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Home/Legal & Regulatory and Reimbursement/Medtronic Sues NuVasive, Again
Legal & Regulatory and Reimbursement

Medtronic Sues NuVasive, Again

August 30, 2012 2 min read Premium comments

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Medtronic Sues NuVasive, Again
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NuVasive, Inc. and Medtronic, Inc. are in a dispute again over some Gary Michelson-based technology.

NuVasive disclosed in an 8-K SEC filing on August 23 that Medtronic, through its subsidiary, Warsaw Orthopedic, Inc., was asserting additional patent claims against the company in ongoing patent litigation.

Specifically, the complaint filed by Medtronic in the U.S. District Court for the Northern District of Indiana alleges that various NuVasive spinal implants (including its CoRoent XL family of spinal implants) infringe U.S. Patent No. 8, 021, 430, and that NuVasive’s Osteocel Plus bone graft product infringes U.S. Patent No. 5, 676, 146 C2. These additional patents expire in the next three to four years. Osteocel Plus is the product NuVasive acquired from Osiris Therapeutics Inc.

NuVasive strongly denies infringing any valid claims of these additional patents and intends to defend the lawsuit vigorously. NuVasive is assessing all offensive and defensive measures available to it, including the assertion of counterclaims and the use of administrative reexamination procedures available through the U.S. Patent and Trademark Office.

Medtronic wants compensatory damages from profits lost to the firm and an order to halt the NuVasive’s alleged infringement. Legal issues between Medtronic and NuVasive date back to 2008 when Medtronic filed an even larger lawsuit involving nine additional instances of alleged patent infringement technology, including NuVasive’s MaXcess Retractor System and Helix ACP Cervical Plates.

Rulings on the majority of those counts are still in progress.

The first phase of the trial included three disputed claims by Medtronic and one disputed claim from NuVasive. Each claim had a favorable outcome for the company that filed. In 2011, Medtronic won all three cases entitling it to $101 million in lost profits and royalties. NuVasive was awarded $660, 000.

Phase II of the trial is set to begin January 2013.

Industry Impact

GlobalData analyst Joseph Gregory writes that the recent string of IP lawsuits has “likely sent a wave of concern and opportunity. Medtronic received a substantial sum in the first phase of the 2008 trial. At the time of the verdict, this was the fourth-largest patent infringement claim in history. Marketplace competitors, such as DePuy Spine, Zimmer and Integra, may see this result as an opportunity to take similar legislative action against other competitors to reap comparable sums. At the same time, these competitors may begin to reexamine their legal coffers to ensure ample funds are available should these types of lawsuits befall them. GlobalData estimates that the global spinal fusion market will to grow to a value of $7.8 billion by 2018.”

React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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