Monsanto Technology LLC v Cargill International SA & Anor

Factual and Procedural Background

This opinion concerns an action for infringement of a European Patent (UK) relating to glyphosate tolerant 5-enolpyruvylshikimate-3-phosphate synthases (EPSPS enzymes), which confer resistance to the herbicide Round Up. The claimants (referred to as Plaintiff) hold the patent, and the defendants (referred to as Defendant) import soybean meal produced from genetically modified soybeans carrying a gene encoding one of the patented EPSPS enzymes from Argentina into the United Kingdom. The dispute focuses on a cargo of 5000 tonnes shipped on the MV Podhale.

The Defendant challenges infringement and validity of the patent, asserting no infringement occurs under UK law and alleging invalidity on grounds of anticipation, obviousness, and insufficiency. The Plaintiff applies to amend the patent. The Defendant also alleges the Plaintiff is estopped from enforcing the patent due to acquiescence in the importation acts.

The case involves complex technical evidence relating to genetic sequences, enzyme kinetics, immunological tests, and the survival of genetic material through soybean processing. The court must consider the construction of patent claims, the presence of patented genetic material in the imported meal, and the validity of the patent in light of prior art and technical sufficiency.

Legal Issues Presented

1. Whether the importation of soybean meal containing genomic fragments of the patented gene infringes the patent claims under UK law, particularly in relation to method claims and products "directly obtained" by the patented process.
2. The proper construction of key claim terms, including "isolated DNA sequence" and "Class II EPSPS enzyme".
3. The validity of the patent claims, including anticipation by prior publications and strains, obviousness in light of prior art and common general knowledge, and sufficiency of disclosure relating to immunological tests and kinetic parameters.
4. The admissibility and evidential weight of late-filed experiments conducted by a third party (the Syngenta experiments).
5. Whether the Plaintiff is estopped from enforcing the patent due to alleged acquiescence in unlicensed importation in Argentina.
6. The allowability and discretion to permit amendments to the patent claims.

Arguments of the Parties

Plaintiff's Arguments

• The patent is valid and infringed by the Defendant's importation of soybean meal containing genomic DNA fragments encoding the patented EPSPS gene.
• The presence of the Round Up Ready (RuR) gene sequence in the imported meal was demonstrated by multiple experiments including Southern blot and PCR.
• The term "isolated" in the claims refers to DNA sequences separated and purified for laboratory use, not to genomic DNA in plants or progeny.
• "Class II EPSPS enzyme" is properly construed as an enzyme that does not react with antibodies raised against Class I EPSPS enzymes, consistent with the patent specification and European Patent Office (EPO) interpretation.
• The amendments sought to restrict the claims to the commercially successful RuR sequence are allowable and should be permitted.
• The Defendant's acquiescence claim fails as no representation or conduct by the Plaintiff indicated consent to unlicensed importation.

Defendant's Arguments

• No infringement occurs as the imported soybean meal is not a product "directly obtained" by the patented process but a downstream product many generations removed from the original transformed plant.
• The DNA in the meal is degraded by processing and cannot infringe patent claims directed to isolated DNA sequences.
• The definition of "Class II EPSPS enzyme" requires inability to react with Class I antibodies, which has not been demonstrated for the RuR enzyme.
• The patent is invalid for anticipation by prior publications (Henner and Moore) and obviousness in light of prior art including Fischer.
• The patent is insufficient for failing to provide adequate guidance on the immunological test and kinetic parameters, making it impossible to determine infringement or validity across the claim breadth.
• The late-filed Syngenta experiments should be admitted as they are critical evidence of non-infringement and invalidity.
• The Plaintiff is estopped from enforcing the patent due to acquiescence in the Argentinean market.

Table of Precedents Cited

Court's Reasoning and Analysis

The court undertook a detailed analysis of the patent claims, the scientific evidence, and the legal principles governing patent infringement and validity. The key points of the reasoning are as follows:

• Infringement: The court held that the imported soybean meal is not "directly obtained" by the patented transformation process, as it is many generations removed from the original transformed plant. The meal is a processed product, and the DNA present is degraded and not "isolated" as required by the claims. Therefore, the method claims and DNA sequence claims are not infringed by importation of the meal.
• Presence of patented gene in meal: Experimental evidence from Southern blot and PCR indicates that some genomic DNA containing the RuR gene sequence survives processing and is present in the meal. However, the DNA is not in an isolated or purified form as claimed.
• Construction of "isolated DNA sequence": The court interpreted "isolated" to mean DNA separated and purified from other molecular species for laboratory use, not DNA present in the genome of transformed plants or their progeny.
• Definition of "Class II EPSPS enzyme": The court concluded that the phrase must be understood in light of the specification and EPO interpretation as enzymes that do not react with antibodies raised against Class I EPSPS enzymes. The RuR enzyme's immunological profile was not shown to meet this requirement, leading to failure of infringement claims dependent on this definition.
• Validity - anticipation and obviousness: The prior art publications Henner and Moore disclose EPSPS enzymes and bacterial strains relevant to the claims, but the evidence did not establish that these disclosures anticipated the patent claims or rendered the invention obvious. The Fischer paper cautioned on assay conditions and did not make the invention obvious.
• Validity - sufficiency: The court identified difficulties in the specification regarding the immunological test and kinetic parameter assays, but found that the claims were not insufficient as the skilled person could perform the tests, though with some burden. The breadth of the claims was not shown to be unsupported by the specification.
• Syngenta experiments: The court excluded late-filed experiments due to procedural prejudice and incomplete documentation, limiting the Defendant's evidential support on key issues.
• Amendments: The court found that the amendments restricting the claims to the RuR sequence were disclosed implicitly in the original application and allowed the amendments to proceed, as they represented a voluntary restriction to the commercially successful embodiment.
• Acquiescence: The Defendant's claim that the Plaintiff was estopped by acquiescence failed due to lack of evidence of any representation or conduct by the Plaintiff indicating consent to unlicensed importation.

Holding and Implications

The court's final decision is as follows:

No claim of the patent is infringed by the importation of soybean meal on board the MV Podhale.

The patent is valid.

The Plaintiff's application to amend the patent claims to restrict them to the Round Up Ready (RuR) sequence is granted.

The direct effect of this decision is that the Defendant's importation of soybean meal does not constitute patent infringement under UK law. The patent remains enforceable in its amended form. No new legal precedent is established beyond the application of existing principles to the facts of this case. The Defendant's acquiescence defense is rejected, and the late-filed Syngenta experiments are excluded from evidence due to procedural fairness concerns.