Soy Meal a “Dead Material”- No Functional DNA

27th January, 2011 - 1:01 pm Categories: Patent Litigation Pharma/Biotech Patent Litigations

A Patent Infringement suit was filed by Monsanto Technology LLC against Cefetra, Vopak Agencies and Alfred C. Toepfer International GmbH, for exporting soy meal from Argentina to European Community. The judgement was carried out by the court of justice of European Communities “Grand Chamber”. Preliminary ruling under Article 234 EC from the Rechtbank’s’Gravenhage (Netherlands).

Introduction:

Monsanto’s European patent EP0546090 (‘090) granted on 19 June 1996, discloses “Glyphosate tolerant 5-enolpyruvylshikimate-3-phosphate synthases”, the patent being valid, inter alia, in Netherlands. Glyphosate, a non-selective herbicide, exhibits an anti-growth effect on plants by inhibiting Class I enzyme 5-enol-pyruvylshikimate-3-phosphate synthase (also called ‘EPSPS’). As a result plants die due to its toxic effect.

The patent ‘090 describes a class of EPSPS enzymes i.e. Class II EPSPS enzymes instead Class I which are resistant to glyphosate. Hence, plants containing such enzymes survive the use of glyphosate, and only the weeds get destroyed. The genes encoding these Class II enzymes have been isolated from three different bacteria. Those genes were incorporated into the DNA of a soy plant, called RR (Roundup Ready) soybean plant. As a result, the RR soybean plant produces a Class II EPSPS enzyme called CP4-EPSPS, which is glyphosate-resistant. It thus becomes resistant to the herbicide ‘Roundup’.

Infringement Suit Filed:-

The RR soybean is cultivated on a large scale in Argentina, where Monsanto did not hold any patent protection for his invention. Importing soy meal from Argentina into Amsterdam port on 16 June 2005, 21 March and 11 May 2006 by Cefetra, Vopak and Toepfer had led to a case of Patent infringement and hence Monsanto applied for injunctions against the three before Rechtbank’s-Gravenhage, on the basis of Article 16 of Regulation No 1383/2003, and for a prohibition of infringement of the European patent in all countries in which the patent is valid. Samples of exported soy meal were tested by Monsanto to determine whether they originated from RR soyabeans. Results revealed the presence of CP4-EPSPS in the soya meal and the DNA sequence encoding it.

In turn, Cefetra, supported by Argentine State, argued that Article 53a of the 1995 Law is exhaustive in character, stating that if the DNA present in the soy meal can no longer perform its function in that substance, Monsanto opposing the marketing of the soy meal solely on the ground that the DNA is present in it. It claimed the connection between the limited patentability referred to in recitals 23 and 24 in the preamble to the Directive and the scope of the protection conferred by a patent. Recital 23 in the preamble to the Directive (European Union Law) states that a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention. Recital 24 in the preamble to the Directive (European Union Law) indicates that, in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs. Monsanto argued stating that “The purpose of the Directive is not to limit the protection for biotechnological inventions that exists in Member States neither does it affect the protection conferred by Article 53 of the 1995 Law, which is absolute. A restriction on protection would be incompatible with Article 27 of the TRIPS Agreement”

But, the key statement by Rechtbank’s-Gravenhage (where the case was filed initially) after observing Article 53a(3) of the 1995 Law, like Article 9 of the Directive, stands were:-

– The DNA/genetic material hold the exclusive right of the proprietor of the patent if the genetic information is found in that material and performs its function therein.

– This concludes that soy meal being a dead material does not expresses the functional DNA.

Hence, Article 53a(3) of the 1995 Law and Article 9 of the Directive, does not go in favor of Monsanto’s arguments of his patent being infringed and explicitly states that DNA function was observed in the soy plant at the given moment, and it could again express its function when isolated from soy meal and transferred to a living material.

On the above circumstances, the following articles were discussed:-

1. Article 9 of Directive 98/44/EC of the European Parliament states that the patented product (enzyme and its encoding DNA) is contained in the soy meal, where it does not perform the function for which it is patented, but did perform that function previously in the soy plant, of which the meal is a processed product, or would possibly again be able to perform that function after it had been extracted from the soy meal and inserted into the cell of a living organism.

2. Article 9 of the Directive effects an exhaustive harmonization of the protection it confers, with the result that it precludes the national patent legislation from offering absolute protection to the patented product as such, regardless of whether it performs its function in the material containing it.

3. Article 9 of the Directive precludes the holder of a patent issued prior to the adoption of that directive from relying on the absolute protection for the patented product accorded to it under the national legislation then applicable.

Key Take Away:-

In this context of patent infringement case, I would like to highlight two facts :-

Firstly, though the soy meal as stated by the court to be a “dead material” exported from Argentina is likely to be produced from soy plant, incorporating with the modified DNA encoding CP4-EPSPS, revealed by the tests could be a ardent fact of infringing, evidently, Monsanto’s protected process patent (though not product patent) in the European territory while trading the plant product into its (European) community where Monsanto holds still a valid patent.

Secondly, if Monsanto would have hold a Patent protection of RR soybean in Argentina, then Cefetra along with Vopak and Toepfer, certainly had to bear the cost for infringing Monsanto’s invention for the respective territory. Hence, the Infringement Suit would have been in Monsanto’s favor. This reminds our Indian corporates/Inventors and R&D Institutes to rethink their IP Portfolio strategy and to make sure that the patent has been protected globally.

CASE NO – C-428/08

About the Author:- Ms. Minusmita Ray, a Patent Specialist in IIPRD and can be reached at minusmita@iiprd.com

Tagged

argentina, Article 9, C-428/08, cefetra, dead material, DNA, EPSPS, Glyphosate, infringement, Monsanto, patent, roundup ready, soy plant, soybean, toepfer,

One thought on “Soy Meal a “Dead Material”- No Functional DNA”

Rohit says:

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That was very informative and well written. I look forward for further posts from you. Recently I happened to read an article on Paragraph IV patent certifications during 2010,
which I felt quite interesting and informative. I would like to bring your kind attention to that post. Below mentioned is an excerpt of the mentioned article.
Following is a list that provides the drug products for which an Abbreviated New Drug Application (ANDA) containing a “Paragraph IV” patent certification has been filed during the year 2010. The list also includes the corresponding patent numbers which may soon be under scrutiny, which is generally…

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Soy Meal a “Dead Material”- No Functional DNA

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