Illumina, Inc. and Others (Claimants to case no HC-2015-001175) Illumina, Inc. and Another (Claimants in case no HP-2015-000047) v Premaitha Health Plc and Another (Defendants in case nos HC-2015-001175 HP-2015-000047)
| Jurisdiction | England & Wales |
| Judge | Mr Justice Henry Carr |
| Judgment Date | 21 November 2017 |
| Neutral Citation | [2017] EWHC 2930 (Pat) |
| Docket Number | Case No: HC-2015-001175 HP-2016-000001 |
| Court | Chancery Division (Patents Court) |
| Date | 21 November 2017 |
[2017] EWHC 2930 (PAT)
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
PATENTS COURT (ChD)
Royal Courts of Justice
Rolls Building
Fetter Lane, London, EC4A 1NL
THE HON Mr Justice Henry Carr
Case No: HC-2015-001175
HC-2015-000047
HP-2016-000001
Mr Iain Purvis QC, Dr Piers AclandQC andDr James Whyte (instructed by Powell Gilbert LLP) for the Claimants
Mr Thomas Mitcheson QC, Mr Thomas HinchliffeQC andMs. Georgina Messenger (instructed by Allen & Overy LLP) for the Defendants Premaitha Health Plc and Premaitha Limited
Dr Michael Tappin QC and Mr Joe Delaney (instructed by Herbert Smith Freehills LLP) for the Defendant Ariosa Diagnostics, Inc, and (instructed by Clyde & Co LLP) for the Defendants TDL Genetics Limited and The Doctors Laboratory Limited.
Hearing dates: 4–7, 10–14,17,18 and 25–17 July 2017
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.
INDEX
| No. | Section | Paragraphs |
| I. | Introduction | 1 |
| II. | Part A: Judgment in relation to the Lo 1 Patent | 7 |
| 1. | The main issues in dispute | 7 |
| 2. | The skilled team | 8 |
| 3. | Illumina's expert witnesses in relation to Lo 1 | 11 |
| 4. | TDL/Ariosa's expert witnesses in relation to Lo 1 | 18 |
| 5. | Common general knowledge in 1997-technical background to Lo 1 | 26 |
| 6. | The Lo 1 Patent | 65 |
| 7. | Inventive step | 82 |
| 8. | The disclosure of Kazakov | 84 |
| 9. | Obviousness in the light of Kazakov | 93 |
| 10. | Lo 1 – entitlement to priority/enablement | 121 |
| 11. | Disclosure of the Lo 1 Priority Document | 122 |
| 12. | Challenges to priority | 129 |
| 13. | Discovery as such | 184 |
| 14. | Confidentiality and the principle of open justice | 190 |
| 15. | Issues of infringement in relation to the Harmony test | 196 |
| 16. | Premaitha specific issues in relation to Lo 1 | 210 |
| 17. | Whether the claims of Lo 1 are infringed by the IONA test, either as a matter of normal interpretation or as equivalents | 211 |
| 18. | "Detecting" and "detection" | 216 |
| 19. | Declarations of non-infringement in respect of two proposed alternative methods | 237 |
| 20. | Insufficiency | 239 |
| 21. | Title issues in relation to Lo 1 | 242 |
| III. | Part B: Judgment in relation to the Quake Patents | 256 |
| 22. | Issues in dispute | 256 |
| 23. | The skilled team | 257 |
| 24. | The expert witnesses | 258 |
| 25. | Premaitha's experts | 267 |
| 26. | Common general knowledge in 2006 – technical background to the Quake Patents | 272 |
| 27. | Disputed common general knowledge – the 'direction of travel' at the priority date | 294 |
| 28. | The Quake 1 Patent | 328 |
| 29. | The Claims of the Quake 1 Patent | 344 |
| 30. | The Quake 2 Patent | 345 |
| 31. | Shimkets | 346 |
| 32. | Insufficiency | 379 |
| 33. | Added matter | 386 |
| 34. | Issues of infringement of the Quake 1 Patent | 392 |
| 35. | Issues of infringement of the Quake 2 Patent | 418 |
| 36. | Title issues relating to Quake | 420 |
| IV. | Part C – Judgment in relation to the Lo 2 and Lo 3 Patents | 432 |
| 37. | Issues in dispute | 432 |
| 38. | Additional common general knowledge in 2007 | 433 |
| 39. | The Lo 2 Patent | 434 |
| 40. | The Lo 3 Patent | 444 |
| 41. | Proceedings in the EPO | 445 |
| 42. | Obviousness in the light of Shimkets | 446 |
| 43. | Lo 2 and 3 – entitlement to priority | 447 |
| 44. | Title issues in relation to Lo 2 | 472 |
| 45. | Lo 2 — Issues of infringement | 477 |
| 46. | IONA Test – Alternative Proposed Process | 500 |
| 47. | The Additional Alternative Proposed Process | 510 |
| 48. | Overall conclusions | 511 |
Introduction
These proceedings concern three Claims in respect of five biotechnology patents, all of which were heard at the same trial. The first two Claims (HC-2015-001175 and HP-2015-000047) were brought against Premaitha Health Plc and Premaitha Limited (collectively "Premaitha"). The third Claim (HP-2016-000001) was brought against TDL Genetics Limited, The Doctors Laboratory Limited and Ariosa Diagnostics Inc. (collectively "TDL/Ariosa"). The legal teams were outstanding in their presentation of what was, in effect, three inter-related trials.
All of the patents in suit ("the Patents") concern non-invasive prenatal diagnosis ("NIPD") i.e. genetic testing on a foetus (also spelt "fetus") that requires only sampling of the mother's blood, or other non-invasively collected analyte. NIPD is to be contrasted with methods such as amniocentesis and chorionic villus sampling ("CVS") that involve invasive sampling of cells from the amniotic fluid and placenta respectively.
The importance of this area of research will be apparent to all those who have faced the difficult decision of whether to test for genetic disorders, such as Down's syndrome, during pregnancy. Invasive sampling carries with it a risk to the foetus. A genetic test which can be performed without any such risk, merely by taking a blood sample, is of great public benefit.
The Patents comprise three principal patents and two divisionals, namely:
i) EP (UK) 0,994,963 ("Lo 1") which claims a priority date of 4 March 1997 and concerns a method of detecting the presence of a paternally inherited nucleic acid sequence of foetal origin, which is not possessed by the pregnant female, in a maternal serum or plasma sample.
ii) EP (UK) 1,981,995 ("Quake 1") which claims a priority date of 2 February 2006 and concerns a method of detecting foetal aneuploidy in a mixture of maternal and foetal genetic material in a sample of maternal tissue by digital analysis methods. EP (UK) 2,385,143 ("Quake 2") is a divisional of Quake 1 and claims the same priority date.
iii) EP (UK) 2,183,693 ("Lo 2") which claims a priority date of 23 July 2007 and concerns a method of detecting foetal aneuploidy in a mixture of maternal and foetal genetic material in a sample of maternal tissue by random DNA sequencing. EP (UK) 2,514,842 ("Lo 3") is a divisional of Lo 2 and claims the same priority date.
Premaitha has developed a non-invasive prenatal test called "IONA". TDL/Ariosa has developed a non-invasive prenatal test called "Harmony". IONA is claimed by Illumina to infringe all of the Patents, whereas Harmony is claimed to infringe only Lo 1. Premaitha and TDL/Ariosa ("the Defendants") claim that the patents under which they are sued are invalid. Dr Tappin QC, on behalf of TDL/Ariosa, took the lead in relation to Lo 1 and Mr Mitcheson QC and Mr Hinchliffe QC, on behalf of Premaitha, took the lead in relation to the other patents. Premaitha supported TDL/Ariosa's challenges to validity and title of Lo 1. It advanced separate arguments as to non-infringement of Lo 1 by the IONA test.
Mr Purvis QC, on behalf of Illumina, summarised the position in respect of each of the Patents in a table which is reproduced below:
PART A: JUDGMENT IN RELATION TO THE LO 1 PATENT
The main issues in dispute
| Patent | Priority Date | Patentee | Exclusive licensee | Relevant action | Defendant |
| Lo 1 | 4 March 1997 | Sequenom | Illumina | HC-2015-001175 / HP-2016-000001 | Premaitha and Ariosa |
| Quake 1/2 | 2 February 2006 | Stanford University | Verinata | HC-2015-001175 | Premaitha |
| Lo 2/3 | 23 July 2007 | Chinese University of Hong Kong | Illumina | HP-2015-000047 | Premaitha |
With some encouragement from the Court, the parties reduced the number of issues which they chose to pursue by the time that closing speeches were exchanged. However, there was still a great deal left to argue about. The following issues remain in dispute in relation to Lo 1:
i) Whether Lo 1 is obvious in the light of a paper by Kazakov et al., Extracellular DNA in the blood of pregnant women. Cytology 1995 Vol 27 3 ("Kazakov").
ii) Whether Lo 1 is entitled to its claimed priority date of 4 March 1997. It is accepted by Illumina, for the purposes of these proceedings only, that if priority is lost, then Lo 1 is invalid.
iii) Whether the claims of Lo 1 as proposed to be amended are sufficient. Since the priority document must contain an enabling disclosure of the claimed invention, the parties agreed that sufficiency should be considered on the basis of the disclosure of the priority document.
iv) Whether the specification of Lo 1 as proposed to be amended contains matter not disclosed in the application as filed.
v) Whether the claims of Lo 1 relate to a discovery as such.
vi) Whether the Harmony prenatal test (non-polymorphic and polymorphic assay) falls within the claims of Lo 1.
vii) Whether Premaitha's IONA test and/or two proposed alternative methods, in respect of which Premaitha seeks a declaration of non-infringement, fall within the claims of Lo 1.
viii) Whether Illumina is an exclusive licensee under Lo 1.
The Skilled Team
Lo 1 is directed to a team interested in developing non-invasive methods of prenatal diagnosis. The team would comprise a clinician and a human molecular geneticist (also called a molecular biologist). The clinical side of the team would take the lead in assessing the potential clinical or diagnostic significance of a new piece of information.
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