Monsanto v' Cargill

1
Monsanto v. Cargill

• An isolated case?

2
Background

• Monsantos transgenic Roundup Ready soybean is
  resistant to Roundup herbicide - but it is
  not patented in Argentina
• Cargill buys transgenic soybean meal in Argentina
  and ships to Europe where there are patents on
  the isolated DNA encoding an EPSPS gene which
  provides resistance to Roundup herbicide

3
Siezed Ships

• Monsanto got court orders to seize ships carrying
  soybean meal containing the patented isolated
  DNA from courts in UK, Netherlands, and Spain
• In Spain the new judge excleded enough evidence
  to decide that Monsanto did not have a case

4
Siezed Ships

• In the Netherland Monsanto won a judgement that
  the court referred to the ECJ with respect to the
  Biotechnology Directive (later).
• In the UK the judge found that the gene sequence
  was present in the imported soymeal, but then
  decided a claim construction that precluded
  infringement.

5
isolated is a technical term

• isolated was not defined in patent
• So the court defined isolated as applied to
  DNA that had been removed from the genome and is
  in a form ready for further processing.
• The DNA in the soymeal was not in such a state
  although it could be isolated from the soymeal
  and used in a way envisaged by the patent.

6
But in defendant Cargills patents

• US Patent 6,537,750
• EP 1107661 B1
• not only claim isolated DNA but define
  "isolated" as follows

7

• As used herein, "isolated" refers to a nucleotide
  sequence corresponding to the regulatory element
  of a fatty acid desaturase gene, but free of
  sequences that normally flank one or both sides
  of the regulatory element in a plant genome. An
  isolated regulatory element can be, for example,
  a recombinant DNA molecule, provided one of the
  nucleic acid sequences normally found flanking
  that recombinant DNA molecule in a
  naturally-occurring genome is removed or absent.
  Thus, isolated regulatory elements include,
  without limitation, a recombinant DNA that exists
  as a separate molecule (e.g., a genomic DNA
  fragment produced by PCR or restriction
  endonuclease treatment) with no flanking
  sequences present, as well as a recombinant DNA
  that is incorporated into a vector, an
  autonomously replicating plasmid, or into the
  genomic DNA of a plant as part of a hybrid or
  fusion nucleic acid molecule.

8
The UK claims

• Isolated DNA encoding an EPSPS gene
• Process of isolating the DNA
• Process of making a DNA plasmid
• Process of transforming plant cells
• Process of making a glyphosate resistant plant
• Process of using the plant to improve yield in
  the field

9
Interpretation by Judge Pumfrey

• It is clear that the early claims relate only to
  laboratory work and require DNA to be isolated
  within the meaning , i.e. not be in the soymeal
• The interpretation of isolated precludes per se
  protection for the sequence within a cell as it
  will not be isolated.

10
Monsanto v. Cargill

• Settled prior to appeal

11
Ely Lilly v. HGS

• Claim was to isolated nucleic acid molecule
  encoding a neutokine-a polypeptide
• isolated was defined in the specification
• The parties did not dispute the meaning
• isolated was not construed

12
Application of the EPO Biotechnology Directive

• Biotechnology Directive does not apply to the UK
  patent because of no infringement
• But it does apply to the Spanish and Dutch
  patents
• Article 9 the Directive creates issues for patent
  scope

13
In the Netherlands

• He imports were found to be infringing .
• BUT the decision was referred to the EC to
  construe Article 9 of the Biotechnolgy directive

14
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 is
  incorporated and in which the genetic information
  is contained and performs its function.

15
Directive 98/44/EC on the legal protection of
Biotechnological Inventions

• Passed July 30, 1998
• In UK applies to patents filed after 28 Jul 2000
• In Germany applies to patents filed after 30 Jul
  2000
• In Netherlands France applies to all patents