Medimmune Ltd v Novartis Pharmaceuticals UK Ltd and Another

JurisdictionEngland & Wales
CourtChancery Division (Patents Court)
JudgeThe Hon Mr Justice Arnold,Mr. Justice Arnold,MR JUSTICE ARNOLD
Judgment Date10 February 2012
Neutral Citation[2012] EWHC 181 (Pat),[2011] EWHC 1669 (Pat)
Date10 February 2012
Docket NumberCase No: HC11C01304,Case No: HC09C04770

[2011] EWHC 1669 (Pat)

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT

Royal Courts of Justice

Strand, London, WC2A 2LL

Before:

The Hon Mr Justice Arnold

Case No: HC09C04770

Between:
Medimmune Limited
Claimant
and
(1) Novartis Pharmaceuticals UK Limited
(2) Medical Research Council
Defendants

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.

The Hon Mr Justice Arnold Mr. Justice Arnold

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

1

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.

2

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.

3

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:

4

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.

5

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.

6

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.

7

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

8

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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