Abbott Diabetes Care Inc. v Dexcom Incorporated
| Jurisdiction | England & Wales |
| Judge | Mr Justice Mellor |
| Judgment Date | 15 January 2024 |
| Neutral Citation | [2024] EWHC 36 (Pat) |
| Year | 2024 |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP-2021-000025 & HP-2021-000026 |
and
and
[2024] EWHC 36 (Pat)
Mr Justice Mellor
Case No: HP-2021-000025 & HP-2021-000026
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
Rolls Building, 7 Fetter Lane,
London, EC4A 1NL
Daniel Alexander KC, James Abrahams KC, Michael Conway and Jennifer Dixon (instructed by Taylor Wessing LLP) for the Abbott parties
Benet Brandreth KC and David Ivison (instructed by Bird & Bird LLP) for the Dexcom parties
Hearing dates: 30 th November, 2 nd, 5–7 th, 12 th–13 th December 2022
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.
Remote hand-down: This judgment will be handed down remotely by circulation to the parties or their representatives by email and release to The National Archives. The deemed date of hand down is 10.30 am on Monday 15 th January 2024.
THE HON Mr Justice Mellor
| INTRODUCTION | 5 |
| The Abbott patents | 6 |
| The Dexcom patents | 7 |
| The expert witnesses | 7 |
| Common general knowledge | 8 |
| Diabetes | 8 |
| CGM devices | 13 |
| Summary of CGM Devices | 19 |
| EP627 | 30 |
| The Invention | 32 |
| THE SKILLED TEAM & CGK | 35 |
| CLAIMS / CONSTRUCTION | 35 |
| Claim 1 | 36 |
| “Predetermined routine” | 38 |
| Nature of the “second indication” | 39 |
| Analysis | 39 |
| Claim 5 | 42 |
| INFRINGEMENT | 42 |
| Abbott's case on infringement | 42 |
| Dexcom's non-infringement points | 44 |
| VALIDITY: NOVELTY & INVENTIVE STEP | 46 |
| The STS Guide | 46 |
| Claim 1 | 47 |
| Abbott's arguments against anticipation | 48 |
| Bunte | 49 |
| CONCLUSIONS ON EP627 | 53 |
| EP223 | 54 |
| THE TECHNICAL CONTEXT OF EP223 | 54 |
| THE SKILLED TEAM OF EP223 | 56 |
| Composition of the skilled team | 56 |
| CGK for EP223 | 58 |
| Mobile phones / health applications | 58 |
| CGM devices | 58 |
| Mobile phones | 58 |
| Installation checks | 61 |
| Regulatory considerations for medical device software | 61 |
| The Disputes on CGK | 62 |
| DISCLOSURE OF THE PATENT | 68 |
| Inventive concept | 76 |
| CLAIMS / CONSTRUCTION | 77 |
| Claim 1 | 77 |
| ‘Safety critical application’ | 78 |
| Integers 1.2(b) – (d) individually | 79 |
| Integers 1.2(b) – (d) compendiously | 80 |
| Discussion | 84 |
| Claims 7 and 9 | 86 |
| INFRINGEMENT OF EP223 | 87 |
| ‘installation check’ | 87 |
| ‘functional check’ | 89 |
| Selective enablement | 91 |
| The finding of no infringement by the Mannheim Court | 91 |
| Claims 7 and 9 | 92 |
| VALIDITY: NOVELTY | 93 |
| Gejdos | 93 |
| Introduction | 93 |
| Disclosure | 93 |
| Safety critical application? | 95 |
| Installation check | 96 |
| Functional check | 97 |
| Selective enablement | 98 |
| VALIDITY: INVENTIVE STEP | 99 |
| Lebel | 99 |
| Dexcom's case | 100 |
| Dr Palerm's evidence | 101 |
| Abbott's criticisms | 102 |
| Analysis | 103 |
| Dexcom's Gillette arguments | 104 |
| Claims 7 and 9 | 106 |
| EP159 & EP539 | 109 |
| Introduction | 109 |
| The EP159 / 539 Skilled Addressee | 110 |
| CGK points in dispute | 111 |
| Level of consensus on blood glucose levels for hypoglycaemia | 111 |
| Glycaemic variability | 112 |
| Alarm fatigue | 112 |
| The accuracy of CGM devices | 112 |
| The Specification(s) | 113 |
| CONSTRUCTION — claim 1 of EP159 | 115 |
| CONSTRUCTION – claim 1 of EP539 | 116 |
| EP539 Amendment | 117 |
| Extension of protection | 117 |
| Clarity | 118 |
| VALIDITY | 119 |
| Introduction | 119 |
| Brauker 2007 | 120 |
| Shariati | 124 |
| Alleged Obviousness | 126 |
| Applicable principles – Inventive Step | 126 |
| Dexcom's hindsight case | 129 |
| STS-7 Guide | 131 |
| Disclosure | 131 |
| Obviousness of a predictive fixed alert | 131 |
| Navigator Guide | 133 |
| Disclosure | 133 |
| Obviousness of a fixed predictive alert | 133 |
| Other features of the claims | 134 |
| EP159, integer 1(d) – temperature correction | 134 |
| EP539, integer 1(h) – different outputs for indicators | 134 |
| EP539, integers 1(k)-1(l), visual target range | 134 |
| Dexcom's arguments against obviousness | 135 |
| Insufficiency | 136 |
| OVERALL CONCLUSIONS | 136 |
INTRODUCTION
This is my judgment from Trial A in these proceedings, the first of three trials concerning various patents owned by Abbott and by Dexcom which have application in the field of Continuous Glucose Monitoring (CGM) devices. Originally there were five patents in issue for this trial, but shortly before trial Abbott withdrew its allegation of infringement of EP625, leaving four patents in issue, two owned by Abbott, EP627 and EP223 and two owned by Dexcom EP159 and EP539. Some prior art citations were also abandoned in the lead up to trial, but at trial, there remained 9 prior art citations to consider, as well as other validity attacks.
CGM devices are used by diabetic patients for the purpose of monitoring their blood glucose, with a view to taking action if their blood glucose becomes too high (hyperglycaemia – requiring an injection of insulin) or too low (hypoglycaemia – requiring consumption of carbohydrate). The patents which are in issue in this trial relate, broadly, to features which involve providing users with information about their blood glucose levels and certain other characteristics. The exception is EP223 which relates to a method of checking that the application that operates on the device is installed and functioning properly.
There are only a handful of companies in the world involved in making CGM devices of the kind in issue. Abbott and Dexcom are the leading ones. Each has various CGM devices which it sells or proposes to sell in the UK. In the case of Dexcom, the products in issue are the G6, G7 and Dexcom ONE (“D1”) systems. These are similar in several respects. In the case of Abbott, the products in issue are the FreeStyle Libre 2 (“FSL2”) and FreeStyle Libre 3 (“FSL3”).
The basic technology for these products is similar and none of the patents relate to the core functionality: they are largely features or options for the user interfaces. Here I introduce each of the patents in order of their priority dates, none of which are challenged. I analyse the issues on each patent in turn below. In general, I have addressed relevant authorities in the context of the patent where the principle issue arose (e.g. obviousness in relation to EP159), but I have kept the relevant principles in mind throughout.
The Abbott patents
EP (UK) 2 146 627 (“ EP627”) is entitled “Method and Apparatus for Providing Data Processing and Control in Medical Communication System”. Its priority date is 14 April 2007 (the “2007 Priority Date”).
This patent describes various aspects of a CGM but claims only a subset of the functionality disclosed. The inventive concept of the claims is said to be a method of notifying a patient of a glucose condition without thereby interrupting a routine being performed on a user interface, by outputting a first “gentle” or passive indication during the execution of the routine, to allow its continued use, but then also notifying the patient of the condition by providing a second more pronounced notification after the routine has completed.
EP627 is contended to be infringed by Dexcom's G6, G7 and D1 systems. Dexcom contends it is invalid for lack of novelty and/or inventive step, insufficiency and lack of patentable subject matter.
EP (UK) 2 476 223 (“ EP223”) is entitled “Methods and Articles of Manufacture for Hosting a Safety Critical Application on an Uncontrolled Data Processing Device” and has a priority date of 8 September 2009 (the “2009 Priority Date”). EP223 is contended to be infringed by the G6, G7 and D1 systems. Dexcom contends it is invalid for lack of novelty and/or inventive step and insufficiency. There is a conditional application to amend claim 1 (opposed only on the ground that it does not cure the alleged invalidity).
The Dexcom patents
EP (UK) 2 914 159 (“ EP159”) is contended to be infringed by Abbott's FSL2 and FSL3 systems. Abbott contends it is invalid for lack of novelty and inventive step, and insufficiency.
EP (UK) 3 782 539 (“ EP539”) is accepted to be invalid as granted. Dexcom applies to amend it: the unconditional amendment is opposed on grounds of clarity and extension of scope. If the amendment is allowed, the scope of EP539 would become materially the same as EP159 and therefore the issues, and the final result, on EP539 is accepted to be the same as for EP159.
The priority date of both EP159 and EP539 is 30 October 2012 (the “2012 Priority Date”).
The expert witnesses
At the first CMC, I was inclined to and did limit the number of expert witnesses for which the parties requested permission, but at a later hearing I was persuaded to give permission for up to three experts on each side. At trial, Abbott called a single expert – Dr Cesar Palerm, and Dexcom called two – Professor Nick Oliver and Dr Vlad Stirbu.
Dr Palerm is an engineer who has spent the bulk of his career in the field of glucose monitoring and control. From 2004–2007, he conducted research at the University of...
To continue reading
Request your trial