Monsanto Technology LLC v Cargill International SA & Anor

A product is obtained directly by means of a patented process only where it is the immediate product of that process, or retains the identity of an intermediate product. Genetic information transmitted through successive generations does not itself preserve the identity of the original transformed organism.

For patent construction, “isolated” DNA means a purified DNA fragment separated from other molecular species. A Class II EPSPS enzyme was construed as one which does not react with antibodies raised against a Class I enzyme, in addition to satisfying the claim’s stated kinetic and antibody criteria.

Anticipation requires a clear and unmistakeable enabling disclosure. Obviousness asks what the uninventive skilled person would have done using the common general knowledge. The patent was valid, but the importation of soybean meal did not infringe.

Monsanto sued Cargill for infringement of a patent concerning glyphosate-tolerant EPSPS enzymes and genetic material. Cargill imported soybean meal produced in Argentina from Round Up Ready soya beans.

The alleged infringement concerned method claims and claims to DNA sequences. Cargill also challenged validity for anticipation, obviousness and insufficiency, and opposed Monsanto’s application to amend the claims to refer more specifically to the Round Up Ready sequence.

The central issues were whether soybean meal was a product obtained directly by the patented transformation process, whether surviving DNA was “isolated” and encoded a Class II EPSPS enzyme, whether the patent was anticipated or obvious, whether its claims were insufficient, and whether amendment should be permitted.

1. Infringement. The importation of soybean meal was not the importation of a product obtained directly by means of the patented process under section 60(1)(c) of the Patents Act 1977. The patented process transformed a plant cell. The meal was produced many generations later and was not the immediate product of that transformation. The survival of genetic information did not preserve the identity of the original transformed plant.
2. Meaning of “isolated”. In the claims, “isolated” meant a purified DNA fragment separated from other molecular species for further use. It was the antithesis of genomic DNA and did not include DNA present in the genome of a plant or its progeny. The genomic DNA found in the meal therefore could not satisfy claims requiring an isolated sequence.
3. Class II EPSPS. The claim’s reference to a Class II EPSPS imported the specification’s distinction from Class I enzymes. The enzyme had to lack reaction with antibodies raised against a Class I EPSPS, as well as satisfying the claim’s express kinetic and Class II antibody requirements. The presence of the Round Up Ready sequence had not been shown to satisfy that requirement.
4. Experimental evidence. The Syngenta experiments were excluded for procedural unfairness. They were late, inadequately documented, uninspected and not reliably repeatable, and Monsanto had no proper opportunity to test the evidence or investigate the significance of the antibody-purification method. Parties in complex patent litigation are ordinarily entitled to inspect and test experimental evidence before it is relied upon.
5. Validity. The patent was not anticipated by Henner, because it was not shown that the disclosed B subtilis EPSPS was a Class II enzyme. Moore anticipated claim 6, since disclosure of PG2982 and the ability to obtain it from the disclosed culture made the microorganism available to the public. The wider obviousness attack based on Moore failed because the skilled person would not have been led, without more, to investigate and identify the relevant EPSPS gene. The attacks based on Henner and Fischer also failed.
6. Insufficiency. The claims were not insufficient. Although the immunological testing was onerous, the evidence did not establish that it was incapable of being performed. The kinetic testing was adequately directed by the cited methodology. Nor was it shown that the claimed Class II enzymes formed a bogus class united only by the two disclosed examples.
7. Amendment. The application as filed disclosed the Round Up Ready sequence, including the serine-to-leucine substitution at position 2, expressly and implicitly. The amendment restricted the claims to the commercially successful embodiment disclosed in the patent. Leave to amend was granted.
8. Disposition. No claim was infringed by the importation of the Podhale soybean meal. The patent was valid and the application to amend succeeded.