Medimmune Ltd v Novartis Pharmaceuticals UK Ltd and Another
| Jurisdiction | England & Wales |
| Judge | The Hon Mr Justice Arnold,Mr. Justice Arnold,MR JUSTICE ARNOLD |
| Judgment Date | 10 February 2012 |
| Neutral Citation | [2012] EWHC 181 (Pat),[2011] EWHC 1669 (Pat) |
| Docket Number | Case No: HC11C01304,Case No: HC09C04770 |
| Court | Chancery Division (Patents Court) |
| Date | 10 February 2012 |
[2011] EWHC 1669 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
The Hon Mr Justice Arnold
Case No: HC09C04770
Richard Meade QC, Tom Mitcheson and James Whyte (instructed by Marks & Clerk Solicitors LLP) for the Claimant
Simon Thorley QC, Justin Turner QC and Joe Delaney (instructed by Allen & Overy LLP) for the First Defendant
The Second Defendant did not appear and was not represented
Hearing dates: 10–13, 16–20, 24–27 May 2011
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Contents
| Topic | Paragraphs |
| Introduction | 1–7 |
| Technical background | 8–90 |
| Amino acids | 9–11 |
| Proteins | 12–15 |
| Nucleic acids | 16–22 |
| Genes | 23–24 |
| Transcription and translation | 25–26 |
| The genetic code | 27–28 |
| Genetic engineering | 29–33 |
| Recombinant production of proteins | 34–36 |
| Creation of cDNA libraries | 37–38 |
| Antibodies | 39–41 |
| Antibody diversity | 42–44 |
| Specificity and affinity | 45–51 |
| Antibody structure and function | 52–59 |
| Antibody fragments | 60–62 |
| Polyclonal and monoclonal antibodies | 63–64 |
| Uses of antibodies | 65 |
| Making antibodies for human use | 66–69 |
| Creation of antibody libraries | 70 |
| Screening libraries by plaque lift | 71–72 |
| Bacteriophages | 73–76 |
| Phage lifecycle | 77–79 |
| Phage vectors | 80 |
| Phagemids | 81–83 |
| Phage display | 84–90 |
| The skilled team | 91–97 |
| The expert witnesses | 98–152 |
| The preparation of experts' reports in patent cases | 99–114 |
| Professor Brammar | 115–118 |
| Dr Teillaud | 119–123 |
| Dr Huse | 124–148 |
| Dr Logtenberg | 149–152 |
| Common general knowledge | 153–167 |
| Better and Skerra & Plückthun | 155–156 |
| Bird | 157 |
| Orlandi, Sastry and Ward | 158–161 |
| Huse | 162–167 |
| Phage display | 168–171 |
| Smith | 169 |
| Parmley & Smith | 170 |
| Scott & Smith | 171 |
| PD3 | 172–215 |
| Example 1 | 194–196 |
| Example 2 | 197 |
| Example 3 | 198 |
| Example 4 | 199–203 |
| Example 5 | 204 |
| Example 6 | 205–206 |
| Example 7 | 207–209 |
| Example 8 | 210 |
| Example 9 | 211 |
| Example 10 | 212 |
| Examples 11–14 | 213 |
| Examples 15 | 214 |
| Matters not disclosed in PD3 | 215 |
| 511 | 216–246 |
| Example 13 | 227 |
| Example 14 | 228–229 |
| Example 15 | 230 |
| Example 16 | 231–232 |
| Example 17 | 233–234 |
| Example 19 | 235 |
| Example 21 | 236 |
| Example 27 | 237–238 |
| Example 28 | 239 |
| Example 29 | 240–241 |
| Example 35 | 242 |
| The claims | 243–246 |
| 777 | 247–248 |
| Construction: the law | 249–250 |
| Construction of claim 5 of | 511 |
| 251–290 | "A range of binding specificities" |
| 252–268 | "A population of filamentous bacteriophage particles" and "each filamentous bacteriophage particle contains a phagemid genome" |
| 269–290 | Construction of claim 1 of |
| 777 | 291–302 |
| "By fusion with a gene III protein" | 292–301 |
| "A population of filamentous bacteriophage particles" and "each filamentous bacteriophage particle contains nucleic acid" | 302 |
| Priority of the claimed inventions from PD3 | 303–344 |
| The law | 303–304 |
| Claim 8 of 511 | 305 |
| Phagemid and Fab | 306–326 |
| Phagemid: Example 1 | 307–318 |
| Phagemid and Fab: Example 7 read in the light of Example 1 | 319–326 |
| Derivative | 327–343 |
| Claim 1 of 777 | 344 |
| The prior art | 345–374 |
| Parmley & Smith | 346–355 |
| The Banbury Conference | 356–374 |
| Obviousness | 375–457 |
| The skilled team, the common general knowledge and the inventive concept | 380 |
| General points | 381–384 |
| Obviousness over Parmley & Smith | 385–408 |
| The difference | 392 |
| Was it obvious? | 393–408 |
| Obviousness over the Banbury Conference disclosure | 409–457 |
| The difference | 410 |
| Was it obvious? | 411–421 |
| Secondary evidence: Professor Smith's own work | 422–436 |
| Secondary evidence: reaction to the invention | 437 |
| Secondary evidence: other people who had the idea | 438–455 |
| Overall conclusion | 456–457 |
| Insufficiency | 458–492 |
| The law | 458–484 |
| The present case | 485–492 |
| Added matter | 493–502 |
| The law | 493–494 |
| The present case | 495–502 |
| Development of ranibizumab | 503–519 |
| Step 1 | 506 |
| Step 2 | 507–508 |
| Step 3 | 509 |
| Step 4 | 510 |
| Step 5 | 511 |
| Step 6 | 512 |
| Step 7 | 513 |
| Step 8 | 514 |
| Step 9 | 515 |
| Step 10 | 516 |
| Step 11 | 517 |
| In summary | 518–519 |
| Infringement: did the process fall within the claims? | 520–527 |
| Infringement: is the product obtained directly by means of the process? | 528–577 |
| Infringement under the law prior to the Biotech Directive | 529–549 |
| Infringement under the Biotech Directive | 550–577 |
| Summary of conclusions | 578 |
Introduction
The Claimant ("MedImmune", formerly known as Cambridge Antibody Technology Ltd ("CAT")) and the Second Defendant ("the MRC") (jointly, "the Patentees") are joint proprietors of European Patents (UK) Nos. 0 774 511 ("511") and 2 055 777 ("777") (together, "the Patents"). MedImmune is the exclusive licensee of the MRC's interest in the Patents. MedImmune alleges that the First Defendant ("Novartis") has infringed the Patents by sales of a pharmaceutical product whose international non-proprietary name is ranibizumab and which is sold under the trade mark Lucentis. Lucentis is approved for the treatment of an eye condition known as wet age-related macular degeneration, which can lead to loss of vision. Novartis disputes infringement and counterclaims for revocation of the Patents. The MRC has been joined to the claim so as to be bound by the result, but has not played an active part in the proceedings. Ranibizumab was developed by Genentech, Inc., which is not a party to the proceedings.
The Patents are members of a family of European patents and patent applications based on International Patent Application No. PCT/GB91/01134 filed on 10 July 1991 which was subsequently published as WO 92/01047 ("the Application"). Each of the patents in this family claims priority from five priority documents, namely:
i) United Kingdom Patent Application No. 9015198 filed on 10 July 1990;
ii) United Kingdom Patent Application No. 9022845 filed on 19 October 1990;
iii) United Kingdom Patent Application No. 9024503 filed on 12 November 1990;
iv) United Kingdom Patent Application No. 9104744 filed on 6 March 1991; and
v) United Kingdom Patent Application No. 91110549 filed on 15 May 1991.
511 is a divisional of the parent, European Patent No 0 589 877 ("877"), while 777 is a divisional of a divisional of a divisional of 511. The relationship between the Patents, the other members of the family, the Application and the priority documents is conveniently shown in the following diagram:
Novartis challenges the entitlement of the Patents to priority. Attention has focussed on the entitlement of the Patents to priority from the third of the priority documents listed above ("PD3") since (a) MedImmune accepts that the Patents are invalid if they are not entitled to priority from that document and (b) Novartis does not rely upon any prior art which was made available to the public in the interval between the filing dates of the first and third priority documents. Novartis disputes both that the claimed inventions are disclosed by PD3 and that the Patentees have the right to claim priority from PD3. It became clear at an early stage of the trial, however, that the parties were not ready to contest the latter issue. Accordingly, it was agreed that that issue will be tried separately at a later date.
Although MedImmune has not conceded that the Patents are invalid over any particular item of prior art if they are not entitled to priority from PD3, it is convenient to note at this point that some of the work described in the Patents was published on 6 December 1990 in a paper by McCafferty et al, "Phage antibodies displaying antibody variable domains", Nature, 348, 552–554 ("McCafferty"). The authors of McCafferty were a group of four scientists from CAT and the MRC Laboratory of Molecular Biology led by Dr (now Sir) Greg Winter. Those four together with eight others are the named inventors of the Patents.
Apart from the priority attack, Novartis' principal challenge to the validity of the claims of the Patents in issue is that they are obvious over Parmley and Smith, "Antibody-selectable filamentous fd phage vectors: affinity purification of target genes", Gene, 73, 305–318 (1988) ("Parmley & Smith") and a talk entitled "Filamentous phage as vectors for antibody libraries" given by Professor George Smith of the University of Missouri at a conference on "Vectors for Cloning the Immune Response" held at the Banbury Center, Cold Spring Harbor Laboratory, New York on 23–26 April 1990 ("the Banbury Conference"). In addition, Novartis contends that the Patents are invalid on the grounds of insufficiency and added matter.
The claims in issue are claims 5–8 of 511 and claim 1 of 777. All of these claims are process claims. MedImmune alleges that Novartis has infringed these claims by virtue of section 60(1)(c) of the Patents Act 1977. Novartis disputes both that Lucentis was produced by a process which falls within the scope of the claims and that Lucentis is a product "obtained directly by means of" any of the claimed processes.
Technical background
The following account of the technical background to this dispute is largely based on the technical primer ("the Primer") which the parties sensibly agreed for use in these proceedings, supplemented to a...
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