Council Directive 98/44/EC on Biotechnological Inventions Arts. 8, 9, Secs. 53, 53a Dutch Patent Act - "Roundup Ready"

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1 The Netherlands Council Directive 98/44/EC on Biotechnological Inventions Arts. 8, 9, Secs. 53, 53a Dutch Patent Act - "Roundup Ready" The following questions are referred to the European Court of Justice: 1. Should Art. 9 of Directive 98/44/EC of the European Parliament and the Council of 6 July 1998 on the Protection of Biotechnological Inventions (OJ EC L 1998, no. 213 pp ) be interpreted such that the protection offered by this provision can also be invoked in a situation as in the present proceedings in which the product (the DNA) constitutes part of a material (soya flour) imported into the European Union and is not performing its function at the moment of the alleged infringement, but did however perform the same (in the soya plant) or could possibly, after the DNA has been isolated from the material and introduced to the cell of an organism, again perform its function? 2. Assuming that the DNA sequence described in claim 6 of the EP patent is present in the soya flour imported into the Community by Cefetra and ACTI, and assuming that the DNA is, in the sense of Art. 9 Directive 98/44/EC of the European Parliament and the Council of 6 July 1998 on the Protection of Biotechnological Inventions (OJ EC L 1998, no. 213 pp ), has been processed to soya flour and is not performing its function in the same: Does the protection of a patent for biological material according to the Directive, and in particular to Art. 9, prevent domestic patent law from additionally conferring absolute protection on the product (the DNA) as such, regardless of the fact whether the DNA performs its function, or should the protection of Art. 9 of the Directive be considered to be exhaustive in the situation intended by this provision in which the product consists of genetic information or contains such information, and such product has been processed to material wherein the genetic information is incorporated? 3. Does it make a difference to the answer to the previous question that the patent EP has been filed and granted (on 19 June 1996) before the Directive 98/44/EC of the European Parliament and the Council of 6 July 1998 on the protection of biotechnological inventions (OJ EC L 1998, no. 213 pp ) has come into force and that absolute product protection was provided under domestic patent law before this Directive came into force? 4. Could any of the answers to the above concern the TRIPS Agreement, in particular Arts. 27 and 30? Interim Decisions of the Hague District Court, 19 March and 24 September 2008 Monsanto Technology v. Cefetra, Argentina et al. From the decisions:

2 2.3 Monsanto is the rightful owner of the European Patent no. EP with the title Glyphosate tolerant 5-enolpyruvylshikimate-3-phosphate synthases. The patent was granted on 19 June 1996 and is valid in Austria, Belgium, Switzerland, Germany, France, the United Kingdom, Italy, Liechtenstein, Luxemburg, the Netherlands and Sweden. Following opposition proceedings, the amended claims read as follows. 1. An isolated DNA sequence encoding a Class II EPSPS enzyme, said enzyme being an EPSPS enzyme having a K m for phosphoenolpyruvate (PEP) between µm and a K i (glyphosate)/k m (PEP) ratio between 3-500, which enzyme is capable of reacting with antibodies raised against a Class II EPSPS enzyme selected from the group consisting of the enzymes of SEQ ID NO:3 and SEO ID NO:5. 2. A DNA sequence of claim 1 wherein said K m for phosphoenolpyruvate is between 2-25 µm. 3. A DNA sequence of claim 1 wherein said K i /K m ratio is between An isolated DNA sequence encoding a protein which exhibits EPSPS activity wherein said protein is capable of reacting with antibodies raised against a Class II EPSPS enzyme selected from the group consisting of the enzymes of SEQ ID NO:3 and SEQ ID NO:5. 5. The DNA sequence of Claim 4 wherein said antibodies are raised against a Class II EPSPS enzyme of SEQ ID NO:3. 6. A DNA sequence encoding a Class II EPSPS enzyme selected from the group consisting of SEQ ID NO:3 and SEQ ID NO:5. 7. A recombinant, double-stranded DNA molecule comprising in sequence: a) a promoter which functions in plant cells to cause the production of an RNA sequence; b) a structural DNA sequence that causes the production of an RNA sequence which encodes a Class II EPSPS enzyme capable of reacting with antibodies raised against a Class II EPSPS enzyme selected from the group consisting of the enzymes of SEQ ID No:3 and SEQ ID No:5 and c) a 3' non-translated region which functions in plant cells to cause the addition of a stretch of polyadenyl nucleotides to the 3' end of the RNA sequence where the promoter is heterologous with respect to the structural DNA sequence and adapted to cause sufficient expression of the fusion polypeptide to enhance the glyphosate tolerance of a plant cell transformed with said DNA molecule Claims 1 and 4 and the dependent claims 2, 3 and 5 claim protection for an isolated DNA sequence. Cefetra and ACTI correctly take the view that these claims cannot have been infringed [by the importation of soya bean products] because the DNA is not present in isolation, but is contained in the soya flour. The Court cannot agree with Monsanto in its argument that the DNA sequence was inserted from its natural environment the bacterial chromosome into the DNA of the soya plant and that the flour of the bean should, for that reason, be considered an isolated DNA sequence or should include the same. The average person skilled in the art will understand the concept of an isolated DNA in the sense it is 2

3 ordinarily understood, i.e. a DNA that normally is released from the cell of an organism for further processing. Monsanto did not present any reasons as to why the average person skilled in the art would interpret this concept in the context of the patent different from its ordinary meaning. 4.5 The court also disagrees with the argument that the soya flour can be qualified as a product directly obtained through application of the method claims 14, and 28. While the soya plant and the soybeans can be considered directly obtained through the method, the flour is obtained through a further crushing process with a number of processing steps... This process is too far removed to assume a direct link between the method and the soya flour Monsanto argues that the DNA sequence covered by claim 6 in other words, the sequence that encodes for the synthesis of a Class II EPSPS enzyme is contained in the samples taken from the shipment of the KEOYANG NOBLE [as evidence of infringement] Even though the DNA sequence may only be present in the soya flour in limited quantities, this does not alter the fact that the patent of Monsanto is infringed, at least if the scope of protection of the patent comprises the product, that is, the DNA as such (a question to dealt with hereafter). There is no reason why in such situation Monsanto should be deprived of its rights, particularly because the DNA is present in the soya flour thanks to the advantages offered by the patent. It may well be that Monsanto could not object to marketing of the soya flour based on its patent rights if the residual DNA could be considered an accidental contamination that, for example, originates from an earlier shipment. Yet no such case has been argued, nor is it obvious to the court Assuming the presence of the DNA sequence specified in claim 6 in the soya flour, the question is now whether the patent of Monsanto is infringed in case of marketing the soya flour in the Community. Cefetra, Argentina and ACTI are of the opinion that this is not the case. In this context they argue the following The scope of protection of the claimed DNA sequence of claim 6 (and the claimed DNA molecule of claims 7, 8, 11, 12 and 13) is exclusively determined by Sec. 53a Dutch Patent Act 1995, in particular by subsection 3. Sec. 53a was included in the Patent Act in order to implement Biotech Directive 98/44/EC of 6 July 1998, Arts. 8 and 9 in particular CHAPTER II Scope of protection Article 8 1. The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall extend to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics. 2. The protection conferred by a patent on a process that enables a biological material to be produced possessing specific characteristics as a result of the invention shall extend to biological material directly obtained through that process and to any other biological material derived from the directly obtained biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics. Article 9 The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product in incorporated and in which the genetic information is contained and performs its function. 3

4 In a letter dated 9 August 2006 addressed to the ambassador of Argentina, the European Commission endorsed the above point of view. The letter states: Therefore, according to Article 9 of the Directive, it is not enough that the genetic information has been incorporated in the product and that it is always present in the same, but that it is also necessary that this genetic information bears its function. (...) Consequently, the protection to the patents cannot be extended to the derived products in which the genetic information is residual and does not exercise its genetic function In accordance with Art. 9 of the Directive, Sec. 53a (3) Patent Act includes any material in which the DNA is processed under the exclusive right of the patent holder in case the genetic information is incorporated in that material and performs its function therein. In the case at issue, the soya flour represents the result of the crushing process, and the DNA is present in that flour. However, it goes without saying that the DNA cannot perform its function in the dead material, this is, the flour. The position of Monsanto is that it would be sufficient that the DNA has performed its function in the soya plant at a given time, or could again perform such function after being isolated from the soya flour and transferred to living material. Yet, this is at odds with the wording of the provision and there is no evidence that the Community legislature envisaged such scope of protection. On the other hand, it should be taken into account that a gene, even as part of an organism, will not continuously perform its function. There are, for example, genes that are only activated in specific stress situations such as heat, drought or a disease. Moreover, the Court does not consider it irrelevant that during the cultivation of the soya plants, from which the flour is manufactured, advantage is taken of the invention without payment of a corresponding compensation Sec. 53a(1) Patent Act does not independently establish a scope of protection for Monsanto's patent on account of the fact that, following replication, the replicated DNA itself complies with the description set forth in the cited claims and hence directly qualifies for protection, just like the original DNA. However, also with regard to the replicated DNA the question is whether, following processing into a different material, the scope of protection is limited to the situation that the DNA performs its function If the marketing of the soya flour cannot be prevented on the basis of Sec. 53a (3) Patent Act, the question then becomes relevant whether the traditional absolute protection of products 2 under Sec. 53 Patent Act can be relied upon in addition to the special protection under Sec. 53a (3) Patent Act A systematic interpretation of the law provides an affirmative answer in this respect. Sec. 53c (1) Patent Act provides for an exception (farmers' privilege) that explicitly mentions Secs. 53 and 53a Patent Act. Sec. 53a Patent Act, however, does not mention an exception to 2 Sec Subject to the provisions of Secs 54 to 60, a patent shall confer on its owner the exclusive right: a. to make, use, put on the market or resell, hire out or deliver the patented product, or otherwise deal in it in or for his business, or to offer, import or stock it for any of those purposes; b. to use the patented process in or for his business or to use, put on the market, or resell, hire out or deliver the product obtained directly as a result of the use of the patented process, or otherwise deal in it in or for his business, or to offer, import or stock it for any of those purposes, with the exception of any product excluded from the grant of a patent pursuant to Sec. 3. 4

5 Sec. 53, although such mention would have been obvious in view of the fact that Sec. 53a covers situations that fall within Sec In consideration of this starting point, and while the opposite is not clear, there seems to be reason to assume that the Directive does not alter the absolute product protection conferred by Sec. 53 Patent Act, and rather provides for a minimum protection. The wording of Art. 9 of the Directive seems to support this view by using the verb extends to and not, for example, is limited to, or words to this effect. It can moreover be added that, if the Directive would not allow a broader protection, as is the position of the Spanish Court [decision of Commercial Court Madrid, Case No. 488/07 of 27 July 2007, this issue p. ], the Court finds itself facing the inconsistent situation that even an isolated DNA, as long as it is not further processed, would not be included in the scope of protection. This kind of limitation, even if intended, neither seems justified to the Court in the light of the objective and scope of the Directive nor in the light of the protection of the public order. Moreover, this interpretation seems to be at odds with Arts. 3 (2) and 5 (2) of the Directive where the patentability of (among other things) isolated DNA is actually guaranteed. If the Directive does not affect the absolute product protection, Art. 9 of the Directive and the corresponding Sec. 53a Patent Act could offer additional protection in a situation where the DNA is no longer identifiably present, as Sec. 53 Patent Act could not apply here Nonetheless, the Court considers the reasons in favour of this interpretation insufficiently clear. Also in consideration of the significant interests of the parties it sees good reason, as requested by Monsanto, to address some preliminary questions to the European Court of Justice regarding the interpretation of the Directive, also with regard to the considerations under Argentina also raised the defence that the claims of Monsanto should be dismissed on account of the fact that Monsanto would abuse its rights and not act just and equitable towards Argentina, its agricultural sector and its European importers such as Cefetra and ACTI. In a nutshell, the objections of Argentina relate to the fact that, on the one hand, Monsanto rendered Argentina completely dependent on its RR soya plant by encouraging the plantation thereof (in the meantime more than 90% of the plants consist of the RR soya plant) whilst, on the other hand, it did in no way whatsoever make clear that it would take measures against the marketing outside of Argentina. According to Argentina, Monsanto was familiar with the fact that a large quantity of the soya would be exported. For many years, Monsanto nonetheless did not oppose to this and kept silent. Argentina, according to its statement, would be severely affected if Monsanto was allowed to block exports to the European Community The Court realises that Argentina has a significant interest in the marketing of soya products in the Community. But in the present circumstances, the Court finds no reason to assume that Monsanto did abuse its rights or act unjustly or inequitable already on account of the fact that Argentina could have foreseen that Monsanto would want to invoke its patent rights wherever possible, that is, not in Argentina (where the patent application of Monsanto was refused for procedural reasons), but in the Community. Although less relevant for the merits of the case, yet of importance from a procedural point of view, Argentina joined the action as a party in support of Cefetra, and it is only the stance of Cefetra that matters. And it cannot be assumed that Monsanto did abuse its rights or did not act just and equitable towards Cefetra.... C.H. 5

6 Patent Law United Kingdom Patent Act Secs. 60(1)(c) - "Roundup Ready" 1. A claim over "an isolated DNA sequence..." concerns a sequence that had been seperated out as a fragment for further cloning and amplification in a plasmid DNA. It is not infringed by a product that embodies genomic DNA or of a plant transformed using a plasmid incorporating DNA having that sequence [74-77]. 2. The term "encoding a Class II enzyme" must be interpreted with reference to the description that describes them as unable "to react with polyclonal antibodies perpared from class I EPSPS ezymes under conditions where other Class I EPSPS enzymes would readily react with Class 1 antibodies". This was the interpretation of the claim given by the EPO Boards of Appeal in appeal proceedings, and there had to be good reasons to depart from such interpretation given that these formed part of one of the grounds for decision [82]. There was no infringement, because it was not proven that the fragments found in the meals did not react in this way [85]. 3. The fact the DNA present in the meal was completely irrelevant to the meal as an animal feed and not genetic material in any serious sense is irrelevant and no defence had infringement been found otherwise [89]. 4. Infringement of a process claim comprises products "directly obtained from the process", which should be interpreted as "the immediate product of the process". While all the roundup ready soybean plants in Argentina were lineal descendants of the original plant, the meals produced therefrom could not be defined as the direct product of the transformation, and thus importation of such meals was no infringement of claim over "a method of producing genetically transformed plants...". Nothing of the originally transformed plant has survived [35-38]. English Patents Court, 10 October 2007 Monsanto Technology LLC v. Cargill International SA Note: The facts of this case are very similar to the Spanish Monsanto Decision of the Madrid Commercial Court reported in more detail in this issue. While both courts arrived at the result that the meals imported from Argentinian modified soybeans were not infringing, the reasoning of the courts is completely different. The angle of infringement of the patented process (claim 14 of Monsanto's patent) was argued only in the UK. Summarised from [2008] Fleet Street Reports 7

7 SPAIN Patent Act, Art a) and 50.4; Biotech Directive 98/44/EC, Arts. 8, 9, 23, 24 - "Roundup Ready" 1. The scope of biotechnological patents has to be determined according to Art Patent Act (equivalent to Art. 9 Directive 98/44 EC) in light of recitals 8, 23 and 24 of said Directive. 2. Infringement of a claim over a genetic sequence requires proof not only that the allegedly infringing product contains that sequence, but that the sequence in this product continues to perform its function. This is not the case where the genetic material is inactivated and can no longer be used as propagating material. Decision of Commercial Court Madrid, Case No. 488/07 27 July 2007 Monsanto Technology LLC v. Sesostris S.A.E. From the facts: The plaintiff, the agricultural company Monsanto Technology LLC., is the proprietor of European Patent EP 546,090 in respect of an invention called Glyphosphate tolerant 5- enolpyruvylshikimate-3-phosphate synthases. The patent is validated in Spain (Spanish Patent ES 2,089,232). The plaintiff exploits the patent through commercialisation of soybeans called Roundup Ready Soybeans which are genetically modified to become resistant to the herbicide Roundup. The defendant, a Spanish company, imports soy meal from Argentina into Spain. The defendant did not contest that the soy meal contains the DNA sequence patented by the plaintiff. The defendant imports said soy meal without authorisation by the plaintiff. As the patent ES 2,089,232 would grant the plaintiff the excusive right over products containing the patented sequence, the plaintiff alleges that the importation of the meal amounts to infringement of its patent according to Arts a) and 50.4 Spanish Patent Act. The court found that there was no infringement and dismissed the case. For the corresponding UK case, see the decision of the English High Court Monsanto v. Cargill, 10 October 2007, in this issue. In Monsanto's procedure against the Dutch importers (Monsanto v. CEFETRA et al.), the Hague District Court by decision of 9 March 2008 decided to refer the case to the ECJ in order to answer certain questions on the interpretation of Art. 9 Biotech Directive. Findings: "1. The plaintiff s claim for injunction and damages will be granted if the importation of soy meal infringes the plaintiff s patent. A patent provides negative rights, i.e. the right to exclude others from using and commercially or industrially exploiting the technical invention covered by the patent. It also grants the right to prevent fabrication, offer for sale or importation of a product covered by the patent, and to prohibit the use or offer of methods protected by the patent, if the third party knows or the circumstances make it evident that the use of the method without permission of the patentee is prohibited.

8 The scope of protection of the patent varies according to the type of patent, depending on the fact whether it is a product, method or use patent. Thus, the product patent grants the right to prohibit any kind of industrial exploitation of the object covered by the patent, for example launching the product. The scope of protection of a method patent is limited to the exploitation of the protected method, although extensions are made to products directly obtained from the application of the patented method (direct products of the claimed process). Finally, a use patent grants the right to impede the use of the object of the patent for a purpose specified in the patent. To give effect to patent rights, the legislator grants the patentee a series of different actions 2. The plaintiff states that in 1991, it invented a glyphosphate tolerant 5- enolpyruvylshikimate-3-phosphate syntheses, registered as European Patent EP 546,090, Spanish Patent ES 2,089,232. It uses the invention to obtain cultivations of certain plants via an amelioration of their genetic code to make them herbicide-resistant (especially glyphosateresistant). The plaintiff is exploiting its patent through commercialisation of soybeans called roundup ready soybeans. That is a variety of genetically modified soybeans The defendant, Sesostris, imports soybean meal containing the DNA sequence patented by the plaintiff. The plaintiff regards the defendant s behaviour as falling under Arts a) [presumably Article 50.1 a)] and 50.4 Patent Act. Article 50.1 a) of the Patent Act stipulates that: A patent shall give the owner the right to prevent any third party from undertaking the following acts without his consent: (a) manufacturing, offering for sale, putting on the market or using the product for the abovementioned purposes; Article 50.4 of the Patent Act establishes that: Where the subject matter of the patent is a product that contains genetic information or that consists of genetic information, patent rights shall extend, irrespective of article 5 (4), to all material in which the product is incorporated and in which the genetic information is contained and fulfils its function. To resolve the dispute one also has to resort to the claims of the patent as according to Article 60 Patent Act, the scope of protection conferred by a patent or patent application shall be determined by the content of the claims. The description and drawings shall, however, be used to interpret the claims. The plaintiff stipulated that the infringed claim was claim 1. This claim has the following wording (): An isolated DNA sequence encoding a Class II EPSPS enzyme, said enzyme being an EPSPS enzyme having a Km for phosphoenylpyruvate (RER) between um and a Ki (glyphosate)/ Km (PEP) ratio between 3-500, which enzyme is capable of reacting with antibodies raised against a class II EPSPS enzyme selected from the group consisting of the enzymes of SEQ ID NO: 3 and SEQ ID NO: 5. According to the description of the patent, the invention refers to a new class of Glyphosphate tolerant 5-enolpyruvylshikimate-3-phosphate synthases. The plaintiff has developed soya seeds that contain the patented DNA sequence, whereby both the seeds and the plants contain the DNA sequence. 2

9 3. The patent in dispute is to be considered a biotechnological patent, protecting biological material in the sense of Art. 4.3 Patent Act The defendant inter alia deals with the import of soybean meal... According to document No. (unchallenged by the defendant), the soybean meal imported by the defendant is a product obtained from soybeans by a process called Crushing, by which the soybean is transformed in order to gain soya oil and other sub-products, inter alia soybean meal. The process of Crushing consists of three steps: first, the preparation of the soybean, second, the extraction of oil and obtaining of meal, and third, obtaining the sub-products (soybean meal). Now, to find out whether the behaviour of the defendant infringes the plaintiff s patent, it has to be examined whether the product imported by the defendant falls under claim 1, which is the one the plaintiff considers to be infringed. The claim protects an isolated DNA sequence encoding a Class II EPSPS enzyme. If one bears in mind that the defendant does not import a DNA sequence, but rather soybean meal, which is not included in said claim, one could conclude that the defendant s behaviour does not infringe Art a) Patent Act. However, as the patent in dispute is of a biotechnological nature, we have to analyse whether the soybean meal meets the requirements of Art Patent Act, because in that case there would be patent infringement. Art Patent Act reads... This provision has been introduced by Law 10/2002 of 29 April, incorporating Directive 98/44/EC on the legal protection of biotechnological inventions. Thereby, Art is the literal implementation of Article 9 of the Directive, which states: The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product is incorporated and in which the genetic information is contained and performs its function. The ECJ has stated in its decision of 16 June 2005, Case C-456/03 [Commission of the European Communities v. Italian Republic] in paragraph 87 that Articles 8 to 11 of the Directive seek to grant specific rights since they define the scope of protection conferred by patents relating to a biological invention. As to the scope of protection provided for in Article 9 of the Directive and Art Spanish Patent Act, the plaintiff argues that these provisions lead to a broadening of protection for biotechnological patents. Following a logical and teleological interpretation of said provisions, it should be deemed that the protection were to be extended also to products which incorporate the genetic material and in which the genetic material is able to fulfil a function that need not necessarily be the effective and active function of the patented sequence. However, this interpretation has to be rejected for various reasons. First of all, one has to bear in mind what is laid down in recital 8 of the Directive 98/44/CE: Whereas legal protection of biotechnological inventions does not necessitate the creation of a separate body of law in place of the rules of national patent law; whereas the rules of national patent law remain the essential basis for the legal protection of biotechnological inventions given that they must be adapted or added to in certain specific respects in order to take adequate account of technological developments involving biological material which also fulfil the requirements for patentability; This leads to the conclusion that biotechnological patents are governed by the same principles as other technical patents. Therefore, the aim of the European legislator is not to extend the protection of biotechnological patents after all, it is pointed out in recital 8 that no special 3

10 national patent law is required, but that it is merely necessary to complete and adapt the existing law in certain, specific aspects. The patent law of Spain has to be interpreted restrictively. It must not be forgotten that pursuant to Art. 49 Spanish Patent Act, the patentee is granted an exclusive right, creating a legal monopoly and as such constituting an exception to the principle of free trade granted under Art. 38 Spanish Constitution. That means that like all exceptions to this general principle, the patent has to be an object of restrictive interpretation. Secondly, the interpretation [suggested by the plaintiff] cannot be upheld with regard to recitals 23 and 24 of the Directive, either: (23) Whereas a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention; (24) Whereas, 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; That leads us to the understanding that the invention does not consist of the DNA sequence as such, but rather of the function it fulfils. Furthermore, these recitals allow us to consider that the protection of biotechnological patents cannot be extended without a legal basis for any such extension. Thus, protection for a biotechnological patent is determined by the requirements of Art Patent Act. As it has been explained above, the plaintiff s patent is a biotechnological one It remains necessary to analyse whether the other requirements of Art Spanish Patent Act are complied with, because these conditions are not independent and exclusive, but cumulative. Therefore, it is required that the genetic information has been incorporated in a new material, that the genetic information is contained therein and fulfils its function. 4. In the first place, it is essential to analyse whether the imported meal has been produced from soya beans containing the patented DNA sequence. The conclusion has to be positive. In that sense, it has to be kept in mind that the legal representative of the defendant has declared that the imported meal was genetically modified. The opinion submitted by the plaintiff () showed that the aim of an experiment was to determine the existence of CP4 EPSPS proteins in samples of meal of roasted soya beans; According to the expert opinion, the result of all the samples that had been analysed was positive. In turn, the defendant brought forward expert evidence () doubting the opinion submitted by the plaintiff However, if one bears in mind that the legal representative of the defendant itself stated that the latter imported genetically imported [read: modified] soybean meal from Argentina and with a view to the expert opinion submitted by the plaintiff (specialised in these kind of experiments) it has to be concluded that the patented DNA sequence is contained in the soya bean meal. With respect to the other requirements of Art of Spanish Patent Act, one has to consider the expert opinion of the expert in biotechnologies, Dr. It states that due to the process used for the extraction of the soya beans and the obtaining of the soya meal conducted at temperatures up to 115 C, the proteins are irreversibly inactivated. The produced meal does neither contain proteins nor functional genetic material including transgenic one. 4

11 According to the expert s statement, the accomplished immunological experiment does not permit a definite evaluation of whether the detected protein is functional as the proteins are inactivated. Practically the totality of the genetic material would be degenerated. Concerning the function of the patented gene in the soya meal, the expert states that because of the method applied for obtaining the soya meal, the latter does not contain functional genetic material. Moreover, the presence of the genetic material would not add any value to the meal since the herbicide-glyphosate-resistance is a valuable characteristic trait only during the developing phase of the plant, enabling a treatment with herbicides that kill all plants not carrying the genetic material. The value of this genetic information is manifested during the vegetative phase of the plant and therefore it is relevant to use the genetically modified seed for the sowing. However, the process of obtaining the soya meal destroys the seed so that it cannot be used for sowing anymore. Finally, the expert states that the meal obtained from genetically modified soybeans is substantially equivalent to the one obtained from conventional beans. According to the conclusions drawn by the expert Dr., the plaintiff has not brought forward any means to confirm that: the genetic information would be incorporated in any new material, that it would be contained therein, and that it would fulfil its function. Particularly relevant here is the need to prove that the genetic information incorporated in the new material continues to fulfil its function, especially in light of recital 24 of the Directive. In order to have industrial application, the latter points out the necessity to indicate said function, which obviously has to be fulfilled continuously in the new material in which it is incorporated. If one considers that the function of the genetic sequence contained in the first claim is to codify an enzyme tolerant of glyphosate so that the plants carrying that sequence can be treated with said herbicide without being damaged, it has to be concluded that the plaintiff has not shown that the genetic sequence fulfils its function in the soybean meal imported by Sesostris. First, because in the opinion of the expert of the defendant, the soybean meal due to its process of production does not contain functioning enzymes or genetic material. Second, because the function of the DNA sequence is to be glyphosate-resistant so that the plants developed out of seed incorporating the genetic sequence support the use of herbicides. That implies that the function of the genetic sequence is valuable during the vegetative phase of the plant. Third, due to the process of producing the meal the seed is destroyed so that it cannot be used for sowing anymore. Fourth, because the genetic material does not add any value to the soya bean meal, as the latter is substantially equivalent to the one obtained from conventional varieties. Translated from the original by Friederike Busch, Max Planck Institute Munich 5