Patent Baristas

The European Court of Justice in Luxembourg ruled against Monsanto Co. stating that “Monsanto cannot prohibit the marketing in the EU of soy meal containing, in a residual state, a [patented] DNA sequence.” Therefore, the European patent for the trait that makes soybeans resistant to the company’s Roundup herbicide doesn’t extend to soy meal made from the patented seeds.

Monsanto is the holder of European patent EP 0 546 090 granted on 19 June 1996 relating to ‘Glyphosate tolerant 5-enolpyruvylshikimate-3-phosphate synthases’ (‘the European patent’). The European patent is valid, inter alia, in the Netherlands. Glyphosate is a non-selective herbicide. In a plant, it works by inhibiting the Class I enzyme 5-enol-pyruvylshikimate-3-phosphate synthase (also called ‘EPSPS’), which plays an important role in the growth of the plant. The effect of glyphosate is that the plant dies.

The European patent describes a class of EPSPS enzymes which are not sensitive to glyphosate. Plants containing such enzymes survive the use of glyphosate, whilst weeds are destroyed. The genes encoding these Class II enzymes have been isolated from three different bacteria. Monsanto has inserted those genes into the DNA of a soy plant it has 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’.

The RR soybean is cultivated on a large scale in Argentina, where there is no patent protection for the Monsanto invention. Argentine growers planted about 43 million acres of soybeans containing Monsanto’s Roundup Ready trait last year, making the country the company’s second-biggest soybean market after the U.S., according to a Monsanto report. About 95 percent of soybeans grown in Argentina contain Monsanto’s Roundup Ready trait.

Cefetra argued that if the DNA present in the soy meal can no longer perform its function in that substance, Monsanto cannot oppose the marketing of the soy meal solely on the ground that the DNA is present in it. There is a 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.

Monsanto argued that the purpose of the Directive is not to limit the protection for biotechnological inventions that exists in Member States. The Directive does not 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.

The first question

By its first question, the national court asks, essentially, whether Article 9 of the Directive is to be interpreted as conferring patent right protection in circumstances such as those of the case in the main proceedings, in which the patented product is contained in the soy meal, where it does not perform the function for which it was 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 its function after it has been extracted from the soy meal and inserted into the cell of a living organism.

In that regard, it must be noted that Article 9 of the Directive makes the protection for which it provides subject to the condition that the genetic information contained in the patented product or constituting that product ‘performs’ its function in the ‘material … in which’ that information is contained.

The second question

By its second question, the national court asks, essentially, whether Article 9 of the Directive effects an exhaustive harmonization of the protection it confers, with the result that it precludes 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.

That question is based on the premise, referred to in the order for reference, that a national provision such as Article 53 of the 1995 Law does in fact accord absolute protection to the patented product.

The third question

By its third question, the national court asks, essentially, whether 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.

Like the second question, the third is based on the premise that a national provision such as Article 53 of the 1995 Law did in fact accord absolute protection to the patented product when the patent was issued prior to the Directive.

The fourth question

By its fourth question, the national court asks, essentially, whether Articles 27 and 30 of the TRIPS Agreement affect the interpretation given of Article 9 of the Directive.

On those grounds, the Court (Grand Chamber) ruled:

Article 9 of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions is to be interpreted as not conferring patent right protection in circumstances such as those of the case in the main proceedings, in which the patented product 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.

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.

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.

Articles 27 and 30 of the Agreement on Trade-Related Aspects of Intellectual Property Rights, constituting Annex 1C to the Agreement establishing the World Trade Organization (WTO), signed at Marrakesh on 15 April 1994 and approved by Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994) do not affect the interpretation given of Article 9 of the Directive.

Apparrently, if a product has the DNA ground up, it never existed. I guess it’s all in the timing.

The EU court case is C-428/08 Monsanto Technology LLC v. Cefetra BV, Cefetra Feed Service BV, Cefetra Futures BV and State of Argentina and Monsanto Technology LLC v. Vopak Agencies Rotterdam BV and Alfred C. Toepfer International GmbH.