Spinal Kinetics v. Synthes Lawsuit, Dec 13, 2011

[Slackwater]

Spinal Kinetics (M6-L and M6-C) countersued Synthes (ProDisc-L, Prodisc-). Synthes originally sued Spinal Kinetics and others producing Artifical Disc Replacements. Spinal Kinetics got the judicial decision at the U.S. District Court.

There may be other patents involved. There are some documents at at United States District Court, Northern District of California (San Jose / Oakland). I see some docs earlier than 12/13/11, but not the final one.

Synthes / ProDisc, is part of a Johnson and Johnson merger earlier in 2011.

Press Release: LINK.PDF
EuroInvestor: Link.HTM

Spinal Kinetics Wins in Synthes Patent Suit
Synthes patent 7,429,270 is found invalid

DECEMBER 13, 2011, SUNNYVALE, CA. - Spinal Kinetics, the designer and manufacturer of the innovative M6® Artificial Disc, today announced that a jury in the United States District Court, Northern District of California, has found that the M6 does not infringe on Synthes’ U.S. Patent No. 7,429,270. The jury found the Synthes ‘270 patent invalid.

The M6-C cervical and M6-L lumbar artificial discs help patients suffering from degenerative disc disease of the spine; a common cause of chronic and severe back and neck pain. The M6 technology provides an alternative to spinal fusion and is designed to preserve motion and reduce the chances of subsequent degeneration of adjacent discs. Introduced internationally in 2006, M6 has quickly become a market leader in Europe and is available in over 17 countries worldwide. With over 13,500 implants to date, the M6 continues to generate enthusiasm among both patients and surgeons searching for a more physiologic disc replacement technology.

“We are very pleased with the jury’s verdict in this case,” said Tom Afzal, Spinal Kinetics’ President and CEO. “The interest in the M6 disc is accelerating around the world, and the positive verdict allows us to focus our resources and efforts on making the M6 available to more patients in more countries, including future clinical trials in the U.S.”

The M6 is the only artificial disc that replicates the anatomic structure and biomechanics of a natural disc by incorporating both an artificial nucleus and annulus. In the U.S., Spinal Kinetics has successfully completed an FDA IDE Pilot Study of the M6-C in patients with both single and two level disease, and has received approval from the FDA to initiate an IDE Pivotal Study.

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Patent 7,429,270
Abstract

Disclosed is an intervertebral implant (1) comprising a central axis (2), a bottom cover plate (3) and a top cover plate (4), which are respectively provided with an exterior surface (7; 8) that extends transversal to the central axis (2), and a central part (10). Said central part (10) is located between the cover plates (3; 4) and is provided with a sleeve (12) encompassing a fiber system (5) that is connected to the cover plates (3; 4) and is embedded in an enveloping body (25) made of a homogeneous material. In analogy with the anatomic structure of the natural disk, the inventive intervertebral implant (1) can transfer occurring compressive forces onto the cover plates (3, 4) thereof as tensile forces that are applied to the individual fibers of the fiber system (5) thereof.

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slackwater_sf

[Slackwater]

Originally Posted by Slackwater

Press Release: LINK.PDF


Spinal Kinetics Wins in Synthes Patent Suit
Synthes patent 7,429,270 is found invalid

DECEMBER 13, 2011, SUNNYVALE, CA. -

The law firm representing Spinal Kinetics also issued a press release. The words are similar and slightly different. The wording implies to my untrained eye that the invalid Synthes patent was important:

Dickstein/Shapiro LLC Press Release (LINK):

“This decision is a hard-fought win for Spinal Kinetics” said Tom Afzal, CEO of Spinal Kinetics. “We are pleased that the jury found the Synthes patent invalid and not infringed—allowing for Spinal Kinetics to continue to develop innovative and practical motion preservation systems to treat degenerative diseases in the spine. Spinal Kinetics greatly appreciates the excellent work done by the Dickstein Shapiro trial team.”

[JKDE302]

What does this mean for the immediate future?

[laid up doc]

jkde -

very little. until there are trials enrolling, nothing will happen. trials last years and it's probably 10 yrs til the M6 would be on the market in a best-case scenario.

the FDA can bite my ***. so can Aetna, and the dr who misdiagnosed me for so long. but... the M6-L wasn't around then, so maybe it was all for the best

[Slackwater]

Originally Posted by JKDE302

What does this mean for the immediate future?

Originally Posted by laid up doc

jkde -

very little. until there are trials enrolling, nothing will happen. trials last years and it's probably 10 yrs til the M6 would be on the market in a best-case scenario.

The question might be realistically answered by the FDA CDRH.Ortho Section and Spinal Kinetics. The M6-C appears to be further in the queue with FDA Clinical Trials than the M6-L.

12/13/11: Tom Afzal, Spinal Kinetics, President and CEO, Spinal Kinetics (ref 1)

“the positive verdict allows us to focus our resources and efforts on making the M6 available to more patients in more countries, including future clinical trials in the U.S.”

www.clinicaltrials.gov does not list Spinal Kinetics at this time. It may be due to the clinical trial deferral / suspension pending the outcome of the earlier litigation by Synthes preventing the M6-C from going forward. It appears the first M6-C was used in the U.S. approximately 1Q-2008 (ref 2).

Spinal Kinetics has successfully completed an FDA IDE Pilot Study of the M6-C (cervical) in patients with both single and two level disease in the USA, and it has received approval from the FDA to initiate an IDE Pivotal Study (ref 3). I found no data on the M6-L (lumbar). May I suggest that the M6-C FDA Clinical Trial / IDE Pivotal Study might resume, pending the company's financial situation and investor confidence.

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slackwater_sf