Roche Diabetes Care Wins UK Medtech Patent Litigation Against Insulet | Allen & Overy LLP

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 Omnipod. It also owns EP (UK) 1,335,764 (the patent), which expires August 30, 2021. In mid-2018, Roche Diabetes Care Limited (Roche) launched its own insulin pump known as Accu – Chek Solo (the Solo device).

Insulet claimed that Roche infringed the patent directly, indirectly and by equivalency. Roche denied the infringement and requested revocation of the patent, claiming that the alleged invention was not new, would have been obvious and added significance.

Although the proceedings took place under the Shorter Trials Scheme and the trial lasted only three court days, the judgment nonetheless contains 593 paragraphs covering a large amount of documents. Four of the most notable points are discussed below.

1. Do regulatory concerns count as “technical” or “business” constraints in the QP’s mindset?

A key initial consideration was how state of mind might affect Common General Knowledge (CGK) attributable to a person skilled in the art. Building on the support of Aldous LJ in Dyson vs. Hoover devices [2001] EWCA Civ 1440, Ms. Treacy considered that “the mindset of the qualified person or team is part of the CGK that would guide the team’s approach to a given problem and affect the actions that are obvious to them. to take “.

In general, the mindset of those skilled in the art has been considered to be limited to technical matters. In the context of designing a medical device such as an insulin pump, the operation and safety of the device is paramount, which means that the focus would be on making incremental changes and improvements. . In this case, however, Ms. Treacy had to consider the impact (if any) of regulatory procedures and processes on the mindset of the QP or team as they reflect issues. commercial safety rather than technical or other technical constraints on the design. .

It used to be a gray area. Here, it was judged that the fact that certain regulatory considerations were partly driven by commercial matters did not mean that they would not influence the approach of the skilled person or the team. In other words, a factor such as the ease of obtaining regulatory approval for a new product versus building an existing product may play a role in the court’s assessment of whether an invention is obvious or not. In this case, this led the judge to consider that the regulatory constraints were part of an underlying matrix of considerations which led to a conservative approach to the design and also that the existing technologies and products would constitute a good basis for a future action.

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

2. Direct counterfeiting, counterfeiting by equivalence and indirect counterfeiting

For this assessment, Ms. Treacy considered claims 1, 2, 3, 43 and 45 (as renumbered) of the patent (and broken down by whole number if necessary – for example, whole numbers 1A-1I). This followed a careful examination of the construction of the contested integers following an examination of the relevant legal principles. Ms. Treacy distilled her approach to interpretation as having the following in mind:

  • the purpose of the patentee as disclosed by the claims;
  • interpreted using description and drawings;
  • without excessive literalism;
  • but also by recalling that the language used in the claims ultimately delimits the territory claimed by the patentee; and that
  • the patent is addressed to a person skilled in the art concerned.

(a) Direct offense

This was assessed as a matter of normal interpretation of the claims. With regard to claim 1, Roche had accepted that the integers 1A to 1E were present in the Solo Device. Ms Treacy went on to say that while the integers 1H and 1I were present in the solo device, the integer 1F was not.

A notable point was raised regarding Integer 1G, which stated that “…the enclosure is free of user input components to provide flow instructions to the local processor”. The Solo device has been agreed by the parties to be free of user input components, with the exception of the “quick bolus” buttons. These buttons are enabled by default – however, users can disable them. Insulet argued that (i) disabling the buttons would place the solo device within the scope of the entire device, and (ii) significant categories of solo device users would likely disable the buttons. Ms Treacy felt that was not the case. Just as just turning off an item doesn’t mean it would stop harming, an item that didn’t harm when it was on wouldn’t suddenly turn off when it was off. Indeed, turning off an element does not change its function – it is not a modification or adaptation of the device. Therefore, the Solo Device also fell apart from Integer 1G.

Overall, claims 1, 2, 43 and 45 were not directly violated by the Solo Device. Claim 3 has not been considered in the context of direct infringement.

(b) Equivalence offense

The integer 1G (see above) was again considered in the context of counterfeiting by equivalence, with Insulet saying that the presence of the ‘quick bolus’ buttons was irrelevant, meaning the device fell within the scope of application of claim under doctrine.

Particular attention was paid to the first Actavis vs. Eli Lilly [2017] UKSC 48 question: “is substantially the same result obtained substantially in the same way as the invention, that is to say 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 considered that, at the light of Icescape vs. 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 anticipated that the invention would be inexpensive enough to be disposable by having the more expensive electronics in the remote control device. This contrasts with the Solo Device, which had its electromechanical components on its case, suggesting an increase in the cost and complexity of the device. This meant that it wouldn’t be disposable in much the same way. Therefore, Ms. Treacy felt that because the Solo Device did not achieve substantially the same result as contemplated by the patent in the same way, the answer to Actavis’ first question was “no”.

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

(c) Indirect offense

The judge also concluded that Roche’s supply of components that could be used to assemble a device would not indirectly violate a claim for a kit because the device that could be assembled would not have satisfied the integers 1F and 1G.

In view of the above, Ms. Treacy considered that the Solo Device did not infringe the patent.

3. Disclosure in the Specification Regarding the Scope of Protection in the Claims

The description of a prior art PCT application, PhiScience, has been argued as disclosing two alternative embodiments, one of which (a “tubeless pump”) would anticipate certain claimed features of the patent. Insulet objected to this, in particular on the grounds that (i) none of PhiScience’s claims protected such an embodiment, and (ii) the patent application was abandoned before grant and was never marketed, of so it cannot be true that a tubeless pump was taught when Insulet argued that tubeless patch pumps were a whole new generation of devices.

The judge disagreed with this objection. To restrict the disclosure in the specification by reference to the claims (or lack thereof) would be a mistake, as the claims and the specification serve different functions. In reference to Laddie J in Merck & Co vs. Generics (UK) [2003] EWHC 2842 (Tap), the specification communicates to the public what the invention is and the claims are the monopoly that the patentee has chosen to claim. The extent of the monopoly is a choice made on the basis of the patent owner’s risk assessment. Further, the judge added that it would be wrong to take into account a perceived commercial flaw or the conduct of an inventor when interpreting the specification.
Therefore, the judge ruled that PhiScience had disclosed the disputed incarnation.

4. The shorter test program

These procedures were carried out under the Shorter Trials Scheme (CPR PD57AB). It is a system that aims to achieve shorter and earlier litigation trials at a reasonable and proportionate cost. In accordance with this stated objective, the procedure was closed in one year: the complaint form was issued on July 31, 2020, the trial took place from May 11 to 13, 2021 and the judgment was rendered on July 9, 2021.

However, the complexity and number of disputes involved seemed to push the system to its limits. The judge said that although the trial proceeded on schedule, “it was necessary for everyone involved to maintain a high degree of discipline to achieve this result”, and that there was “a period of time. after the trial longer than what could have been the case if there was more time available during the hearing ”. The judge also noted that the limited time available for cross-examination due to the tight trial schedule meant that “heavy burdens” were placed on both lawyers and witnesses.

In particular, given the importance of oral expert testimony in English patent proceedings, the pros and cons of STS should be carefully considered before enrolling.

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