Patents - Abbott Diabetes Care Inc v Dexcom Inc.
Author Thirunavukkarasye-Raveendran Licence CC BY- 4.0 Deed Source Wikimedia Commons |
Patents Court (Mr Justice Mellor) Abbott Diabetes Care Inc and others v Dexcom Incorporated and others [2024] EWHC 36 (Pat)
This was the first of three trials between Abbott Diabetes Care Inc. and its subsidiaries ("Abbott") and Dexcom Incorporated and its subsidiaries ("Dexcom") over patents owned by those companies in the field of continuous glucose monitoring ("CGM"). Abbott sued Dexcom for infringing EP (UK) 2 146 627 ("EP627") entitled "Method and Apparatus for Providing Data Processing and Control in Medical Communication System" and EP (UK) 2 476 223 ("EP223") entitled "Methods and Articles of Manufacture for Hosting a Safety Critical Application on an Uncontrolled Data Processing Device". Dexcom counterclaimed for revocation of both patents on grounds of lack of novelty and inventive step and insufficiency. Dexcom sued Abbott for infringing EP (UK) 2 914 159 ("EP159") and EP (UK) 3 782 539 ("EP539") and Dexcom counterclaimed for revocation on grounds of lack of novelty and inventive step and insufficiency. Mr Justice Mellor tried these actions and counterclaims on 30 Nov, 2, 5, 6, 7, 12 and 13 Nov 2023 and handed down judgment on 15 Jan 2024 (Abbott Diabetes Care Inc and others v Dexcom Inc. and Others [2024] EWHC 36 (Pat)). By para [622] of his judgment, the learned judge found that EP627 had been anticipated but would have been infringed had the patent been valid. He also held that claim 1 of EP223 had been anticipated and would not have been infringed. As for Dexcom's patents, he held that EP529 and EP159 were anticipated and obvious but would have been infringed had they been valid.
Structure of the Judgment
Because he had 4 patents to consider this judgment contained 625 paragraphs. His lordship discussed the expert witnesses and their evidence between para [12] and para [16], common general knowledge ("CGK") between [17] and [123], EP627 between [124] and [240], EP223 between [241] and [485] and EP159 and EP539 between [486] and [620].
Abbott's Patents
EP627
This is a patent for a CGM which notifies a patient of a glucose condition while continuing to operate. The patient receives an alert referred to as "the first indication" while the device is running and then a second more noticeable "second indication" after the device has finished its task. The invention is described in more detail between para [133] and [138] of Mr Justice Mellor's judgment. Claim 1 broken down into integers is as follows. The expressions that the judge considered to be in issue are underlined:
1 | A method comprising |
1.1 | executing, on a receiver unit (104, 106), a predetermined routine associated with an operation of an analyte monitoring device (1010); |
1.2 | detecting a predefined alarm condition associated with the analyte monitoring device (1020); |
1.3 | outputting, to a user interface of the receiver unit, a first indication associated with the detected predefined alarm condition during the execution of the predetermined routine (1030); and |
1.4 | outputting, to the user interface of the receiver unit, a second indication associated with the detected predefined alarm condition (1040); wherein |
1.5 | the second indication is output after the completion of the execution of the predetermined routine; |
1.6 | the predetermined routine is executed without interruption during the outputting of the first indication; |
1.7 | the first indication includes a temporary indicator and, |
1.8 | further, the second indication includes a predetermined alarm associated with the detected predefined alarm condition; and |
1.9 | the predetermined routine includes one or more processes that interface with the user interface of the receiver unit. |
"i) The PDR is executed on the receiver unit, which has a user interface.
ii) It must be associated with an operation of an analyte monitoring device.
iii) It must include one or more processes that interface with the user interface of the receiver unit.
iv) During the execution of the PDR, a first indication is output to the user interface associated with the detected predefined alarm condition (which alarm condition is associated with the analyte monitoring device).
v) The PDR must execute without interruption during the output of the first indication.
vi) The first indication (which (as above) is associated with the detected predefined alarm condition) includes a temporary indicator.
vii) After the completion of the execution of the PDR, the second indication is output, the second indication being associated with the detected predefined alarm condition.
viii) The second indication includes a predetermined alarm associated with the detected predefined alarm condition."
5 | The method of claim 1 wherein |
5.1 | the second indication is active at the end of the predetermined routine. |
- its own user guide to its first CGM device known as "the STS Guide", and
- US patent number US7860492B2 for a Method and device for inhibiting interruption of a running application by an event ("Bunte").
His lordship described the STS Guie between para [197] and para [202]. He set out Dexcom's case between [203] and [210] and Abbott's answer between [211] and [214]. He concluded at [215] that EP267 lacked novelty over the STS Guide,
1 | A method for hosting a safety critical application on an uncontrolled data processing device, |
1.1 | the uncontrolled data processing device being configured to permit a user to make software and/or hardware changes to the uncontrolled data processing device, |
1.2 | the method comprising: |
1.2(a) | determining, with an uncontrolled data processing device, whether a safety critical application is installed properly and functions properly on the uncontrolled data processing device; |
1.2(b) | preventing, with the uncontrolled data processing device, certain features of the safety critical application from operating on the uncontrolled data processing device upon verification that the safety critical application did not install properly or does not function properly on the uncontrolled data processing device, |
1.2(c) | wherein the preventing comprises disabling safety critical features of the safety critical application from being executed on the uncontrolled data processing device and |
1.2(d) | enabling non-safety critical features of the safety critical application to be executed on the uncontrolled data processing device; and |
1.2(e) | permitting, with the uncontrolled data processing device, the safety critical application to operate free of any restrictions on the uncontrolled data processing device upon verification that the safety critical application is installed properly and functions properly on the uncontrolled data processing device, |
1.3 | wherein the safety critical application is a medically-related application and the uncontrolled data processing device is a wireless personal device comprising a display, |
1.4 | the uncontrolled data processing device being in data communication with at least one of an analyte monitoring device, a drug administration device, or a combination of both an analyte monitoring device and a drug administration device |
1.5 | wherein the uncontrolled data processing device is a mobile phone |
7 | The method of any of the preceding claims, comprising: |
7.1 | identifying, with the uncontrolled data processing device, a first current environment of the uncontrolled data processing device, the first current environment associated with a time when safety critical application is permitted to operate on the uncontrolled data processing device; |
7.2 | identifying, with the uncontrolled data processing device, a second current environment of the uncontrolled data processing device, the second current environment associated with a time after the safety critical application is permitted to operate on the uncontrolled data processing device; |
7.3 | comparing, with the uncontrolled data processing device, the second current environment with the first current environment; and |
7.4 | determining, with the uncontrolled data processing device, whether an environment change has occurred. |
Similarly, Claim 9:
9 | The method of claim 7, comprising: |
9.1 | determining, with the uncontrolled data processing device, whether the safety critical application functions properly on the uncontrolled data processing device after a determination that a change in environment occurred; |
9.2 | preventing, with the uncontrolled data processing device, certain features of the safety critical application from operating on the uncontrolled data processing device when determined that safety critical application does not function properly on the uncontrolled data processing device after the determination that the change in environment occurred; and |
9.3 | permitting, with the uncontrolled data processing device, the safety critical application to operate free of any restrictions on the uncontrolled data processing device when determined that safety critical application functions properly on the uncontrolled data processing device after the determination that the change in environment occurred. |
The first step was to construe Claim 1. The judge said at [337] that that claim was for a method of hosting a safety-critical application on an uncontrolled data processing device ("UDPD") such as a mobile phone. It was common ground that the claim contemplated both an installation check and a functional check which could take place later. If either check fails, the safety-critical features are disabled and the features that are not safety-critical are enabled. That is a process called "selective enablement". The parties could not agree on the meaning of some of the wording of the claim and their respective contentions are set out between [341] and [368]. His lordship set out his conclusions between [368] and [378].
i) Whether the installation process of the G6 met the requirements of an "installation check" of integer 1.2(a).
ii) Whether the "time check" on the G6 device met the requirements of the "functional check" of integer 1.2 (a)l and
iii) Whether those checks in combination met the requirements of "preventing" in integer 1.2 (d).
The judge construed Claims 7 and 9 between [380] and [384] and considered between [415] and [420] whether either claim had been infringed. He found that there had been no infringement.
"i) first, to ensure that an SCA (such as the operating software for a CGM reader) continues to operate correctly in an uncontrolled, dynamic environment (specifically a mobile phone in the proposed amended claim) by performing the necessary testing on the uncontrolled device itself, rather than such testing of the software and its correct functioning being carried out by the manufacturer prior to release; and
ii) second, where a check fails, a user may be allowed to continue to access non-safety critical functionality while safety critical features are disabled."
"An implantable infusion pump possesses operational functionality that is, at least in part, controlled by software operating in two processor ICs which are configured to perform some different and some duplicate functions. The pump exchanges messages with an external device via telemetry. Each processor controls a different part of the drug infusion mechanism such that both processors must agree on the appropriateness of drug delivery for infusion to occur. Delivery accumulators are incremented and decremented with delivery requests and with deliveries made. When accumulated amounts reach or exceed, quantized deliverable amounts, infusion is made to occur. The accumulators are capable of being incremented by two or more independent types of delivery requests. Operational modes of the infusion device are changed automatically in view of various system errors that are trapped, various system alarm conditions that are detected, and when excess periods of time lapse between pump and external device interactions."
"Overall, I am unable to accept that EP223 was obvious over Lebel for two principal reasons. First, because the route taken in the obviousness attack was not spelled out (either at all or clearly enough). Second, because the attack seemed to me to be essentially an argument that it was obvious (from the CGK) to replace the dedicated reader unit in Lebel with a UDPD."
The Patents
"i) The patents set out to allow users to receive alerts or alarms indicative of glycaemic condition in a "more accurate and useful way" ([0010] - under Summary).
ii) The patents describe various components of a continuous analyte monitoring system from [0023] - [0074]. This includes visual displays showing glucose information in the form of a trend graph and a single numerical value ([0058] and figure 4A). The trend graph shows upper and lower boundaries representing a target range in which the user should maintain their glucose. The visual boundaries shown may be different from the boundaries that generate an alert ([0071]).
iii) A low alert screen is displayed when the user's glucose drops below a 'pre-set limit', shown as 55mg/dL ([0059] and figure 4B. Dr Palerm pointed out this replicates the 'Low Glucose Alarm' screen in the STS-7. A 'Going Low' alert is also described to indicate to the user that their blood glucose will soon be in the low range ([0063] and figure 4D).
iv) Predictive alerts may be provided when a severe hypoglycaemic event is predicted to occur in the near future, the example given being a blood glucose value of 55mg/dL. In such a case the processor is said to be programmed with a blood glucose value below which the user is considered to be hypoglycaemic ([0064] - [0065])."
Claim 1 of EP159
1 | a | A system (100) for processing data, the system comprising: |
b | a continuous analyte sensor (8) configured to be implanted within a body; and | |
c | sensor electronics (12) configured to receive and process sensor data output by the sensor, the sensor electronics coupled to a processor module, | |
| the processor module configured to: | |
d | apply a conversion function to sensor data, the conversion function taking into account temperature correction; | |
e | evaluate sensor data (520) using a first function to determine whether a real time glucose value meets one or more first criteria, wherein the one or more first criteria comprises a first threshold that is configured to be settable; | |
f | evaluate sensor data (530) using a second function to determine whether a real time glucose value meets one or more second criteria, wherein the one or more first criteria comprises a second threshold that is a fixed value; | |
g | activate a hypoglycaemic indicator (540) if either the one or more first criteria or the one or more second criteria are met; and | |
h | provide an output (550) based on the activated hypoglycaemic indicator. |
1 | a | A system (100) for processing data, the system comprising: |
| b | a continuous analyte sensor (8) configured to be implanted within a body |
| c | sensor electronics (12) configured to receive and process sensor data output by the sensor (8); and |
| d | the sensor electronics (12) coupled to a processor module (214), the processor module (214) configured to: |
| e | evaluate sensor data to determine whether a real time glucose value meets a first threshold (TV2) that is configured to be settable; |
| f | evaluate sensor data to determine whether the real time glucose value meets a second threshold (TVp) in a predetermined time frame or time horizon; |
| g | activate a hypoglycaemic indicator if either the first threshold (TV2) or the second threshold (TVp) are met; and |
| h | provide an output based on the activated hypoglycaemic indicator, wherein the output comprises at least one of an audible, tactile or visual output, and wherein the output is differentiated and/or provides information selectively based on whether the hypoglycaemic indicator was activated based on the first threshold or whether the hypoglycaemic indicator was activated based on the second threshold; |
|
| characterised in that |
| i | the second threshold is a fixed predetermined threshold, wherein the second threshold is not settable, |
| j | wherein the processor module is configured to visually display a glucose target range with a high target boundary and a low target boundary on a user interface, and wherein the low target boundary visually displayed is different from the first threshold |
| k | and wherein the high target boundary visually displayed is different from a third threshold (TV1) associated with a hyperglycaemic indicator, such that the range between the first and third thresholds is wider than the range between the low and high target boundaries. |
Application to Amend
Abbott objected to the application on the grounds that the proposed amendment to integer 1 (f) would extend the patent's protection and lack clarity and precision. Dexcom argued that the proposal introduced a restriction whereas Abbott argued that it would be an extension. The judge agreed with Abbott at [529]. Since s.14 (5) (b) of the Patents Act 1977 requires claims to be clear and concise Abbott objected to the complexity and prolixity of the proposed amendment. The judge upheld the objection at [531]. The application to amend was refused.
Skilled Addresses
"It may be easy, given a knowledge of a later invention, to select from the general teachings of a prior art document certain conditions, and apply them to an example in that document, so as to produce an end result having all the features of the later claim. However, success in so doing does not prove that the result was inevitable. All that it demonstrates is that, given knowledge of the later invention, the earlier teaching is capable of being adapted to give the same result. Such an adaptation cannot be used to attack the novelty of a later patent."
"i) that the prior art disclosure must 'plant the flag' - i.e. there must be a clear and unambiguous disclosure of all the features of the claim.
ii) of [the judge's] own observations in Commscope Technologies LLC v Solid Technologies Inc, [2022] EWHC 769 (Pat) at [189], which [he did] not repeat here.
iii) of the dicta of Meade J. in Fisher and Paykel Healthcare Ltd v Flexicare Medical Ltd, [2020] EWHC 3282 (Pat):
'150...The fact that something unmentioned is not expressly ruled out does not mean that it is disclosed, still less to the standard required for anticipation.'
Prior Art - Novelty
Shariati
His lordship considered Shariari between [562] and [572] and concluded that Shariati anticipated both of Dexcon's patents.
"i) First, that it is trite that the mere fact that the skilled addressee could, without technical difficulty, have taken an allegedly obvious step based on the prior art cannot render an invention obvious. It is not necessary to show that the skilled addressee would actually press ahead and physically implement the invention - as this may depend on a host of non-technical considerations - but the idea needs to be one which would occur to the uninventive skilled addressee as a technical solution. This is a multifactorial and fact-sensitive question: see e.g. Actavis v ICOS at [63].
ii) Thus, while it is well-established that the existence of one obvious route does not itself diminish the obviousness of other routes, the context in which the skilled addressee is working is important - see Actavis v ICOS at [69]:
'... the existence of alternative or multiple paths of research will often be an indicator that the invention contained in the claim or claims was not obvious. If the notional skilled person is faced with only one avenue of research, a 'one way street', it is more likely that the result of his or her research is obvious than if he or she were faced with a multiplicity of different avenues. But it is necessary to bear in mind the possibility that more than one avenue of research may be obvious. In Brugger v Medic-Aid Ltd (No 2) [1996] RPC 635, 661, Laddie J stated:
'[I]f a particular route is an obvious one to take or try, it is not rendered any less obvious from a technical point of view merely because there are a number, and perhaps a large number, of other obvious routes as well.'
He concluded that Dexcom's patents were obvious over those Guides as well as over Brauker and Shariati.
Anyone wishing to discuss this article can call me on 020 7404 5252 or send me a message through my contact form.
Comments