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20 February 2024NewsBig PharmaLiz Hockley

EPO revokes spinal cord therapy patent as Medtronic, Boston Scientific win appeal

Board determines that Nevro added subject matter to patent through amendment |  Medtronic and Boston Scientific have successfully overturned 2019 decision rejecting opposition.

A European Patent Office (EPO) appeal board has revoked a pain management system patent belonging to medical device company Nevro on the grounds of added subject matter, following a challenge from rivals Medtronic and Boston Scientific.

The Technical Board of Appeal’s decision, published last week (February 16), invalidates Nevro’s European patent number EP2207587, entitled “Multi-frequency Neural Treatments and Associated Systems and Methods”.

Claim 1 of the patent describes a system for treating pain using spinal cord stimulation therapy.

This technology involves a device sending electrical pulses to the spinal cord to mask pain signals from reaching the brain and provide relief.

Oppositions to the ‘587 patent, filed by Medtronic and Boston Scientific in 2015 and 2016 respectively, were rejected by the EPO in January 2019—a decision that both firms appealed.

Medtronic and Boston Scientific said the patent was invalid on the basis of, inter alia, added subject matter under Article 100 (c) EPC. In their appeals, they objected to the claim construction used by the EPO’s Opposition Division, and a “lack of willingness” to provide details of its claim construction during oral proceedings.

Nevro asked the Board of Appeal to dismiss these appeals or maintain the ‘587 patent on the basis of an auxiliary request submitted during opposition proceedings—in which claim 13 of the patent was amended.

However, the Board sided with Medtronic and Boston Scientific that amendments to the patent took it beyond the content of the application as filed, with claim 1 encompassing systems not originally disclosed.

This also applied to the auxiliary request, as the change to claim 13 did not address the objections against the main request.

Nevro withdrew its request for oral proceedings on January 23 of this year and did not contest the Board’s preliminary opinion that affirmed the added subject matter. The decision was therefore handed down via written procedure.

$85m settlement

California-based Nevro received US Food and Drug Administration (FDA) approval for its Senza spinal cord stimulation system in 2015, for patients suffering from chronic pain.

Since then, Boston Scientific and Medtronic have launched their own spinal cord stimulation devices.

In August 2022, Boston Scientific agreed to pay Nevro $85 million to settle litigation over spinal cord therapy technology.

Nevro had sued Boston in 2016, alleging that Boston’s 10kHz spinal cord stimulation system infringed its patents. In response, Boston Scientific accused Nevro of infringing four of its patents.

As part of the deal, Nevro granted Boston Scientific a worldwide licence to operate spinal cord stimulation therapy at frequencies below 1,500 Hz.

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