Generics (UK) Ltd trading as Mylan v Warner-Lambert Company LLC
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold,The Hon Mr Justice Arnold |
| Judgment Date | 10 September 2015 |
| Neutral Citation | [2015] EWHC 2548 (Pat) |
| Docket Number | Case Nos: HP-2014-000035, HP-2014-000021, HC-2014-001795 |
| Court | Chancery Division (Patents Court) |
| Date | 10 September 2015 |
and
and
[2015] EWHC 2548 (Pat)
The Hon Mr Justice Arnold
Case Nos: HP-2014-000035, HP-2014-000021, HC-2014-001795
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NLL
Piers Acland QC and Kathryn Pickard (instructed by Taylor Wessing LLP) for Mylan (validity)
Richard Meade QC and Isabel Jamal (instructed by Powell Gilbert LLP) for Actavis (validity)
Tom Mitcheson QC, Miles Copeland and Katherine Moggridge (instructed by Allen & Overy LLP) for Warner-Lambert (validity)
Charlotte May QC and Tim Austen (instructed by Allen & Overy LLP) for Warner-Lambert and Pfizer (infringement and threats)
Adrian Speck QC (instructed by Powell Gilbert LLP) for Actavis (infringement and threats)
Michael Silverleaf QC, Philip Moser QC and Richard Davis (instructed by the Government Legal Department) for the Secretary of State (infringement)
Hearing dates: 29–30 June, 1–3, 6, 8 July 2015 (validity), 9–10, 13–15, 17 July 2015 (infringement and threats)
Further written submissions 29 July and 18 August 2015 (infringement)
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 | 1–6 |
| The parties | 7–10 |
| The witnesses: validity | 11–24 |
| Neuroscientists | 12–18 |
| Clinicians | 19–22 |
| Factual witnesses | 23–24 |
| The witnesses: infringement and threats | 25–35 |
| Factual witnesses | 25–30 |
| Expert witnesses | 31–35 |
| Technical background | 36–82 |
| The nervous system | 37–44 |
| Pain | 45 |
| Types of pain | 46 |
| Nociceptive pain | 47 |
| Inflammatory pain | 48–49 |
| Neuropathic pain | 50–53 |
| Causes of Neuropathic pain | 54 |
| DPN and PHN | 55 |
| Trigeminal neuralgia | 56 |
| Fibromyalgia | 57 |
| Idiopathic pain | 58 |
| Hyperalgesia and allodynia | 59 |
| Sensitisation | 60 |
| Central sensitisation | 61–67 |
| Animal models | 68 |
| Rat paw formalin test | 70 |
| Carrageenin test | 71 |
| Complete Freund's Adjuvant ("CFA") test | 72–73 |
| Chronic constriction injury ("CCI") model | 74 |
| Spinal nerve ligation model | 75 |
| Neuroma model | 76–77 |
| Treatments for pain | 78–80 |
| Gabapentin | 81 |
| Pregabalin | 82 |
| "Off-label" prescribing | 83 |
| IMS data, Read codes and ICD 10 codes | 84–87 |
| Introduction to second medical use patents with claims in Swiss form | 88–92 |
| The Patent | 93–110 |
| The claims | 111–112 |
| The skilled team | 113–119 |
| Common general knowledge | 120–239 |
| The law | 120–125 |
| This case: general observations | 126–130 |
| Whose knowledge? | 131–132 |
| Use of gabapentin for the treatment of pain | 133 |
| Literature references | 134–137 |
| USA | 138–147 |
| UK | 148–152 |
| Overall | 153 |
| Anticonvulsants | 154–161 |
| Calcium channels | 162 |
| Central sensitisation | 163–165 |
| The Textbook of Pain | 166–179 |
| The concept of central sensitisation | 180 |
| Central sensitisation as a contributor to peripheral neuropathic pain | 181–182 |
| The reorganised state | 183–189 |
| Central sensitisation as a contributor to inflammatory pain | 190 |
| Central sensitisation as a common mechanism in peripheral neuropathic and inflammatory pain | 191 |
| No involvement of central sensitisation in central neuropathic pain | 193–196 |
| The link between central sensitisation, neuropathic pain and secondary hyperalgesia and allodynia | 197–205 |
| Rat paw formalin test | 206–235 |
| Carrageenin and post-operative pain models | 236–238 |
| Relationship between the formalin test, carrageenin model and post-operative pain model | 239 |
| Construction | 240–261 |
| The nature of the claims | 241–242 |
| Technical features of claim I | 243 |
| Pain | 244–252 |
| Treating | 253–255 |
| The mental element | 256 |
| Claim 3 | 257–261 |
| The prior art | 262–288 |
| Taylor I | 263–265 |
| Taylor II | 266–273 |
| Mellick | 274–276 |
| Gee | 277–280 |
| Radulovic | 281–288 |
| Obviousness | 289–338 |
| The law | 289–293 |
| General points relied on by Warner-Lambert | 294–298 |
| Mellick | 299–307 |
| Taylor II | 308–324 |
| Gee | 325–327 |
| Radulovic | 328–337 |
| Overall conclusion | 338 |
| Insufficiency | 339–358 |
| The law | 339–342 |
| Assessment | 343–345 |
| Claim 13: idiopathic pain | 346 |
| Claim 3: neuropathic pain | 347–352 |
| Claims 4: cancer pain | 353 |
| Claim 6: phantom limb pain | 354 |
| Claim 14: fibromyalgia pain | 355 |
| Claims 10, 11 and 12 | 356 |
| Claim 1: pain | 357 |
| Overall conclusion | 358 |
| Infringement: Introduction | 359 |
| Infringement: the facts | 360–564 |
| NHS England, CCGs, GPs and pharmacies | 361–363 |
| The NHS in Wales, Scotland and Northern Ireland | 364–367 |
| Lyrica | 368–371 |
| Recommended does of pregabalin | 372 |
| Misuse of pregabalin | 373–375 |
| Prescribing practices | 376–380 |
| Clinical software | 381–383 |
| Dispensing practices | 384–389 |
| The NHS Drug Tariff | 390–394 |
| Medicine margin | 395–398 |
| The percentage of pregabalin prescribed for each indication | 399–415 |
| The abridged procedure for marketing authorisations and skinny labels | 416–418 |
| An unprecedented situation | 419 |
| Pfizer's preparations for loss of exclusivity | 420–424 |
| Actavis | 425–442 |
| The wording of Actavis' SmPC and PIL | 443–447 |
| Genesis of the proceedings | 448–458 |
| Steps taken by Pfizer to prevent generic pregabalin being prescribed or dispensed for pain | 459–505 |
| Department of Health and NHS England | 460–471 |
| NPSG and PMSG | 472 |
| Welsh Government, Northern Ireland Executive and Scottish Government | 473–477 |
| PSNC | 478–480 |
| NICE | 481–482 |
| RPS | 483 |
| Pharmacy customers | 484 |
| BPS and RCGP | 485 |
| Pharmacy Voice | 486 |
| Software providers | 487–490 |
| MHRA | 491 |
| Community Pharmacy Wales and the RPS's Director for Wales | 492 |
| Community Pharmacy Scotland | 493 |
| Superintendent pharmacists | 494–495 |
| BNF | 496 |
| CCGs and Health Boards | 497 |
| PAG | 498 |
| NHS Highland and NHS Grampian | 499–500 |
| SIGN | 501 |
| NPA | 502 |
| RCP | 503 |
| GMC and GPhC | 504 |
| BMA | 505 |
| Pfizer's Brand Equalisation deals | 506 |
| Pfizer's application for interim relief | 507–509 |
| Pfizer's application against NHS England | 510 |
| Guidance issued by NHS England, NHS Wales and NHS Northern Ireland | 511–513 |
| Changes to clinical software | 514–515 |
| Actavis' knowledge as to the effect of a skinny label on the dispensing of Lecaent | 516 |
| Actavis' foresight and knowledge of the steps taken by Pfizer | 517 |
| Steps taken by Actavis to ensure Lecaent was not dispensed for pain | 518–521 |
| Further steps demanded by Pfizer | 522–549 |
| Labelling | 526–527 |
| A reminder letter to CCGs and Health Boards | 528–529 |
| A letter to software providers | 530–532 |
| Contractual restriction on wholesalers | 533–534 |
| NHS guidance | 535–536 |
| Changes to dm+d | 537–541 |
| A letter to hospitals | 542–543 |
| An order against the Department of Health | 544–545 |
| The modified Consilient scheme | 546–547 |
| Guidance to hospital doctors | 548 |
| Compensation to CCGs, Health Boards and others | 549 |
| Effect of the guidance issued by NHS England and others | 550–558 |
| Other generic suppliers of pregabalin | 559–560 |
| Has generic pregabalin been dispensed for pain? | 561–564 |
| Regulatory issues | 565–589 |
| Could Pfizer have launched a skinny label product? | 566–575 |
| Could Actavis have communicated with CCGs and others prior to receipt of their marketing authorisation? | 576–584 |
| Could Actavis have supplied Lecaent packs in a cellophane wrapper bearing a notice? | 585–589 |
| Did Actavis intend Lecaent to be dispensed for the treatment of pain? | 590–597 |
| Pfizer's claim under section 60(1)(c): the law | 598–660 |
| The statutory framework | 598–601 |
| Swiss form claims in more detail | 602–605 |
| The judgment of the Court of Appeal | 606–615 |
| Is the Court of Appeal's judgment binding? | 616–619 |
| Is the Court of Appeal's judgment wrong? | 620–632 |
| How should the Court of Appeal's judgment be applied? | 633–639 |
| The position of pharmacists with respect to infringement | 640 |
| What is the relevant date? | 641–648 |
| What relief does Pfizer seek? | 649–653 |
| What are the relevant legal duties? | 654 |
| Pfizer's claim under section 60(1)(c): assessment | 661–677 |
| As at 8 December 2014 | 663–671 |
| As at 17 February 2015 | 672–673 |
| As at 15 July 2015 | 674–676 |
| Conclusion | 677 |
| Pfizer's claim under section 60(2) | 678–684 |
| Counterclaim for declaratory relief | 685–689 |
| Doctors | 686 |
| Pharmacists | 687 |
| Patients | 688 |
| Conclusion | 689 |
| Counterclaim for threats | 690–721 |
| The law | 691–694 |
| The alleged threats | 695–708 |
| Letter to Department of Health 28 October 2014 | 696 |
| Communications with PSNC 5 and 13 November 2014 | 697–699 |
| Letter to NICE 13 November 2014 | 700 |
| Letter to superintendent pharmacists 10 December 2014 | 701 |
| Letter to CCGs 12 December 2014 | 702 |
| Email to PAG 12 December 2014 | 703 |
| Letter to Department of Health 9 January 2015 | 704 |
| Letter to Murrays healthcare Ltd 8 February 2015 | 705 |
| Letter to BMA 18 February 2015 | 706 |
| Letter to superintendent pharmacists 20 February 2015 | 707 |
| Assessment | 709–721 |
| Communications with PSNC... |
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