Federal Circuit Vacates PTAB’s Decisions in Axonics, Inc. v. Medtronic, Inc.

Written by: Rory R. Lootsma

Sacral neuromodulation stimulates nerves above the tailbone to treat fetal incontinence and related bowel and bladder control issues.  After California-based Axonics Inc. (“Axonics”) entered the sacral neuromodulation market in late 2019, MedTronic sued for patent infringement.  Axonics filed for inter partes review (IPR) of the asserted patents at the Patent Trial and Appeal Board (PTAB).  Although MedTronic initially prevailed in the IPR, Axonics has now succeeded on appeal at the Federal Circuit.

Medtronic’s two patents–U.S. Patent No. 8,626,314, titled “Implantable Medical Lead Including a Plurality of Tine Elements,” and U.S. Patent No. 8,036,756, titled “Implantable Medical Electrical Stimulation Lead Fixation Method and Apparatus”–relate to “a neurostimulation lead and a method for implanting and anchoring the lead.” Axonics, Inc., v. Medtronic, Inc. (Fed. Cir. 2023).

In its ’314 decision and ’756 decision, the PTAB had held all challenged claims of the ’314 and ’756 patents “not unpatentable” for obviousness. The PTAB analyzed whether a relevant skilled artisan would have been motivated to combine two prior art references, one of which taught a device for treating the trigeminal nerve.  The PTAB held that in this context, Axonics failed to prove sufficient motivation to combine.

The Federal Circuit has now vacated those decisions, holding that the PTAB was wrong to confine its analysis to the context in one of the two references.  The relevant context is that of the claims, which the court held were not so limited.  The Federal Circuit also held that the PTAB should not have confined relevant art to medical leads specifically for sacral-nerve stimulation, because the two patents’ claims were not limited to the sacral-nerve context.  The Federal Circuit found that the shared specification of the two patents was not limited to the sacral-nerve context.  The Federal Circuit found these errors were sufficient to vacate the PTAB’s initial decisions and has sent the cases back to the PTAB for further proceedings.