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Medtronic, Axonics Patent War Continues for Sacral Neuromodulation (Revised)

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Medtronic (MDT) recently announced that it has received a favorable decision with respect to a long-standing patent dispute related to sacral neuromodulation. Specifically, per Medtronic’s press release, its sacral neuromodulation device family, the InterStim systems has received positive verdict in one of the seven ongoing patent infringement cases over intellectual property against the company’s peer in the field of implantable sacral neuromodulation (SNM) devices, Axonics Modulation Technologies.

As per Medtronic, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office entirely rejected Axonics' attempt to invalidate a key Medtronic patent.

The Chronology

Last November, Medtronic had filed charges of infringement of seven patents against Axonics.

In response, in March, Axonics Modulation Technologies filed seven inter partes review (IPR) petitions contesting the validity of seven Medtronic patents. However, PTAB’s latest verdict has rejected without hearing the challenge to Medtronic's U.S. Patent No. 9,463,324 ('324 patent).

Last week, the PTAB also decided to institute full IPR proceedings related to the six additional patents that are at issue. As stated in Medtronic’s press release, “the PTAB has also decided to institute full IPR proceedings related to the six additional patents at issue. In those IPR proceedings, the PTAB will hear testimony and argument from both sides.”

An Axonics’ spokesperson however stated that in September, “PTAB found that based on the IPRs, there is a "reasonable likelihood" that the claims in 6 of the 7 Medtronic patents are invalid; they found one patent to be valid ('324).”


Medtronic's Sacral Neuromodulation at a Glance

The Medtronic InterStim system for bladder control and bowel control addresses symptoms of overactive bladder, non-obstructive urinary retention, and chronic fecal incontinence through direct modulation of the nerve activity.  The InterStim system electrically stimulates the sacral nerves to normalize neural communication between the bladder and brain, and between the bowel and brain.

InterStim therapy can improve the condition of a pelvic floor disorder and allow a patient to lead a full life.

In August, the company commenced the enrolment for a prospective, multicenter, global, post-market study of its InterStim Micro neurostimulator — Evaluation of InterStim Micro System Performance and Safety (“ELITE”) — for sacral neuromodulation (“SNM”) therapy. Notably, the neurostimulator was cleared by the FDA in the same month and subsequently launched in the United States. It had received the CE Mark in January.

Per the medical fraternity, although the SNM therapy has already been established as safe and effective, the ELITE study is expected to reinforce the same in patients implanted with the new InterStim Micro system. This is expected to encourage more patients to seek the SNM therapy.

Industry Prospects

Per a report by Reports and Data published on GlobeNewswire, the global SNM market was valued at $2189.1 million in 2018 and is projected to reach $3153.4 million by year 2026 at a CAGR of approximately 4.9%. Factors like rising elderly population, increasing incidents of neurological diseases and failure of conventional treatments are likely to drive the market.

Given the market potential, the study is expected to further establish the efficacy of the SNM therapy and boost Medtronic’s business.

Price Performance

Shares of the company have lost 5.1% in the past year compared with the industry’s 2.6% fall.

Zacks Rank & Key Picks

Currently, Medtronic carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are QIAGEN N.V. (QGEN) , Thermo Fisher Scientific Inc. (TMO) and Globus Medical, Inc. (GMED).

QIAGEN’s long-term earnings-growth rate is estimated at 22.3%. It currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Thermo Fisher’s long-term earnings-growth rate is estimated at 15.5%. It currently carries a Zacks Rank #2 (Buy).

Globus Medical’s long-term earnings growth rate is estimated at 13%. The company presently carries a Zacks Rank #2.

(We are reissuing this article to correct a mistake. The original article, issued on September 28, 2020, should no longer be relied upon.)

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