Kirin-Amgen Inc. and Others v Transkaryotic Therapies Inc. and Others and other appeals
| Jurisdiction | England & Wales |
| Judge | LORD JUSTICE ALDOUS,LADY JUSTICE HALE,LORD JUSTICE LATHAM |
| Judgment Date | 27 March 2003 |
| Neutral Citation | [2003] EWCA Civ 524,[2002] EWCA Civ 1096 |
| Docket Number | A3/2001/1577/A3/2001/1577A/A3/2001/1577B A3/2002/0928 A3/2002/1498,A3/2001/1577 |
| Court | Court of Appeal (Civil Division) |
| Date | 27 March 2003 |
[2002] EWCA Civ 1096
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM CHANCERY DIVISION
MR JUSTICE NEUBERGER
Royal Courts of Justice
Strand,
London, WC2A 2LL
Lord Justice Aldous
Lady Justice Hale and
Lord Justice Latham
A3/2001/1577/A3/2001/1577A/A3/2001/1577B
A3/2001/1942
A3/2002/0928
A3/2002/1498
Antony Watson QC, Andrew Waugh QC and Colin Birss (instructed by Taylor Joynson Garrett) for Kirin Amgen
David Kitchin QC, Richard Meade and Lindsay Lane (instructed by Bird & Bird) for the Hoechst Marion Roussel Limited
This is the judgment of the court.
These appeals are against orders of Neuberger J in three sets of proceedings, two of them being brought by companies seeking declarations of non-infringement and revocation of European Patent UK No. 0148605 and the third being an action alleging infringement of that patent by its registered proprietor Kirin-Amgen Incorporated and their exclusive licensees. We will refer to them as Amgen. The practical effect of those actions was that Amgen claimed relief for infringement and the appellants Transkaryotic Therapies Inc. and Hoechst Marion Roussel Limited denied infringement and counterclaimed for revocation. We will refer to them as TKT.
There were other proceedings against what may be conveniently called the Roche parties, but after judgment Amgen and those parties settled their differences.
The judge concluded that claim 19 and its dependent claims were invalid upon the ground of insufficiency. Otherwise he rejected the attack upon the patent. He held that TKT infringed claim 26. What we have called the main appeal is concerned with those conclusions. TKT contend that the patent is invalid and not infringed. Amgen contend that the judge should have rejected the attack on claim 19 and its dependent claims. They also support the findings of the judge in their favour on additional grounds to those contained in that part of the judge's judgment that was in their favour.
After judgment the judge had to decide a number of disputes relating to the order that should be made. To do that he directed that there should be a hearing starting on 3rd May 2001. At that hearing it was not possible to finalise the order, but the judge made an interim order dated 16th May 2001 which included a declaration that claim 19 and its dependent claims were invalid, but the other claims were valid. He also ordered that Amgen should serve on TKT an application notice annexing a copy of the specification of the patent in the form in which it was proposed to amend it. The order gave directions for resolution of the amendment proceedings and to enable the court to decide whether relief should be granted under section 63 of the Patents Act 1977. The order also adjourned to a later date other disputes. Pursuant to that order, on 18th May 2001 Amgen served an application to amend the patent so as to delete claim 19 and its dependent claims.
The other disputes came back before the court and were resolved by the judge in his judgment and order of 8th August 2001. The appeal against part of that order raises distinct issues.
On 10th and 11th September there was another hearing to decide the form of the injunction, the issues on delivery up and the terms upon which the injunction would be stayed. They were resolved by the judge in his judgment and order of 13th September 2001.
There followed in February 2002 the hearing of the application to amend. In his judgment of 21st March 2002, the judge decided to give Amgen permission to amend by deleting claims 19 to 25. The order made on 18th April 2002 gave permission to amend the patent and also contained a proviso that Amgen "need not secure such amendments from the Comptroller of Patents pending an appeal on the issue of the validity …". It also declared that the specification of the patent was framed in good faith and with reasonable skill and knowledge. The result being that the requirements of section 63 of the 1977 Act were satisfied and relief by way of damages and costs became possible. The order went on to deal with damages or an account and costs. TKT appeal against the declaration that the patent was framed in good faith and with reasonable skill and knowledge.
The Main Appeal
The patent was filed on 12th December 1984. It is entitled "Production of erythropoietin" which we will refer to as EPO. EPO is a protein that functions in the blood to regulate the production of red blood cells. They transport oxygen from the lungs into all the body tissues. Under normal circumstances only minute quantities of EPO are produced because red blood cells last for about 120 days in the circulation. In humans EPO is produced by certain cells in the kidney. When the level of oxygen in the blood drops, those kidney cells respond by producing more EPO and releasing it into the blood. Circulating EPO then binds to other proteins on the surface of certain cells in the bone marrow which divide and ultimately become red blood cells. When the oxygen carrying capacity of the blood returns to normal EPO production by the kidney is reduced.
The amount of EPO present in the blood is minuscule. Although EPO can be detected in blood, it was never purified from this source. In 1977 EPO was reported by Miyake et al. to have been purified in small amounts from urine from patients with aplastic anaemia. In fact only a few milligrams of urinary EPO were obtained from some 660 gallons of urine.
Amgen did not discover EPO, but the work carried out by Dr Lin (the inventor) and his aides, which forms the basis of the patent, identified the amino acid sequence of EPO, and identified and located the nucleotide sequences that coded for human EPO. From that it was possible, by using known genetic engineering techniques, to produce substantial amounts of EPO.
The skilled addressee of the patent would have been familiar with the basics of DNA and the techniques of recombinant technology. They have been set out in a number of judgments e.g. Genentech Inc's Patent [1989] RPC 147 at 158, but for convenience we adopt the clear explanation given by the judge of that technology as applied to the discovery and production of EPO.
"41. EPO is a protein. Proteins are molecules which carry out many vital biochemical functions. They consist of one or more chains of polypeptides. (EPO only has one polypeptide chain, so I shall ignore proteins with more than one chain). A polypeptide is a chain of amino acids. There are twenty different amino acids, and some of them are more common than others. Each amino acid has a carboxyl group (-COOH) at one end and an amino group (-NH 2) at the other end. Each amino acid can be written:
H|
NH 2—C—COOH
|
Rwhere R is its specific constituent, which varies from one amino acid to another. This specific constituent is known as the side chain of the amino acid, because, when the amino acid is in a polypeptide, this constituent is, in effect, a branch off the polypeptide chain.
42. In a polypeptide, amino acids are linked by a peptide bond, which is formed with the loss of an -OH from the carboxyl group of one amino acid and an -H from the amino group of the other acid, i.e. with the effective loss of a water molecule. Thus, the simplest polypeptide (i.e. one with two amino acids) has one peptide bond and may be written:
HOH
||||
NH 2—C—C—N—C—COOH
|||
R 1 H R 2
Strictly each amino acid component in a polypeptide or protein is referred to as an amino acid residue, but a residue is sometimes called simply an amino acid.
43. Many side chains are subjected to modification during the process of their formation. An important and relevant example of such modification is the addition of saccharides (or sugar residues), a process known as glycosylation.
44. While glycosylation does not normally occur in bacteria, it does occur in higher organisms. Glycosylation can involve addition of a single sugar residue, or a substantial number of sugar residues. Such residues can substantially vary in size, structure, and composition one from the other. There are two common types of glycosylation, N-glycosylation and O-glycosylation. The reference to N and O is a reference to the atom (nitrogen and oxygen respectively) to which the carbohydrate residue (known as the "glycan") attaches. A glycosylated protein is known as a glycoprotein. EPO is in a glycoprotein.
45. In a polypeptide, the amino acid chain is treated as starting at the amino end of the first amino acid, known as the N-terminus or NH 2-terminus, and ending with a carboxyl group of the last amino acid, known as the C-terminus or COOH-terminus. A polypeptide only becomes a protein once it is folded into the correct shape, often with cross linking between cysteine amino acids known as...
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