Medtronic faces patent review revival as Fed Cir faults PTAB

Precedential decision marks blow for medical device maker after earlier win | PTAB criticised for “fundamental legal error” and “narrow definition”.

Medtronic should face a fresh challenge over a neurostimulation device patent because the Patent Trial and Appeal Board ( PTAB) erred in its findings, according to a US Court of Appeals for the Federal Circuit panel.

In the precedential decision delivered yesterday, July 10, the judges said that the PTAB should once more review Axonics’ arguments that the patents-in-suit are invalid due to prior art.

Axonics petitioned the PTAB to examine Medtronic’s US patent numbers 8,626,314 and 8,036,756, after Medtronic sued the company for infringement.

The medical device maker’s patents describe and claim a neurostimulation lead and a method for implanting and anchoring the lead.

Axonics challenged various claims of the Medtronic patents for obviousness in inter partes reviews but the PTAB concluded that Axonics “had failed to prove that any of the challenged claims unpatentable”.

But on appeal, the Federal Circuit agreed with Axonics that the board had erred in its obviousness analysis, and ruled that because “the errors cannot be regarded as harmless, the decision must be vacated and remanded”.

The court opined that the board committed “a fundamental legal error”, and that it was incorrect in its view that “the relevant art is medical leads specifically for sacral neuromodulation”.

Such a finding was flawed because the Medtronic patents’ claims are not limited to the sacral-nerve context and the shared specification, properly read, is not so limited either, added the court.

Further, the Federal Circuit said that the Medtronic patent claims make no reference to sacral anatomy or sacral neuromodulation, meaning that “they cannot be properly construed as so limited”.

“Neither the board nor Medtronic has cited any authority for treating the relevant art as limited to a narrow subset of what the claims of a patent cover—a conclusion that would risk curtailing prior art analysis of a claim to less than its exclusive-rights-protecting scope.

“And we have repeatedly ruled that what constitutes “analogous art” for section 103 purposes is tied to ‘the claimed invention’,” said the court.

Adding that the only reasonable reading of the specification is contrary to the board’s narrow definition, the court concluded “that substantial evidence does not support the board’s limitation of ‘the relevant art’ to sacral-nerve stimulation”.

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