Roche Diabetes Care Succeeds in UK Medtech Patent Dispute Against Insulet

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In the latest UK medical technology (Medtech) patent decision Insulet v Roche Diabetes Care [2021] EWHC 1933 (Pat), Ms Pat Treacy (sitting as a judge of the High Court) held that (i) Roche Diabetes Care’s Accu-Chek Solo insulin pump did not infringe Insulet’s patent (either directly, indirectly, or by way of equivalence), and (ii) the patent was invalid.

Factual Background

Insulet Corporation (Insulet) is a medical device company that produces a remote-controlled patch insulin pump for the treatment of diabetes, known as the Omnipod. It is also the proprietor of EP (UK) 1 335 764 (the Patent), which is due to expire on 30 August 2021. In mid-2018, Roche Diabetes Care Limited (Roche) launched its own insulin pump known as the Accu-Chek Solo (the Solo Device).

Insulet claimed that Roche infringed the Patent directly, indirectly, and by way of equivalence. Roche denied infringement and counterclaimed for revocation of the Patent, asserting that the alleged invention was not novel, would have been obvious and that it added matter.

Although the proceedings were under the Shorter Trials Scheme and the trial only consisted of three hearing days, the judgment nonetheless runs to 593 paragraphs covering a great deal of material. Four of the most notable points are considered below.

1. Do Regulatory Concerns Count as “Technical” or “Commercial” Constraints within the Skilled Person’s Mindset?

A key initial consideration was how mindset could affect the Common General Knowledge (CGK) attributable to a skilled person. Drawing support from Aldous LJ in Dyson Appliances v Hoover [2001] EWCA Civ 1440, Ms Treacy held that “the mindset of the skilled person or team forms part of the CGK which would guide the team’s approach to any given problem and affect the steps it would be obvious for them to take”.

Generally, the skilled person’s mindset has been thought to be limited to technical matters. In the context of designing a medical device such as an insulin pump, the device’s operation and safety are paramount, meaning that there would be a general focus on making incremental changes and improvements. In this case, however, Ms Treacy had to consider the impact (if any) of the regulatory procedures and processes on the mindset of the skilled person or team to the extent that they reflect commercial rather than technical safety issues or other technical constraints on design.

This has previously been a grey area. Here, it was held that the fact that some regulatory considerations were in part motivated by commercial issues did not mean that they would not influence the approach of the skilled person or team. To put it another way, a factor such as the ease of obtaining regulatory approval for a new product versus building off of an existing product may play a part in the Court’s evaluation of whether an invention is obvious or not. In this case, this led the Judge to consider that regulatory constraints formed part of an underlying matrix of considerations that drove a conservative approach to design and also that existing technologies and products would be a good basis for future action.

This approach somewhat contrasts with the decision of the Court of Appeal in Reckitt & Colman Products v Richardson-Vicks [1997] EWCA Civ 1500. There the Court rejected the more extreme argument that a skilled team would have included a regulatory expert and that regulatory expert would have viewed it as impossible or so difficult to obtain regulatory approval for the claimed combination drug such that the team would not have tried to do so. However, it is consistent with the approach adopted in Teva v Leo [2014] EWHC 3096 where Birss J (as he then was) considered that regulatory uncertainties were a relevant commercial consideration capable, in principle, of playing a role in the skilled person’s thinking.

2. Direct Infringement, Infringement by Equivalence, and Indirect Infringement

For this evaluation, Ms Treacy considered Claims 1, 2, 3, 43 and 45 (as renumbered) of the Patent (and broken down by integer as necessary – for example, Integers 1A-1I). This followed an extensive consideration of the construction of the integers that were in dispute following a review of the relevant legal principles. Ms Treacy distilled her approach to interpretation as having the following in mind:

  • the patentee’s purpose as disclosed by the claims;
  • interpreted with the assistance of the description and drawings;
  • without undue literalism;
  • but also remembering that the language used in the claims ultimately delineates the territory claimed by the patentee; and that
  • the patent is addressed to a person skilled in the relevant art.

(a) Direct infringement

This was assessed as a matter of normal interpretation of the claims. In respect of Claim 1, Roche had accepted that Integers 1A to 1E were present in the Solo Device. Ms Treacy went on to hold that while Integers 1H and 1I were present in the Solo Device, Integer 1F was not.

One notable point arose concerning Integer 1G, which provided that “…the housing is free of user input components for providing flow instructions to the local processor”. The Solo Device was agreed by the parties to be free from user input components, save for the “quick bolus” buttons. These buttons are enabled by default – however, users can disable them. Insulet contended that (i) disabling the buttons would bring the Solo Device within the scope of the Integer, and (ii) significant classes of Solo Device users would likely disable the buttons. Ms Treacy held that this is not the case. Similar to how merely turning an element off does not mean that it would cease to infringe, an element that would not infringe when switched on would not suddenly become infringing when switched off. This is because turning off an element does not change its function – it is not a modification or adaption of the device. Therefore, the Solo Device also fell outside of Integer 1G.

In all, Claims 1, 2, 43 and 45 were not directly infringed by the Solo Device. Claim 3 was not considered in the context of direct infringement.

(b) Infringement by Equivalence

Integer 1G (see above) was again considered in the context of infringement by equivalence, with Insulet asserting that the presence of the “quick bolus” buttons was immaterial, meaning that the device was within the scope of the Claim under the doctrine.

Significant consideration was given to the first Actavis v Eli Lilly [2017] UKSC 48 question: “is substantially the same result achieved in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?” The key to this question was whether it was sufficient simply to consider the overall result to be achieved by the invention, or whether the means used to achieve the result were also part of the inventive concept. Ms Treacy held that, in light of Icescape v Ice-World International [2018] EWCA Civ 2219, the result and the means used to achieve the invention were all part of the inventive concept in this context.

The Patent envisaged that the invention would be low enough in cost to be disposable by having the more expensive electronics in the remote control device. This is in contrast to the Solo Device, which had its electromechanical components on its housing, suggesting an increase in the cost and complexity of the device. This meant that it would not be disposable in substantially the same way. Therefore, Ms Treacy held that because the Solo Device does not achieve substantially the same result as envisaged by the Patent in substantially the same way, the answer to the first Actavis question was “no”.

As a result, the Solo Device did not infringe Integer 1G by equivalence.

(c) Indirect Infringement

The Judge also held that Roche’s supply of components that could be used to assemble a device would not indirectly infringe a claim to a kit because the device that could be assembled would not have satisfied Integers 1F and 1G.

Taking the above into account, Ms Treacy held that the Solo Device did not infringe the Patent.

3. Disclosure in the Patent Specification Versus the Scope of Protection in the Claims

The specification of a prior art PCT application, PhiScience, was argued to disclose two alternative embodiments, one of which (a “tubeless pump”) would anticipate certain claimed features of the Patent. Insulet objected to this including on the basis that (i) none of the claims of PhiScience protected such an embodiment, and (ii) the patent application was abandoned before the grant and never commercialised, such that it cannot be the case that a tubeless pump was being taught as Insulet argued tubeless patch pumps constituted a whole new generation of devices.

The Judge disagreed with this objection. Narrowing the disclosure in the specification by reference to the claims (or lack thereof) would be wrong, as the claims and the specification perform different functions. With reference to Laddie J in Merck & Co v Generics (UK) [2003] EWHC 2842 (Pat), the specification conveys to the public what the invention is, and the claims are the monopoly that the patentee has chosen to claim. The breadth of the monopoly is a choice made based on the patentee’s risk assessment. In addition, the Judge added that it would be wrong to take into account a perceived commercial failing or conduct of an inventor when interpreting the specification.
Therefore, the Judge held that PhiScience disclosed the disputed embodiment.

4. The Shorter Trial Scheme

These proceedings were conducted under the Shorter Trials Scheme (PD57AB of the CPR). This is a scheme that aims to achieve shorter and earlier trials for litigation, at a reasonable and proportionate cost. In line with that stated objective, proceedings were concluded within a year: the Claim Form was issued on 31 July 2020, the trial took place 11-13 May 2021, and judgment was handed down 9 July 2021.

However, the complexity and number of disputes at issue did appear to push the scheme to the limit. The Judge stated that while the trial fit within the time allocated, “it was necessary for all involved to maintain a high degree of discipline to achieve that result”, and that there was “a longer post trial period than might have been the case had there been more time available during the hearing”. The Judge also noted that the short time available for cross-examination due to the tight trial timetable meant that “significant burdens” were placed on both counsel and the witnesses.

Particularly given the importance of oral expert witness evidence in English patent proceedings, careful consideration should be given to the advantages and disadvantages of the STS before opting into it.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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