Abbott Diabetes Care Incorporated and Others v Dexcom Incorporated and Others
| Jurisdiction | England & Wales |
| Judge | Mr Justice Richards |
| Judgment Date | 18 October 2023 |
| Neutral Citation | [2023] EWHC 2591 (Ch) |
| Court | Chancery Division |
| Docket Number | Case No: HP-2021-000025 |
[2023] EWHC 2591 (Ch)
Mr Justice Richards
Case No: HP-2021-000025
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
Rolls Building
Fetter Lane
London, EC4A 1NL
Daniel Alexander KC, James Whyte, Jennifer Dixon (instructed by Taylor Wessing LLP) for the Claimants
Iain Purvis KC and David Ivison (instructed by Bird & Bird LLP) for the Defendants
Hearing dates: 6,7 July (reading days); 10–14 July; 20–21 July 2023
Approved Judgment
This judgment was handed down remotely at 10.30am on 18 October 2023 by circulation to the parties or their representatives by e-mail and by release to the National Archives.
This is the third trial in a series of UK patent infringement/validity trials concerning continuous glucose monitoring (“CGM”) systems. CGM technology enables people with diabetes to monitor the level of glucose in their blood. This is achieved by inserting beneath the skin a tiny sensor which forms part of a wearable unit which is adhered to the skin (often on the arm). The sensor measures the concentration of glucose in surrounding tissue and transmits information to a receiver (often a smartphone) so that the user can see at a glance whether their blood glucose is within a normal range.
The Claimants (“Abbott” unless it is necessary to refer to a particular Claimant individually) own European Patent (UK) No. 2 549 918 (the “Patent”). The Patent has a priority date of 24 March 2010 (the “Priority Date”) and relates to designs for an “inserter”: a device which positions CGM components into or onto the user, including by inserting the sensor beneath the skin. Abbott asserts that the Patent is infringed by a “G7 Applicator” sold by the Defendants (“Dexcom”) and sues Dexcom for infringement. Dexcom counterclaims for declarations that the Patent is invalid. Abbott has, in turn, proposed various Conditional Amendments (“CA1”, “CA2” etc) to the Patent to take effect if any of the claims in the Patent are held to be invalid.
THE ISSUES
I need to determine the following issues:
i) the construction of various claims within the Patent;
ii) whether the G7 Applicator infringes Claim 1 or Claim 7 of the Patent as properly construed, it being common ground that the Conditional Amendments raise no different issues relevant to infringement from those of the unamended claims;
iii) whether the Patent's claims should be declared invalid because of the presence of “added matter”;
iv) a squeeze argument as to whether the Patent is anticipated by, or obvious over, three aspects of the prior art namely:
a) US/2009/0124979 A1 (“Raymond”)
b) US/2005/0101912 A1 (“Faust”)
c) US/2010/00049129 A1 (“Yokoi”)
v) a squeeze argument as to whether the Patent is insufficient in the “ Biogen sense” namely that it teaches a reader to perform the claimed invention to some extent, but not to the full extent of the claims.
THE WITNESSES
I had no witness evidence of fact. Both sides rely only on expert evidence. Abbott relies on expert evidence of Mr Douglas Jennings, a design engineer, and Dr Michael Schoemaker, a chemist and biochemist by training who has experience working on the development of CGM systems. Dexcom relies on expert evidence of Mr Andrew Varde, an engineer who has worked on the development of medical devices, and of Professor Pantelis Georgiou, who is Professor of Biomedical Electronics at Imperial College, London. Mr Jennings, Mr Varde and Dr Schoemaker were cross-examined, but Professor Georgiou was not.
I do not need to provide a detailed review of each expert's evidence since neither side suggested that any expert lacked expertise or was failing to comply with duties imposed by CPR 35. I regarded all of the experts' reports as fair. Both sides had taken care to ensure that their experts' evidence was untainted by hindsight by asking them first about common general knowledge (“CGK”), then showing them the prior art and only then showing them the patent in suit. I can, therefore, deal relatively briefly with some specific criticisms that were made of aspects of the experts' evidence.
Mr Varde
Abbott does not challenge Mr Varde's expertise in matters of mechanical engineering. However, it does suggest that, since he is not an expert in CGM systems specifically or in CGM device design, he is not able to assist on the question of the general knowledge of a skilled team in the field of CGM specifically as at the Priority Date. I do not accept that criticism. Mr Varde has worked on the design of needle-deploying medical devices for approximately half of his career. While doing so, he has obtained an understanding of spring-driven mechanisms, triggers, needles and user “cues” to promote the correct use of such devices. Mr Jennings had no greater experience of CGM systems specifically than did Mr Varde. Dr Schoemaker is a CGM specialist, but his specialism is on the chemistry of the sensors that such devices employ.
I do not, therefore, accept Abbott's implicit point that somehow its team of experts was better able to approximate the “skilled team” than was Dexcom's team. As Jacob LJ explained in Technip France SA's Patent [2004] RPC 46, the primary function of expert witnesses in patent trials is to educate the Court in the technology. Their secondary function is, by providing opinions on evaluative factual questions such as “obviousness”, to assist the Court in reaching its own conclusion on those questions with the reasons for those opinions, rather than the opinions themselves being of most assistance. I have concluded that all the experts put forward have been able to provide valuable assistance and I would not categorise the assistance provided by one expert team as being any less than that provided by the other.
Abbott suggested that there were instances in which Mr Varde's opinions were unduly affected by hindsight. I have, of course, sought to avoid deploying hindsight in my own conclusions on the question of “obviousness”. However, I do not consider that Mr Varde's opinions, or those of other experts, have been so tainted by hindsight as to prevent them being of use in my own evaluation. A specific criticism of the way in which Mr Varde dealt with (non-existent) data on complaints concerning CGM inserters is dealt with in paragraph 49 below.
Mr Jennings
Dexcom placed some emphasis on corrections that Mr Jennings made to one of his expert reports after the parties had exchanged skeleton arguments. I understand why Dexcom did so and I deal with the point in paragraph 89 below. I find nothing improper in the amendments that Mr Jennings made but have concluded that the opinion he expressed in his unamended report is of greater weight.
Dr Schoemaker
Dexcom suggests that much of the evidence of Dr Schoemaker, who has no background in mechanical engineering, was simply irrelevant. I do not agree. While I have rejected any suggestion that his specific background in CGM devices gives his opinion evidence any greater weight, not least given that he is a chemist rather than a mechanical engineer, I have benefited from his evidence on CGM products specifically.
THE SKILLED TEAM AS AT THE PRIORITY DATE
The characteristics of a notional team “skilled in the art” are of direct relevance to a number of the issues that arise for determination. As Jacob LJ put it in Technip France SA's Patent [2004] EWCA Civ 381:
The ‘man skilled in the art’ is invoked at many critical points of patent law. The claims of a patent must be understood as if read by that notional man—in the hackneyed but convenient phrase the ‘court must don the mantle of the skilled man.’ Likewise many questions of validity (obviousness, and sufficiency for instance) depend upon trying to view matters as he would see them. He indeed has statutory recognition—Arts 56, 83 and 100 of the EPC expressly refer to ‘the person skilled in the art’.
The parties prepared an agreed statement of the common general knowledge (the “Joint CGK Statement”). From that statement, together with the fact that Dexcom expressed no significant disagreement with the articulation of the characteristics of the skilled team that Abbott set out in closing, I have concluded that the following matters were common ground. I have also borne in mind the more lengthy description of the skilled team set out in the Joint CGK Statement:
i) The Patent (both as granted and as proposed to be amended by the Conditional Amendments) is addressed primarily to persons having expertise in the fields of mechanical engineering and having some expertise as a product designer.
ii) That mechanical engineer would be working within a larger team in the field of medical device design and development. That larger team (the “Skilled Team”) would have expertise across various disciplines such as manufacturing and production engineers, biologists and chemists, clinicians and medics, regulatory and quality departments and electronics and software engineers.
iii) As regards the claims of the Patents that are relevant to the present proceedings (including those claims as proposed to be amended by the Conditional Amendments) the Skilled Team would be involved in the design and development of an inserter for a medical device. As regards Claim 7 of the Patent, the Skilled Team would be looking at the design and development of an inserter for an analyte sensor specifically. Although the claims of the Patent (including as amended by the Conditional Amendments) are not limited to inserters for CGM systems specifically, the intended addressees of the Patent would be involved in the design and development of an inserter specifically for a CGM system.
iv) The Skilled Team would be led by a project leader with...
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