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13 July 2021MedtechAlex Baldwin

English court says Roche did not infringe insulin pump patents

The  English High Court has cleared  Roche of patent infringement claims over its line of insulin pumps but shot down the pharma giant’s attempt to invalidate the plaintiff’s patent.

The action was brought by medical device company  Insulet, which claimed that Roche had infringed its European patent (UK1,335,764), covering a “device and system for patient infusion”.

To prove the validity of the patent and Roche’s infringement, Insulet relied on five claims of its patent—claims 2 and 3 and amended claims 1, 42 and 44.

Roche’s ‘Solo’ pumps, launched in 2018, allegedly infringed Insulet’s patent both directly and indirectly, but Roche argued that the patent was invalid over two prior art documents referred to as ‘PhiScience’ and ‘MiniMed’.

Deputy Judge Treacy ruled that claim 1 of the 764 patent was not infringed by the Solo device due to the absence of “two important aspects of the claim” in Roche’s device, which relate to water-resistant housing.

Treacy also found no infringement on claim two or three, noting again that the absence of two integers from the Solo device narrowly precluded it from infringement. For the amended claims, both claims 43 and 45 were also found to not be infringed by Solo.

A question of validity

With Treacy convinced that Solo did not infringe, the question turned to the validity of the ‘764 patent.

Roche’s accusation of invalidity rested on the prior art. The first of which, PhiScience, is a German patent application first filed in May 2000, a few months prior to Insulet’s.

Given the length of the analysis, the claims were broken into eight integers which were compared to the prior art.

PhiScience’s application describes a “Portable device and method for the mobile supply of medicaments with wireless transmission of data for control or programming purposes”.

In summary, Treacy concluded that solutions four of the eight integers discussed were obvious over PhiScience, but given the importance of integer 1B and 1H (which describe the exit port assembly of the pump) to the inventive concept of claim 1 of the ‘764 patent, the patent was found to not have been predicted by PhiScience.

The second prior art, MiniMed, was an international patent application published in March 2000, titled: “External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities”.

Similarly to PhiScience, Treacy found that the ‘764 patent was obvious over four of the integers, but given the importance of 1B and 1H, ruled that the patent was not obvious over MiniMed.

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