged a classic tenet of patent law - that incorporating something patented into another product does not normally prevent the patented article from being protected - but did not apply this to DNA sequences. Instead, the Advocate General said that Article 9 meant that patent protection should only be given to DNA sequences where the DNA sequence is currently expressing its function.

The Advocate General's view was that Article 9 was an extension of ordinary patent law principles.

"I consider that ... 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 the effect that, in EU territory, the protection conferred on DNA sequences is a 'purpose-bound' protection. Even though the directive does not expressly indicate that the protection to be conferred on DNA sequences must be of that order, many elements connected with the overall system of patents for biotechnological products militate in favour of that interpretation." Opinion, paragraph 29

The Advocate General justified this interpretation as necessary to ensure that patent owners did not get a disproportionate and overly wide level of protection. It would also prevent "an unspecified number of derivative products" coming under the control of the patentee, and provide an answer to the classic DNA conundrum of where to set the boundaries of protection.

The Advocate General's view was reinforced by the fact that purpose-bound protection is not a novel approach for biotech patents, or for patents generally (especially pharmaceutical patents). National law in Germany and in France already has purpose-bound protection for human DNA sequences, and it is settled EPO practice for pharmaceutical products that where a substance has already been patented it can still be patented for a new, different use.

The Advocate General's view was that Monsanto's patent was not infringed. The patented DNA sequence was not expressing its function (protecting plants from Roundup) at the time of the alleged infringement (when it was imported). This was despite the fact that it had previously done so (as a plant), and was capable of performing that function again (the meal can potentially be used to create such plants again).

Can national law provide greater protection?

The Dutch Court asked whether patent protection under the Directive is exhaustive or whether national law could confer additional protection.

The Advocate General's view was that the Directive is an exhaustive body of rules in the areas it covers, and that national law cannot confer any greater level of protection. The Directive could not effectively harmonise the law across the EU if Member States could individually confer additional protection; the Directive's main aim was not to extend protection for genetic patents but to achieve consistent laws in Member States.

Does the Directive apply retrospectively?

The Dutch Court asked whether the Directive should be applied retrospectively to patents granted before the Directive came into force.

The Advocate General's view was that it should be applied retrospectively. Because the Directive has no transitional provisions, when a patent was granted is irrelevant. Moreover, permitting a regime that applies differently to patents granted before the Directive than to those granted afterwards would defeat the Directive's primary harmonising intention, and create unnecessary barriers to trans-border trade.

Is there a conflict with TRIPS?

The Dutch Court asked whether TRIPS should be taken into account for the purposes of the first three questions.

The Advocate General's view was that his interpretation of the Directive did not conflict with the TRIPS obligations. There was nothing in TRIPS that prevented purpose-bound protection for DNA sequences, and TRIPS was not relevant because it was concerned with a uniform set of obligations applicable to patentability, not (as in this litigation) to the extent of the protection which should be given to granted patents.

Footnotes

1. Monsanto Technology LLC v Cefetra BV and Others, Case C-428/08, Advocate General Mengozzi

2. Council Directive 98/44/EC

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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